A Prophylactic HIV Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DREP Alone and in Combination With a Clade C ENV Protein in Healthy HIV-uninfected Adults

Healthy Adults Clinical Trial

Official title: EHVA P01/ANRS VRI08: A Prophylactic HIV Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DREP Alone and in Combination With a Clade C ENV Protein in Healthy HIV-uninfected Adults

Status Active, not recruiting

Clinical Trial Summary

EHVA P01 is an international, phase I, prophylactic HIV vaccine trial to evaluate the safety and immunogenicity of HIV Clade C DREP alone and in Combination with a Clade C ENV protein in healthy HIV-uninfected adults.

Clinical Trial Description

The study is looking at the use of a new vaccine against the HIV virus. There are two parts to the study. One part is open-label to assess the safety of this vaccine, since this will be the first time that it has been used in humans. The second part is to see how well, and for how long, the vaccine activates the immune system. But this trial is not looking at whether or not the vaccine is effective in terms of protection against HIV. It is just assessing whether and how well the immune system responds.

Since this is the first time the vaccine has been used in humans, the safety will be assessed initially in healthy young adults. 10 participants aged 18-55 years will be given one of two different doses (0.2 and 1.0 mg) by injection into the arm muscle. There will be careful monitoring for any reactions to the vaccine.

As long as there are no safety concerns, the second part of the study can then be started. This will see how well the immune system has been activated using different dose levels of the vaccine. About 60 participants aged 18-55 years will be given one of three doses schedules (0.2mg, 1.0mg of the new vaccine and 4.0mg of a conventional vaccine). Chance will determine which dose each individual is given. Participants are only blind to the dose of vaccine administered but laboratory technicians assessing the safety parameters and immune responses will be blinded. The vaccine is given by injection into the muscle of the upper arm. Two injections, four weeks apart, are needed for the first part of the trial. There are three vaccinations in part two of the trial. There are likely to be mild side-effects near to the injection site. There may also be more general side-effects such as headache, temperature and chills. Participants will be asked to record any symptoms in an online diary. In order to see how well the immune system is responding, participants will need to give blood samples at several time points. The vaccines are not made from HIV and cannot cause HIV infection. However, the vaccines are likely to cause participants to produce antibodies against HIV that are detected by the rapid HIV antibody tests that are used in routine testing and a test that detects and measures antibodies in the blood used for confirmation. It is recommended that participants have an up to date vaccination status for any required immunisations including authorised COVID-19 vaccines. Vaccination with licensed (including authorised COVID-19) vaccines should be avoided from 28 days before and after each injection .

An independent steering committee will regularly review the information on safety and look at the immune responses to see which dose of the candidate vaccine could go forward to effectiveness testing in future trials. Before this study can start, the protocol describing the procedures and information to be provided to volunteers will be reviewed by the national drug authority and a multi-centre research ethics committee in the participating countries. ;

Related Conditions & MeSH terms

• Healthy Adults

• NCT number: NCT04844775
• Study type: Interventional
• Source: ANRS, Emerging Infectious Diseases
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 5, 2022
• Completion date: September 30, 2024