Overseen ByChristine M Johnston, MD, MPH
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Washington
No Placebo Group
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?To evaluate the effect of intramuscular RZV vaccine on VZV-specific skin TRM and circulating T-cells
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.
12456What 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.
12347What 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.
12456Do 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.
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.Participant Groups
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.
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
Research locations nearbySelect from list below to view details:
University of Washington Virology Research ClinicSeattle, WA
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Who is running the clinical trial?
University of WashingtonLead Sponsor
National Institute on Aging (NIA)Collaborator
References
A critical appraisal of 'Shingrix', a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus. [2021]HZ/Su, branded as 'Shingrix', is one of the newest vaccines to be submitted for multi-national regulatory approval. It is targeted to prevent shingles, a global concern with aging populations. A live attenuated vaccine for shingles has been available for over a decade, however it is contraindicated in specific subgroups of people, and there are added concerns regarding long-term immunogenicity. HZ/Su is the first subunit vaccine developed to protect against shingles. This paper provides a critical appraisal of current evidence regarding HZ/Su.
Recombinant Zoster Vaccine (Shingrix®): A Review in Herpes Zoster. [2022]Shingrix® is a recombinant zoster vaccine (RZV) that contains a varicella zoster virus glycoprotein E antigen and the AS01B adjuvant system. The subunit vaccine is approved for the prevention of herpes zoster (HZ) [EU, USA, Japan, Canada and Australia] and postherpetic neuralgia (PHN) [EU and Australia] in adults aged ≥ 50 years. In the pivotal trials in adults aged ≥ 50 years (ZOE-50) and ≥ 70 years (ZOE-70), RZV significantly reduced the risk of HZ and PHN. Its protective efficacy waned minimally over 4 years and was well preserved in adults aged ≥ 70 years. In patients with breakthrough disease, RZV reduced HZ-related pain severity, burden of illness and burden of interference with activities of daily living. RZV was more reactogenic than placebo, with injection-site reactions, myalgia and fatigue being the most common solicited adverse reactions. However, most solicited adverse reactions were transient and were mild to moderate in severity. RZV represents a novel, highly effective and well-tolerated vaccine option for HZ and PHN in adults aged ≥ 50 years. RZV is not contraindicated in immunocompromised individuals, and is preferred over a live attenuated HZ vaccine in immunocompetent individuals, according to the US and Canadian guidelines.
Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) - United States, October 2017-June 2018. [2020]Recombinant zoster vaccine (RZV; Shingrix), an adjuvanted glycoprotein vaccine, was licensed by the Food and Drug Administration (FDA) and recommended by the Advisory Committee on Immunization Practices for adults aged ≥50 years in October 2017 (1). The previously licensed live-attenuated zoster vaccine (ZVL; Zostavax) is recommended for adults aged ≥60 years. RZV is administered intramuscularly as a 2-dose series, with an interval of 2-6 months between doses. In prelicensure clinical trials, 85% of 6,773 vaccinated study participants reported local or systemic reactions after receiving RZV, with approximately 17% experiencing a grade 3 reaction (erythema or induration >3.5 inches or systemic symptoms that interfere with normal activity). However, rates of serious adverse events (i.e., hospitalization, prolongation of existing hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death) were similar in the RZV and placebo groups (2). After licensure, CDC and FDA began safety monitoring of RZV in the Vaccine Adverse Event Reporting System (VAERS) (3). During the first 8 months of use, when approximately 3.2 million RZV doses were distributed (GlaxoSmithKline, personal communication, 2018), VAERS received a total of 4,381 reports of adverse events, 130 (3.0%) of which were classified as serious. Commonly reported signs and symptoms included pyrexia (fever) (1,034; 23.6%), injection site pain (985; 22.5%), and injection site erythema (880; 20.1%). No unexpected patterns were detected in reports of adverse events or serious adverse events. Findings from early monitoring of RZV are consistent with the safety profile observed in prelicensure clinical trials.
Shingrix: A New Herpes Zoster Vaccine. [2020]Shingrix, a new vaccine for herpes zoster.
[Zoster disease after Shingrix vaccination]. [2021]Shingrix is a recombinant adjuvant subunit vaccine. The vaccine is approved in Germany for prevention of zoster manifestation and postherpetic neuralgia in adults aged ≥60 years. In the case of bullous skin lesions after vaccination with Shingrix a zoster disease should be considered. Unexpected side effects associated with the vaccination should be reported to the Drug Commission of the German Medical Association.
Recombinant Zoster Vaccine (Shingrix): Real-World Effectiveness in the First 2 Years Post-Licensure. [2022]Shingrix (recombinant zoster vaccine) was licensed to prevent herpes zoster, dispensed as 2 doses given 2-6 months apart among adults aged ≥50 years. Clinical trials yielded efficacy of >90% for confirmed herpes zoster, but post-market performance has not been evaluated. Efficacy of a single dose and a delayed second dose and efficacy among persons with autoimmune or immunosuppressive conditions have not been studied. We aimed to assess post-market vaccine effectiveness of Shingrix.
An Analysis of Spontaneously Reported Data of Vesicular and Bullous Cutaneous Eruptions Occurring Following Vaccination with the Adjuvanted Recombinant Zoster Vaccine. [2022]With the approval of the adjuvanted recombinant zoster vaccine (RZV; Shingrix, GSK) in October 2017, GSK established enhanced safety surveillance measures to allow prompt identification of potential safety signals not observed during clinical development. In Germany, cases of vesicular and bullous cutaneous eruptions following RZV vaccination were reported.