Shingrix Vaccine Safety and Immunogenicity in People With HIV

Overseen By Maura M Manion, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

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 All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 2 months

225 Participants Needed

Trial Summary

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}

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.

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.

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

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 United States, European Union, Canada for the following indications:

Approved in United States as Shingrix for:

• Prevention of shingles in healthy adults over age 50 and in immunocompromised adults over age 18

Approved in European Union as Shingrix for:

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

Approved in Canada as Shingrix for:

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

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

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]

Shingrix is an approved vaccine in Germany for preventing shingles (zoster) and its complications, specifically for adults aged 60 and older.

If patients experience bullous skin lesions after receiving Shingrix, it is important to consider the possibility of zoster disease and report any unexpected side effects to the appropriate medical authorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Zoster disease after Shingrix vaccination]. Kohn, D., Wetzig, T.[2021]

SHINGRIX, a non-live herpes zoster vaccine, is safe for patients on immunosuppressive therapy, making it a suitable option for those with inflammatory bowel disease who are at higher risk for infections.

A case report of a 74-year-old woman with ulcerative proctosigmoiditis revealed blistering autoimmune skin disorders following SHINGRIX vaccination, suggesting a potential, though previously unreported, adverse effect of the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blistering autoimmune skin reaction following SHINGRIX vaccination in an ulcerative colitis patient: Case report and literature review. Bell, H., Kamal, N., Wong, U.[2021]

In a phase 3 study involving 569 adults with haematological malignancies, the adjuvanted recombinant zoster vaccine (Shingrix) demonstrated a strong immunogenic response, with 80.4% of participants showing a humoral vaccine response compared to only 0.8% in the placebo group, indicating its efficacy in this high-risk population.

While the vaccine was more reactogenic than placebo, with higher reports of pain and fatigue, the overall safety profile was similar between the vaccine and placebo groups, suggesting that the benefits of vaccination outweigh the risks for immunocompromised individuals.

NCBI (Pubmed)

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. Dagnew, AF., Ilhan, O., Lee, WS., et al.[2020]

Shingrix® is a highly effective recombinant zoster vaccine that significantly reduces the risk of herpes zoster (HZ) and postherpetic neuralgia (PHN) in adults aged 50 and older, with efficacy remaining strong even after 4 years.

While Shingrix® is associated with more side effects than a placebo, such as injection-site reactions and fatigue, these reactions are generally mild to moderate and transient, making it a well-tolerated option for preventing HZ and PHN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

A review of 2.5 years of post-marketing data from over 32 million doses of the adjuvanted recombinant zoster vaccine (RZV) found no significant safety concerns related to vesicular and bullous skin eruptions following vaccination.

The analysis showed that the number of herpes zoster (HZ) cases reported was lower than expected in the general population, suggesting that RZV vaccination does not increase the risk of HZ reactivation.

NCBI (Pubmed)

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. Pirrotta, P., Tavares-Da-Silva, F., Co, M., et al.[2022]

This study aims to evaluate the immune response to the Shingrix vaccine in 308 patients, including those with liver cirrhosis and liver transplant recipients, to understand how immunosuppression affects vaccine efficacy.

By measuring specific antibody and T cell responses at multiple time points, the research seeks to establish a routine test for monitoring vaccination success and its correlation with clinical protection against shingles.

NCBI (Pubmed)

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. Vollmer-Raschdorf, S., Rashidi-Alavijeh, J., Voigt, S., et al.[2023]

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]