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Safety profile of theRTS,S/AS01 malariavaccine in infantsand children:additional data froma phase IIIrandomized controlledtrial in sub-SaharanAfrica Yolanda Guerra MendozaElodie GarricAmanda Leach2019 год

Safety profile of the RTS,S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa
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Аннотация: A phase III, double-blind, randomized, controlled trial (NCT00866619) in sub-Saharan Africa showed RTS,S/AS01 vaccine efficacy against malaria. We now present in-depth safety results from this study. 8922 children (enrolled at 5–17 months) and 6537 infants (enrolled at 6–12 weeks) were 1:1:1-randomized to receive 4 doses of RTS,S/AS01 (R3R) or non-malaria control vaccine (C3C), or 3 RTS,S/AS01 doses plus control (R3C). Aggregate safety data were reviewed by a multi-functional team. Severe malaria with Blantyre Coma Score ≤2 (cerebral malaria [CM]) and gender-specific mortality were assessed post-hoc. Serious adverse event (SAE) and fatal SAE incidences throughout the study were 24.2%–28.4% and 1.5%–2.5%, respectively across groups; 0.0%–0.3% of participants reported vaccination-related SAEs. The incidence of febrile convulsions in children was higher during the first 2–3 days post-vaccination with RTS,S/AS01 than with control vaccine, consistent with the time window of post-vaccination febrile reactions in this study (mostly the day after vaccination). A statistically significant numerical imbalance was observed for meningitis cases in children (R3R: 11, R3C: 10, C3C: 1) but not in infants. CM cases were more frequent in RTS,S/AS01-vaccinated children (R3R: 19, R3C: 24, C3C: 10) but not in infants. All-cause mortality was higher in RTS,S/AS01-vaccinated versus control girls (2.4% vs 1.3%, all ages) in our setting with low overall mortality. The observed meningitis and CM signals are considered likely chance findings, that – given their severity – warrant further evaluation in phase IV studies and WHO-led pilot implementation programs to establish the RTS,S/AS01 benefit-risk profile in real-life settings.
Год издания: 2019
Авторы: Yolanda Guerra Mendoza, Elodie Garric, Amanda Leach, Marc Lievens, Opokua Ofori‐Anyinam, Jean‐Yves Pirçon, Jens‐Ulrich Stegmann, Pascale Vandoolaeghe, Lucas Otieno, Walter Otieno, Seth Owusu‐Agyei, Jahit Sacarlal, Nahya Salim Masoud, Hermann Sorgho, Marcel Tanner, Halidou Tinto, Innocent Valéa, Ali Mtoro, Patricia Njuguna, Martina Oneko, Godfrey Allan Otieno, Kephas Otieno, Samwel Gesase, Mary J. Hamel, Irving Hoffman, Seyram Kaali, Portia Kamthunzi, Peter G. Kremsner, Miguel Lanaspa, Bertrand Lell, John Lusingu, Anangisye Malabeja, Pedro Aíde, Pauline Akoo, Daniel Ansong, Kwaku Poku Asante, James A. Berkley, Samuel Adjei, Tsiri Agbenyega, Selidji Todagbé Agnandji, Lode Schuerman
Издательство: Taylor & Francis
Источник: Human Vaccines & Immunotherapeutics
Ключевые слова: Malaria Research and Control, Hepatitis Viruses Studies and Epidemiology, Hepatitis C virus research
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Europe PMC (PubMed Central) (PDF)
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Dipòsit Digital de la Universitat de Barcelona (Universitat de Barcelona) (PDF)
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Oxford University Research Archive (ORA) (University of Oxford) (PDF)
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