Shingrix Vaccine for Shingles
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Vaccination
Participants receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) at the approved dose and schedule
Follow-up
Participants are monitored for safety and effectiveness after vaccination, including measurement of gE-specific IgG and CD4 T cells
Treatment Details
Interventions
- Shingrix
Shingrix is already approved in United States, European Union, Canada for the following indications:
- Prevention of shingles in healthy adults over age 50 and in immunocompromised adults over age 18
- Prevention of herpes zoster (shingles) and postherpetic neuralgia (PHN) in adults 50 years of age and older
- 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
National Institute on Aging (NIA)
Collaborator