24 results on '"Javier Ruiz Guiñazú"'
Search Results
2. Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: A double-blind randomized controlled trial.
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Miguel W Tregnaghi, Xavier Sáez-Llorens, Pio López, Hector Abate, Enrique Smith, Adriana Pósleman, Arlene Calvo, Digna Wong, Carlos Cortes-Barbosa, Ana Ceballos, Marcelo Tregnaghi, Alexandra Sierra, Mirna Rodriguez, Marisol Troitiño, Carlos Carabajal, Andrea Falaschi, Ana Leandro, Maria Mercedes Castrejón, Alejandro Lepetic, Patricia Lommel, William P Hausdorff, Dorota Borys, Javier Ruiz Guiñazú, Eduardo Ortega-Barría, Juan P Yarzábal, Lode Schuerman, and COMPAS Group
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Medicine - Abstract
The relationship between pneumococcal conjugate vaccine-induced antibody responses and protection against community-acquired pneumonia (CAP) and acute otitis media (AOM) is unclear. This study assessed the impact of the ten-valent pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) on these end points. The primary objective was to demonstrate vaccine efficacy (VE) in a per-protocol analysis against likely bacterial CAP (B-CAP: radiologically confirmed CAP with alveolar consolidation/pleural effusion on chest X-ray, or non-alveolar infiltrates and C-reactive protein ≥ 40 µg/ml); other protocol-specified outcomes were also assessed.This phase III double-blind randomized controlled study was conducted between 28 June 2007 and 28 July 2011 in Argentine, Panamanian, and Colombian populations with good access to health care. Approximately 24,000 infants received PHiD-CV or hepatitis control vaccine (hepatitis B for primary vaccination, hepatitis A at booster) at 2, 4, 6, and 15-18 mo of age. Interim analysis of the primary end point was planned when 535 first B-CAP episodes, occurring ≥2 wk after dose 3, were identified in the per-protocol cohort. After a mean follow-up of 23 mo (PHiD-CV, n = 10,295; control, n = 10,201), per-protocol VE was 22.0% (95% CI: 7.7, 34.2; one-sided p = 0.002) against B-CAP (conclusive for primary objective) and 25.7% (95% CI: 8.4%, 39.6%) against World Health Organization-defined consolidated CAP. Intent-to-treat VE was 18.2% (95% CI: 5.5%, 29.1%) against B-CAP and 23.4% (95% CI: 8.8%, 35.7%) against consolidated CAP. End-of-study per-protocol analyses were performed after a mean follow-up of 28-30 mo for CAP and invasive pneumococcal disease (IPD) (PHiD-CV, n = 10,211; control, n = 10,140) and AOM (n = 3,010 and 2,979, respectively). Per-protocol VE was 16.1% (95% CI: -1.1%, 30.4%; one-sided p = 0.032) against clinically confirmed AOM, 67.1% (95% CI: 17.0%, 86.9%) against vaccine serotype clinically confirmed AOM, 100% (95% CI: 74.3%, 100%) against vaccine serotype IPD, and 65.0% (95% CI: 11.1%, 86.2%) against any IPD. Results were consistent between intent-to-treat and per-protocol analyses. Serious adverse events were reported for 21.5% (95% CI: 20.7%, 22.2%) and 22.6% (95% CI: 21.9%, 23.4%) of PHiD-CV and control recipients, respectively. There were 19 deaths (n = 11,798; 0.16%) in the PHiD-CV group and 26 deaths (n = 11,799; 0.22%) in the control group. A significant study limitation was the lower than expected number of captured AOM cases.Efficacy was demonstrated against a broad range of pneumococcal diseases commonly encountered in young children in clinical practice.www.ClinicalTrials.gov NCT00466947.
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- 2014
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3. Safety and Humoral Immunogenicity of Different Dose Levels of Ad26.COV2.S as a 2-Dose Regimen in COVID-19 Vaccine-Naïve Healthy Adults: A Phase 3 Randomized Clinical Trial
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Veronica V. Rezelj, Fred Paddenburg, Marie Enajite Diegbe, Julius Nangosyah, Emil C. Reisinger, Weihong Hu, Carla Truyers, Gert Scheper, Mathieu Le Gars, Jenny Hendriks, Frank Struyf, Macaya Douoguih, Hanneke Schuitemaker, and Javier Ruiz-Guiñazú
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Ad26.COV2.S ,vaccine ,COVID-19 ,adult ,immunogenicity ,spike-binding antibodies ,Medicine - Abstract
Background: This study aimed to support the end-of-shelf life specification (2.5 × 1010 virus particles [vp]) for the standard Ad26.COV2.S dose (5 × 1010 vp). Methods: This randomized, double-blind Phase 3 study evaluated immunogenicity, reactogenicity, and safety of several Ad26.COV2.S dose levels (range 1.25 to 9 × 1010 vp) in 1593 adults between June 2021 and July 2023. Results: Spike-binding antibody responses 28 days post-dose 1 were non-inferior for the 9 × 1010 vp, but not the 2.5 × 1010 vp group when compared with the standard dose. Non-inferiority was demonstrated in terms of spike-binding antibody responses 14 days post-dose 2 for each dose level, including the lowest dose level of 1.25 × 1010 vp, compared to 28 days after one dose and 14 days after two doses of the standard dose. Spike-binding antibody levels correlated well with virus neutralizing titers. There was no impact of pre-existing Ad26.COV2.S neutralizing titers on immunogenicity at any dose level. All dose levels were well tolerated. Conclusions: This study highlights the challenges associated with conducting clinical studies in a rapidly evolving environment and underscores the importance of platform data that can guide initial vaccine specifications such as shelf life during accelerated vaccine development. The present study supports the end-of-shelf life specifications for the approved Ad26.COV2.S dose, and could provide useful information in future vaccine developments using adenovirus vector vaccines.
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- 2024
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4. Mechanistic modeling projections of antibody persistence after homologous booster regimens of COVID‐19 vaccine Ad26.COV2.S in humans
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Anna Dari, Philippe Jacqmin, Yuki Iwaki, Martine Neyens, Mathieu Le Gars, Jerald Sadoff, Karin Hardt, Javier Ruiz‐Guiñazú, and Juan José Pérez‐Ruixo
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Therapeutics. Pharmacology ,RM1-950 - Abstract
Abstract Mechanistic model‐based simulations can be deployed to project the persistence of humoral immune response following vaccination. We used this approach to project the antibody persistence through 24 months from the data pooled across five clinical trials in severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2)‐seronegative participants following vaccination with Ad26.COV2.S (5 × 1010 viral particles), given either as a single‐dose or a homologous booster regimen at an interval of 2, 3, or 6 months. Antibody persistence was quantified as the percentage of participants with detectable anti‐spike binding and wild‐type virus neutralizing antibodies. The projected overall 24‐month persistence after single‐dose Ad26.COV2.S was 70.5% for binding antibodies and 55.2% for neutralizing antibodies, and increased after any homologous booster regimen to greater than or equal to 89.9% for binding and greater than or equal to 80.0% for neutralizing antibodies. The estimated model parameters quantifying the rates of antibody production attributed to short‐lived and long‐lived plasma cells decreased with increasing age, whereas the rate of antibody production mediated by long‐lived plasma cells was higher in women relative to men. Accordingly, a more pronounced waning of antibody responses was predicted in men aged greater than or equal to 60 years and was markedly attenuated following any homologous boosting regimen. The findings suggest that homologous boosting might be a viable strategy for maintaining protective effects of Ad26.COV2.S for up to 24 months following prime vaccination. The estimation of mechanistic modeling parameters identified the long‐lived plasma cell pathway as a key contributor mediating antibody persistence following single‐dose and homologous booster vaccination with Ad26.COV2.S in different subgroups of recipients stratified by age and sex.
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- 2023
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5. Development of patient- and observer-reported outcome measures to assess COVID-19 signs and symptoms in children and adolescents
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Carla Romano, Margaret Mayorga, Javier Ruiz-Guiñazú, Géralyn C. Trudel, Sheri Fehnel, Kelly McQuarrie, Eric K. H. Chan, and Eva G. Katz
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Patient-reported outcome ,Observer-reported outcome ,COVID-19 ,Content validity ,Pediatric ,Adolescent ,Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background The Symptoms of Infection with Coronavirus-19 (SIC) is a 30-item patient-reported outcome measure to evaluate the presence and severity of COVID-19 signs/symptoms in adults. This study expanded the context of use of the adult SIC among adolescents aged 12–17 years and supported a pediatric adaptation (the Pediatric SIC [PedSIC]) for caregiver assessment of signs/symptoms in children aged
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- 2023
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6. Effectiveness and impact of the 10-valent pneumococcal conjugate vaccine, PHiD-CV: review of clinical trials and post-marketing experience
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Tomas Mrkvan, Stephen I. Pelton, Javier Ruiz-Guiñazú, Arto A. Palmu, and Dorota Borys
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carriage ,children ,effectiveness ,efficacy ,impact ,phid-cv ,pneumococcal conjugate vaccine ,pneumococcal disease ,Internal medicine ,RC31-1245 - Abstract
Introduction: Pneumococcal diseases (including septicemia, meningitis, pneumonia, and upper respiratory infections) constitute a major public health problem. The World Health Organization recommends pneumococcal conjugate vaccine immunization of young children worldwide. Areas covered: We reviewed evidence on the effects of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV), which is used in childhood immunization programs in over 45 countries or regions. The effectiveness of PHiD-CV against invasive pneumococcal disease (IPD), pneumonia, and acute otitis media was assessed. We also present its effect on pneumococcal nasopharyngeal carriage (NPC) and indirect effects (herd protection) among unvaccinated individuals. Expert commentary: Results from randomized, double-blind trials and post-marketing studies in various countries provide evidence of the protective efficacy, effectiveness, and impact of PHiD-CV against pneumococcal diseases. Data from different geographic locations also show reductions in NPC of vaccine pneumococcal serotypes, laying the foundation for indirect protection against pneumococcal disease. In countries where PHiD-CV is included in childhood immunization programs, there are signs of herd protection for vaccine serotypes among unvaccinated individuals. Although increases in non-vaccine serotype IPD and NPC rates were observed, there was an overall reduction of pneumococcal disease.
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- 2018
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7. Quantifying Antibody Persistence After a Single Dose of <scp>COVID</scp> ‐19 Vaccine Ad26. <scp>COV2</scp> .S in Humans Using a Mechanistic Modeling and Simulation Approach
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Anna Dari, Muriel Boulton, Martine Neyens, Mathieu Le Gars, Belén Valenzuela, Georgi Shukarev, Vicky Cárdenas, Javier Ruiz‐Guiñazú, Jerald Sadoff, Richard M. W. Hoetelmans, and Juan José Pérez Ruixo
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Pharmacology ,Pharmacology (medical) - Abstract
Understanding persistence of humoral immune responses elicited by vaccination against coronavirus disease 2019 (COVID-19) is critical for informing the duration of protection and appropriate booster timing. We developed a mechanistic model to characterize the time course of humoral immune responses in severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-seronegative adults after primary vaccination with the Janssen COVID-19 vaccine, Ad26.COV2.S. The persistence of antibody responses was quantified through mechanistic modeling-based simulations. Two biomarkers of humoral immune responses were examined: SARS-CoV-2 neutralizing antibodies determined by wild-type virus neutralization assay (wtVNA) and spike protein-binding antibodies determined by indirect spike protein enzyme-linked immunosorbent assay (S-ELISA). The persistence of antibody responses was defined as the period of time during which wtVNA and S-ELISA titers remained above the lower limit of quantification. A total of 442 wtVNA and 1,185 S-ELISA titers from 82 and 220 participants, respectively, were analyzed following administration of a single dose of Ad26.COV2.S (5 × 10
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- 2022
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8. Impact of protein D-containing pneumococcal conjugate vaccines on non-typeable Haemophilus influenzae acute otitis media and carriage
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Christopher Clarke, Lauren O. Bakaletz, Javier Ruiz-Guiñazú, Dorota Borys, and Tomas Mrkvan
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acute otitis media ,nasopharyngeal carriage ,non-typeable haemophilus influenzae ,protein d ,vaccine ,Internal medicine ,RC31-1245 - Abstract
Introduction: Protein D-containing vaccines may decrease acute otitis media (AOM) burden and nasopharyngeal carriage of non-typeable Haemophilus influenzae (NTHi). Protein D-containing pneumococcal conjugate vaccine PHiD-CV (Synflorix, GSK Vaccines) elicits robust immune responses against protein D. However, the phase III Clinical Otitis Media and PneumoniA Study (COMPAS), assessing PHiD-CV efficacy against various pneumococcal diseases, was not powered to demonstrate efficacy against NTHi; only trends of protective efficacy against NTHi AOM in children were shown. Areas covered: This review aims to consider all evidence available to date from pre-clinical and clinical phase III studies together with further evidence emerging from post-marketing studies since PHiD-CV has been introduced into routine clinical practice worldwide, to better describe the clinical utility of protein D in preventing AOM due to NTHi and its impact on NTHi nasopharyngeal carriage. Expert commentary: Protein D is an effective carrier protein in conjugate vaccines and evidence gathered from pre-clinical, clinical and observational studies suggest that it also elicits immune response that can help to reduce the burden of AOM due to NTHi. There remains a need to develop improved vaccines for prevention of NTHi disease, which could be achieved by combining protein D with other antigens.
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- 2017
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9. Efficacy of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine against acute otitis media and nasopharyngeal carriage in Panamanian children – A randomized controlled trial
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Xavier Sáez-Llorens, Stella Rowley, Digna Wong, Mirna Rodríguez, Arlene Calvo, Marisol Troitiño, Albino Salas, Vielka Vega, Maria Mercedes Castrejón, Patricia Lommel, Thierry G. Pascal, William P. Hausdorff, Dorota Borys, Javier Ruiz-Guiñazú, Eduardo Ortega-Barría, Juan Pablo Yarzabal, and Lode Schuerman
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acute otitis media ,children ,efficacy ,nasopharyngeal carriage ,pneumococcal conjugate vaccination ,Immunologic diseases. Allergy ,RC581-607 ,Therapeutics. Pharmacology ,RM1-950 - Abstract
We previously reported 10-valent pneumococcal non-typeable Haemophilus influenzae (NTHi) protein D conjugate vaccine (PHiD-CV) efficacy in a double-blind randomized trial (ClinicalTrials.gov: NCT00466947) against various diseases, including acute otitis media (AOM). Here, we provide further analyses. In the Panamanian subset, 7,359 children were randomized (1:1) to receive PHiD-CV or control vaccine at age 2/4/6 and 15–18 months. Of these, 2,000 had nasopharyngeal swabs collected. AOM cases were captured when parents sought medical attention for children with AOM symptoms; surveillance was enhanced approximately 2 y into the study through regular telephone calls or home visits by study personnel, who advised parents to visit the clinic if their child had AOM symptoms. Mean follow-up was 31.4 months. Clinical AOM (C-AOM) cases were assessed by physicians and confirmed by otorhinolaryngologists. Middle ear fluid samples, taken from children with C-AOM after specific informed consent, and nasopharyngeal samples were cultured for pathogen identification. For 7,359 children, 2,574 suspected AOM cases were assessed by a primary healthcare physician; 649 cases were C-AOM cases as per protocol definition. From the 503 MEF samples collected, 158 resulted in a positive culture. In the intent-to-treat cohort (7,214 children), PHiD-CV showed VE against first C-AOM (24.0% [95% CI: 8.7, 36.7]) and bacterial (B-AOM) episodes (48.0% [20.3, 66.1]) in children
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- 2017
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10. Immunization with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) according to different schedules in infants in South Africa: a phase III trial
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Shabir A Madhi, Anthonet Koen, Lisa Jose, Marta Moreira, Nadia van Niekerk, Clare Cutland, Nancy François, Javier Ruiz-Guiñazú, Juan Pablo Yarzabal, Dorota Borys, and Lode Schuerman
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expanded program on immunization ,immunogenicity ,pneumococcal conjugate vaccine ,safety ,vaccination schedule ,infants ,Internal medicine ,RC31-1245 - Abstract
Background: Limited clinical data exists to assess differences between various infant pneumococcal conjugate vaccine schedules. In this trial, we evaluated immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administered using 3 different immunization schedules in HIV unexposed-uninfected infants in South Africa. Methods: In this phase III, open, single‐center, controlled study (clinicaltrials.gov: NCT00829010), 300 infants were randomized (1:1:1) to 1 of 3 PHiD-CV schedules: 3-dose priming and booster (3 + 1); 3-dose priming without booster (3 + 0); or 2-dose priming and booster (2 + 1). The booster was administered at 9–10 months of age. immune responses were assessed up to 21 months after primary vaccination. Results: Post‐priming antibody levels tended to be lower in the 2 + 1 group. At 6 months post‐priming, antibody concentrations and opsonophagocytic activity titers were within similar ranges after 2‐ or 3‐dose priming. Robust increases were observed pre‐ to post‐booster in the 3 + 1 and 2 + 1 groups. Conclusions: PHiD-CV was immunogenic when administered in different schedules. Post‐booster responses suggest effective immunological priming with both 2‐ and 3‐dose primary series and support administration of the booster dose at 9–10 months of age.
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- 2017
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11. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
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Jerald, Sadoff, Glenda, Gray, An, Vandebosch, Vicky, Cárdenas, Georgi, Shukarev, Beatriz, Grinsztejn, Paul A, Goepfert, Carla, Truyers, Hein, Fennema, Bart, Spiessens, Kim, Offergeld, Gert, Scheper, Kimberly L, Taylor, Merlin L, Robb, John, Treanor, Dan H, Barouch, Jeffrey, Stoddard, Martin F, Ryser, Mary A, Marovich, Kathleen M, Neuzil, Lawrence, Corey, Nancy, Cauwenberghs, Tamzin, Tanner, Karin, Hardt, Javier, Ruiz-Guiñazú, Mathieu, Le Gars, Hanneke, Schuitemaker, Johan, Van Hoof, Frank, Struyf, Macaya, Douoguih, and Marcus, Zervos
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Adult ,Male ,2019-20 coronavirus outbreak ,COVID-19 Vaccines ,Adolescent ,Coronavirus disease 2019 (COVID-19) ,viruses ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,030204 cardiovascular system & hematology ,law.invention ,Young Adult ,03 medical and health sciences ,Immunogenicity, Vaccine ,0302 clinical medicine ,Double-Blind Method ,law ,Humans ,Medicine ,030212 general & internal medicine ,Vector (molecular biology) ,Aged ,Proportional Hazards Models ,Ad26COVS1 ,business.industry ,Incidence ,Immunogenicity ,Patient Acuity ,COVID-19 ,virus diseases ,General Medicine ,Middle Aged ,Virology ,Hospitalization ,Clinical trial ,Multicenter study ,Asymptomatic Diseases ,Recombinant DNA ,Female ,business - Abstract
The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation.In an international, randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned adult participants in a 1:1 ratio to receive a single dose of Ad26.COV2.S (5×10The per-protocol population included 19,630 SARS-CoV-2-negative participants who received Ad26.COV2.S and 19,691 who received placebo. Ad26.COV2.S protected against moderate to severe-critical Covid-19 with onset at least 14 days after administration (116 cases in the vaccine group vs. 348 in the placebo group; efficacy, 66.9%; adjusted 95% confidence interval [CI], 59.0 to 73.4) and at least 28 days after administration (66 vs. 193 cases; efficacy, 66.1%; adjusted 95% CI, 55.0 to 74.8). Vaccine efficacy was higher against severe-critical Covid-19 (76.7% [adjusted 95% CI, 54.6 to 89.1] for onset at ≥14 days and 85.4% [adjusted 95% CI, 54.2 to 96.9] for onset at ≥28 days). Despite 86 of 91 cases (94.5%) in South Africa with sequenced virus having the 20H/501Y.V2 variant, vaccine efficacy was 52.0% and 64.0% against moderate to severe-critical Covid-19 with onset at least 14 days and at least 28 days after administration, respectively, and efficacy against severe-critical Covid-19 was 73.1% and 81.7%, respectively. Reactogenicity was higher with Ad26.COV2.S than with placebo but was generally mild to moderate and transient. The incidence of serious adverse events was balanced between the two groups. Three deaths occurred in the vaccine group (none were Covid-19-related), and 16 in the placebo group (5 were Covid-19-related).A single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe-critical disease, including hospitalization and death. Safety appeared to be similar to that in other phase 3 trials of Covid-19 vaccines. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722.).
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- 2021
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12. Impact of HIV status and vaccination schedule on bacterial nasopharyngeal carriage following infant immunisation with the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in South Africa
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Marta Moreira, Nancy François, Sonia Schoonbroodt, Shabir A. Madhi, Lisa Jose, Lode Schuerman, Nadia van Niekerk, Javier Ruiz-Guiñazú, Clare L. Cutland, Linda de Gouveia, Anthonet Koen, Juan Pablo Yarzabal, and Dorota Borys
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Vaccination schedule ,030231 tropical medicine ,HIV Infections ,Booster dose ,medicine.disease_cause ,Pneumococcal Infections ,Pneumococcal conjugate vaccine ,Haemophilus influenzae ,Pneumococcal Vaccines ,South Africa ,03 medical and health sciences ,0302 clinical medicine ,Conjugate vaccine ,Nasopharynx ,Streptococcus pneumoniae ,medicine ,Humans ,030212 general & internal medicine ,Immunization Schedule ,Vaccines, Conjugate ,General Veterinary ,General Immunology and Microbiology ,business.industry ,Vaccination ,Public Health, Environmental and Occupational Health ,Infant ,Infectious Diseases ,Carriage ,Immunology ,Molecular Medicine ,business ,medicine.drug - Abstract
Background Nasopharyngeal carriage (NPC) of Streptococcus pneumoniae is a precondition for pneumococcal disease and a source of transmission. This trial evaluated NPC of S. pneumoniae and other pathogens post-vaccination with the pneumococcal non-typeable Haemophilus influenzae (NTHi) protein D conjugate vaccine (PHiD-CV) in human immunodeficiency virus (HIV)-infected (HIV+), HIV-exposed-uninfected (HEU), and HIV-unexposed-uninfected (HUU) South African children. Methods In this phase III, open, single‐centre, controlled study (ClinicalTrials.gov: NCT00829010), 484 children were stratified by HIV status: 83 HIV+, 101 HEU, and 300 HUU. HIV+ and HEU children received a 3 + 1 PHiD-CV vaccination schedule: primary vaccination, age 6/10/14 weeks, and booster dose, age 9–10 months. HUU infants were randomised (1:1:1) to 3-dose priming and booster (HUU/3+1); 3-dose priming without booster (HUU/3+0); or 2-dose priming and booster (HUU/2+1). Bacterial NPC was assessed 8 times up to 24–27 months of age. Results Overall pneumococcal carriage rates were similar across 3+1 groups irrespective of HIV status; trends towards higher carriage rates in the HIV+ than HEU and HUU/3+1 groups were observed at 24–27 months of age. In HUU children, carriage of any pneumococcal serotype was similar for the three different dosing schedules at all timepoints; carriage of vaccine-type pneumococci tended to be lower at 16–19 months and 24–27 months of age in children who had received a booster dose (HUU/2+1 and HUU/3+1 groups) than in the HUU/3+0 group. Carriage rates of NTHi, Staphylococcus aureus and Moraxella catarrhalis were comparable between all groups. Conclusions HIV infection or exposure did not seem to alter the effect of PHiD-CV on pneumococcal NPC in children during their first 2 years of life. NPC prevalence of vaccine-type pneumococci following vaccination series tended to be lower in children who had received a booster dose in comparison to those who had not.
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- 2020
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13. Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S
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Jerald, Sadoff, Glenda, Gray, An, Vandebosch, Vicky, Cárdenas, Georgi, Shukarev, Beatriz, Grinsztejn, Paul A, Goepfert, Carla, Truyers, Ilse, Van Dromme, Bart, Spiessens, Johan, Vingerhoets, Jerome, Custers, Gert, Scheper, Merlin L, Robb, John, Treanor, Martin F, Ryser, Dan H, Barouch, Edith, Swann, Mary A, Marovich, Kathleen M, Neuzil, Lawrence, Corey, Jeffrey, Stoddard, Karin, Hardt, Javier, Ruiz-Guiñazú, Mathieu, Le Gars, Hanneke, Schuitemaker, Johan, Van Hoof, Frank, Struyf, Macaya, Douoguih, and Marcus, Zervos
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Adult ,Ad26COVS1 ,Adolescent ,SARS-CoV-2 ,Patient Acuity ,COVID-19 ,Vaccine Efficacy ,General Medicine ,Kaplan-Meier Estimate ,Middle Aged ,Hospitalization ,Young Adult ,Immunogenicity, Vaccine ,Double-Blind Method ,Humans ,Follow-Up Studies - Abstract
The Ad26.COV2.S vaccine was highly effective against severe-critical coronavirus disease 2019 (Covid-19), hospitalization, and death in the primary phase 3 efficacy analysis.We conducted the final analysis in the double-blind phase of our multinational, randomized, placebo-controlled trial, in which adults were assigned in a 1:1 ratio to receive single-dose Ad26.COV2.S (5×10Median follow-up in this analysis was 4 months; 8940 participants had at least 6 months of follow-up. In the per-protocol population (39,185 participants), vaccine efficacy against moderate to severe-critical Covid-19 at least 14 days after administration was 56.3% (95% confidence interval [CI], 51.3 to 60.8; 484 cases in the vaccine group vs. 1067 in the placebo group); at least 28 days after administration, vaccine efficacy was 52.9% (95% CI, 47.1 to 58.1; 433 cases in the vaccine group vs. 883 in the placebo group). Efficacy in the United States, primarily against the reference strain (B.1.D614G) and the B.1.1.7 (alpha) variant, was 69.7% (95% CI, 60.7 to 76.9); efficacy was reduced elsewhere against the P.1 (gamma), C.37 (lambda), and B.1.621 (mu) variants. Efficacy was 74.6% (95% CI, 64.7 to 82.1) against severe-critical Covid-19 (with only 4 severe-critical cases caused by the B.1.617.2 [delta] variant), 75.6% (95% CI, 54.3 to 88.0) against Covid-19 leading to medical intervention (including hospitalization), and 82.8% (95% CI, 40.5 to 96.8) against Covid-19-related death, with protection lasting 6 months or longer. Efficacy against any severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was 41.7% (95% CI, 36.3 to 46.7). Ad26.COV2.S was associated with mainly mild-to-moderate adverse events, and no new safety concerns were identified.A single dose of Ad26.COV2.S provided 52.9% protection against moderate to severe-critical Covid-19. Protection varied according to variant; higher protection was observed against severe Covid-19, medical intervention, and death than against other end points and lasted for 6 months or longer. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722.).
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- 2022
14. Bacterial nasopharyngeal carriage following infant immunization with pneumococcal conjugate vaccines according to a 2+1 schedule in children in South Africa: an exploratory analysis of two clinical trials
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Marta C. Nunes, Anthonet Koen, Shabir A. Madhi, Nancy François, Lisa Jose, Lode Schuerman, Sonia Schoonbroodt, Marta Moreira, Nadia van Niekerk, Juan Pablo Yarzabal, Dorota Borys, Clare L. Cutland, and Javier Ruiz-Guiñazú
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Male ,0301 basic medicine ,Staphylococcus aureus ,Schedule ,Pediatrics ,medicine.medical_specialty ,Heptavalent Pneumococcal Conjugate Vaccine ,Vaccination schedule ,Immunology ,medicine.disease_cause ,complex mixtures ,Pneumococcal Infections ,Pneumococcal conjugate vaccine ,Haemophilus influenzae ,Pneumococcal Vaccines ,South Africa ,03 medical and health sciences ,0302 clinical medicine ,stomatognathic system ,Nasopharynx ,Drug Discovery ,Streptococcus pneumoniae ,Prevalence ,otorhinolaryngologic diseases ,Humans ,Medicine ,Prospective Studies ,030212 general & internal medicine ,Immunization Schedule ,Pharmacology ,business.industry ,Infant ,Clinical trial ,030104 developmental biology ,Immunization ,Child, Preschool ,Carrier State ,Molecular Medicine ,Female ,business ,Conjugate ,medicine.drug - Abstract
Background: We evaluated bacterial nasopharyngeal carriage (NPC) prevalence and cumulative acquisition following 7-valent pneumococcal conjugate vaccine (PCV7) or pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administration. Methods: Participants were children from two clinical trials in a South African center who received PCV7 (n = 250) or PHiD-CV (n = 100) at ~6 weeks, ~14 weeks, and ~9–10 months of age, and were enrolled between Dec2009-Apr2010 and Mar2009-May2010 in the PCV7 and PHiD-CV studies, respectively. Sample collection, most microbiological assessments, and data re-analysis methods were identical. Results: NPC prevalence of any pneumococcal serotype was 18.5% and 17.0% at pre-vaccination, and 63.1% and 67.3% in 24–27 month-old children among PCV7 and PHiD-CV recipients, respectively. In 24–27 month-old children, 96.1% and 99.0% of PCV7 and PHiD-CV recipients had acquired ≥1 pneumococcal serotype, 53.7% and 62.9% ≥1 PCV7 serotype, 1.5%, and 3.1% ≥1 of serotypes 1, 5 or 7F, 23.2% and 19.6% serotype 6A, 23.2% and 21.7% serotype 19A, 88.7%, and 91.0% H. influenzae, and 50.3% and 62.9% Staphylococcus aureus, respectively. Conclusions: This analysis of two concurrent clinical trials did not reveal differences in bacterial NPC prevalence or acquisition in PCV7- and PHiD-CV-vaccinated children. Trial registration: South African National Clinical Trial Register (NHREC DOH-27-0511-299); ClinicalTrials.gov (NCT00829010).
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- 2020
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15. Effectiveness of pneumococcal Haemophilus influenzae protein D conjugate vaccine against pneumonia in children: A cluster-randomised trial
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Lode Schuerman, Hanna Rinta-Kokko, Marta Moreira, Esa Ruokokoski, A. A. Palmu, T. Puumalainen, Dorota Borys, Patricia Lommel, Jukka Jokinen, Magali Traskine, Heta Nieminen, Terhi Kilpi, and Javier Ruiz-Guiñazú
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Male ,medicine.medical_specialty ,Vaccination schedule ,Lipoproteins ,030231 tropical medicine ,Rate ratio ,medicine.disease_cause ,Pneumococcal Infections ,Haemophilus influenzae ,Pneumococcal Vaccines ,03 medical and health sciences ,0302 clinical medicine ,Bacterial Proteins ,Double-Blind Method ,Internal medicine ,medicine ,Humans ,030212 general & internal medicine ,Hepatitis vaccine ,Finland ,Immunization Schedule ,General Veterinary ,General Immunology and Microbiology ,business.industry ,Public Health, Environmental and Occupational Health ,Vaccine trial ,Infant ,Immunoglobulin D ,Pneumonia ,medicine.disease ,Vaccination ,Otitis Media ,Infectious Diseases ,Otitis ,Molecular Medicine ,Female ,medicine.symptom ,Carrier Proteins ,business - Abstract
BACKGROUND Pneumococcal conjugate vaccines have potential to prevent significant proportion of childhood pneumonia. Finnish Invasive Pneumococcal disease vaccine trial was designed to assess the vaccine effectiveness (VE) of the 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against several outcomes. We now report results for pneumonia. METHODS In this nationwide, cluster-randomised, double-blind trial, children younger than 19 months received PHiD-CV10 in 52 clusters or hepatitis vaccines as control in 26 clusters. Infants younger than 7 months at the first vaccination received either 3+1 or 2+1 vaccination schedule, children aged 7-11 months received 2+1, and those 12-18 months of age two-dose schedule. All hospitalizations and outpatient visits to hospital associated with ICD-10 codes compatible with pneumonia were identified through the National Care Register and 1-3 frontal chest X-ray images per event were collected. External readers who were unaware of the patients' vaccination status retrospectively interpreted the images. The evaluated outcomes were hospital-diagnosed, hospital-treated pneumonia as primary diagnosis, and radiologically confirmed pneumonia during the blinded, intention-to-treat follow-up period from the first vaccination to the end of 2011. Total VE was calculated as 1 minus rate ratio of all pneumonia episodes. RESULTS 47 366 children were enrolled from February 2009, to October 2010. VE against all episodes of hospital-diagnosed pneumonia was 27% (95% confidence interval [CI]: 14%, 38%), 32% (95% CI: 3%, 52%), and 23% (95% CI: -5%, 44%) in subjects enrolled at age
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- 2018
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16. Immunologic non-inferiority and safety of the investigational pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) 4-dose vial presentation compared to the licensed PHiD-CV 1-dose vial presentation in infants: A phase III randomized study
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Sheikh Farzana Zaman, Farzana Zaman, Khalequ Zaman, Asma Binte Aziz, Dorota Borys, Sayeed-Bin Faisal, Ahsan Habib, Javier Ruiz-Guiñazú, and Magali Traskine
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Male ,medicine.medical_specialty ,030231 tropical medicine ,Immunization, Secondary ,Booster dose ,Serogroup ,medicine.disease_cause ,Rubella ,Vial ,Measles ,Pneumococcal Infections ,Haemophilus influenzae ,Pneumococcal Vaccines ,03 medical and health sciences ,Immunogenicity, Vaccine ,0302 clinical medicine ,Conjugate vaccine ,Internal medicine ,medicine ,Humans ,Public Health Surveillance ,030212 general & internal medicine ,Reactogenicity ,General Veterinary ,General Immunology and Microbiology ,business.industry ,Vaccination ,Infant, Newborn ,Public Health, Environmental and Occupational Health ,Infant ,medicine.disease ,Antibodies, Bacterial ,Streptococcus pneumoniae ,Infectious Diseases ,Molecular Medicine ,Female ,business - Abstract
To support vaccination programs in developing countries, a 4-dose vial presentation of pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) was developed. This study assessed immunologic non-inferiority and safety of the investigational PHiD-CV 4-dose versus licensed 1-dose vial presentation in infants.In this phase III, mono-center, observer-blind study in Bangladesh, 6-10-week-old infants were randomized 1:1 to receive PHiD-CV primary vaccination (at ages 6, 10, 18 weeks) and a booster dose (at age 9 months) with a 4-dose vial (with preservative, 4DV group) or 1-dose vial (preservative-free, 1DV group). DTPw-HBV/Hib was (co)-administered per study protocol and polio, measles and rubella vaccines as part of the national immunization program. Non-inferiority of PHiD-CV 4-dose versus 1-dose vial for each vaccine pneumococcal serotype (VT) and vaccine-related serotype 19A in terms of antibody geometric mean concentration (GMC) was assessed (criterion: upper limit of 2-sided 95% confidence interval of antibody GMC ratios [1DV/4DV]2-fold). Immune responses were measured. Solicited, unsolicited and serious adverse events (AEs) were evaluated.Of 320 infants (160 per group) vaccinated during the primary vaccination phase, 297 received a booster. Non-inferiority was demonstrated for each VT and 19A. One month post-primary vaccination, for most VT, ≥97.9% of infants in each group had antibody concentrations ≥0.2 μg/mL; for 19A ≥ 80.1% reached this threshold. Pneumococcal antibody responses and opsonophagocytic activity for each VT and 19A were within similar ranges between groups after primary and booster vaccination, as were anti-protein D responses. Booster immune responses were observed in both groups. Reported AEs were within similar ranges for both presentations.Immunologic non-inferiority of PHiD-CV 4-dose vial (with preservative) versus PHiD-CV 1-dose vial (preservative-free) was demonstrated. Immune responses and reactogenicity following primary/booster vaccination were within similar ranges for both presentations. PHiD-CV 4-dose vial would help improve access and coverage in resource-limited countries. Clinical Trial Registry: NCT02447432.
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- 2018
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17. Impact of protein D-containing pneumococcal conjugate vaccines on non-typeable Haemophilus influenzae acute otitis media and carriage
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Javier Ruiz-Guiñazú, Tomas Mrkvan, Christopher Clarke, Lauren O. Bakaletz, and Dorota Borys
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0301 basic medicine ,Haemophilus Infections ,Acute otitis media ,Lipoproteins ,030106 microbiology ,Immunology ,Nasopharyngeal carriage ,medicine.disease_cause ,Pneumococcal conjugate vaccine ,Haemophilus influenzae ,Microbiology ,Pneumococcal Vaccines ,03 medical and health sciences ,Immunogenicity, Vaccine ,0302 clinical medicine ,Immune system ,Bacterial Proteins ,Nasopharynx ,Drug Discovery ,otorhinolaryngologic diseases ,Animals ,Humans ,Medicine ,030212 general & internal medicine ,Immunization Schedule ,Pharmacology ,Vaccines, Conjugate ,business.industry ,Vaccination ,Immunoglobulin D ,medicine.disease ,Otitis Media ,Pneumonia ,Treatment Outcome ,Carriage ,Otitis ,Acute Disease ,Molecular Medicine ,medicine.symptom ,Carrier Proteins ,business ,medicine.drug - Abstract
Protein D-containing vaccines may decrease acute otitis media (AOM) burden and nasopharyngeal carriage of non-typeable Haemophilus influenzae (NTHi). Protein D-containing pneumococcal conjugate vaccine PHiD-CV (Synflorix, GSK Vaccines) elicits robust immune responses against protein D. However, the phase III Clinical Otitis Media and PneumoniA Study (COMPAS), assessing PHiD-CV efficacy against various pneumococcal diseases, was not powered to demonstrate efficacy against NTHi; only trends of protective efficacy against NTHi AOM in children were shown. Areas covered: This review aims to consider all evidence available to date from pre-clinical and clinical phase III studies together with further evidence emerging from post-marketing studies since PHiD-CV has been introduced into routine clinical practice worldwide, to better describe the clinical utility of protein D in preventing AOM due to NTHi and its impact on NTHi nasopharyngeal carriage. Expert commentary: Protein D is an effective carrier protein in conjugate vaccines and evidence gathered from pre-clinical, clinical and observational studies suggest that it also elicits immune response that can help to reduce the burden of AOM due to NTHi. There remains a need to develop improved vaccines for prevention of NTHi disease, which could be achieved by combining protein D with other antigens.
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- 2017
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18. Immunization with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) according to different schedules in infants in South Africa: a phase III trial
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Juan Pablo Yarzabal, Dorota Borys, Anthonet Koen, Javier Ruiz-Guiñazú, Clare L. Cutland, Nancy François, Lisa Jose, Lode Schuerman, Shabir A. Madhi, Nadia van Niekerk, and Marta Moreira
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Vaccination schedule ,Immunology ,Priming (immunology) ,medicine.disease_cause ,Pneumococcal Infections ,Pneumococcal conjugate vaccine ,Haemophilus influenzae ,Pneumococcal Vaccines ,South Africa ,03 medical and health sciences ,0302 clinical medicine ,Conjugate vaccine ,030225 pediatrics ,Drug Discovery ,medicine ,Humans ,030212 general & internal medicine ,Immunization Schedule ,Pharmacology ,Booster (rocketry) ,business.industry ,Immunogenicity ,Infant ,Virology ,Treatment Outcome ,Immunization ,Molecular Medicine ,business ,medicine.drug - Abstract
Limited clinical data exists to assess differences between various infant pneumococcal conjugate vaccine schedules. In this trial, we evaluated immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administered using 3 different immunization schedules in HIV unexposed-uninfected infants in South Africa.In this phase III, open, single-center, controlled study (clinicaltrials.gov: NCT00829010), 300 infants were randomized (1:1:1) to 1 of 3 PHiD-CV schedules: 3-dose priming and booster (3 + 1); 3-dose priming without booster (3 + 0); or 2-dose priming and booster (2 + 1). The booster was administered at 9-10 months of age. immune responses were assessed up to 21 months after primary vaccination.Post-priming antibody levels tended to be lower in the 2 + 1 group. At 6 months post-priming, antibody concentrations and opsonophagocytic activity titers were within similar ranges after 2- or 3-dose priming. Robust increases were observed pre- to post-booster in the 3 + 1 and 2 + 1 groups.PHiD-CV was immunogenic when administered in different schedules. Post-booster responses suggest effective immunological priming with both 2- and 3-dose primary series and support administration of the booster dose at 9-10 months of age.
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- 2017
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19. Efficacy of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine against acute otitis media and nasopharyngeal carriage in Panamanian children – A randomized controlled trial
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Digna Wong, Patricia Lommel, Stella Rowley, Juan Pablo Yarzabal, Dorota Borys, William P. Hausdorff, Xavier Sáez-Llorens, Marisol Troitiño, Javier Ruiz-Guiñazú, Albino Salas, Mirna Rodriguez, Vielka Vega, Thierry G. Pascal, Maria Mercedes Castrejon, Lode Schuerman, Eduardo Ortega-Barria, and Arlene Calvo
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Male ,nasopharyngeal carriage ,efficacy ,Nasopharyngeal carriage ,medicine.disease_cause ,Haemophilus influenzae ,law.invention ,Pneumococcal Vaccines ,0302 clinical medicine ,Randomized controlled trial ,law ,Nasopharynx ,Immunology and Allergy ,Non typeable ,030212 general & internal medicine ,Haemophilus Vaccines ,Pneumococcal conjugate vaccination ,Exudates and Transudates ,Research Papers ,Treatment Outcome ,Carrier State ,Female ,Haemophilus Infections ,Panama ,Acute otitis media ,Lipoproteins ,Immunology ,Ear, Middle ,Pneumococcal Infections ,03 medical and health sciences ,Bacterial Proteins ,Double-Blind Method ,children ,pneumococcal conjugate vaccination ,Conjugate vaccine ,030225 pediatrics ,otorhinolaryngologic diseases ,medicine ,Humans ,Pharmacology ,business.industry ,acute otitis media ,Infant ,Correction ,Immunoglobulin D ,Otitis Media ,Carrier Proteins ,business ,Follow-Up Studies - Abstract
We previously reported 10-valent pneumococcal non-typeable Haemophilus influenzae (NTHi) protein D conjugate vaccine (PHiD-CV) efficacy in a double-blind randomized trial (ClinicalTrials.gov: NCT00466947) against various diseases, including acute otitis media (AOM). Here, we provide further analyses. In the Panamanian subset, 7,359 children were randomized (1:1) to receive PHiD-CV or control vaccine at age 2/4/6 and 15–18 months. Of these, 2,000 had nasopharyngeal swabs collected. AOM cases were captured when parents sought medical attention for children with AOM symptoms; surveillance was enhanced approximately 2 y into the study through regular telephone calls or home visits by study personnel, who advised parents to visit the clinic if their child had AOM symptoms. Mean follow-up was 31.4 months. Clinical AOM (C-AOM) cases were assessed by physicians and confirmed by otorhinolaryngologists. Middle ear fluid samples, taken from children with C-AOM after specific informed consent, and nasopharyngeal samples were cultured for pathogen identification. For 7,359 children, 2,574 suspected AOM cases were assessed by a primary healthcare physician; 649 cases were C-AOM cases as per protocol definition. From the 503 MEF samples collected, 158 resulted in a positive culture. In the intent-to-treat cohort (7,214 children), PHiD-CV showed VE against first C-AOM (24.0% [95% CI: 8.7, 36.7]) and bacterial (B-AOM) episodes (48.0% [20.3, 66.1]) in children
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- 2017
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20. 119. A Respiratory Syncytial Virus Prefusion F Protein (RSVPreF3) Candidate Vaccine Administered in Older Adults in a Phase I/II Randomized Clinical Trial Is Well Tolerated
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Marie-Pierre David, Katie Steenackers, Nancy Dezutter, Laurence Fissette, Matthew Davis, Juliane Koch, Edward Kerwin, Jelena Tica, Charles Fogarty, Brandon Essink, Corinne Vandermeulen, Isabel Leroux-Roels, Narcisa Mesaros, Charles P Andrews, and Javier Ruiz Guiñazú
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medicine.medical_specialty ,Intention-to-treat analysis ,business.industry ,Immunogenicity ,Antibody titer ,Virus ,law.invention ,Infectious Diseases ,Clinical research ,AcademicSubjects/MED00290 ,Oncology ,Randomized controlled trial ,law ,Internal medicine ,Respiratory Syncytial Virus Vaccines ,Poster Abstracts ,Medicine ,business ,Adverse effect - Abstract
Background RSV is a common cause of respiratory acute illness in older adults (OA). We evaluated safety and reactogenicity of RSVPreF3 candidate vaccine in young adults (YA) and OA. Methods In this phase I/II, placebo-controlled, multi-country trial (NCT03814590), YA aged 18–40 years were randomized 1:1:1:1 and received 2 doses of Low-, Medium- or High-dose of RSVPreF3 non-adjuvanted vaccine, or placebo, 2 months apart. Following favorable safety evaluation, a staggered enrolment with 2 steps followed in OA aged 60–80 years, who were randomized 1:1:1:1:1:1:1:1:1:1 to receive 1 of the 9 RSV vaccine formulations containing Low-, Medium- or High-dose of RSVPreF3 non-adjuvanted or adjuvanted with AS01E or AS01B, or placebo (same schedule). Safety/reactogenicity up to 1 month post-dose 1 are reported here. Results Exposed set was comprised of 48 YA and 1005 OA. Within 7 days post-dose 1, any solicited/unsolicited adverse event (AE) ranged from 58.3% to 83.3% across YA vaccinees (placebo YA: 58.3%) and from 29.9% to 84.2% across OA vaccinees (placebo OA: 33.7%) (Fig 1). Pain was the most common solicited local AE, being reported in ≤ 58.3% of YA (placebo YA: 0.0%) and at higher rates in the adjuvanted groups (≤ 75.7%) vs non-adjuvanted groups of OA (≤ 14.1%) and placebo OA (4.1%) (Fig 2A). Of solicited general AEs, fatigue (YA: ≤ 41.7% in vaccinees vs 50.0% in placebo; OA: ≤ 48.5% in vaccinees vs 16.3% in placebo) and headache (YA: ≤ 33.3% in vaccinees vs 16.7% in placebo; OA: ≤ 27.7% in vaccinees vs 8.2% in placebo) were most commonly reported (Fig 2B), while fever ≥ 38.0 °C was observed in ≤ 3.0% of OA vaccinees (placebo OA: 0.0%). Grade 3 solicited local and general AEs were observed in OA only, with erythema (≤ 4.9% in vaccinees vs 0.0% in placebo) and fatigue (≤ 2.0% in vaccinees vs 1.0% in placebo) being most common (Fig 2). No serious AEs (SAEs) were reported in YA. A number of 11 OA reported a SAE within 1 month post-dose 1, but none was fatal or assessed as vaccine-related. No clinically significant abnormalities occurred in hematological/biochemical parameters in any group. Figure 1. Percentage of participants presenting at least one type of solicited/unsolicited adverse event (AE) within 7 days post-dose 1 Figure 2. Percentage of participants with at least one type of solicited adverse event (AE) within 7 days post-dose 1 Conclusion First dose of RSVPreF3 candidate vaccine is well tolerated. AE rates tended to be higher after AS01B-adjuvanted formulations compared to other vaccine formulations. No safety concerns were raised. Funding GlaxoSmithKline Biologicals SA Disclosures Jelena Tica, PhD, GSK group of companies (Employee, Shareholder) Javier Ruiz Guiñazú, MD MSc, GSK group of companies (Employee, Shareholder) Charles P. Andrews, MD, GSK group of companies (Scientific Research Study Investigator) Charles Fogarty, MD, GSK group of companies (Grant/Research Support) Edward Kerwin, MD, Amphastar (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)AstraZeneca (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Boehringer Ingelheim (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Chiesi (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Cipla (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)GSK group of companies (Employee, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Mylan (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Novartis (Employee, Advisor or Review Panel member, Research Grant or Support, Speaker’s Bureau)other around 40 pharmaceutical companies (Other Financial or Material Support, conducted multicenter clinical research trials)Pearl (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Sunovion (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Theravance (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau) Isabel Leroux-Roels, MD PhD, GSK group of companies (Scientific Research Study Investigator) Corinne Vandermeulen, MD PhD, GSK group of companies (Other Financial or Material Support, My university only received Grant/Research Support) Marie-Pierre David, MSc, GSK group of companies (Employee, Shareholder) Nancy Dezutter, PhD, PharmD, RPh, GSK group of companies (Employee, Shareholder) Laurence Fissette, MSc, GSK group of companies (Employee) Juliane Koch, MD, GSK group of companies (Employee, Shareholder) Narcisa Mesaros, MD, MSc, GSK group of companies (Employee)
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- 2020
21. Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children: A randomized, controlled study
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Fakrudeen Shafi, Akari Suyama, Tomohide Sato, Tomohiro Oishi, Naohisa Kawamura, Haruo Kuroki, Asayuki Iwai, Javier Ruiz-Guiñazú, Satoshi Iwata, Mitsunobu Miyazu, Nancy François, Yasunobu Tokoeda, and Dorota Borys
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Serotype ,safety ,Male ,Adolescent ,Immunology ,immunogenicity ,medicine.disease_cause ,Diphtheria-Tetanus-acellular Pertussis Vaccines ,complex mixtures ,Pneumococcal conjugate vaccine ,Pneumococcal Infections ,Haemophilus influenzae ,Pneumococcal Vaccines ,Young Adult ,children ,Japan ,Conjugate vaccine ,medicine ,Immunology and Allergy ,Humans ,Child ,Pharmacology ,Reactogenicity ,business.industry ,Immunogenicity ,Vaccination ,pneumococcal conjugate vaccine ,Child, Preschool ,Pertussis vaccine ,Female ,business ,medicine.drug ,Research Paper ,co-administration - Abstract
This phase III, randomized, open-label, multicenter study (NCT01027845) conducted in Japan assessed the immunogenicity, safety, and reactogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, given intramuscularly) co-administered with diphtheria-tetanus-acellular pertussis vaccine (DTPa, given subcutaneously). Infants (N=360 ) were randomized (2:1) to receive either PHiD-CV and DTPa (PHiD-CV group) or DTPa alone (control group) as 3-dose primary vaccination (3-4-5 months of age) and booster vaccination (17-19 months of age). Immune responses were measured before and one month after primary/booster vaccination and adverse events (AEs) were recorded. Post-primary immune responses were non-inferior to those in pivotal/efficacy European or Latin American pneumococcal protein D-conjugate vaccine studies. For each PHiD-CV serotype, at least 92.6% of infants post-primary vaccination and at least 97.7% of children post-booster had pneumococcal antibody concentrations ≥0.2 μg/ml, and at least 95.4% post-primary and at least 98.1% post-booster had opsonophagocytic activity (OPA) titers ≥8 . Geometric mean antibody concentrations and OPA titers (except OPA titer for 6B) were higher post-booster than post-priming for each serotype. All PHiD-CV-vaccinated children had anti-protein D antibody concentrations ≥100 EL.U/ml one month post-primary/booster vaccination and all were seroprotected/seropositive against each DTPa antigen. Redness and irritability were the most common solicited AEs in both groups. Incidences of unsolicited AEs were comparable between groups. Serious AEs were reported for 47 children (28 in PHiD-CV group); none were assessed as vaccine-related. In conclusion, PHiD-CV induced robust immune responses and was well tolerated when co-administered with DTPa in a 3-dose priming plus booster regimen to Japanese children.
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- 2015
22. Abstracts from the 8th International Congress of the Asia Pacific Society of Infection Control (APSIC)
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Nantanit Sutthiruk, Mari Botti, Julie Considine, Andrea Driscoll, Ana Hutchinson, Kumthorn Malathum, Cucunawangsih Cucunawangsih, Veronica Wiwing, Vivien Puspitasari, Rathina Kumar Shanmugakani, Yukihiro Akeda, Takuya Kodera, Pitak Santanirand, Kazunori Tomono, Takayuki Yamanaka, Hiroyuki Moriuchi, Hiroyuki Kitajima, Yuho Horikoshi, Alyona Lavrinenko, Ilya Azizov, Nurlan Tabriz, Margulan Kozhamuratov, Yekatherine Serbo, Dahae Yang, Woonhyoung Lee, Il Kwon Bae, Jae Hyun Lee, Hyukmin Lee, Jung Ok Kim, Seok Hoon Jeong, Kyungwon Lee, Thiba Peremalo, Priya Madhavan, Sharina Hamzah, Leslie Than, Eng Hwa Wong, Mohd Nasir Mohd Desa, Kee Peng Ng, Marionne Geronimo, Maria Fe Tayzon, Maria Jesusa Maño, Angela Chow, Pei-Yun Hon, Mar-Kyaw Win, Brenda Ang, Yee-Sin Leo, Tina See, Rocio Alvarez Marin, Marta Aires de Sousa, Nicolas Kieffer, Patrice Nordmann, Laurent Poirel, Wison Laochareonsuk, Sireekul Petyu, Pawin Wanasitchaiwat, Sutasinee Thana, Chollathip Bunyaphongphan, Woranan Boonsomsuk, Pakpoom Maneepongpermpoon, Silom Jamulitrat, Dorairajan Sureshkumar, Kalyanaraman Supraja, Soundararajan Sharmila, Benny Setiawan, Nicolaski Lumbuun, Haruo Nakayama, Toshiko Ota, Naoko Shirane, Chikako Matuoka, Kentaro Kodama, Masanobu Ohtsuka, Silverose Ann Andales Bacolcol, Melecia Velmonte, Allan Alde, Keithleen Chavez, Arlene Joy Esteban, Aisa Jensen Lee, Tai-Chin Hsieh, null Shio-ShinJean, Huey-Jen Huang, Shu-Ju Huang, Yu-Huan Huang, Pei-Chen Cheng, Su-Fang Yu, Shih-Ming Tsao, Yuan-Ti Lee, Chien-Feng Li, Min-Chi Lu, Nattapol Pruetpongpun, Thana Khawcharoenporn, Pansachee Damronglerd, Nuntra Suwantarat, Anucha Apisarnthanarak, Sasinuch Rutjanawech, Lisa Cushinotto, Patty McBride, Harding Williams, Hans Liu, Phan Thi Hang, Dinh Pham Phuong Anh, Ngai Le, Dung Khu, Lam Nguyen, Roel Beltran Castillo, Ram Gopalakrishnan, Venkatasubramanian Ramasubramanian, Subramanian Sreevidya, Ranganathan Jayapradha, Atsushi Umetsu, Tetsuhiro Noda, Kenyuu Hashimoto, Akihiro Hayashi, Mikie Kabashima, Ursula Jadczak, Knut Elvelund, Marit Johnsen, Bente Borgen, Egil Lingaas, Chia-Hua Mao, Fu-Chieh Chang, Chang-Pan Liu, Ru-Hui Chao, Fu-chieh Chang, Chang-pan Liu, Junpen Pawapotako, Chadanan Prasertpan, Wantanee Malaihuan, Phisit Uirungroj, Chalermpong Saenjum, Teerapat Ouirungrog, Sue Borrell, Pauline Bass, Leon Worth, Zhao Xian-li, Li Xiao-long, Yao Xue-hua, Ren Wei, Zhang Xia Zeng, Man Ying Kong, Christopher Koon Chi Lai, Suet Yi Lee, Ngai Chong Tsang, M. M. O’Donoghue, M. V. Boost, L. K. P. Suen, G. K. Siu, K. W. Mui, C. K. C. Lai, D. N. C. Tsang, Yuka Sato, Mariko Tateishi, Mutsuko Mihashi, Jose Paulo Flor, Marko Bautista, V. Jay De Roxas, Justine Vergara, Nicolo Andrei Añonuevo, Marion Kwek, Jose Acuin, Anna Josea Sanchez, Avel Bathan, Jamilah Binte Jantan, Chua Chor Guek, Eu Chiow Kian, Pampe Anak Pirido, Nur Fadilah Binte Mohd Aron, Leah May Estacio, Francis Alvarez Palana, Michelle Gracia, Nur Syafiqah Binte Shamsuddin, Kersten Timbad Castro, Madonna Baloria, Faezah Binte Adam, Zhang Wei, Poh Bee Fong, Marimuthu Kalisvar, I-Ju Chuang, null Yi-ChunCho, Yu-Fen Chiu, Lung-Chih Chen, Yi-Chun Lin, Shao-Xing Dong, Yi-Chieh Lee, Hui-Chen Kuan, Hsin-Hua Lin, Chia-Chun Chi, Chin-Te Lu, Tang Ya-Fen, Su Li-Hsiang, Liu Jien-Wei, Hsuehlan Chao, PinRu ChangChien, WeiFang Chen, ChungHsu Lai, Lutfe Ara, Syed Mohammad Niaz Mowla, Shaikh Mahmud Kamal Vashkar, Wai Fong Chan, Mabel Yin ChunYau, Karen Kam LingChong, Tze OnLi, Rajwinder Kaur, Ng Po Yan, Gloria Chor Shan Chiu, Christina W. Y. Cheung, Patricia T. Y. Ching, Radley H. C. Ching, Conita H. S. Lam, C. H. Kan, Shirley S. Y. Lee, C. P. Chen, Regina F. Y. Chan, Annie F. Y. Leung, Isadora L. C. Wong, S. S. Lam, Queenie W. L. Chan, Cecilia Chan, Seyed Sadeq Seyed Nematian, Charles John Palenik, Mehrdad Askarian, Nahid Hatam, Itaru Nakamura, Hiroaki Fujita, Ayaka Tsukimori, Takehito Kobayashi, Akihiro Sato, Shinji Fukushima, Tetsuya Matsumoto, V. James De Roxas, V James De Roxas, Nicolo AndreiAñonuevo, Yeng May Ho, Jia Qi Kum, Bee Fong Poh, Kalisvar Marimuthu, Tzu-Yin Liu, Sin-Man Chu, Hui-Zhu Chen, Tun-chieh Chen, Yichun Chen, Ya-Ching Tsao, Sumawadee Skuntaniyom, Pirawadee Tipluy, Sangwan Paengta, Ratchanee wongsaen, Sutthiphun thanomphan, Samettanet Tariyo, Buachan Thongchuea, Pattama Khamfu, Sutthiphan Thanomphan, Wipaporn Natalie Songtaweesin, Suvaporn Anugulruengkit, Rujipat Samransamruajkit, Darintr Sosothikul, Ornanong Tansrijitdee, Anry Nakphunsung, Patchareeyawan Srimuan, Jirachaya Sophonphan, null ThanyaweePuthanakit, Kunyanut Payuk, Wilawan Picheansathian, Nongkran Viseskul, Elizabeth DeNardo, Rachel Leslie, Todd Cartner, Luciana Barbosa, Heinz-Peter Werner, Florian H. H. Brill, Julia Yaeko Kawagoe, Elizabeth De Nardo, Sarah Edmonds- Wilson, David Macinga, Patricia Mays-Suko, Collette Duley, Tran Thi Thuy Hang, Tran Thi My Hanh, Christopher Gordon, Roopa Durairaj, Anusha Rohit, Saujanya Saravanakumar, Jothymani Hemalatha, Ryuichi Hirano, Yuichi Sakamoto, Shoji Yamamoto, Naoki Tachibana, Miho Miura, Fumiyo Hieda, Yoshiro Sakai, Hiroshi Watanabe, Silverose Ann Bacolcol, Keitleen Chavez, Jia-Wei Lim, Aung-Aung Hein, Grace Tin, Vanessa Lim, Huwi-chun Chao, Chiu-Yin Yeh, Mei-feng Lo, Chonlada Piwpong, Songyos Rajborirug, Ploypailin Preechawetchakul, Yada Pruekrattananapa, Tharntip Sangsuwan, Ratchanee Wongsaen, Sungwan Paengta, Napatnun Nilchon, Sutthipun Thanompan, Samattanet Tariyo, Svetlana Kolesnichenko, Yerbol Tishkambayev, Asylkhan Alibecov, Yekaterina Serbo, Youngwon Nam, Jae Hyeon Park, Yun Ji Hong, Taek Soo Kim, Jeong Su Park, Kyoung Un Park, Eui-Chong Kim, Samuel Abumhere Aziegbemhin, Onaiwu Enabulele, Yao-Shen Tung, An-Chi Chen, Shen-Min Huang, Yui-Yein Yang, Li-Hung Wu, Chin-cheng Lin, Tzu Hao Lien, Jia Hao Chang, Yu Shan Huang, Yi Shun Chen, Sasithorn Sirilun, Phisit Ouirungroj, Suwanna Trakulsomboon, Patcharee Prasajak, Maryanne W. N. Kwok, Lady S. H. Ng, Lindy M. T. Wong, Lenina S. L. Poon, Mary K. L. Lai, Holly H. S. Cheng, S. K. Fong, Cindy F. Y. Leung, Jumpei Hasegawa, Hiroki Shirakawa, Sachiko Wakai, Makiko Mieno, Shuji Hatakeyama, Manu Deeudom, Prasit Tharavichitkul, Terrence Chinniah, Jackson Tan, Kavitha Prabu, Sartaj Alam, Aung Kyaw Wynn, Rashidah Ahmad, Amalina Sidek, Dg Azizah Samsuddin, Noraini Ajis, Aliyah Ahmad, Susylawathi Magon, Boon Chu, Jiqiu Kuang, Yan Gao, Shoujun Wang, Yunxiao Hao, Rong Liu, Dongmei Li, Hui Wang, Hisanori Nishio, Hitomi Mori, Yoshiko Morokuma, Takaaki Yamada, Makiko Kiyosuke, Sachie Yasunaga, Kazuhiro Toyoda, Nobuyuki Shimono, Dmitriy Babenko, Anar Turmuhambetova, Antonella Cheşcă, Mark A. Toleman, Lyudmila L. Akhmaltdinova, Mark Albert Magsakay, Angelo Macatibag, Jeannica Kriselle Lerios, Alyona Lavrineko, Dmitry Babenko, Eugene Sheck, Mikhail Edelstein, Lih-Yue Li, Chiung-Wen Chan, Hui-Chuan Pan, Wipa Vanishakije, Warisra Jaikampun, Su-Yin Li, Jian-Feng Li, Yu-Ping Wu, Chiao-Hui Lin, Ping-Chin Chang, Samatanet Tariyo, Suttsiphan Thanompan, Suchada Sukkra, Khalequ Zaman, Sheikh Farzana Zaman, Farzana Zaman, Asma Aziz, Sayeed-Bin Faisal, Magali Traskine, Javier Ruiz-Guiñazú, Dorota Borys, Wendy Wai Yee Lam, May Chow, Lucy Choy, Joseph Kam, Sharifah Azura Salleh, Razila Yacob, Siti Rokiah Yusof, Nordiah Awang Jalil, Maria Lourdes Millan, Jose Lito Acuin, Melecia A. Velmonte, Silverose Ann A. Bacolcol, Ching-I Ting, Sunisa Dissayasriroj, Terrence Rohan Chinniah, Jauharatud DiniSuhaimi, Aizzuddin Mirasin, Nurul Morni, Azizah Samsuddin, Amalina AbuBakar, Amanie Shafiee, Julaini Safar, Leung Annie, Fung Yuk Ling, Lau Edna, Luk Kristine, Satoshi Shinomiya, Kumiko Yamamoto, Kayoko Kjiwara, Mitsuhiro Yamaguchi, Wei Zhang, Bee-Fong Poh, Ming-Chin Chan, Chih-Chien Wang, Huan-Yu Huang, Chiung-Ling Lai, Sajeerat Kosol, Wantana Sakolwirat, Patchanee Paepong, Sawalee Jansanga, Pattarin Jaisamoot, Nuttha Thongnuanual, Chittima Srithong, Somporn Somsakul, Sutima Plongpunth, Mukkapon Punpop, Porntip Malathum, Kulada Peautiwat, Nattawipa boon kirdram, Pimpaporn Klunklin, Geetha Samethadka, Naoko Suzuki, Hitomi Asada, Masao Katayama, Atsushi Komano, Hidehiro Watanabe, Hye Kyung Seo, Joo-Hee Hwang, Myoung Jin Shin, Su Young Kim, Eu Suk Kim, Kyoung-Ho Song, Hong Bin Kim, Lai-Si Un, Choi-Ian Vong, Jocelyn Koh, Sherly Agustinus, Rozita Bte Abu Hassan, Yin Phyu Thinn, Benjamin Ng, Soe Pyae Tun, Su Mon Thi Ha, Xue Xiaoting, Lin Li, Leyland Chuang, Attanayaka Mudiyanselage Chulani Niroshika, Kaluarachchige Anoma Kaluarachchi Perera, Dimingo Kankanamalage Diana Grace Fernando, Bodhipakshage Rohini Hemamala, Chiu-yin Yeh, Hui-Chun Yang, Hsiang-Ju Chiu, Ya-Ling Shih, Yu-Shan Chien, Wan-Yi Lin, Chia-Yun Pan, Ying-Yun Chang, Chiu-Yuch Yea, Ming-Hsien Chu, Li-Chu Lee, Lin Yu-Hsiu, Guo Siao-Pei, Leung Pak-On, Sie Mei-Fe, Chen Jyh-Jou, Chang Yong-Yuan, Shu-Yuan Kuo, Yu-Hsiu Lin, Ji-Sheng Zhang, Pak-On Leung, Mei-Fe Sie, Jyh-Jou Chen, Yan-Ru Chen, Ying-Ling Chen, Chi-Fen Taou, Hsiao-Shan Chen, Hung-Jen Tang, Shin Yu Chen, Yin Yin Chen, Fu Der Wang, Tzu-Ping Shih, Chin-Yu Chen, Su-Jung Chen, Mei-chi Wu, Wan-ju Yang, Mei-ling Chou, Man-Ling Yu, Li-Chu Li, Cheng-Wei Chu, Wen-Hao Tsou, Wen-Chih Wu, Wen-Chi Cheng, Cho-Ching Sun, Shu-Hua Lu, Hsin-Ling Yang, Cheng-Yu Lu, Nitchawan Hirunprapakorn, Sirilux Apivanich, Ttipakorn Pornmee, Chonnikarnt Beowsomboon, Itthaporn Kumkoom, Nongyao Kasatpibal, Jittaporn Chitreecheur, JoAnne D. Whitney, Surasak Saokaew, Kirati Kengkla, Margaret M. Heitkemper, Thanomvong Muntajit, Siriluk Apivanich, Hang Thi Phan, Anh Pham Phuong Dinh, and Tuyet Thi Kim Nguyen
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0301 basic medicine ,Microbiology (medical) ,business.industry ,030106 microbiology ,Public Health, Environmental and Occupational Health ,03 medical and health sciences ,Infectious Diseases ,Asia pacific ,Environmental protection ,International congress ,Medicine ,Infection control ,Pharmacology (medical) ,Socioeconomics ,business - Published
- 2017
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23. Immunogenicity of a 2 + 1 Infant Vaccination Series with 13-Valent Pneumococcal Conjugate Vaccine (PCV13) Followed by Pneumococcal Non-Typeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV): a Randomized Trial Exploring Interchangeability of PCVs
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Maria Yolanda Cervantes-Apolinar, Miguel Angel Rodríguez-Weber, Pedro Sánchez-Márquez, Roberto Carreño-Manjarrez, Dorota Borys, Eduardo Ortega-Barria, Abiel Mascareñas de los Santos, and Javier Ruiz-Guiñazú
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business.industry ,Immunogenicity ,030231 tropical medicine ,medicine.disease_cause ,Virology ,Pneumococcal conjugate vaccine ,Haemophilus influenzae ,law.invention ,Vaccination ,03 medical and health sciences ,0302 clinical medicine ,Infectious Diseases ,Oncology ,Infant vaccination ,Randomized controlled trial ,Conjugate vaccine ,law ,Immunology ,medicine ,Non typeable ,030212 general & internal medicine ,business ,medicine.drug - Published
- 2017
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24. Vaccination with 10-valent pneumococcal conjugate vaccine in infants according to HIV status
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Marta Moreira, Clare L. Cutland, Javier Ruiz-Guiñazú, Juan-Pablo Yarzabal, Shabir A. Madhi, Peter V. Adrian, Anthonet Koen, Nancy François, Dorota Borys, Lisa Jose, Lode Schuerman, and Nadia van Niekerk
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safety ,10-valent pneumococcal conjugate vaccine ,Lipoproteins ,030231 tropical medicine ,Immunization, Secondary ,HIV Infections ,immunization ,medicine.disease_cause ,complex mixtures ,Pneumococcal Infections ,Haemophilus influenzae ,Pneumococcal Vaccines ,South Africa ,03 medical and health sciences ,0302 clinical medicine ,Bacterial Proteins ,Conjugate vaccine ,Humans ,Medicine ,030212 general & internal medicine ,Vaccines, Conjugate ,Reactogenicity ,business.industry ,Immunogenicity ,Vaccination ,Infant ,HIV ,acquired immunodeficiency syndrome ,Immunoglobulin D ,Clinical Trial/Experimental Study ,General Medicine ,medicine.disease ,Antibodies, Bacterial ,Virology ,Pneumococcal infections ,Immunization ,Immunoglobulin G ,Africa ,ComputingMethodologies_DOCUMENTANDTEXTPROCESSING ,Hiv status ,Carrier Proteins ,business ,Research Article - Abstract
Supplemental Digital Content is available in the text, Background: Phase III, open-label, single-center, controlled study in South Africa (ClinicalTrials.gov: NCT00829010) to evaluate immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in human immunodeficiency virus (HIV)-infected (HIV+), HIV-exposed-uninfected (HEU), and HIV-unexposed-uninfected (HUU) children. Methods: Children stratified by HIV status received PHiD-CV primary vaccination (age 6/10/14 weeks; coadministered with routine childhood vaccines) and booster dose (age 9–10 months). Immune responses, assessed using enzyme-linked immunosorbent and functional assays, and safety were evaluated up to 14 months post-booster. Results: Of 83, 101, and 100 children enrolled in HIV+, HEU, and HUU groups, 70, 91, and 93 were included in according-to-protocol immunogenicity cohort. For each vaccine-serotype, percentages of children with antibody concentrations ≥0.2 μg/mL were ≥97% 1 month post-primary vaccination and ≥98.5% 1 month post-booster (except for 6B and 23F at both timepoints). Post-primary vaccination, functional antibody responses were lower in HIV+ children: for each vaccine-serotype, percentages of children with opsonophagocytic activity (OPA) titres ≥8 were ≥72%, ≥81%, and ≥79% for HIV+, HEU, and HUU children. Post-booster, ≥87% of children in each group had OPA titres ≥8. Reactogenicity was similar across groups. Thirty one (37%) HIV+, 25 (25%) HEU, and 20 (20%) HUU children reported ≥1 serious adverse event. Five HIV+ and 4 HEU children died. One death (sudden infant death syndrome; HEU group; 3 days post-dose 1) was considered potentially vaccine-related. Conclusion: PHiD-CV was immunogenic and well-tolerated in HIV+, HEU, and HUU children, and has the potential to provide substantial benefit irrespective of HIV infection status.
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- 2017
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