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

130 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this wait-list control trial is to learn if having access to a new dashboard displaying information about immunosuppressed Veterans missing vaccinations for Shingrix can improve Shingrix vaccination rates at VA facilities. The main question\[s\] it aims to answer is: Will vaccination rates improve more rapidly for facilities with access to the dashboard compare to facilities without access? VA facility personnel will be granted access to the dashboard and outcomes (vaccination rates) will be measured using electronic health record data.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the Shingrix vaccine for immunosuppressed veterans?

Research shows that Shingrix, a vaccine for preventing shingles, is effective in adults over 50 and those with weakened immune systems, such as cancer patients. Clinical trials have demonstrated over 90% effectiveness in preventing shingles, making it a strong option for immunosuppressed individuals. ^{1 2 3 4 5}

Is the Shingrix vaccine safe for immunosuppressed individuals?

The Shingrix vaccine is generally considered safe for people on immunosuppressive therapy, but some rare skin reactions have been reported, such as blistering and rashes. Common side effects include redness and tenderness at the injection site, fatigue, and stomach upset. ^{1 2 4 6 7}

How is the Shingrix vaccine different from other treatments for immunosuppressed patients?

Shingrix is unique because it is a non-live recombinant vaccine, making it safe for immunosuppressed patients, unlike live vaccines like ZOSTAVAX®. It is specifically designed to prevent herpes zoster (shingles) and is administered in two doses, which is different from some other vaccines that may only require a single dose. ^{1 2 3 4 8}

Research Team

Gabriela Schmajuk, MD MS

Principal Investigator

San Francisco VA Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. 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]

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

Recombinant Zoster Vaccine (Shingrix): Real-World Effectiveness in the First 2 Years Post-Licensure. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Zoster disease after Shingrix vaccination]. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Herpes Zoster Vaccination Rates in Hematological and Oncological Patients-Stock Taking 2 Years after Market Approval. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Bullous fixed drug eruption following administration of the recombinant adjuvant Shingrix vaccine. [2021]

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

Dermatomal rash after Shingrix vaccination: cause or coincidence? [2022]

8. 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]