Pharmacy and Poisons Board

Pharmacy and Poisons Board

Ensuring Safety, Quality and Efficacy of Medicines


Protocol No: ECCT/17/05/04 Date of Protocol: 02-12-2016

Abstract of Study:

A safe and effective HIV vaccine is presently an elusive cornerstone of HIV prevention. A successful global prophylactic HIV vaccine will likely need to protect against the diverse strains and clades of HIV that may be encountered. This study is a randomized, double-blind, placebocontrolled, parallel-group, multicenter, Phase 1/2a study in healthy HIV-uninfected adult men and women between the ages 18 to 50 years, inclusive. Vaccines used in this study are Ad26.Mos4.HIV, Clade C gp140, and Mosaic gp140. The primary objectives of this study are to assess safety/tolerability of the different vaccine regimens and to assess env-binding antibody responses of the 2 different vaccine regimens. In total, 150 participants will participate in this study with 25 participants in Group 1, 100 participants in Group 2, and 25 participants in Group 3. Kericho site will enroll 25 participants. Participants will receive intramuscular doses of study vaccine or placebo at 4 time points: Ad26.Mos4.HIV or placebo will be given at Weeks 0 and 12; Ad26.Mos4.HIV together with either Clade C gp140 plus adjuvant or a combination of Mosaic and Clade C gp140 plus adjuvant, or placebo will be given at Weeks 24 and 48. The study will be conducted in 3 phases: a 6-week screening period; a 48-week vaccination period during which subjects will be vaccinated at baseline (Week 0) and at Weeks 12, 24, and 48; and a follow-up period to the final visit at Week 72. The duration of the subject’s participation will be approximately 76 weeks.

Study Title:

A randomized, parallel-group, placebo-controlled, double-blind Phase 1/2a study in healthy HIV-uninfected adults to assess safety/tolerability and immunogenicity of 2 different prime/boost regimens: priming with tetravalent Ad26.Mos4.HIV and boosting with tetravalent Ad26.Mos4.HIV and either Clade C gp140 plus adjuvant OR a combination of Mosaic and Clade C gp140 plus adjuvant