Therapeutic vaccination: Phase I / II clinical study on patients randomized blinded to the experimental vaccine or placebo regimen. we want to evaluate the safety and the immunogenicity of a vaccine that includes a first administration of the ChAdOx1.tHIVconsvX product and a second one with MVA.tHIVconsvX in HIV-1 positive adults treated early and able to control the infection for a long time.
This clinical study looks at an experimental therapeutic vaccine for adults living with HIV-1. Unlike vaccines that stop people from catching an infection, a therapeutic vaccine is designed to help people who already have a condition fight it more effectively. The trial tests two vaccine doses given one after the other: ChAdOx1.tHIVconsvX followed by MVA.tHIVconsvX. These vaccines aim to train the body's natural defences to spot parts of HIV that do not easily change or mutate. Because this is an early Phase 1/2 trial, the main goals are to check safety and see how the immune system reacts. Half of the participants may receive a dummy injection (placebo) to ensure fair comparisons. The study is open to adults aged 18 and over who started HIV medication early after diagnosis and have kept the virus suppressed for a long time.
At a glance
What is this study about?
HIV is a virus that affects the body's immune system. Modern treatments, called antiretroviral therapy, are very good at keeping the virus at undetectable levels. However, these medicines must be taken every day for life because HIV hides inside resting cells where medicines cannot completely remove it. Scientists are searching for new ways to help the body's own immune system keep the virus under control without needing daily pills.
This study tests a treatment known as a 'therapeutic vaccine'. While standard vaccines prevent you from getting sick in the first place, therapeutic vaccines are given to people who already have an infection to help their immune cells fight back. The trial tests two vaccines given in sequence. They use harmless viral carriers to deliver targets from HIV, teaching the immune system to spot the parts of the virus that rarely change.
Because this is an early-stage trial (Phase 1/2), doctors want to find out two key things: whether the vaccines are safe and well-tolerated, and whether they produce a measurable immune response. The study is randomised and blinded, meaning volunteers will be grouped by chance to receive either the active vaccine or a dummy shot (placebo), and neither they nor their doctors will know which one they received until the study ends.
Key takeaways
- Tests an experimental two-step vaccine designed to train the immune system against HIV.
- Early-stage (Phase 1/2) trial focusing on safety and the body's immune reaction.
- For adults aged 18+ who started HIV treatment early and have good, long-term viral control.
- Some volunteers will receive the experimental vaccine, while others receive a placebo.
- Participation is voluntary and does not replace your standard daily HIV care.
Who may be eligible?
To take part, you must be 18 years of age or older and living with HIV-1. The study is open to people of all genders.
This trial is specifically designed for people who were diagnosed and started effective HIV treatment early, and who have successfully kept the virus under control for a long time. This usually means your viral load has stayed undetectable on your current medication.
Because safety is the top priority in early trials, people with other uncontrolled health conditions or specific immune problems may not be able to join. The study doctors will review your medical history and run routine blood tests to confirm if the trial is right for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- You are aged 18 or older.
- You have been diagnosed with HIV-1.
- You started taking HIV treatment relatively soon after your diagnosis.
- Your viral load has been well controlled and undetectable for a long time.
- You are willing to attend regular clinic appointments and have blood tests.
What does participation involve?
Taking part involves receiving two separate injections spaced over several weeks or months. You will be randomly assigned to receive either the trial vaccines or a placebo injection. You will continue with your regular HIV care while attending scheduled clinic visits for monitoring. During these visits, the study team will ask how you feel, check your vital signs, and take blood samples to measure your immune response and viral levels. The trial will involve regular check-ups over several months to monitor your health and safety closely.
Potential risks and benefits
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Common questions
Will this vaccine cure my HIV?
No, this trial is not expected to cure HIV. It is an early test to see if the vaccine is safe and if it helps the immune system recognise the virus.
Do I have to stop taking my regular HIV medication?
No. You should continue taking your normal HIV treatment exactly as prescribed unless the study doctors give you specific, monitored instructions.
What is a placebo, and might I get one?
A placebo is a harmless dummy injection that contains no active medicine. It helps researchers prove that any changes seen are truly caused by the vaccine.
Will taking part cost me anything?
No, the trial treatment and extra tests are free. Many trials also help cover reasonable travel expenses to and from clinic visits.
Can I leave the study if I change my mind?
Yes, taking part is entirely voluntary. You can stop participating at any time, and your normal healthcare will continue as usual.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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