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59. Optimising the timing of whooping cough immunisation in mums (OpTIMUM) through investigating pertussis vaccination in pregnancy: an open-label, equivalence, randomised controlled trial

Author

Calvert, Anna, primary, Amirthalingam, Gayatri, additional, Andrews, Nick, additional, Basude, Sneha, additional, Coleman, Matthew, additional, Cuthbertson, Hannah, additional, England, Anna, additional, Greening, Vanessa, additional, Hallis, Bassam, additional, Johnstone, Edward, additional, Jones, Christine E, additional, Karampatsas, Konstantinos, additional, Khalil, Asma, additional, Le Doare, Kirsty, additional, Matheson, Mary, additional, Peregrine, Elisabeth, additional, Snape, Matthew D, additional, Vatish, Manu, additional, Heath, Paul T, additional, Burtt, Agnieszka, additional, Byrne, Wendy, additional, Capp, Angelika, additional, Carty, Lotoyah, additional, Chawla, Krina, additional, Collins, Sarah, additional, Cornish, Emily, additional, Daniel, Olwenn, additional, Fretwell, Jessica, additional, Gorringe, Andrew, additional, Gubbins, Teresa, additional, Hall, Tom, additional, Johnston, Susan, additional, Khan, Uzma, additional, Lim, Suzy, additional, Martin, Nicki, additional, Morey, Ella, additional, Mossop, Jude, additional, O'Brien, Katie, additional, Owino, Nelly, additional, Powell, Deborah, additional, Ramkhelawon, Laxmee, additional, Ratcliffe, Helen, additional, Roberts, Hannah, additional, Roseman, Fenella, additional, Sparks, Laura, additional, Stapley, Lorraine, additional, Taylor, Stephen, additional, Walbridge, Fiona, additional, Watts, Rosie, additional, Wellstead, Susan J., additional, and Wishlade, Tabitha, additional

Published
2023
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61. Improving the Treatment of Neonatal Sepsis in Resource-Limited Settings: Gaps and Recommendations

Author

Sturrock,Sarah, Sadoo,Samantha, Nanyunja,Carol, Le Doare,Kirsty, Sturrock,Sarah, Sadoo,Samantha, Nanyunja,Carol, and Le Doare,Kirsty

Abstract

Sarah Sturrock,1 Samantha Sadoo,2 Carol Nanyunja,3 Kirsty Le Doare1,4,5 1Centre for Neonatal and Paediatric Infection, St George’s, University of London, London, UK; 2Department of Infectious Disease Epidemiology and International Health, London School of Hygiene & Tropical Medicine, London, UK; 3MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda; 4UK Health Security Agency, Salisbury, UK; 5Makerere University, Johns Hopkins University, Kampala, UgandaCorrespondence: Sarah Sturrock, Centre for Neonatal and Paediatric Infection, Maternal and Neonatal Vaccine Immunology Research Group, St George’s, University of London, Cranmer Terrace, London, SW17 0RE, United Kingdom, Tel +44 7855 478 360, Email ssturroc@sgul.ac.ukAbstract: Neonatal sepsis causes significant global morbidity and mortality, with the highest burden in resource-limited settings where 99% of neonatal deaths occur. There are multiple challenges to achieving successful treatment of neonates in this setting. Firstly, reliable and low-cost strategies for risk identification are urgently needed to facilitate treatment as early as possible. Improved laboratory capacity to allow identification of causative organisms would support antimicrobial stewardship. Antibiotic treatment is still hampered by availability, but also increasingly by antimicrobial resistance – making surveillance of organisms and judicious antibiotic use a priority. Finally, supportive care is key in the management of the neonate with sepsis and has been underrecognized as a priority in resource-limited settings. This includes fluid balance and nutritional support in the acute phase, and follow-up care in order to mitigate complications and optimise long-term outcomes. There is much more work to be done in identifying the holistic needs of neonates and their families to provide effective family-integrated interventions and complete the package of neonatal sepsis management in resource-limited settings.Keywords: neonate, low

Published
2023

62. Adverse maternal, fetal, and newborn outcomes among pregnant women with SARS-CoV-2 infection: an individual participant data meta-analysis

Author

Kalafat, Erkan (ORCID 0000-0003-0658-138X & YÖK ID 197389), Smith, Emily R.; Oakley, Erin; Grandner, Gargi Wable; Ferguson, Kacey; Farooq, Fouzia; Afshar, Yalda; Ahlberg, Mia; Ahmadzia, Homa; Akelo, Victor; Aldrovandi, Grace; Barr, Beth A. Tippett; Bevilacqua, Elisa; Brandt, Justin S.; Broutet, Nathalie; Buhigas, Irene Fernandez; Carrillo, Jorge; Clifton, Rebecca; Conry, Jeanne; Cosmi, Erich; Crispi, Fatima; Crovetto, Francesca; Delgado-Lopez, Camille; Divakar, Hema; Driscoll, Amanda J.; Favre, Guillaume; Flaherman, Valerie J.; Gale, Chris; Gil, Maria M.; Gottlieb, Sami L.; Gratacos, Eduard; Hernandez, Olivia; Jones, Stephanie; Khagayi, Sammy; Knight, Marian; Kotloff, Karen; Lanzone, Antonio; Le Doare, Kirsty; Lees, Christoph; Litman, Ethan; Lokken, Erica M.; Laurita Longo, Valentina; Madhi, Shabir A.; Magee, Laura A.; Martinez-Portilla, Raigam Jafet; McClure, Elizabeth M.; Metz, Tori D.; Miller, Emily S.; Money, Deborah; Moungmaithong, Sakita; Mullins, Edward; Nachega, Jean B.; Nunes, Marta C.; Onyango, Dickens; Panchaud, Alice; Poon, Liona C.; Raiten, Daniel; Regan, Lesley; Rukundo, Gordon; Sahota, Daljit; Sakowicz, Allie; Sanin-Blair, Jose; Soderling, Jonas; Stephansson, Olof; Temmerman, Marleen; Thorson, Anna; Tolosa, Jorge E.; Townson, Julia; Valencia-Prado, Miguel; Visentin, Silvia; von Dadelszen, Peter; Waldorf, Kristina Adams; Whitehead, Clare; Yassa, Murat; Tielsch, Jim M., School of Medicine, Kalafat, Erkan (ORCID 0000-0003-0658-138X & YÖK ID 197389), Smith, Emily R.; Oakley, Erin; Grandner, Gargi Wable; Ferguson, Kacey; Farooq, Fouzia; Afshar, Yalda; Ahlberg, Mia; Ahmadzia, Homa; Akelo, Victor; Aldrovandi, Grace; Barr, Beth A. Tippett; Bevilacqua, Elisa; Brandt, Justin S.; Broutet, Nathalie; Buhigas, Irene Fernandez; Carrillo, Jorge; Clifton, Rebecca; Conry, Jeanne; Cosmi, Erich; Crispi, Fatima; Crovetto, Francesca; Delgado-Lopez, Camille; Divakar, Hema; Driscoll, Amanda J.; Favre, Guillaume; Flaherman, Valerie J.; Gale, Chris; Gil, Maria M.; Gottlieb, Sami L.; Gratacos, Eduard; Hernandez, Olivia; Jones, Stephanie; Khagayi, Sammy; Knight, Marian; Kotloff, Karen; Lanzone, Antonio; Le Doare, Kirsty; Lees, Christoph; Litman, Ethan; Lokken, Erica M.; Laurita Longo, Valentina; Madhi, Shabir A.; Magee, Laura A.; Martinez-Portilla, Raigam Jafet; McClure, Elizabeth M.; Metz, Tori D.; Miller, Emily S.; Money, Deborah; Moungmaithong, Sakita; Mullins, Edward; Nachega, Jean B.; Nunes, Marta C.; Onyango, Dickens; Panchaud, Alice; Poon, Liona C.; Raiten, Daniel; Regan, Lesley; Rukundo, Gordon; Sahota, Daljit; Sakowicz, Allie; Sanin-Blair, Jose; Soderling, Jonas; Stephansson, Olof; Temmerman, Marleen; Thorson, Anna; Tolosa, Jorge E.; Townson, Julia; Valencia-Prado, Miguel; Visentin, Silvia; von Dadelszen, Peter; Waldorf, Kristina Adams; Whitehead, Clare; Yassa, Murat; Tielsch, Jim M., and School of Medicine

Abstract

Introduction: despite a growing body of research on the risks of SARS-CoV-2 infection during pregnancy, there is continued controversy given heterogeneity in the quality and design of published studies. Methods: we screened ongoing studies in our sequential, prospective meta-analysis. We pooled individual participant data to estimate the absolute and relative risk (RR) of adverse outcomes among pregnant women with SARS-CoV-2 infection, compared with confirmed negative pregnancies. We evaluated the risk of bias using a modified Newcastle-Ottawa Scale. Results: we screened 137 studies and included 12 studies in 12 countries involving 13 136 pregnant women. Pregnant women with SARS-CoV-2 infection-as compared with uninfected pregnant women-were at significantly increased risk of maternal mortality (10 studies; n=1490; RR 7.68, 95% CI 1.70 to 34.61); admission to intensive care unit (8 studies; n=6660; RR 3.81, 95% CI 2.03 to 7.17); receiving mechanical ventilation (7 studies; n=4887; RR 15.23, 95% CI 4.32 to 53.71); receiving any critical care (7 studies; n=4735; RR 5.48, 95% CI 2.57 to 11.72); and being diagnosed with pneumonia (6 studies; n=4573; RR 23.46, 95% CI 3.03 to 181.39) and thromboembolic disease (8 studies; n=5146; RR 5.50, 95% CI 1.12 to 27.12). Neonates born to women with SARS-CoV-2 infection were more likely to be admitted to a neonatal care unit after birth (7 studies; n=7637; RR 1.86, 95% CI 1.12 to 3.08); be born preterm (7 studies; n=6233; RR 1.71, 95% CI 1.28 to 2.29) or moderately preterm (7 studies; n=6071; RR 2.92, 95% CI 1.88 to 4.54); and to be born low birth weight (12 studies; n=11 930; RR 1.19, 95% CI 1.02 to 1.40). Infection was not linked to stillbirth. Studies were generally at low or moderate risk of bias. Conclusions: this analysis indicates that SARS-CoV-2 infection at any time during pregnancy increases the risk of maternal death, severe maternal morbidities and neonatal morbidity, but not stillbirth or intrauterine growth restriction, Funded by the Bill & Melinda Gates Foundation grant to ERS (INV- 022057).

Published
2023

63. Standardizing case definitions for monitoring the safety of maternal vaccines globally: GAIA definitions, a review of progress to date

Author

Davies, Hannah G., Bowman, Conor, Watson, Gabriella, Dodd, Caitlin, Jones, Christine E., Munoz, Flor M., Heath, Paul T., Cutland, Clare L., and Le Doare, Kirsty

Abstract

In 2014, the Global Alignment on Immunization safety Assessment in pregnancy consortium (GAIA) was formed, with the goal of developing a harmonized, globally-concerted approach to actively monitor the safety of vaccines in pregnancy. A total of 26 standardized definitions for the classification of adverse events have been developed. The aim of this review was to identify and describe studies undertaken to assess the performance of these definitions. A literature search was undertaken to identify published studies assessing the performance of the definitions, and reference lists were snowballed. Data were abstracted by two investigators and a narrative review of the results is presented. Four studies that have evaluated 13 GAIA case definitions (50%) were identified. Five case definitions have been assessed in high-income settings only. Recommendations have been made by the investigators to improve the performance of the definitions. These include ensuring consistency across definitions, removal of the potential for ambiguity or variations in interpretation and ensuring that higher-level criteria are acceptable at lower levels of confidence. Future research should prioritize the key case definitions that have not been assessed in low- and middle-income settings, as well as the 13 that have not undergone any validation.

Published
2023

64. An open-label, phase IV randomised controlled trial of two schedules of a four-component meningococcal B vaccine in UK preterm infants

Author

Calvert, Anna, Andrews, Nick, Barlow, Sheula, Borrow, Ray, Black, Charlotte, Bromage, Barbara, Carr, Jeremy, Clarke, Paul, Collinson, Andrew C, Few, Karen, Hayward, Naomi, Jones, Christine E, Le Doare, Kirsty, Ladhani, Shamez N, Louth, Jennifer, Papadopoulou, Georgia, Pople, Michelle, Scorrer, Tim, Snape, Matthew D, and Heath, Paul T

Abstract

ObjectiveTo compare immunological responses of preterm infants to a four-component meningococcal B vaccine (4CMenB; Bexsero) following a 2+1 vs a 3+1 schedule, and to describe reactogenicity of routine vaccines.DesignAn open-label, phase IV randomised study conducted across six UK sites.SettingNeonatal units, postnatal wards, community recruitment following discharge.Participants129 preterm infants born at a gestation of <35 weeks (64 in group 1 (2+1), 65 in group 2 (3+1)) were included in the analysis. Analysis was completed for postprimary samples from 125 participants (59 in group 1, 66 in group 2) and for postbooster samples from 118 participants (59 in both groups).InterventionsInfants randomised to 4CMenB according to a 2+1 or a 3+1 schedule, alongside routine vaccines.Main outcome measuresSerum bactericidal antibody (SBA) assays performed at 5, 12 and 13 months of age: geometric mean titres (GMTs) and proportions of infants achieving titres ≥4 compared between groups.ResultsThere were no significant differences in SBA GMTs between infants receiving a 2+1 compared with a 3+1 schedule following primary or booster vaccination, but a significantly higher proportion of infants had an SBA titre ≥4 against strain NZ98/254 (porin A) at 1 month after primary vaccination using a 3+1 compared with a 2+1 schedule (3+1: 87% (95% CI 76 to 94%), 2+1: 70% (95% CI 56 to 81%), p=0.03).At 12 weeks of age those in the 3+1 group, who received a dose of 4CMenB, had significantly more episodes of fever >38.0°C than those in the 2+1 group who did not (group 2+1: 2% (n=1); 3+1: 14% (n=9); p=0.02).ConclusionsBoth schedules were immunogenic in preterm infants, although a lower response against strain NZ98/254 was seen in the 2+1 schedule; ongoing disease surveillance is important in understanding the clinical significance of this difference.Trial registration numberNCT03125616.

Published
2024
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67. Using Dried Blood Spots for a Sero-Surveillance Study of Maternally Derived Antibody against Group B Streptococcus

Author

Auma, Erick, primary, Hall, Tom, additional, Chopra, Simran, additional, Bilton, Sam, additional, Ramkhelawon, Laxmee, additional, Amini, Fahimah, additional, Calvert, Anna, additional, Amirthalingam, Gayatri, additional, Jones, Christine E., additional, Andrews, Nick, additional, Heath, Paul T., additional, and Le Doare, Kirsty, additional

Published
2023
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70. Paediatric, Maternal and Congenital Mpox, Prevention, and Treatment: A Systematic Review and Meta-Analysis

Author

Sanchez Clemente, Nuria, primary, Coles, Charlotte, additional, Paixão, Enny S., additional, Brickley, Elizabeth B., additional, Whittaker, Elizabeth, additional, Alfven, Tobias, additional, Rulisa, Stephen, additional, Agudelo-Higuita, Nelson, additional, Torpiano, Paul, additional, Agravat, Priyesh, additional, Thorley, Emma V., additional, Drysdale, Simon B., additional, Le Doare, Kirsty, additional, and Muyembe, Jean-Jacques, additional

Published
2023
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77. Group B streptococcus infection during pregnancy and infancy: estimates of regional and global burden

Author

Gonçalves, Bronner P, primary, Procter, Simon R, additional, Paul, Proma, additional, Chandna, Jaya, additional, Lewin, Alexandra, additional, Seedat, Farah, additional, Koukounari, Artemis, additional, Dangor, Ziyaad, additional, Leahy, Shannon, additional, Santhanam, Sridhar, additional, John, Hima B, additional, Bramugy, Justina, additional, Bardají, Azucena, additional, Abubakar, Amina, additional, Nasambu, Carophine, additional, Libster, Romina, additional, Sánchez Yanotti, Clara, additional, Horváth-Puhó, Erzsébet, additional, Sørensen, Henrik T, additional, van de Beek, Diederik, additional, Bijlsma, Merijn W, additional, Gardner, William M, additional, Kassebaum, Nicholas, additional, Trotter, Caroline, additional, Bassat, Quique, additional, Madhi, Shabir A, additional, Lambach, Philipp, additional, Jit, Mark, additional, Lawn, Joy E, additional, Søgaard, Kirstine K., additional, van Kassel, Merel N., additional, Snoek, Linde, additional, de Gier, Brechje, additional, van der Ende, Arie, additional, Hahné, Susan J M, additional, Harden, Lois M., additional, Ghoor, Azra, additional, Mbatha, Sibongile, additional, Lowick, Sarah, additional, Laughton, Barbara, additional, Jaye, Tamara, additional, Lala, Sanjay G, additional, Sithole, Pamela, additional, Msayi, Jacqueline, additional, Kumalo, Ntombifuthi, additional, Msibi, Tshepiso Nompumelelo, additional, Arumugam, Asha, additional, Murugesan, Nandhini, additional, Rajendraprasad, Nandhini, additional, Priya, Mohana, additional, Mabrouk, Adam, additional, Katana, Patrick Vidzo, additional, Mwangome, Eva, additional, Newton, Charles R., additional, Mucasse, Humberto, additional, Aerts, Celine, additional, Massora, Sergio, additional, Medina, Valeria, additional, Rojas, Andrea, additional, Amado, Daniel, additional, Llapur, Conrado J., additional, Hossain, A. K. M. Tanvir, additional, Rahman, Qazi Sadeq-ur, additional, Ip, Margaret, additional, Seale, Anna, additional, Heath, Paul T., additional, Le Doare, Kirsty, additional, Khalil, Asma, additional, Schrag, Stephanie J., additional, Sobanjo-ter Meulen, Ajoke, additional, Mason, Elizabeth, additional, Blau, Dianna M, additional, El Arifeen, Shams, additional, Assefa, Nega, additional, Onyango, Dickens, additional, Sow, Samba O., additional, Mandomando, Inacio, additional, Ogbuanu, Ikechukwu, additional, Kotloff, Karen L., additional, Scott, J. Anthony G., additional, Gurley, Emily S., additional, Barr, Beth A. Tippet, additional, and Mahtab, Sana, additional

Published
2022
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78. Protocol for the Birth Asphyxia in African Newborns (Baby BRAiN) Study: a Neonatal Encephalopathy Feasibility Cohort Study

Author

Nanyunja, Carol, Sadoo, Samantha; https://orcid.org/0000-0002-4921-3651, Mambule, Ivan, Mathieson, Sean R, Nyirenda, Moffat, Webb, Emily L, Mugalu, J, Robertson, Nicola J, Nabawanuka, A, Gilbert, Guillaume, Bwambale, J, Martinello, Kathryn; https://orcid.org/0000-0002-7490-7313, Bainbridge, Alan, Lubowa, Samson, Srinivasan, Latha, Ssebombo, H, Morgan, Cathy, Hagmann, Cornelia; https://orcid.org/0000-0003-2647-9809, Cowan, Frances M, Le Doare, Kirsty; https://orcid.org/0000-0002-5104-085X, Wintermark, Pia; https://orcid.org/0000-0002-7611-6670, Kawooya, Michael, Boylan, Geraldine B, Nakimuli, Annettee, Tann, Cally J, Nanyunja, Carol, Sadoo, Samantha; https://orcid.org/0000-0002-4921-3651, Mambule, Ivan, Mathieson, Sean R, Nyirenda, Moffat, Webb, Emily L, Mugalu, J, Robertson, Nicola J, Nabawanuka, A, Gilbert, Guillaume, Bwambale, J, Martinello, Kathryn; https://orcid.org/0000-0002-7490-7313, Bainbridge, Alan, Lubowa, Samson, Srinivasan, Latha, Ssebombo, H, Morgan, Cathy, Hagmann, Cornelia; https://orcid.org/0000-0003-2647-9809, Cowan, Frances M, Le Doare, Kirsty; https://orcid.org/0000-0002-5104-085X, Wintermark, Pia; https://orcid.org/0000-0002-7611-6670, Kawooya, Michael, Boylan, Geraldine B, Nakimuli, Annettee, and Tann, Cally J

Abstract

BACKGROUND: Neonatal encephalopathy (NE) is a leading cause of child mortality worldwide and contributes substantially to stillbirths and long-term disability. Ninety-nine percent of deaths from NE occur in low-and-middle-income countries (LMICs). Whilst therapeutic hypothermia significantly improves outcomes in high-income countries, its safety and effectiveness in diverse LMIC contexts remains debated. Important differences in the aetiology, nature and timing of neonatal brain injury likely influence the effectiveness of postnatal interventions, including therapeutic hypothermia. METHODS: This is a prospective pilot feasibility cohort study of neonates with NE conducted at Kawempe National Referral Hospital, Kampala, Uganda. Neurological investigations include continuous video electroencephalography (EEG) (days 1-4), serial cranial ultrasound imaging, and neonatal brain Magnetic Resonance Imaging and Spectroscopy (MRI/ MRS) (day 10-14). Neurodevelopmental follow-up will be continued to 18-24 months of age including Prechtl's Assessment of General Movements, Bayley Scales of Infant Development, and a formal scored neurological examination. The primary outcome will be death and moderate-severe neurodevelopmental impairment at 18-24 months. Findings will be used to inform explorative science and larger trials, aiming to develop urgently needed neuroprotective and neurorestorative interventions for NE applicable for use in diverse settings. DISCUSSION: The primary aims of the study are to assess the feasibility of establishing a facility-based cohort of children with NE in Uganda, to enhance our understanding of NE in a low-resource sub-Saharan African setting and provide infrastructure to conduct high-quality research on neuroprotective/ neurorestorative strategies to reduce death and disability from NE. Specific objectives are to establish a NE cohort, in order to 1) investigate the clinical course, aetiology, nature and timing of perinatal brain injury; 2) describe

Published
2022

79. The safety and immunogenicity of a combined pertussis containing vaccine Tdap for HIV infected pregnant women and their newborns (WoMANPOWER) – A study protocol for a randomized clinical trial

Author

Nakabembe, Eve, primary, Abu-Raya, Bahaa, additional, Kyohere, Mary, additional, Tusubira, Valerie, additional, Amone, Alexander, additional, Nakibuuka, Lydia, additional, Cochet, Madeleine, additional, Nakimuli, Annettee, additional, Voysey, Merryn, additional, Gorringe, Andrew, additional, Heath, Paul T., additional, Musoke, Philippa, additional, Andrews, Nick, additional, Sekikubo, Musa, additional, Sadarangani, Manish, additional, and Le Doare, Kirsty, additional

Published
2022
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80. Comparison of Neurodevelopmental Outcomes in Children With Group B Streptococcal Sepsis and Meningitis

Author

Davies, Hannah G, primary, O’Sullivan, Catherine P, additional, Al Janabi, Hareth, additional, Rattue, Hilary, additional, Trotter, Caroline, additional, Giorgakoudi, Kyriaki, additional, Ramsay, Mary, additional, Ladhani, Shamez, additional, Lamagni, Theresa, additional, Okike, Ifeanyichukwu O, additional, Le Doare, Kirsty, additional, and Heath, Paul T, additional

Published
2022
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83. Protocol for the Birth Asphyxia in African Newborns (Baby BRAiN) Study: a Neonatal Encephalopathy Feasibility Cohort Study

Author

Nanyunja, Carol, primary, Sadoo, Samantha, additional, Mambule, Ivan, additional, Mathieson, Sean R, additional, Nyirenda, Moffat, additional, Webb, Emily L, additional, Mugalu, J, additional, Robertson, Nicola J, additional, Nabawanuka, A, additional, Gilbert, Guillaume, additional, Bwambale, J, additional, Martinello, Kathryn, additional, Bainbridge, Alan, additional, Lubowa, Samson, additional, Srinivasan, Latha, additional, Ssebombo, H, additional, Morgan, Cathy, additional, Hagmann, Cornelia, additional, Cowan, Frances M, additional, Le Doare, Kirsty, additional, Wintermark, Pia, additional, Kawooya, Michael, additional, Boylan, Geraldine B, additional, Nakimuli, Annettee, additional, and Tann, Cally J, additional

Published
2022
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84. An internally validated prediction model for critical COVID-19 infection and intensive care unit admission in symptomatic pregnant women

Author

Kalafat, Erkan, primary, Prasad, Smriti, additional, Birol, Pinar, additional, Tekin, Arzu Bilge, additional, Kunt, Atilla, additional, Di Fabrizio, Carolina, additional, Alatas, Cengiz, additional, Celik, Ebru, additional, Bagci, Helin, additional, Binder, Julia, additional, Le Doare, Kirsty, additional, Magee, Laura A., additional, Mutlu, Memis Ali, additional, Yassa, Murat, additional, Tug, Niyazi, additional, Sahin, Orhan, additional, Krokos, Panagiotis, additional, O’brien, Pat, additional, von Dadelszen, Peter, additional, Palmrich, Pilar, additional, Papaioannou, George, additional, Ayaz, Reyhan, additional, Ladhani, Shamez N., additional, Kalantaridou, Sophia, additional, Mihmanli, Veli, additional, and Khalil, Asma, additional

Published
2022
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85. COVID-19 vaccination during pregnancy: coverage and safety

Author

Blakeway, Helena, primary, Prasad, Smriti, additional, Kalafat, Erkan, additional, Heath, Paul T., additional, Ladhani, Shamez N., additional, Le Doare, Kirsty, additional, Magee, Laura A., additional, O’Brien, Pat, additional, Rezvani, Arezou, additional, von Dadelszen, Peter, additional, and Khalil, Asma, additional

Published
2022
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87. Vaccinating Children against SARS-CoV-2: A Literature Review and Survey of International Experts to Assess Safety, Efficacy and Perceptions of Vaccine Use in Children.

Author

Hookham, Lauren, Lee, Hillary C., Patel, Divya A., Coelho, Mariana, Giglio, Norberto, Le Doare, Kirsty, and Pannaraj, Pia S.

Subjects
VACCINATION of children, VACCINE effectiveness, HEALTH attitudes, VACCINE safety, LITERATURE reviews
Abstract

Introduction: The balance of risks and benefits of COVID-19 vaccination in children is more complex than in adults with limited paediatric data resulting in no global consensus on whether all healthy children should be vaccinated. We sought to assess the safety, efficacy, and effectiveness of childhood vaccination against SARS-CoV-2, as well as better understanding perceptions of vaccination in parents and vaccine experts. Methods: We performed a literature review for COVID-19 vaccine safety, efficacy, effectiveness, and perceptions. We searched international safety databases for safety data and developed an electronic survey to elicit country-specific COVID-19 immunisation data, including vaccine regulations, policies, rates, and public attitudes solicited from vaccine experts. Results: Nine studies were included in the final safety analysis. Local reactions were frequently reported across all studies and vaccine types. Adverse events reported to surveillance systems tended to be non-serious, and commonly included injection site reactions and dizziness. Twenty-three studies reported immunogenicity, efficacy, and effectiveness data. There were nine randomised control trials of six different vaccine types, which showed seroconversion of neutralising antibodies in vaccinated children ranging from 88% to 100%. The vaccine efficacy for Pfizer and Moderna vaccines ranged from 88% to 100%. There were 118 survey responses representing 55 different countries. Reported vaccination rates ranged from <1% to 98%. Most respondents described "mixed opinions" regarding paediatric vaccination policies in their country. By region, a more positive public attitude towards vaccination correlated with higher vaccination rates. Discussion: In this mixed-methods review, we have found evidence that vaccination against COVID-19 in children is safe, efficacious, and effective. Overall, the combined evidence from both the literature review and survey highlights the need for further data on both the safety and effectiveness of COVID-19 vaccinations in children. [ABSTRACT FROM AUTHOR]

Published
2023
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88. Optimising the Timing of whooping cough Immunisation in MUMs (OpTIMUM): A randomised controlled trial investigating the timing of pertussis vaccination in pregnancy

Author

Calvert, Anna, Karampelas, Konstantinos, Andrews, Nick, England, Anna, Hallis, Bassam, Jones, Christine E, Khalil, Asma, Le Doare, Kirsty, Matheson, Mary, Snape, Matthew D., and Heath, Paul T.

Abstract

Background: Pertussis is a highly infectious respiratory illness caused by the bacteria Bordetella pertussis. A resurgence of pertussis, even in countries with good vaccine coverage, has led to an increase in infant deaths. In response to this, many countries have introduced pertussis vaccination in pregnancy. This strategy is effective at preventing infant disease, but there remains uncertainty about what gestational timing is best to ensure maximal protection of the infant. These uncertainties are the rationale for this randomised controlled trial and a sub-study investigating pertussis-specific antibody in breastmilk. Protocol: We will recruit 354 pregnant women and will randomise them to receive their pertussis vaccination in one of three gestational age windows: ≤23+6, 24-27+6 and 28-31+6 weeks of gestation. Vaccination will be with Boostrix-IPV® and participants will be asked to complete a symptom diary for seven days following vaccination. Blood sampling will be performed prior to vaccination, two weeks following vaccination and at the time of delivery. A cord blood sample will be collected at delivery and a blood sample collected from the infant 4-10 weeks after completion of the primary immunisations. Individuals participating in the breastmilk sub-study will provide a sample of colostrum within 48 hours of delivery and samples of breastmilk at two weeks and around five-six months. Blood samples will be analysed using enzyme linked immunosorbent assay (ELISA) techniques for pertussis toxin, filamentous haemagglutinin and pertactin. A subset of serum samples will also be analysed using a functional assay. Colostrum and breastmilk samples will be analysed using functional assays.Discussion: Although pertussis vaccination has been shown to be safe and effective in pregnancy there remains debate about the optimal timing for the administration during pregnancy. This study will investigate antibody responses in serum and breastmilk when vaccination is performed in three different time periods.Clinicaltrials.gov registration: NCT03908164 (09/04/2019)

Published
2021

89. Invasive group B Streptococcus disease with recurrence and in multiples: towards a better understanding of GBS Late-onset sepsis

Author

Freudenhammer, Mirjam, Karampatsas, Konstantinos, Le Doare, Kirsty, Lander, Fabian, Armann, Jakob, Acero Moreno, Daniel, Boyle, Margaret, Buxmann, Horst, Campbell, Ruth, Chalker, Victoria, Cunney, Robert, Doherty, Lorraine, Davies, Eleri, Efstratiou, Androulla, Elling, Roland, Endmann, Matthias, Essers, Jochen, Hentschel, Roland, Jones, Christine E., Kallsen, Steffen, Kapatai, Georgia, Krüger, Marcus, Ladhani, Shamez, Lamagni, Theresa, Lindsay, Diane, Meehan, Mary, O’Sullivan, Catherine P., Patel, Darshana, Reynolds, Arlene J., Roll, Claudia, Schulzke, Sven, Smith, Andrew, Stein, Anja, von der Wense, Axel, Voss, Egbert, Wieg, Christian, Härtel, Christoph, Heath, Paul T., and Henneke, Philipp

Subjects
Male, group B Streptococcus, recurrence, Drug-Related Side Effects and Adverse Reactions, Immunology, Twins, Medizin, microbiome, Streptococcus agalactiae, Pregnancy, Risk Factors, Sepsis, Streptococcal Infections, ddc:570, late-onset sepsis, Humans, Immunology and Allergy, Age of Onset, Pregnancy Complications, Infectious, Retrospective Studies, Original Research, Immunität (Medizin), Triplets, Microbiota, Infant, Newborn, Streptococcus, Múltiples, Anti-Bacterial Agents, Europe, multiples, Dysbiosis, Female
Abstract

Group B Streptococcus (GBS) is a common intestinal colonizer during the neonatal period, but also may cause late-onset sepsis or meningitis in up to 0.5% of otherwise healthy colonized infants after day 3 of life. Transmission routes and risk factors of this late-onset form of invasive GBS disease (iGBS) are not fully understood. Cases of iGBS with recurrence (n=25) and those occurring in parallel in twins/triplets (n=32) from the UK and Ireland (national surveillance study 2014/15) and from Germany and Switzerland (retrospective case collection) were analyzed to unravel shared (in affected multiples) or fixed (in recurrent disease) risk factors for GBS disease. The risk of iGBS among infants from multiple births was high (17%), if one infant had already developed GBS disease. The interval of onset of iGBS between siblings was 4.5 days and in recurrent cases 12.5 days. Disturbances of the individual microbiome, including persistence of infectious foci are suggested e.g. by high usage of perinatal antibiotics in mothers of affected multiples, and by the association of an increased risk of recurrence with a short term of antibiotics [aOR 4.2 (1.3-14.2), P=0.02]. Identical GBS serotypes in both recurrent infections and concurrently infected multiples might indicate a failed microbiome integration of GBS strains that are generally regarded as commensals in healthy infants. The dynamics of recurrent GBS infections or concurrent infections in multiples suggest individual patterns of exposure and fluctuations in host immunity, causing failure of natural niche occupation. CA Extern

Published
2021

95. Indirect effects of COVID-19 on maternal, neonatal, child, sexual and reproductive health services in Kampala, Uganda

Author

Burt, Jessica Florence, primary, Ouma, Joseph, additional, Lubyayi, Lawrence, additional, Amone, Alexander, additional, Aol, Lorna, additional, Sekikubo, Musa, additional, Nakimuli, Annettee, additional, Nakabembe, Eve, additional, Mboizi, Robert, additional, Musoke, Philippa, additional, Kyohere, Mary, additional, Namara Lugolobi, Emily, additional, Khalil, Asma, additional, and Le Doare, Kirsty, additional

Published
2021
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96. COVID-19 and maternal and perinatal outcomes – Authors' reply

Author

Chmielewska, Barbara, primary, Barratt, Imogen, additional, Townsend, Rosemary, additional, Kalafat, Erkan, additional, van der Meulen, Jan, additional, Gurol-Urganci, Ipek, additional, O'Brien, Pat, additional, Morris, Edward, additional, Draycott, Tim, additional, Thangaratinam, Shakila, additional, Le Doare, Kirsty, additional, Ladhani, Shamez, additional, von Dadelszen, Peter, additional, Magee, Laura A, additional, and Khalil, Asma, additional

Published
2021
Full Text
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