Shingrix Vaccine for Shingles

Overseen By Virology Research Clinic

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Washington

Must not be taking: Immunosuppressants, Cytotoxics, Anticancer, others

Disqualifiers: Hepatitis, Autoimmune, Immunosuppression, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Shingrix vaccine to determine its effects on specific immune cells in the skin and blood. It targets individuals seeking to prevent shingles, a painful rash caused by the same virus as chickenpox. The trial includes two groups: adults aged 30-40 and those 70 and older. All participants must be HIV-negative and must not have received certain previous vaccines. This trial suits those who have not been vaccinated for shingles or chickenpox and fall within these age groups. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective Shingrix vaccine benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on long-term use of oral or parenteral steroids, high-dose inhaled steroids, or medications that may cause bleeding, you may not be eligible to participate.

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 long-term steroids, high-dose inhaled steroids, or medications that may cause bleeding, you might not be eligible to participate.

What is the safety track record for the Shingrix vaccine?

Research has shown that Shingrix, a vaccine to prevent shingles, is generally safe. Studies have found that Shingrix is more than 90% effective in preventing shingles in adults aged 50 and older, demonstrating its high efficacy.

The FDA has approved the vaccine for this age group, confirming its safety. Shingrix might cause temporary discomfort, such as pain, redness, and swelling at the injection site. Some individuals may also experience muscle pain, tiredness, headaches, or a slight fever. These side effects are usually mild and resolve on their own.

Overall, Shingrix is considered safe and well-tolerated based on its approval and widespread use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Shingrix is unique because it provides stronger and longer-lasting protection against shingles compared to older vaccines like Zostavax. Unlike Zostavax, which is a live attenuated vaccine, Shingrix is a recombinant vaccine that uses a non-live antigen and an adjuvant system to boost the body's immune response. This makes Shingrix especially effective for older adults, who are at higher risk for shingles and may have weaker immune systems. Researchers are excited about Shingrix because it has shown over 90% efficacy in preventing shingles, offering a more reliable option for reducing the incidence of this painful condition.

What is the effectiveness track record for the Shingrix vaccine for shingles?

Studies have shown that Shingrix is highly effective in preventing shingles. Research indicates that Shingrix prevents shingles in adults over 90% of the time. In another study, the vaccine reduced the risk of postherpetic neuralgia (a painful condition following shingles) by 91.2% compared to a placebo. For adults over 50, two doses of Shingrix provided about 74% protection against shingles. Overall, Shingrix serves as a strong defense against shingles and its complications. Participants in this trial will be divided into two cohorts based on age: one cohort for those aged 30-40 and another for those 70 years or older. ^{6 7 8 9 10}

Who Is on the Research Team?

Christine M Johnston, MD, MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for healthy adults in two age groups: 30-40 and 70 or older, who do not have HIV. Participants should not have active hepatitis B or C, history of organ transplants, be immunosuppressed due to illness or drugs, pregnant, planning pregnancy soon after vaccination, prone to excessive scarring or bleeding disorders. They must also never have received a Shingrix vaccine before.

Inclusion Criteria

Cohort 1: 30-40 years of age

Cohort 2: 70 years of age or older

HIV seronegative

Exclusion Criteria

VZV seronegative

Active Hepatitis C infection or active Hepatitis B infection. Persons with serologic evidence of hepatitis C infection that has cleared spontaneously, or with a history of treated hepatitis C with a sustained virologic response, can be enrolled. Persons with a history of resolved hepatitis B infection (negative for hepatitis B surface antigen) can be enrolled

You are allergic to lidocaine, silver nitrate, or mupirocin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) at the approved dose and schedule

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after vaccination, including measurement of gE-specific IgG and CD4 T cells

up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Shingrix

Trial Overview The study tests the effect of the Shingrix vaccine on specific immune cells in the skin and blood that fight against the varicella-zoster virus (VZV), which causes chickenpox and shingles. The goal is to understand how well these cells are generated after getting an intramuscular shot of Shingrix.

How Is the Trial Designed?

Group I: Cohort 2: 70 years of age or older Experimental Treatment 1 Intervention

Group II: Cohort 1: 30-40 year of age Experimental Treatment 1 Intervention

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?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

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]

HZ/Su, also known as 'Shingrix', is a new subunit vaccine designed to prevent shingles, particularly important for aging populations who are at higher risk.

Unlike the older live attenuated shingles vaccine, HZ/Su is suitable for a broader range of individuals, addressing safety concerns and potential long-term effectiveness issues associated with the previous vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A critical appraisal of 'Shingrix', a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus. Bharucha, T., Ming, D., Breuer, J.[2021]

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 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]

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]

The recombinant zoster vaccine (RZV; Shingrix) is effective and recommended for adults aged 50 and older, showing a safety profile consistent with prelicensure trials, where serious adverse events were similar to placebo rates.

In the first 8 months post-licensure, out of 3.2 million doses distributed, 4,381 adverse event reports were received, with common reactions being fever and injection site pain, but no unexpected safety concerns were identified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) - United States, October 2017-June 2018. Hesse, EM., Shimabukuro, TT., Su, JR., 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]

Citations

1. shingrixhcp.com shingrixhcp.com/efficacy-safety/efficacy-data/

SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) SHINGRIX delivered greater than 90 percent efficacy against shingles. graphic Data from ZOE-50 and pooled analysis from ZOE-50/-70.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6590925/

Shingrix: A New Herpes Zoster Vaccine - PMC The incidence of PHN per 1,000 person-years was 0.1 in the HZ/su group and 0.9 in the placebo group, showing a vaccine efficacy of 91.2% in adults aged 50 and ...

3. acpjournals.org acpjournals.org/doi/10.7326/ANNALS-24-02409

Effectiveness of Recombinant Herpes Zoster Vaccine in the ... Vaccine effectiveness against any HZ outcome was 56.1% (95% CI, 53.1% to 59.0%), with similar VE between immunocompetent (56.5% [CI, 53.2% to ...

4. cidrap.umn.edu cidrap.umn.edu/varicella/study-estimates-74-efficacy-shingles-vaccine-patients-over-50

Study estimates 74% efficacy of shingles vaccine in ... Two doses of the adjuvanted recombinant shingles vaccine (Shingrix) are an estimated 74% effective against herpes zoster infection and 84% effective against ...

5. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf329/8171839

Effectiveness of the Adjuvanted Recombinant Zoster Vaccine ... Among adults ≥50 years, 2 doses of recombinant zoster vaccine were highly effective against shingles and postherpetic neuralgia, ...

6. cdc.gov cdc.gov/vaccine-safety/vaccines/shingles-herpes.html

Shingles (Herpes Zoster) Vaccine Safety Both Shingrix and Zostavax shingles vaccines have been shown to be safe ... Effectiveness of Recombinant Zoster Vaccine Against Herpes Zoster in a Real-World ...

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

Package Insert - SHINGRIX SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ). (shingles):. • in adults aged 50 years and older. • in adults aged 18 years and older ...

8. gskpro.com gskpro.com/en-ie/products/shingrix/safety/

Safety | Shingrix (herpes zoster vaccine recombinant, ... SHINGRIX demonstrated >90% efficacy against shingles in all age groups 50 years of age and older based on pooled data from two large, phase 3 randomised control ...

9. shingrix.com shingrix.com/

Shingles Vaccine | SHINGRIX (Zoster Vaccine Recombinant ... SHINGRIX is an FDA-approved vaccine for the prevention of shingles (herpes zoster) in adults 50 years and older. SHINGRIX is not used to prevent chickenpox.

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

Post-marketing safety surveillance for the recombinant zoster ... Herpes zoster (shingles) occurs as a latent reactivation of varicella zoster virus and is typically characterized by painful, blistering ...