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

Highlights • The GMZ2 fusion protein consist of the non-repeat region of falciparum GLURP genetically fused to a msp3 fragment. • The GMZ2 fusion protein elicited functional antibodies in phase 1 studies. • In the ATP analysis, vaccine efficacy adjusted for age and site was 14% (95% CI: 3.6%, 23%)....

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Bibliographic Details
Published in:Vaccine 2016-08, Vol.34 (38), p.4536-4542
Main Authors: Sirima, Sodiomon B, Mordmüller, Benjamin, Milligan, Paul, Ngoa, Ulysse Ateba, Kironde, Fred, Atuguba, Frank, Tiono, Alfred B, Issifou, Saadou, Kaddumukasa, Mark, Bangre, Oscar, Flach, Clare, Christiansen, Michael, Bang, Peter, Chilengi, Roma, Jepsen, Søren, Kremsner, Peter G, Theisen, Michael
Format: Article
Language:English
Subjects:
Adjuvants, Immunologic - administration & dosage
Age
Allergy and Immunology
Aluminum Hydroxide - administration & dosage
Antibodies, Protozoan - blood
Antibody
Antigens
Antigens, Protozoan - immunology
Blood
Burkina Faso
Child, Preschool
Children & youth
Clinical trials
Efficacy
Female
Fever
Gabon
Ghana
GLURP
GMZ2
Humans
Immunoglobulin G - blood
Immunoglobulins
Infant
Malaria
Malaria Vaccines - immunology
Malaria, Falciparum - prevention & control
Male
MSP3
Parasites
Phase 2 clinical trial
Plasmodium falciparum
Proteins
Protozoan Proteins - immunology
Recombinant Fusion Proteins - immunology
Tropical diseases
Uganda
Vaccine
Vaccines
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Summary:Highlights • The GMZ2 fusion protein consist of the non-repeat region of falciparum GLURP genetically fused to a msp3 fragment. • The GMZ2 fusion protein elicited functional antibodies in phase 1 studies. • In the ATP analysis, vaccine efficacy adjusted for age and site was 14% (95% CI: 3.6%, 23%). • Vaccine efficacy was higher in older children. • In GMZ2-vaccinated children, the incidence of malaria decreased with increasing vaccine-induced anti-GMZ2 IgG concentration.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2016.07.041