Between July 2018 and March 2023 people were invited to take part in the PrEPVacc study who are aged 18-40 and likely to be at risk of HIV. They need to be willing to undergo HIV testing and risk reduction counselling including promotion of PrEP and condoms. They are asked to follow all study procedures necessary for the study.
As of March 2023, the study has now completed enrolment and is no longer enrolling participants.
Where is the study taking place?
The study is taking place at five sites across four countries:
Maputo, Mozambique (not part of the clinical trial)
What criteria are there to join the study?
You can take part if:
You are not infected with HIV
You are aged 18-40 years old on the day of screening
You are willing and able to give informed consent before taking part
You are willing and able to come to all the visits and provide blood, urine and other samples at the required time points.
Your home address is accessible for visiting and you intend to remain near the recruitment area for at least 82 weeks from screening.
You are likely to be at risk from exposure to HIV during follow up
You are willing to undergo HIV testing, receive HIV results and risk reduction counselling which includes promotion of PrEP and condoms.
You are willing to use a highly effective method of contraception from screening until 18 weeks after the last injection if you are female, of childbearing age and not sterilised.
You are willing to avoid impregnating female partners from screening until 18 weeks after the last injection if you are male and not sterilised.
You cannot take part if:
You are HIV infected or have an uncertain HIV test result at screening or enrolment.
You have a positive test for Hepatitis B surface antigen.
You are pregnant or breastfeeding
You are taking part in another medical research study or have received a live vaccine within 30 days of randomisation.
You have previously taken part in a HIV vaccine or biologic therapy study.
You have received any blood products or immunoglobulins within 12 weeks of screening.
You are allergic to any part of the vaccine formulation used in this study.
You have a history of severe or multiple allergies to vaccines, drugs or pharmaceutical agents.
You have a generalised disease at the time of randomisation or history of chronic illness that may prevent vaccination.
Certain blood test results are moderately abnormal.
What will I need to do if I take part?
Your involvement in the PrEPVacc study will last at least 17 months from the first vaccine injection. There will be at least 15 clinic visits during the study. Visits will involve various procedures, receiving vaccine injections and PrEP tablets, counselling, learning from your experiences, updating on your health, answering questions about your sexual practices and behaviour, as well as taking blood and urine samples. They will typically last 1-3 hours each.
You will be given a detailed breakdown of what happens at each visit so you know what to expect. Your travel expenses to the clinic will be reimbursed.
Would participation in the study affect my personal life in some way?
We ask women to use contraception during the vaccination period from screening until 18 weeks after the last injection to prevent a pregnancy, as we don't know the effects of this vaccine on the developing baby. We ask men to avoid making their female partners pregnant until 18 weeks after their last injection for the same reason.
What are the possible side effects of vaccines and PrEP?
Like most available medications and vaccines that we take, we know that there can be reactions or side effects. This may include fever, headaches, nausea, aches and pains and fatigue.
In some people PrEP can cause minor side effects like nausea, bloating, diarrhoea and headache. These side effects usually disappear over time.
Will I be protected from HIV if I join the study?
We do not know yet if the vaccines in this study will protect participants from HIV. People who take PrEP correctly are extremely unlikely to catch HIV.
All participants will be counselled on how to prevent HIV infection and will be encouraged to use the available prevention methods through the study.
Can the vaccines give you HIV?
No. It is absolutely NOT POSSIBLE to get HIV infections from the vaccines used in this study. The vaccines do not contain any live HIV, killed HIV, parts taken from HIV or HIV-infected cells. The vaccines are made up of safe chemical components.
What if I don’t want to take part?
Your participation is entirely voluntary, and it is up to you to decide whether or not to take part. If you do decide to take part you can withdraw at any time without giving a reason. If you decide not to take part or withdraw after you have joined, you will not be treated differently by the clinic or lose any other benefits or rights you would otherwise have.
Study locations
PrEPVacc is planning to run the clinical trial at five sites in four countries:
Click on the links above for contact details for participants at each site.
Find a full list of PrEPVacc Partners here