50 Participants Needed

Shingrix Vaccine for Shingles

VR
Overseen ByVirology Research Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the idea that Shingrix Vaccine for Shingles is an effective treatment?

The available research shows that Shingrix is highly effective in preventing shingles and its complications in adults aged 50 and older. In key studies, Shingrix reduced the risk of shingles and its painful aftereffects by over 90%. This protection remained strong over four years, especially in those aged 70 and older. Compared to an older live vaccine, Shingrix is preferred because it is safe for people with weakened immune systems and offers better long-term protection.12345

What data supports the effectiveness of the treatment Shingrix for shingles?

Shingrix is highly effective in preventing shingles and its complications, with clinical trials showing over 90% efficacy in adults aged 50 and older. It also reduces the severity of pain and illness in those who still get shingles after vaccination.12345

What safety data is available for the Shingrix vaccine?

The Shingrix vaccine, also known as the recombinant zoster vaccine (RZV), has undergone extensive safety evaluations. In prelicensure clinical trials, 85% of participants reported local or systemic reactions, with 17% experiencing severe reactions. However, serious adverse events were similar between the vaccine and placebo groups. Postlicensure safety monitoring by the CDC and FDA through the Vaccine Adverse Event Reporting System (VAERS) reported 4,381 adverse events out of 3.2 million doses, with 3% classified as serious. Common reactions included fever, injection site pain, and erythema. No unexpected patterns were detected, and the safety profile was consistent with clinical trials. The vaccine is well-tolerated, with most adverse reactions being mild to moderate and transient.12567

Is the Shingrix vaccine safe for humans?

The Shingrix vaccine is generally considered safe for humans. In clinical trials, most people experienced mild to moderate reactions like pain at the injection site, muscle pain, and fatigue, which were temporary. Serious side effects were rare and occurred at similar rates as in those who received a placebo.12567

Is Shingrix a promising treatment for shingles?

Yes, Shingrix is a promising treatment for shingles. It is a highly effective vaccine that significantly reduces the risk of shingles and its painful complications in adults aged 50 and older. It is well-tolerated and preferred over older vaccines, especially for people with weakened immune systems.12345

How is the Shingrix vaccine different from other treatments for shingles?

Shingrix is a unique shingles vaccine because it is a recombinant subunit vaccine, meaning it uses a piece of the virus combined with an adjuvant (a substance that enhances the body's immune response) to provide strong protection, even in older adults and those with weakened immune systems. Unlike the older live attenuated vaccine, Shingrix is not contraindicated for immunocompromised individuals and has shown over 90% efficacy in preventing shingles.12345

What is the purpose of this trial?

To evaluate the effect of intramuscular RZV vaccine on VZV-specific skin TRM and circulating T-cells

Research Team

CM

Christine M Johnston, MD, MPH

Principal Investigator

University of Washington

Eligibility Criteria

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
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Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Cohort 2: 70 years of age or olderExperimental Treatment1 Intervention
Group II: Cohort 1: 30-40 year of ageExperimental Treatment1 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

Find a Clinic Near You

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+

Findings from Research

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.
Recombinant Zoster Vaccine (Shingrix®): A Review in Herpes Zoster.Syed, YY.[2022]
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.
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.
[Zoster disease after Shingrix vaccination].Kohn, D., Wetzig, T.[2021]

References

Recombinant Zoster Vaccine (Shingrix®): A Review in Herpes Zoster. [2022]
Shingrix: A New Herpes Zoster Vaccine. [2020]
[Zoster disease after Shingrix vaccination]. [2021]
Recombinant Zoster Vaccine (Shingrix): Real-World Effectiveness in the First 2 Years Post-Licensure. [2022]
A critical appraisal of 'Shingrix', a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus. [2021]
An Analysis of Spontaneously Reported Data of Vesicular and Bullous Cutaneous Eruptions Occurring Following Vaccination with the Adjuvanted Recombinant Zoster Vaccine. [2022]
Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) - United States, October 2017-June 2018. [2020]
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