Shingrix Vaccine Safety and Immunogenicity in People With HIV

Recruiting in Palo Alto (17 mi)

Overseen by Maura M Manion, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must be taking: Antiretrovirals

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: Previous Shingrix, Severe allergies, Pregnancy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies how the Shingrix vaccine affects people with HIV and healthy older adults. Shingrix helps prevent shingles by boosting the body's immunity against the virus. Participants will receive two shots and be monitored over time. Shingrix has shown promising results and is recommended for adults aged 50 and over.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on a stable antiretroviral regimen for HIV, you can continue it during the study.

What data supports the effectiveness of the treatment Shingrix in people with HIV?

Shingrix is a highly effective vaccine for preventing herpes zoster (shingles) and postherpetic neuralgia (nerve pain following shingles) in adults aged 50 and over, including those who are immunocompromised. It has been shown to significantly reduce the risk of these conditions and is preferred over live vaccines for people with weakened immune systems. ^{1 2 3 4 5}

Is the Shingrix vaccine generally safe for humans?

Shingrix is generally considered safe for humans, with common side effects including injection-site reactions, muscle pain, and fatigue, which are usually mild to moderate and temporary. It is safe for people with weakened immune systems, but there have been rare reports of skin reactions in some individuals. ^{1 3 5 6 7}

How is the Shingrix vaccine different from other treatments for herpes zoster?

Shingrix is a non-live, recombinant vaccine that is safe for people with weakened immune systems, unlike the older live vaccine Zostavax. It uses a specific protein from the virus and an adjuvant to boost the immune response, making it highly effective in preventing shingles and its complications. ^{1 2 3 4 5}

Research Team

Maura M Manion, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria

This trial is for adults over 18 with HIV who have a viral load under control and are on stable antiretroviral therapy, or elite controllers. Healthy volunteers over 50 can also join. Participants must agree to use contraception if they can become pregnant. Exclusions include pregnancy, breastfeeding, recent shingles or chickenpox vaccines, certain acute illnesses, immunoglobulin treatments within the past 90 days, and severe allergies to Shingrix components.

Inclusion Criteria

I am over 50, healthy, with no chronic issues or immune problems.

Individuals must meet all of the following criteria to be eligible for study participation: Able to provide informed consent.

Has a primary care provider.

Exclusion Criteria

Immunocompromised within the past 6 months.

Pregnancy or breastfeeding.

I have had chickenpox or shingles in the last month.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive two doses of Shingrix vaccine administered by intramuscular injection at months 0 and 2

2 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, with follow-up visits at months 3 and 12

10 months

2 visits (in-person)

Monitoring

Participants use a 28-day memory tool to record symptoms and have up to 4 phone calls to discuss side effects

1 year

Treatment Details

Interventions

• Shingrix (Virus Vaccine)

Trial Overview The study tests how well the Shingrix vaccine boosts immune response in people with HIV compared to healthy older adults. It involves at least four clinic visits over a year where participants receive two shots of Shingrix and provide blood samples through regular draws and possibly apheresis (a process that separates white blood cells from drawn blood).

Participant Groups

Group I: Shingrix Experimental Treatment 1 Intervention

Shingrix will be administered in two 0.5-mL doses approximately 2 months apart.

Shingrix is already approved in Canada for the following indications:

Approved in Canada as Shingrix for:

• Prevention of herpes zoster (shingles) in adults 50 years of age and older

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

National Institutes of Health Clinical Center Bethesda, MD

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3361

Patients Recruited

5,516,000+

Findings from Research

Shingrix is a new vaccine designed to prevent herpes zoster, commonly known as shingles, which can cause painful rashes and complications.

Clinical trials have shown that Shingrix is highly effective in reducing the incidence of shingles in adults, particularly in older populations, making it a significant advancement in herpes zoster prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shingrix: A New Herpes Zoster Vaccine. Maltz, F., Fidler, B.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Shingrix: A New Herpes Zoster Vaccine. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

[Zoster disease after Shingrix vaccination]. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Blistering autoimmune skin reaction following SHINGRIX vaccination in an ulcerative colitis patient: Case report and literature review. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Recombinant Zoster Vaccine (Shingrix®): A Review in Herpes Zoster. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

An Analysis of Spontaneously Reported Data of Vesicular and Bullous Cutaneous Eruptions Occurring Following Vaccination with the Adjuvanted Recombinant Zoster Vaccine. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Tiza-Titre increase and enhanced immunity through an adjuvanted, recombinant herpes zoster subunit vaccine in patients with liver cirrhosis and post-liver transplantation: a study protocol for a prospective cohort study. [2023]