| Protocol No: | ECCT/17/05/04 | Date of Protocol: | 02-12-2016 |
| 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 |
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| Study Objectives: | The primary purpose of this study is to assess safety/tolerability of the different vaccine regimens and of a late boost vaccination; and to assess envelope (Env)-binding antibody (Ab) responses of the 2 different vaccine regimens.
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| Laymans Summary: | Human immunodeficiency virus (HIV) is a virus spread through certain body fluids that attacks the body's immune cells. Over time, HIV can destroy so many immune cells that the body cannot fight off infections and disease. Vaccination is one of the most effective ways to prevent sickness caused by some viruses. A vaccine often contains or produces a non-functional part of the virus that is recognized by the body's protective immune system. The body then produces a response that prevents sickness if the person is exposed to that same virus again. This study is part of research to try to find a possible vaccine against HIV infection. The investigational treatment (HIV vaccine) is made up of 3 vaccines regimens: • Participants will receive Ad26.Mos4.HIV or placebo at Weeks 0 and 12 • Participants will receive Ad26.Mos4.HIV and either Clade C glycoprotein (gp)140 plus adjuvant (aluminium phosphate) at Weeks 24 and 48, or • A combination of Mosaic and Clade C gp140 plus adjuvant (aluminium phosphate), or placebo, at Weeks 24 and 48 In this study, researchers want to know the safety of the investigational treatment. Additionally, researchers want to understand the immune responses induced by the vaccine regimens by performing some tests. Results of this study will serve as a guide for further studies. Participants can take part in this study if they are healthy based on medical history, physical examination, and vital sign measurements. The study will have the following phases: 1. Screening phase: This period will last for a maximum of 6 weeks and will confirm if participants can take part in the study. 2. Vaccination phase: After screening, participants will be put into one of 3 groups randomly (by chance), called Group 1, Group 2 and Group 3. Participants in Group 1 and 2 will receive investigational treatment (HIV vaccine) at Weeks 0, 12, 24, and 48. All vaccines will be given by an injection under the skin. All participants in Group 3 will receive placebo at Weeks 0, 12, 24, and 48. A placebo does not contain the study vaccine but looks like it and is given in the same way. Placebo is given so researchers can confirm changes are due to treatment and not by chance. 3. Follow-up phase: After last dose, there will be follow-up phase of 6 months to continue monitoring the participants’ health and to note if there are any side effects reported by the participants. 4. Long term extension (LTE) phase: Participants from Group 1 and 2, who have received all 4 vaccine doses and test negative for HIV infection at Week 72 will have the option to enter the LTE phase. All other participants discontinued the study after last dose. Participants who choose to continue will receive an optional booster dose of vaccine at about 3 years after the 4th vaccination at week 72. During the study, participants will undergo different study evaluations and tests. These include recording of side effects, clinical laboratory tests, vital signs (such as temperature, heart rate and blood pressure), and physical exams. Blood samples will be taken at several time points to know how many people responded to the vaccine regimen and to what extent. A committee will review the results to make sure the participants in the study are safe from serious side effects. The overall duration of the study can be up to 4 years and 6 months.
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| 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. |
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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 up to 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
main 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 main study visit at Week 72. A long-term extension (LTE)
phase (approximately 3 years after Week 72) will be performed for participants randomized to
Group 1 or Group 2, who have received all 4 vaccinations and are negative for HIV infection at
Week 72. The duration of the subject’s participation will be approximately 72-78 weeks (6 week
screening + 72 weeks main study) for participants not in the LTE phase and approximately 222
weeks for participants who consent to follow-up in the LTE phase.
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