Safety and Immunogenicity of 30 and 100 µg of GMZ2 in Gabonese Children Aged 1-5 Years

Summary

The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already publicly used vaccine against rabies. 30 Gabonese children aged 1-5 years will be enrolled and randomly allocated to receive either malaria vaccine or rabies vaccine without the investigator or the participants knowing what they received. They will receive 3 doses each at one month intervals, and will be followed up for one year to evaluate safety parameters. 30 and 100µg doses for the candidate malaria vaccine GMZ 2 will be evaluated for safety. This is the second time that candidate malaria vaccine GMZ 2 is being tested in Africa, the first time being in Gabonese adults where the product was found to be safe.

Timeline

Start

2008-06

Primary completion

2009-07

Completion

2009-08

Publications

• Belard S, Issifou S, Hounkpatin AB, Schaumburg F, Ngoa UA, Esen M, Fendel R, de Salazar PM, Murbeth RE, Milligan P, Imbault N, Imoukhuede EB, Theisen M, Jepsen S, Noor RA, Okech B, Kremsner PG, Mordmuller B. A randomized controlled phase Ib trial of the malaria vaccine candidate GMZ2 in African children. PLoS One. 2011;6(7):e22525. doi: 10.1371/journal.pone.0022525. Epub 2011 Jul 28.

Drugs

Indications