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Study on Immune Response to Recombinant Zoster Vaccine in People Over 50 Living with HIV

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the immune response to the recombinant Zoster Vaccine in individuals over 50 years of age. The study involves two groups: people living with HIV and those without the virus, matched by age and gender. The vaccine being tested is called Shingrix, which is designed to protect against shingles, a condition caused by the reactivation of the varicella-zoster virus, the same virus that causes chickenpox. The purpose of the study is to compare how well the immune system responds to the vaccine in both groups.

Participants in the study will receive the Shingrix vaccine through an injection into the muscle. The study will monitor the immune response by measuring specific antibodies and immune cells at different times after vaccination. The study will also track any side effects that occur after receiving the vaccine. The trial will last for several months, with follow-up visits to assess the immune response and overall health of the participants.

The study aims to provide valuable information on the effectiveness of the recombinant Zoster Vaccine in people living with HIV compared to those without the virus. This information could help improve vaccination strategies and health outcomes for individuals over 50 years old, particularly those with HIV. Participants will contribute to important research that may benefit others in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide informed consent by signing a document. This confirms your understanding and agreement to participate in the study.

    You must be over 50 years of age and, if living with HIV, have been on combination antiretroviral therapy (cART) for more than 10 years. Your HIV viral load should be less than 50 copies/ml within the last six months.

  2. Step 2

    First vaccination

    You will receive the first dose of the recombinant zoster vaccine (RZV) through an intramuscular injection. This vaccine is designed to help your body build protection against shingles.

    After the injection, you will be monitored for any immediate reactions.

  3. Step 3

    Monitoring after first vaccination

    For the first 7 days after the vaccination, you will be asked to record any side effects in a diary. These may include pain, swelling, or redness at the injection site, as well as general symptoms like fatigue, headache, or fever.

    You will also report any unexpected side effects for 28 days following the vaccination.

  4. Step 4

    Second vaccination

    Approximately 60 days after the first dose, you will receive a second dose of the recombinant zoster vaccine through another intramuscular injection.

    This second dose is important to ensure the effectiveness of the vaccine.

  5. Step 5

    Monitoring after second vaccination

    Similar to the first dose, you will monitor and record any side effects for 7 days after the second vaccination.

    You will also report any unexpected side effects for 28 days following the second vaccination.

  6. Step 6

    Follow-up assessments

    You will have follow-up visits to assess your immune response to the vaccine. Blood samples will be taken at different times, specifically on day 0, day 60, day 90, and day 360.

    These samples will help measure the levels of antibodies and specific immune cells in your blood.

  7. Step 7

    End of study

    The study is expected to conclude by October 31, 2024. By this time, all assessments and follow-ups should be completed.

    Your participation will contribute to understanding the immune response to the vaccine in people over 50 years of age, both with and without HIV.

Who can join the trial?

7 criteria

  • For people living with HIV: Must be registered in the SHCS or in the ANRS CO3 Aquitaine Cohort.
  • For people living with HIV and control group: Must be older than 50 years.
  • For people living with HIV: Must have been on cART (combination antiretroviral therapy) for more than 10 years.
  • For people living with HIV and control group: Must not have been vaccinated with RZV (Recombinant Zoster Vaccine).
  • For people living with HIV: Must have an HIV viral load of less than 50 copies/ml within 6 months from the last blood test. (Viral load is the amount of HIV virus in the blood.)
  • For people living with HIV and control group: Must provide informed consent by signing a document.
  • For people living with HIV and control group in France: Must be affiliated with or a beneficiary of the French social security scheme.

Who cannot join the trial?

5 criteria

  • People who are not living with HIV (Human Immunodeficiency Virus) cannot participate.
  • Participants must be over 50 years old.
  • Participants must have been on cART (combination Antiretroviral Therapy) for more than 10 years.
  • Both men and women can participate.
  • People who are considered part of a vulnerable population are not eligible.
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Investigated drugs

Recombinant Zoster Vaccine (RZV) is a vaccine designed to protect against shingles, a painful rash caused by the reactivation of the chickenpox virus. This vaccine works by boosting the immune system's ability to fight the virus, reducing the risk of developing shingles. In this clinical trial, the vaccine is being tested to see how well it works in people over 50 years old who are living with HIV and have been on antiretroviral therapy for more than 10 years. The goal is to compare their immune response to the vaccine with that of people of the same age and gender who do not have HIV.

What is already known about the treatment

Recombinant Zoster Vaccine (RZV) – This vaccine is administered as an injection, typically into the muscle of the upper arm. It is currently being studied for its effectiveness in people living with HIV who are over 50 years old, compared to those without HIV. The main purpose of this vaccine is to prevent shingles, a painful skin rash caused by the reactivation of the chickenpox virus. At the molecular level, the vaccine works by stimulating the immune system to produce antibodies that can recognize and fight the virus. It is classified as a vaccine, which is a type of biological preparation that provides active acquired immunity to a particular infectious disease.

Investigated diseases

Human Immunodeficiency Virus (HIV) – HIV is a virus that attacks the body's immune system, specifically the CD4 cells (T cells), which are crucial for fighting infections. Over time, HIV can destroy so many of these cells that the body becomes unable to fight off infections and disease. The virus progresses through several stages, starting with acute infection, where flu-like symptoms may occur. This is followed by a chronic stage, where the virus multiplies at lower levels and may not cause symptoms. Without treatment, HIV can advance to acquired immunodeficiency syndrome (AIDS), the most severe phase, where the immune system is severely damaged. During this stage, individuals are vulnerable to opportunistic infections and certain cancers.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504482-23-00Protocol codeCHUBX 2022/40Estimated enrolment225 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

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