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A study of immune system response in adults who develop shingles after receiving recombinant herpes zoster vaccine to understand vaccine protection

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 study involves Shingrix, a vaccine used to prevent herpes zoster, which is commonly known as shingles. Shingles is a painful rash caused by the same virus that causes chickenpox, and it can occur in people who have had chickenpox in the past. The vaccine contains recombinant varicella zoster virus glycoprotein E, which is a protein made in a laboratory that helps the body build protection against the virus. The vaccine is given as an intramuscular injection, which means it is injected into a muscle.

The purpose of this study is to better understand how the immune system responds after receiving the recombinant herpes zoster vaccine. Specifically, the study will look at changes in certain immune system components that help fight the virus. These include cell-mediated immunity, which refers to immune cells that attack infected cells, humoral immunity, which involves antibodies that help neutralize the virus, and lymphocyte typing, which means identifying and counting different types of white blood cells that are important for immune defense. The study aims to examine a temporary change in specific immune responses that may occur after vaccination.

Participants will receive two doses of the vaccine given between two to six months apart. Blood samples will be collected at nine different times over a period of several months to measure how the immune system changes before and after each vaccine dose. The study will follow participants for approximately six months to track these immune responses over time. The measurements taken from the blood samples will help researchers understand the patterns of immune system activity following vaccination.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
First vaccination
You will receive the first dose of Shingrix vaccine.
The vaccine will be given as an injection into the muscle.
This vaccine is used to prevent herpes zoster, also known as shingles.
Step 2
Blood sample collection after first vaccination
Over a period of 3 weeks following the first vaccination, blood samples will be collected from you.
A total of 9 blood samples will be taken during the study period.
These samples will be used to measure specific immune responses and count different types of white blood cells in your body.
Step 3
Second vaccination
You will receive the second dose of Shingrix vaccine.
This dose will be given 2 to 6 months after the first vaccination.
The vaccine will be administered as an injection into the muscle, similar to the first dose.
Step 4
Blood sample collection after second vaccination
Following the second vaccination, additional blood samples will be collected.
These samples are part of the total 9 blood samples taken throughout the study.
The samples will be analyzed to observe changes in your immune system response over time.

Who can join the trial?

5 criteria

You must be a man or woman between 50 and 65 years of age
You must be in good health, meaning you do not have serious medical conditions that could affect your participation
You must be willing to sign a consent form, which is a document showing you agree to take part in the study
You must be willing to have 9 blood samples taken during the study, which means having blood drawn from your arm at different times
You must be willing to receive 2 doses of the vaccine for prevention of shingles, with the second dose given between 2 to 6 months after the first dose

Who cannot join the trial?

1 criterion

No specific exclusion criteria have been provided for this clinical trial

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Verified sites

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Centre hospitalier universitaire de Liege
Verified
Liege, Belgium

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Investigated drugs

Recombinant herpes zoster vaccine is a vaccine used to help prevent shingles, which is a painful rash caused by the varicella-zoster virus (the same virus that causes chickenpox). This vaccine works by helping your immune system recognize and fight the virus. In this study, researchers are looking at how the vaccine affects your immune system after you receive it, particularly how it influences certain immune cells and your body's ability to fight the herpes zoster virus.

Recombinant Varicella Zoster Virus Glycoprotein E

What is already known about the treatment

Recombinant Herpes Zoster Vaccine – This is a vaccine given by injection into the muscle to help prevent shingles, a painful rash caused by the reactivation of the chickenpox virus in people who had chickenpox earlier in life. The vaccine is currently approved and widely used in medical practice, particularly for older adults and people with weakened immune systems. It works by introducing a specific protein from the herpes zoster virus into the body, which trains the immune system to recognize and fight the virus without causing the actual disease. This vaccine belongs to the class of recombinant subunit vaccines, meaning it contains only a piece of the virus rather than the whole virus, making it safer while still providing strong protection.

Investigated diseases

Herpes Zoster – Herpes zoster, also known as shingles, is a viral infection caused by the reactivation of the varicella-zoster virus, the same virus that causes chickenpox. After a person recovers from chickenpox, the virus remains dormant in nerve tissue near the spinal cord and brain. Years or decades later, the virus can reactivate and travel along nerve pathways to the skin, causing herpes zoster. The condition typically presents as a painful rash with blisters that appears in a band or stripe pattern on one side of the body. The rash usually develops on the torso but can occur on the face, eyes, or other parts of the body. Pain, which can be severe, often precedes the rash and may persist even after the rash has healed.