Shingrix Vaccination for Immunosuppressed Veterans

Overseen By Cherish Wilson

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new digital tool can help more immunosuppressed Veterans receive their Shingrix vaccine at VA facilities. The Shingrix vaccine protects against shingles, which is crucial for those with weakened immune systems. Facilities will be divided into two groups: one will receive early access to the dashboard displaying vaccination information, while the other will gain access after a delay. The trial seeks clinicians working at VA facilities with access to electronic health records. The study aims to improve vaccination rates by simplifying the identification of Veterans who need the vaccine. As an unphased trial, it offers a unique opportunity to contribute to innovative solutions that could enhance healthcare delivery for Veterans.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that this dashboard is safe for improving vaccination rates?

Research has shown that the Shingrix vaccine is generally safe for adults, including those with weaker immune systems. In several studies, most side effects were mild, such as soreness at the injection site, muscle pain, or tiredness, while serious side effects remain rare.

One study found Shingrix to be safe for individuals with weakened immune systems, as it did not cause many serious health problems. Another study noted that reports of serious issues, like heart problems, were uncommon.

Overall, evidence suggests that Shingrix is safe for most people, including those with weaker immune systems. It is always important to consult a healthcare provider about any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Shingrix vaccination for immunosuppressed veterans because it offers a promising new approach to preventing shingles in a population that is particularly vulnerable to infections. Unlike many existing shingles vaccines, which may not be as effective for those with weakened immune systems, Shingrix is an adjuvanted recombinant vaccine. This means it uses a non-live component to boost the immune response, potentially offering better protection for immunosuppressed individuals. Additionally, the trial includes the innovative use of a Shingrix dashboard, which could provide early insights and data to participants, enhancing patient engagement and monitoring.

What evidence suggests that this dashboard is effective for improving Shingrix vaccination rates?

Research has shown that the Shingrix vaccine works well for people with weakened immune systems. Studies indicate that Shingrix is about 68.2% effective in preventing shingles in these patients. In some real-world situations, Shingrix has been about 50% effective for people with conditions like inflammatory arthritis who are on treatments that affect the immune system. These findings suggest that Shingrix is a strong option for protecting against shingles, even for those whose immune systems are not at full strength. Participants in this trial will be divided into two groups: one group will receive early access to the Shingrix dashboard, while the waitlist control arm will receive access after 6-9 months. ^{6 7 8 9 10}

Who Is on the Research Team?

Gabriela Schmajuk, MD MS

Principal Investigator

San Francisco VA Medical Center

Are You a Good Fit for This Trial?

This trial is for clinicians working at Veterans Health Administration (VHA) facilities who have access to electronic health records. It's designed to see if a new tool, the Shingrix dashboard, can help improve vaccination rates among immunosuppressed US veterans.

Inclusion Criteria

I work at a VHA facility and can access electronic health records.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Early dashboard access arm receives access to the Shingrix dashboard

6-9 months

Wait-list Control

Wait list control arm receives no intervention for 6-9 months

6-9 months

Follow-up

Participants are monitored for vaccination rates using electronic health record data

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Shingrix Vaccine

Trial Overview The study tests whether a Shingrix vaccination dashboard for clinicians increases the rate of vaccinations in immunosuppressed veterans compared to facilities without this tool. Facilities are split into two groups: one with dashboard access and one without, to measure any differences in vaccination rates.

How Is the Trial Designed?

Group I: Wait list control arm Experimental Treatment 1 Intervention

The wait list control arm will receive no intervention for 6-9 months; after this period, this arm will also receive access to the Shingrix dashboard.

Group II: Early dashboard access Experimental Treatment 1 Intervention

The early dashboard access arm will receive access to the Shingrix dashboard as soon as the study begins.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

San Francisco Veterans Affairs Medical Center

Collaborator

Trials

52

Recruited

211,000+

Published Research Related to This Trial

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]

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]

In a study of Medicare beneficiaries aged over 65, Shingrix demonstrated a vaccine effectiveness of 70.1% for those receiving the full 2-dose regimen and 56.9% for those receiving only 1 dose, indicating that completing the 2-dose series is beneficial.

The vaccine remained effective even for individuals over 80 years old and those with autoimmune or immunosuppressive conditions, with a notable 76.0% effectiveness against postherpetic neuralgia, suggesting its broad applicability in older and at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant Zoster Vaccine (Shingrix): Real-World Effectiveness in the First 2 Years Post-Licensure. Izurieta, HS., Wu, X., Forshee, R., et al.[2022]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9561817/

Efficacy, effectiveness, and safety of herpes zoster vaccine in ... The present evidence shows that the effectiveness of ZVL was 48% among general population while 37% among immunosuppressed individuals (27).

2. shingrixhcp.com shingrixhcp.com/home-ic/efficacy-safety/efficacy-data/

Efficacy Data | SHINGRIX (Zoster Vaccine Recombinant, ... SHINGRIX demonstrated strong efficacy in immunocompromised patients ≥18 years of age. · ‌SHINGRIX Demonstrated 68.2% Efficacy Against Herpes Zoster in auHSCT ...

3. cdc.gov cdc.gov/acip/grade/recombinant-zoster-immunocompromised.html

Use of Recombinant Zoster Vaccine in ... In terms of benefits, the available data indicated that the vaccine was effective for preventing herpes zoster, with VE ranging from 68.2% to ...

4. arthritis-research.biomedcentral.com arthritis-research.biomedcentral.com/articles/10.1186/s13075-025-03565-0

Real-world data on the use of the Shingrix vaccine among ... This study showed that the effectiveness of Shingrix in patients with inflammatory arthritis on immunomodulatory treatment was 50%, and the risk of venous ...

5. gskpro.com gskpro.com/en-gb/products/shingrix/immunocompromised-patients/clinical-data/

Immunocompromised Clinical Data | SHINGRIX SHINGRIX has demonstrated vaccine efficacy against Herpes Zoster in two immunocompromised (IC) patient populations ≥18 years of age (includes post-hoc analyses) ...

6. fda.gov fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert-SHINGRIX.pdf

Package Insert - SHINGRIX The safety of SHINGRIX was evaluated in 6 placebo-controlled clinical studies that enrolled 3,116 subjects aged 18 years and older from 5 different ...

7. shingrixhcp.com shingrixhcp.com/home-ic/

Immunocompromised, 18 years and older SEE DATA. Safety Profile. Learn about the safety profile of SHINGRIX in immunocompromised patients aged 18 years and older. SAFETY INFO. Learn about protection ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11788766/

Post-marketing safety surveillance for the recombinant zoster ... Eighty-six deaths were reported following recombinant zoster vaccine vaccination. •. Cardiovascular event and Guillain-Barre syndrome were the ...

9. cdc.gov cdc.gov/shingles/hcp/vaccine-considerations/immunocompromised-adults.html

Clinical Considerations for Shingrix Use in ... Varicella vaccines contain live virus and are contraindicated for most immunocompromised patients. Other considerations for patients with no ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25010059

Safety, immunogenicity and efficacy of the Shingrix vaccine ... In this pilot study, the Shingrix vaccine appeared safe in highly immunosuppressed pediatric patients. Most adverse events were mild and self- ...