A phase 2b randomized, controlled trial of the efficacy of the GMZ2 malaria vaccine in African children.


Sirima, SB; Mordmüller, B; Milligan, P; Ngoa, UA; Kironde, F; Atuguba, F; Tiono, AB; Issifou, S; Kaddumukasa, M; Bangre, O; Flach, C; Christiansen, M; Bang, P; Chilengi, R; Jepsen, S; Kremsner, PG; Theisen, M; GMZ2 Trial Study Group; , COLLABORATORS; Ouédraogo, A; Kargougou, D; Nébié, I; Débé, S; Diarra, A; Bougouma, E; Hounkpatin, AB; Adegnika, AA; Lell, B; Joanny, F; Honkpehedji, YJ; Agobe, JC; Esen, M; Ajua, A; Asoala, V; Anyorigiya, T; Ansah, NA; Buwembo, W; Mworozi, E; Sekikubo, M; Abubakar, I; Bojang, K; Noor, R; Okech, B; Ejigu, DA; (2016) A phase 2b randomized, controlled trial of the efficacy of the GMZ2 malaria vaccine in African children. Vaccine, 34 (38). pp. 4536-42. ISSN 0264-410X DOI: 10.1016/j.vaccine.2016.07.041

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Abstract

: GMZ2 is a recombinant protein malaria vaccine, comprising two blood-stage antigens of Plasmodium falciparum, glutamate-rich protein and merozoite surface protein 3. We assessed efficacy of GMZ2 in children in Burkina Faso, Gabon, Ghana and Uganda.<br/> : Children 12-60months old were randomized to receive three injections of either 100μg GMZ2 adjuvanted with aluminum hydroxide or a control vaccine (rabies) four weeks apart and were followed up for six months to measure the incidence of malaria defined as fever or history of fever and a parasite density ⩾5000/μL.<br/> : A cohort of 1849 children were randomized, 1735 received three doses of vaccine (868 GMZ2, 867 control-vaccine). There were 641 malaria episodes in the GMZ2/Alum group and 720 in the control group. In the ATP analysis, vaccine efficacy (VE), adjusted for age and site was 14% (95% confidence interval [CI]: 3.6%, 23%, p-value=0.009). In the ITT analysis, age-adjusted VE was 11.3% (95% CI 2.5%, 19%, p-value=0.013). VE was higher in older children. In GMZ2-vaccinated children, the incidence of malaria decreased with increasing vaccine-induced anti-GMZ2 IgG concentration. There were 32 cases of severe malaria (18 in the rabies vaccine group and 14 in the GMZ2 group), VE 27% (95% CI -44%, 63%).<br/> : GMZ2 is the first blood-stage malaria vaccine to be evaluated in a large multicenter trial. GMZ2 was well tolerated and immunogenic, and reduced the incidence of malaria, but efficacy would need to be substantially improved, using a more immunogenic formulation, for the vaccine to have a public health role.<br/>

Item Type: Article
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
Research Centre: Malaria Centre
PubMed ID: 27477844
Web of Science ID: 383004800015
URI: http://researchonline.lshtm.ac.uk/id/eprint/2699472

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