Shingrix Vaccine for Shingles

Overseen By Mary Lee

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Loyola University

Disqualifiers: Zoster post-transplant, Pregnancy, Allergies, 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: Unknown

Duration: 6 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of the Shingrix vaccine in individuals who have undergone an allogeneic stem cell transplant, where stem cells are received from a donor. The goal is to determine if the vaccine can help their immune system combat shingles, a painful rash caused by the same virus responsible for chickenpox. Individuals who had their transplant 1 to 3 years ago and have a stable condition might be suitable candidates. The study aims to assess the safety and effectiveness of Shingrix for these patients. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that patients with chronic graft-versus-host disease on stable immunosuppression are eligible, suggesting that some medications may be continued.

Is there any evidence suggesting that the Shingrix vaccine is likely to be safe for humans?

Research shows that the Shingrix vaccine is generally safe for adults. Studies have found it to be over 90% effective in preventing shingles in people aged 50 and older. In these studies, most participants experienced mild side effects, such as soreness at the injection site, muscle pain, or tiredness.

The FDA has approved Shingrix for preventing shingles in adults over 50, indicating a strong safety record. It's important to note that these studies mostly included healthy adults. The current trial is testing the vaccine in individuals who have had stem cell transplants, so safety results might differ for this group. However, past research suggests Shingrix is a safe option for preventing shingles. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Shingrix vaccine for shingles because it offers a new level of protection for patients who are 1–3 years post-transplant, a group that is often at higher risk for infections. Unlike other shingles vaccines, Shingrix is a non-live vaccine, which is safer for immunocompromised individuals. It uses a recombinant subunit technology, providing strong and long-lasting immunity. This makes Shingrix particularly promising for those with compromised immune systems, as it can potentially reduce the risk of shingles outbreaks significantly more effectively than existing vaccines.

What evidence suggests that the Shingrix vaccine is effective for shingles in patients post-transplant?

Research has shown that the Shingrix vaccine, which participants in this trial will receive, is highly effective at preventing shingles, with over 90% success. Studies have also found it greatly reduces the chance of developing postherpetic neuralgia, a painful condition that can occur after shingles. For instance, one study reported a 91.2% reduction in this condition among vaccinated adults. Shingrix provides strong protection, even for individuals over 50, who face a higher risk for shingles. These findings suggest that Shingrix is a promising option for preventing shingles and its complications. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are 1-3 years post-allogeneic stem cell transplant (AlloSCT) for various blood cancers. They must understand and sign consent, not be pregnant, and can have stable chronic graft-versus-host disease. Excluded are those with active primary cancer, acute illness at vaccination time, unsafe thrombocytopenia levels for injections, prior shingles after AlloSCT or allergies to Shingrix vaccine components.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent

I am undergoing a specific treatment plan.

Donor sources: matched related, matched unrelated, cord blood

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to the recombinant zoster vaccine, Shingrix, or other agents used in study

Patients who are currently pregnant

I had shingles after receiving a stem cell transplant from a donor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Shingrix vaccine in standard dosing and schedule

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Shingrix

Trial Overview The study tests the immune response effectiveness of the Shingrix vaccine in patients who've undergone an allogeneic stem cell transplant. It's a phase II trial designed to assess how well these patients' immune systems respond to this shingles vaccine.

How Is the Trial Designed?

Group I: Shingrix Experimental Treatment 1 Intervention

Patients 1-3 years post transplant will receive the Shingrix vaccine in standard dosing and schedule.

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?

Loyola University

Lead Sponsor

Trials

161

Recruited

31,400+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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. 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 ...

4. 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, ...

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

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

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. 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 ...

10. shingrix.com shingrix.com/

SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) 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.