HIV Vaccine Study (HIV-CORE 0052)
What is the purpose of this trial?
An estimated 36.7 million people are chronically infected with Human Immunodeficiency Virus (HIV), the virus that, if untreated, causes AIDS. Vaccination is the most effective way to prevent many infectious diseases, but developing effective vaccines against HIV is extremely challenging. One of the main reasons for this is the extraordinary ability of the virus to change its genes. There is a great need for safe, effective HIV vaccines.
Oxford University researchers are developing new vaccine candidates for HIV.
The aim of the study is to see if the vaccines are safe and to see if they induce an immune response against human immunodeficiency virus (HIV) infection.
Am I eligible to participate?
What does the trial involve?
During this study, 3 volunteers will be vaccinated in group 1 and 10 volunteers will be vaccinated in group 2. Group 1 will receive one vaccine (ChAdOx1.tHIVconsv1) and have a total of 6 visits over 4 months. Group 2 volunteers will receive three vaccines (ChAdOx1.tHIVconsv1 alone and MVA.tHIVconsv3 and MVA.tHIVconsv4 given in combination one month later) and have a total of 11 visits over 5 months.
Vaccine appointments usually last around 90 minutes, and follow-up appointments around 20 minutes.
Is there any reimbursement for the trial?
Yes, you will be reimbursed at set rates for your time, inconvenience and travel which for this study will be approximately £290 - £535.
What are the advantages of taking part?
You will receive no direct benefit from taking part in this study. However, knowledge gained may in the future help others to avoid HIV infection.
Are there any risks from taking part in the study?
Preclinical studies have been performed in small animals without safety concerns. ChAdOx1.tHIVconsv1 is a first in human vaccine. The MVA.tHIVconsvX vaccines used in this study have been given to a small number of people in the US.
The risks and side effects of the proposed study procedures are:
- Blood samples: drawing blood may cause slight pain and occasionally bruising
- Vaccinations: Common side effects include some mild redness and swelling at the injection site and/or flu-like symptoms within 24 hours of the vaccinations. These usually resolve within 48 hours.
Please refer to the information sheet for full details of procedures and potential risks.
What will happen if I don’t want to carry on with the study?
Participation is voluntary and you are free to change your mind and withdraw at any time. You do not need to provide a reason. This will not affect your subsequent medical care in any way. If you withdraw we might need to offer you a follow up visit, for example to check the vaccination site or a blood result.