Study of Co-administered Na-APR-1 (M74) and Na-GST-1 in Gabonese Children

Summary

Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in hookworm-exposed children aged 6 to 10 years living in the area of Lambaréné, Gabon. Children will receive three doses of the Na-GST-1/Alhydrogel hookworm vaccine co-administered with the Na-APR-1 (M74)/Alhydrogel hookworm vaccine or the hepatitis B vaccine co-administered with sterile saline. All injections will be delivered intramuscularly (deltoid) on approximately Days 0, 56, and 112 or 180.

Timeline

Start

2017-01

Primary completion

2018-12-13

Completion

2019-03-28

Publications

• Zinsou JF, Diemert DJ, Dejon-Agobe JC, Adegbite BR, Honkpehedji YJ, Vodonou KG, Bikangui R, Edoa JR, Massinga Loembe M, Li G, Yazdanbakhsh M, Bottazzi ME, van Leeuwen R, Kremsner PG, Hotez PJ, Bethony JM, Grobusch MP, Adegnika AA. Safety and immunogenicity of the co-administered Na-APR-1 and Na-GST-1 hookworm vaccines in school-aged children in Gabon: a randomised, controlled, observer-blind, phase 1, dose-escalation trial. Lancet Infect Dis. 2024 Jul;24(7):760-774. doi: 10.1016/S1473-3099(24)00104-X. Epub 2024 Mar 18.

Drugs

Indications