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Non‑inferiority of fractional varicella zoster virus glycoprotein E vaccine (AS01B) versus recombinant varicella zoster virus glycoprotein E vaccine in adults with shingles

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What is this trial about?

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

The study focuses on Shingles, a painful rash caused by reactivation of the varicella zoster virus. Participants receive a vaccine that contains a small piece of the virus called glycoprotein E together with an ingredient called AS01B that boosts the immune response. The test product, the Herpes zoster vaccine (recombinant, adjuvanted), is given as a tiny (fractional) amount injected into the skin (intradermal), while the standard vaccine, known as Shingrix, is administered as a full dose into the muscle (intramuscular).

The purpose of the study is to determine whether the smaller dose produces a similar immune protection as the full dose. Volunteers receive two injections about a month apart and provide blood samples at several time points up to six months to measure the level of antibody (proteins that help the body fight the virus) and the number of CD4+ T-cells (immune cells that coordinate the response). After each vaccination, participants record any side effects they experience for one week.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and baseline visit
After joining the study, you will have a baseline visit on day 0. during this visit a blood sample will be taken to measure your current immune response.
You will receive the first dose of the vaccine. if you are in the test group, you will receive herpes zoster vaccine (recombinant, adjuvanted) by an intradermal injection of 0.05 ml. if you are in the comparator group, you will receive shingrix suspension for injection by an intramuscular injection of 0.5 ml. both vaccines contain a recombinant varicella zoster virus glycoprotein e.
Step 2
First week monitoring
For the seven days after the first vaccination you will be asked to record any adverse events such as pain, redness, swelling, fever or fatigue. this information helps assess the safety of the vaccine.
Step 3
First follow‑up visit (day 28)
On day 28, approximately four weeks after the first dose, you will return for a follow‑up visit. a blood sample will be taken to measure the level of antibodies against the virus. these antibodies are proteins that help protect you from shingles.
Step 4
Second follow‑up visit (day 60)
On day 60, about two months after the first dose, another blood sample will be taken to track how your antibody levels are changing over time.
Step 5
Second vaccination (day 90)
On day 90, you will receive the second dose of the same vaccine you received at the baseline visit. the test group receives an intradermal injection of 0.05 ml, and the comparator group receives an intramuscular injection of 0.5 ml.
Step 6
Second week monitoring
For the seven days after the second vaccination you will again record any adverse events. this monitoring is identical to the first week after the initial dose.
Step 7
Primary outcome visit (day 118)
Four weeks after the second vaccination (day 118), a blood sample will be taken to determine the primary outcome: the geometric mean concentration of anti‑E varicella zoster virus antibodies.
Step 8
Final visit (day 180)
Six months after the first vaccination (day 180), you will attend a final visit. a blood sample will be taken to measure antibody levels and to assess the frequency of varicella zoster virus‑specific CD4+ T‑cells, which are a type of immune cell important for long‑term protection.

Who can join the trial?

3 criteria

Be between 50 and 85 years old when you sign the consent form.
Be able to give a personal, signed informed consent, meaning you understand the study and agree to follow its rules.
Either have lived in the Netherlands for at least 30 years or have had chickenpox (a common childhood illness that causes a rash and fever).

Who cannot join the trial?

12 criteria

Have already received a vaccine for shingles (Herpes Zoster) or chickenpox.
Participated in another study that used a similar vaccine within the past 28 days, or plan to be in another study while this trial is ongoing.
Received any other vaccine (not part of this study) within 28 days before the first dose.
Plan to receive any other vaccine within 28 days after the last dose.
Had shingles (Herpes Zoster) in the last 5 years.
Have a medical or mental‑health condition, including recent thoughts of suicide or abnormal lab results, that could make the study risky or unsuitable.
Had a severe reaction to a vaccine before, such as a life‑threatening allergic reaction called anaphylaxis, or are allergic to any ingredient in the study vaccine.
Are immunosuppressed (have a weakened immune system) or have a known immune deficiency.
Have an autoimmune disease (where the body attacks itself) or an active autoimmune disease that needs treatment.
Are using systemic (whole‑body) or topical (skin) corticosteroids.
Have a bleeding disorder that could cause prolonged bleeding, making a muscle injection unsafe.
Are pregnant or breastfeeding. (Women under 53 who have had a period in the last year will have a urine pregnancy test.)

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Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands

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Investigated drugs

Herpes zoster vaccine (recombinant, adjuvanted)
is a vaccine that contains a piece of the varicella‑zoster virus (the virus that causes chickenpox and shingles) called glycoprotein E. This piece is combined with a substance called AS01B that helps the body’s immune system respond more strongly. In the study it is given as a very small (fractional) dose under the skin (intradermal injection) to see if this lower amount can still produce a good immune response against shingles.
Shingrix
is the commercially available shingles vaccine that also contains the same viral glycoprotein E with the AS01B adjuvant. In the trial it is given as the normal full dose into the muscle (intramuscular injection). It serves as the standard comparison to show how the smaller intradermal dose works relative to the regular vaccine dose.

Recombinant Varicella Zoster Virus Glycoprotein E

What is already known about the treatment

Herpes zoster vaccine (recombinant, adjuvanted)
The vaccine is supplied as a powder that is mixed with liquid to make a suspension and given by a tiny intradermal injection of 0.1 ml (or 0.05 ml in the fractional dose study). It is an investigational formulation of a vaccine that is already approved for shingles prevention, being tested in a new low‑dose skin‑injection method. Its main use is to protect adults from developing shingles (herpes zoster) and related complications. The product contains a recombinant varicella‑zoster virus glycoprotein E combined with the AS01B adjuvant, which activates immune cells to produce antibodies and T‑cell responses; it is classified as an adjuvanted subunit vaccine.
Shingrix suspension for injection in pre‑filled syringe
This vaccine comes as a ready‑to‑use liquid suspension that is administered by a standard intramuscular injection of 0.5 ml. It is a fully licensed and widely used vaccine for shingles prevention in adults, especially those 50 years and older. The vaccine is indicated to prevent herpes zoster and the painful nerve condition that can follow it, called post‑herpetic neuralgia. It works by delivering recombinant VZV glycoprotein E together with the AS01B adjuvant, which together stimulate a strong antibody and cellular immune response; it is categorized as an adjuvanted recombinant subunit vaccine.

Investigated diseases

Shingles - It is a painful skin rash caused by reactivation of the chickenpox virus that stays dormant in nerve cells. After years, the virus can awaken, travel along nerves, and cause a band of blisters on the skin. The rash usually appears on one side of the body and may be accompanied by itching, burning, or tingling sensations. The skin lesions heal over a few weeks, but the nerve pain can continue for months. In some people, the nerve pain may become chronic.