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Título:	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
Autor/a:	Guerra Mendoza, Yolanda; Garric, Elodie; Leach, Amanda; Lievens, Marc; Ofori-Anyinam, Opokua; Pirçon, Jean-Yves; Stegmann, Jens-Ulrich; Vandoolaeghe, Pascale; Otieno, Lucas; Otieno, Walter; Owusu-Agyei, Seth; Sacarlal, Jahit; Masoud, Nahya Salim; Sorgho, Hermann; Tanner, Marcel; Tinto, Halidou; Valea, Innocent; Mtoro, Ali Takadir; Njuguna, Patricia; Oneko, Martina; Otieno, Godfrey Allan; Otieno, Kephas; Gesase, Samwel; Hamel, Mary J.; Hoffman, Irving; Kaali, Seyram; Kamthunzi, Portia; Kremsner, Peter; Lanaspa, Miguel; Lell, Bertrand; Lusingu, John; Malabeja, Anangisye; Aide, Pedro Carlos Paulino; Akoo, Pauline; Ansong, Daniel; Asante, Kwaku Poku; Berkley, James A.; Adjei, Samuel; Agbenyega, Tsiri; Agnandji, Selidji Todagbe; Schuerman, Lode
Abstract:	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\xC2\xA0months) and 6537 infants (enrolled at 6-12\xC2\xA0weeks) 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 \xE2\x89\xA42 (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.
Materia(s):	-Vacuna de la malària -Infants -Àfrica subsahariana -Malaria vaccine -Children -Sub-Saharan Africa
Derechos:	cc by (c) GlaxoSmithKline Biologicals S. A., 2019 http://creativecommons.org/licenses/by/3.0/es/
Tipo de documento:	Artículo Artículo - Versión publicada
Editor:	Taylor & Francis
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