RecruitingPHASE2INTERVENTIONAL

Combination Vaccination and Broadly Neutralising Antibody Therapy in HIV

This study, called AbVax, is looking for better ways to manage HIV than lifelong daily medicines. Even though current treatments are effective, they can have side effects, affect daily life, and create stigma. Researchers are investigating if a new approach using special vaccines and powerful antibodies, called bNAbs, can offer long-lasting protection. bNAbs are designed to attack HIV and encourage the immune system to keep the virus under control. The study aims to find the best combination of these vaccines and bNAbs, along with a brief, controlled pause in regular HIV treatment, to give people living with HIV the strongest possible long-term defence against the virus. It hopes to reduce or even eliminate the need for daily pills.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of Oxford

Enrolment target

Start

05 Sep 2025

Estimated completion

30 Jun 2028

HIV

What is this study about?

Currently, people living with HIV need to take daily medication for life. While these treatments, called Antiretroviral Therapy (ART), are very good at controlling the virus, they can sometimes cause side effects, require strict daily routines, and for some, carry a social stigma. This study, called AbVax, is exploring a new approach that could be a significant step forward.

The research focuses on a combination of special vaccines and powerful new treatments called broadly neutralising antibodies (bNAbs). These bNAbs are designed to target HIV directly and also to stimulate your own immune system to fight the virus more effectively. The hope is that this combination could provide long-lasting control of HIV, potentially reducing or even removing the need for daily medication. A unique part of this study is understanding if a short, controlled break from regular HIV treatment, where a tiny amount of virus reappears, can actually help boost the body's protective response when combined with the vaccines and bNAbs.

By carefully studying how these different elements work together, the researchers aim to find the most effective combination to give people living with HIV strong, sustained protection. The ultimate goal is to improve the quality of life for people with HIV by offering alternative, longer-lasting ways to manage the condition.

Key takeaways

Exploring new ways to control HIV without daily medication.
Combines special vaccines and powerful new antibodies (bNAbs).
Aims for long-term control by boosting your body's immune system.
Involves a carefully monitored, temporary pause in regular HIV treatment.
Could improve quality of life for people living with HIV.
Careful monitoring and support throughout the study.

Who may be eligible?

This study is looking for people living with HIV who are generally healthy, aged between 18 and 64.

You would need to be currently taking daily HIV medication and have had the virus under control (undetectable) for at least one year. Your immune system, measured by your CD4 count, should be strong. You will also need to have received at least three doses of the COVID-19 vaccine and the current seasonal flu vaccine.

For women who could become pregnant, you would need to agree to use effective contraception throughout the study. All participants must agree to take precautions to prevent passing on HIV while they are off their regular medication or if the virus becomes detectable.

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.

Are you between 18 and 64 years old and living with HIV?
Have you had your HIV viral load undetectable for at least 1 year on daily medication?
Do you have a strong immune system (good CD4 count)?
Have you had at least 3 COVID-19 vaccine doses and the current flu vaccine?
Are you willing to attend regular clinic visits and have blood tests?
If you could become pregnant, are you willing to use effective contraception during the study period?

Answer every question to see your result.

What does participation involve?

If you join the AbVax study, you would first be assigned to one of three different groups by chance. Depending on your group, you might have a short period where you pause your regular HIV medication. You would then receive either bNAb infusions, a combination of three vaccines spread over 16 weeks, or both vaccines and bNAb infusions. These infusions are given directly into your bloodstream.

After these treatments, all participants will have a planned break from their regular HIV medication, carefully monitored by the study team. This is done to see how long your body can control the virus on its own before it becomes detectable again. Throughout the study, you would have regular visits to the clinic for blood tests and check-ups. The total duration of the study, including follow-up, could be for an extended period to monitor long-term effects.

Potential risks and benefits

Participating in this study might offer a potential benefit of long-term HIV control, possibly reducing or eliminating your need for daily medication. However, it's important to understand there are potential risks, such as temporary side effects from the vaccines or bNAbs, and the planned pause in your regular HIV medication means the virus might temporarily become detectable. This will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Guys and St Thomas' NHS Trust
Verified postcode
London, United Kingdom· Recruiting
St Mary's Clinical Trial Unit
Verified postcode
London, United Kingdom· Recruiting
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What are bNAbs?

bNAbs are special antibodies that can attack many different types of HIV. They are being explored as a treatment that could last longer than daily pills.

Why would I stop my regular HIV medication?

Stopping your medication in a controlled way helps researchers see how well the new vaccines and bNAbs are working to keep the virus under control without daily pills.

Will I be safe if I stop my medication?

This is a carefully controlled part of the study, and you will be closely monitored. Your medication will be restarted if the virus returns too much, or if it's considered medically necessary.

What are the vaccines for?

The vaccines are designed to teach your immune system to better recognise and fight HIV, aiming for stronger and more lasting control of the virus.

How long will I be in the study?

The study involves several treatments and follow-up, and the total duration would be explained in detail if you are considering participation.

How to find out more

Paola Cicconi, MD, PhD

paola.cicconi@ndm.ox.ac.uk 00 44 1865 611425 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.