| Protocol No: | ECCT/19/05/01 | Date of Protocol: | 27-11-2018 |
| Study Title: | A randomized, double-blinded, placebo-controlled, dose-escalation phase 1 clinical trial to evaluate the safety and immunogenicity of recombinant HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in healthy, HIV--1 uninfected adults |
| Study Objectives: | This is a phase 1 study designed to evaluate the safety and tolerability of intramuscular administration of the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in HIV-uninfected adults. Given the small sample size there is no formal hypothesis to be tested. If the safety profile and immunogenicity of one or more dose levels is deemed acceptable, then the results will be used to generate hypotheses for further study in a larger trial. Primary Objectives 1. To evaluate the safety and tolerability of intramuscular administration of the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in HIV-uninfected adults Secondary Objectives 1. To determine the immunogenicity of the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in HIV-uninfected adults Exploratory Objectives 1. To assess additional adaptive and innate immune responses induced by the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted 2. To characterize Env-specific memory B cell repertoire |
| Laymans Summary: | The purpose of this study is find out if the study vaccine is safe and how your immune system responds to it. Although there have been many clinical trials conducted with other HIV vaccine candidates, only a few vaccines have been tested for their efficacy (that is, whether or not the vaccine protects against HIV infection and/or progression to AIDS). Three of these vaccines, Vaxgen’s AIDSVAX, Merck’s MRK-Ad5, and a combined regimen of a DNA and an Ad5-based vaccine showed no efficacy. AIDSVAX used in combination with another study vaccine called ALVAC-HIV was tested for efficacy. The risk of HIV infection was reduced by 31% in volunteers who received the vaccine compared to placebo. Other HIV vaccines are being tested worldwide. In addition, we hope to learn what kinds of side effects may be caused by the study vaccine, and how severe those side effects will be. This means that you may experience the side effects listed in the risks section of this consent document or others that are not yet known. We will also study how your immune system responds to the study product. |
| Abstract of Study: | This is a phase 1 study designed to evaluate the safety and tolerability of intramuscular administration of the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in HIV-uninfected adults. Given the small sample size there is no formal hypothesis to be tested. If the safety profile and immunogenicity of one or more dose levels is deemed acceptable, then the results will be used to generate hypotheses for further study in a larger trial. Primary Objectives 1.To evaluate the safety and tolerability of intramuscular administration of the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in HIV-uninfected adults Secondary Objectives 1.To determine the immunogenicity of the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in HIV-uninfected adults Exploratory Objectives 1.To assess additional adaptive and innate immune responses induced by the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted 2.To characterize Env-specific memory B cell repertoire |