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1. Immune correlates of protection for dengue: State of the art and research agenda

Author

Katzelnick, Leah C, Harris, Eva, Baric, Ralph, Coller, Beth-Ann, Coloma, Josefina, Crowe, James E, Cummings, Derek AT, Dean, Hansi, de Silva, Aravinda, Diamond, Michael S, Durbin, Anna, Ferguson, Neil, Gilbert, Peter B, Gordon, Aubree, Gubler, Duane J, Guy, Bruno, Halloran, M Elizabeth, Halstead, Scott, Jackson, Nicholas, Jarman, Richard, Lok, Shee-mei, Michael, Nelson L, Ooi, Eng Eong, Papadopoulos, Athanasios, Plotkin, Stanley, Precioso, Alexander R, Reiner, Robert, Rey, Felix A, Rodríguez-Barraquer, Isabel, Rothman, Alan, Schmidt, Alexander C, Screaton, Gavin, Sette, Alessandro, Simmons, Cameron, St. John, Ashley L, Sun, Wellington, Thomas, Stephen, Torresi, Joseph, Tsang, John S, Vannice, Kirsten, Whitehead, Stephen, Wilder-Smith, Annelies, and Kyu Yoon, In

Subjects
Infectious Diseases, Vector-Borne Diseases, Rare Diseases, Vaccine Related, Biodefense, Immunization, Prevention, Emerging Infectious Diseases, Prevention of disease and conditions, and promotion of well-being, 3.4 Vaccines, Infection, Good Health and Well Being, Antibodies, Neutralizing, Antibodies, Viral, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Congresses as Topic, Dengue, Dengue Vaccines, Dengue Virus, Humans, Severe Dengue, Dengue virus, Immune correlates of protection, Immune correlates of risk, Natural infection, Vaccine, Participants in the Summit on Dengue Immune Correlates of Protection, Biological Sciences, Agricultural and Veterinary Sciences, Medical and Health Sciences, Virology
Abstract

Dengue viruses (DENV1-4) are mosquito-borne flaviviruses estimated to cause up to ∼400 million infections and ∼100 million dengue cases each year. Factors that contribute to protection from and risk of dengue and severe dengue disease have been studied extensively but are still not fully understood. Results from Phase 3 vaccine efficacy trials have recently become available for one vaccine candidate, now licensed for use in several countries, and more Phase 2 and 3 studies of additional vaccine candidates are ongoing, making these issues all the more urgent and timely. At the "Summit on Dengue Immune Correlates of Protection", held in Annecy, France, on March 8-9, 2016, dengue experts from diverse fields came together to discuss the current understanding of the immune response to and protection from DENV infection and disease, identify key unanswered questions, discuss data on immune correlates and plans for comparison of results across assays/consortia, and propose a research agenda for investigation of dengue immune correlates, all in the context of both natural infection studies and vaccine trials.

Published
2017

2. Dose-sparing effect of two adjuvant formulations with a pandemic influenza A/H7N9 vaccine: A randomized, double-blind, placebo-controlled, phase 1 clinical trial

Author

Vanni, Tazio, primary, Thomé, Beatriz C., additional, Sparrow, Erin, additional, Friede, Martin, additional, Fox, Christopher B., additional, Beckmann, Anna Marie, additional, Huynh, Chuong, additional, Mondini, Gabriella, additional, Silveira, Daniela H., additional, Viscondi, Juliana Y. K., additional, Braga, Patrícia Emilia, additional, Silva, Anderson da, additional, Salomão, Maria da Graça, additional, Piorelli, Roberta O., additional, Santos, Joane P., additional, Gattás, Vera Lúcia, additional, Lucchesi, Maria Beatriz B., additional, Oliveira, Mayra M. M. de, additional, Koike, Marcelo E., additional, Kallas, Esper G., additional, Campos, Lucia M. A., additional, Coelho, Eduardo B., additional, Siqueira, Marilda A. M., additional, Garcia, Cristiana C., additional, Miranda, Milene Dias, additional, Paiva, Terezinha M., additional, Timenetsky, Maria do Carmo S. T., additional, Adami, Eduardo A., additional, Akamatsu, Milena A., additional, Ho, Paulo Lee, additional, and Precioso, Alexander R., additional

Published
2022
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4. Plasmablast Expansion Following the Tetravalent, Live-Attenuated Dengue Vaccine Butantan-DV in DENV-Naïve and DENV-Exposed Individuals in a Brazilian Cohort

Author

Silveira, Cássia G. T., primary, Magnani, Diogo M., additional, Costa, Priscilla R., additional, Avelino-Silva, Vivian I., additional, Ricciardi, Michael J., additional, Timenetsky, Maria do Carmo S. T., additional, Goulart, Raphaella, additional, Correia, Carolina A., additional, Marmorato, Mariana P., additional, Ferrari, Lilian, additional, Nakagawa, Zelinda B., additional, Tomiyama, Claudia, additional, Tomiyama, Helena, additional, Kalil, Jorge, additional, Palacios, Ricardo, additional, Precioso, Alexander R., additional, Watkins, David I., additional, and Kallás, Esper G., additional

Published
2022
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9. Influenza A/H1N1 vaccination of patients with SLE: can antimalarial drugs restore diminished response under immunosuppressive therapy?

Author

Borba, Eduardo F., Saad, Carla G. S., Pasoto, Sandra G., Calich, Ana L. G., Aikawa, Nadia E., Ribeiro, Ana C. M., Moraes, Julio C. B., Leon, Elaine P., Costa, Luciana P., Guedes, Lissiane K. N., Silva, Clovis A. A., Goncalves, Celio R., Fuller, Ricardo, Oliveira, Suzimara A., Ishida, Maria A., Precioso, Alexander R., and Bonfa, Eloisa

Published
2012
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10. Reduced seroprotection after pandemic H1N1 influenza adjuvant-free vaccination in patients with rheumatoid arthritis: implications for clinical practice

Author

Ribeiro, Ana C M, Guedes, Lissiane K N, Moraes, Julio C B, Saad, Carla G S, Aikawa, Nadia E, Calich, Ana Luisa, França, Ivan L A, Carvalho, Jozelio F, Sampaio-Barros, Percival D, Goncalves, Celio R, Borba, Eduardo F, Timenetsky, Maria Carmo S, Precioso, Alexander R, Duarte, Alberto, Bonfa, Eloisa, and Laurindo, Ieda M M

Published
2011
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11. Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases

Author

Saad, Carla G S, Borba, Eduardo F, Aikawa, Nadia E, Silva, Clovis A, Pereira, Rosa M R, Calich, Ana Luisa, Moraes, Julio C B, Ribeiro, Ana C M, Viana, Vilma S T, Pasoto, Sandra G, Carvalho, Jozelio F, França, Ivan L A, Guedes, Lissiane K N, Shinjo, Samuel K, Sampaio-Barros, Percival D, Caleiro, Maria T, Goncalves, Celio R, Fuller, Ricardo, Levy-Neto, Mauricio, Timenetsky, Maria Carmo S, Precioso, Alexander R, and Bonfa, Eloisa

Published
2011
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13. ZikaPLAN : addressing the knowledge gaps and working towards a research preparedness network in the Americas

Author

Wilder-Smith, Annelies, Preet, Raman, Brickley, Elizabeth B., Ximenes, Ricardo Arraes de Alencar, Miranda-Filho, Demócrito de Barros, Turchi Martelli, Celina Maria, Araújo, Thália Velho Barreto de, Montarroyos, Ulisses Ramos, Moreira, Maria Elisabeth, Turchi, Marília Dalva, Solomon, Tom, Jacobs, Bart C., Villamizar, Carlos Pardo, Osorio, Lyda, de Filipps, Ana Maria Bispo, Neyts, Johan, Kaptein, Suzanne, Huits, Ralph, Ariën, Kevin K., Willison, Hugh J., Edgar, Julia M., Barnett, Susan C., Peeling, Rosanna, Boeras, Debi, Guzman, Maria G., de Silva, Aravinda M., Falconar, Andrew K., Romero-Vivas, Claudia, Gaunt, Michael W., Sette, Alessandro, Weiskopf, Daniela, Lambrechts, Louis, Dolk, Helen, Morris, Joan K., Orioli, Ieda M., O'Reilly, Kathleen M., Yakob, Laith, Rocklöv, Joacim, Soares, Cristiane, Ferreira, Maria Lúcia Brito, Franca, Rafael Freitas de Oliveira, Precioso, Alexander R., Logan, James, Lang, Trudie, Jamieson, Nina, Massad, Eduardo, Wilder-Smith, Annelies, Preet, Raman, Brickley, Elizabeth B., Ximenes, Ricardo Arraes de Alencar, Miranda-Filho, Demócrito de Barros, Turchi Martelli, Celina Maria, Araújo, Thália Velho Barreto de, Montarroyos, Ulisses Ramos, Moreira, Maria Elisabeth, Turchi, Marília Dalva, Solomon, Tom, Jacobs, Bart C., Villamizar, Carlos Pardo, Osorio, Lyda, de Filipps, Ana Maria Bispo, Neyts, Johan, Kaptein, Suzanne, Huits, Ralph, Ariën, Kevin K., Willison, Hugh J., Edgar, Julia M., Barnett, Susan C., Peeling, Rosanna, Boeras, Debi, Guzman, Maria G., de Silva, Aravinda M., Falconar, Andrew K., Romero-Vivas, Claudia, Gaunt, Michael W., Sette, Alessandro, Weiskopf, Daniela, Lambrechts, Louis, Dolk, Helen, Morris, Joan K., Orioli, Ieda M., O'Reilly, Kathleen M., Yakob, Laith, Rocklöv, Joacim, Soares, Cristiane, Ferreira, Maria Lúcia Brito, Franca, Rafael Freitas de Oliveira, Precioso, Alexander R., Logan, James, Lang, Trudie, Jamieson, Nina, and Massad, Eduardo

Abstract

Zika Preparedness Latin American Network (ZikaPLAN) is a research consortium funded by the European Commission to address the research gaps in combating Zika and to establish a sustainable network with research capacity building in the Americas. Here we present a report on ZikaPLAN`s mid-term achievements since its initiation in October 2016 to June 2019, illustrating the research objectives of the 15 work packages ranging from virology, diagnostics, entomology and vector control, modelling to clinical cohort studies in pregnant women and neonates, as well as studies on the neurological complications of Zika infections in adolescents and adults. For example, the Neuroviruses Emerging in the Americas Study (NEAS) has set up more than 10 clinical sites in Colombia. Through the Butantan Phase 3 dengue vaccine trial, we have access to samples of 17,000 subjects in 14 different geographic locations in Brazil. To address the lack of access to clinical samples for diagnostic evaluation, ZikaPLAN set up a network of quality sites with access to well-characterized clinical specimens and capacity for independent evaluations. The International Committee for Congenital Anomaly Surveillance Tools was formed with global representation from regional networks conducting birth defects surveillance. We have collated a comprehensive inventory of resources and tools for birth defects surveillance, and developed an App for low resource regions facilitating the coding and description of all major externally visible congenital anomalies including congenital Zika syndrome. Research Capacity Network (REDe) is a shared and open resource centre where researchers and health workers can access tools, resources and support, enabling better and more research in the region. Addressing the gap in research capacity in LMICs is pivotal in ensuring broad-based systems to be prepared for the next outbreak. Our shared and open research space through REDe will be used to maximize the transfer of research

Published
2019
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14. ZikaPLAN: addressing the knowledge gaps and working towards a research preparedness network in the Americas

Author

Wilder-Smith, Annelies, primary, Preet, Raman, additional, Brickley, Elizabeth B., additional, Ximenes, Ricardo Arraes de Alencar, additional, Miranda-Filho, Demócrito de Barros, additional, Turchi Martelli, Celina Maria, additional, Araújo, Thália Velho Barreto de, additional, Montarroyos, Ulisses Ramos, additional, Moreira, Maria Elisabeth, additional, Turchi, Marília Dalva, additional, Solomon, Tom, additional, Jacobs, Bart C., additional, Villamizar, Carlos Pardo, additional, Osorio, Lyda, additional, de Filipps, Ana Maria Bispo, additional, Neyts, Johan, additional, Kaptein, Suzanne, additional, Huits, Ralph, additional, Ariën, Kevin K., additional, Willison, Hugh J., additional, Edgar, Julia M., additional, Barnett, Susan C., additional, Peeling, Rosanna, additional, Boeras, Debi, additional, Guzman, Maria G., additional, de Silva, Aravinda M., additional, Falconar, Andrew K., additional, Romero-Vivas, Claudia, additional, Gaunt, Michael W., additional, Sette, Alessandro, additional, Weiskopf, Daniela, additional, Lambrechts, Louis, additional, Dolk, Helen, additional, Morris, Joan K., additional, Orioli, Ieda M., additional, O’Reilly, Kathleen M., additional, Yakob, Laith, additional, Rocklöv, Joacim, additional, Soares, Cristiane, additional, Ferreira, Maria Lúcia Brito, additional, Franca, Rafael Freitas de Oliveira, additional, Precioso, Alexander R., additional, Logan, James, additional, Lang, Trudie, additional, Jamieson, Nina, additional, and Massad, Eduardo, additional

Published
2019
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15. Pandemic non-adjuvanted influenza A H1N1 vaccine in a cohort of patients with systemic sclerosis

Author

Sampaio-Barros, Percival D, primary, Andrade, Danieli C O, additional, Seguro, Luciana C P, additional, Pasoto, Sandra G, additional, Viana, Vilma S T, additional, Ribeiro, Ana C M, additional, Aikawa, Nadia E, additional, Timenetsky, Maria do Carmo S, additional, Precioso, Alexander R, additional, Silva, Clóvis A, additional, and Bonfa, Eloisa, additional

Published
2017
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17. Pandemic non-adjuvanted influenza A H1N1 vaccine in a cohort of patients with systemic sclerosis.

Author

Sampaio-Barros, Percival D, Andrade, Danieli C O, Seguro, Luciana C P, Pasoto, Sandra G, Viana, Vilma S T, Ribeiro, Ana C M, Aikawa, Nadia E, Timenetsky, Maria do Carmo S, Precioso, Alexander R, and Silva, Clóvis A

Subjects
H1N1 influenza, AGE distribution, IMMUNOSUPPRESSION, INFLUENZA vaccines, LONGITUDINAL method, SEX distribution, SYSTEMIC scleroderma, VIRAL antibodies, TREATMENT effectiveness, SEVERITY of illness index, PREVENTION, VACCINATION, THERAPEUTICS
Abstract

Objective To assess the possible effect of therapy, disease subtype and severity on H1N1 immunogenicity in patients with SSc. Methods Ninety-two patients and 92 age- and gender-matched healthy controls received adjuvant-free influenza A/California/7/2009 (pH1N1) vaccine. Blood samples were collected immediately before and 3 weeks after vaccination to evaluate antibody responses to the H1N1 virus. Efficacy was assessed by seroprotection (SP) and seroconversion (SC) rates and the factor increase in geometric mean antibody titre. Participants received a 21-day symptom diary card and were instructed to report local and systemic adverse events. Results SSc patients were predominantly females (91%) and 61% had limited SSc, 12% had severe skin involvement and 57.6% were on immunosuppressive (IS) therapy. SSc patients and controls presented comparable overall SP (P = 0.20) and SC (P = 0.61) rates. Further evaluation of the possible effect of disease and therapy revealed similar rates of SP and SC in patients with dcSSc vs lcSSc (SP P = 0.62 and SC P = 0.66), severe vs mild/moderate skin involvement (SP P = 1 and SC P = 0.45) and with vs without IS (SP P = 0.26 and SC P = 0.10). The frequency of mild local and minor systemic reactions was similar in patients with dcSSC vs lcSSc (P = 0.70 vs 0.32) and in those with and without severe skin involvement (P = 0.59 vs 0.28). Conclusion The non-adjuvanted influenza H1N1 virus vaccine proved to be safe and effective, independent of SSc clinical subtype, disease severity or therapy. These latter factors do not seem to contribute to mild adverse events observed in SSc. Our data support the annual influenza vaccination recommendation for these patients. Trial registration ClinicalTrials.gov (http://clinicaltrials.gov), NCT01151644 [ABSTRACT FROM AUTHOR]

Published
2018
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18. Epidemiology and Outcomes of Acute Respiratory Distress Syndrome in Children According to the Berlin Definition

Author

Barreira, Eliane R., primary, Munoz, Gabriela O. C., additional, Cavalheiro, Priscilla O., additional, Suzuki, Adriana S., additional, Degaspare, Natalia V., additional, Shieh, Huei H., additional, Martines, João A. D. S., additional, Ferreira, Juliana C., additional, Lane, Christianne, additional, Carvalho, Werther B., additional, Gilio, Alfredo E., additional, and Precioso, Alexander R., additional

Published
2015
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19. Acellular and 'low' pertussis vaccines: adverse events and the role of mutations

Author

Higashi, Hisako G., Luna, Expedito, Precioso, Alexander R., Vilela, Marluce, Kubrusly, Flávia S., Dias, Waldely O., and Raw, Isaias

Subjects
Vaccine adverse events, Acellular pertussis vaccine, Low pertussis vaccine, Pertussis vaccine
Abstract

Objective: to discuss the current PAHO recommendation that does not support the substitution of traditional cellular DTP vaccine by acellular DTP, and the role of mutations, in humans, as the main cause of rare adverse events, such as epileptic-like convulsions, triggered by pertussis vaccine. Data review: the main components related to toxic effects of cellular pertussis vaccines are the lipopolysaccharide of bacterial cell wall and pertussis toxin. The removal of part of lipopolysaccharide layer has allowed the creation of a safer cellular pertussis vaccine, with costs comparable to the traditional cellular vaccine, and which may be a substitute for the acellular vaccine. Conclusion: The new methodology introduced by Instituto Butantan allows for the development of a new safer pertussis vaccine with low LPS content (Plow), and the use of the lipopolysaccharide obtained in the process in the production of monophosphoryl lipid A. This component has shown potent adjuvant effect when administered together with influenza inactivated vaccine, making possible to reduce the antigen dose, enhancing the production capacity and lowering costs. Objetivo: Discutir as recomendações da WHO-OPAS que não consideram indicada a substituição da vacina DTP celular clássica pela DTP acelular e o papel de mutações, em humanos, como principal causa dos raros eventos de convulsões epileptiformes desencadeadas pela vacina pertussis. Revisão dos dados: Os principais componentes relacionados aos efeitos tóxicos da vacina pertussis celular são o lipopolissacarídio da parede celular da bactéria e a toxina pertussis. A remoção de parte da camada lipopolissacarídica permitiu a criação de uma vacina pertussis celular, mais segura e de custo comparável ao da vacina celular tradicional, podendo substituir a vacina pertussis acelular. Conclusão: A nova vacina pertussis, com baixo teor de LPS (Plow) desenvolvida pelo Instituto Butantan, além de oferecer uma vacina mais segura, permite o aproveitamento do lipopolissacarídeo para a produção de monofosforil lipídeo A. Esse componente mostrou-se potente como adjuvante e altamente eficiente quando administrado com a vacina de influenza, levando à possibilidade de se reduzir a dose de antígeno, aumentando a capacidade de produção e redução dos custos.

Published
2009

21. Immunogenicity and Reactogenicity of 2009 Influenza A (H1N1) Inactivated Monovalent Non-Adjuvanted Vaccine in Elderly and Immunocompromised Patients

Author

Miraglia, João L., primary, Abdala, Edson, additional, Hoff, Paulo M., additional, Luiz, André M., additional, Oliveira, Danise S., additional, Saad, Carla G. S., additional, Laurindo, Ieda M. M., additional, Viso, Ana T. R., additional, Tayra, Angela, additional, Pierrotti, Lígia C., additional, Azevedo, Luiz S., additional, Campos, Lúcia Maria A., additional, Aikawa, Nádia E., additional, Timenetsky, Maria do Carmo S. T., additional, Luna, Expedito, additional, Cardoso, Maria Regina A., additional, Guedes, José da S., additional, Raw, Isaias, additional, Kalil, Jorge, additional, and Precioso, Alexander R., additional

Published
2011
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