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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.06.2023

Trial locations

Investigated drugs:

Recombinant Varicella Zoster Virus Glycoprotein E

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.

Investigated diseases:

HIV infection

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 ID:

2023-504482-23-00

Protocol code:

CHUBX 2022/40

NCT ID:

NCT05575830

Trial Phase:

Therapeutic exploratory (Phase II)

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

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