Zoster Vaccine for Shingles

Overseen By Ravi Jhaveri, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Must be taking: Immunosuppressive drugs

Must not be taking: Corticosteroids, Antivirals

Disqualifiers: Pregnancy, Allergic reactions, 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

Compensation: Varies

Number of Visits: 2

Duration: 30-60 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of a shingles vaccine for individuals who have undergone an organ transplant. Participants will receive two doses of the recombinant zoster vaccine and will be monitored for side effects and immune system response. It suits those who had a solid organ transplant over a year ago and have been on stable medication for at least six months. As a Phase 4 trial, the vaccine is already FDA-approved and proven effective, and this research aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must have been on a stable immunosuppressive medication regimen for the last 6 months. You cannot be on active treatment with corticosteroids or other immunosuppressive agents for rejection.

What is the safety track record for the recombinant zoster vaccine?

Research has shown that the recombinant zoster vaccine, also known as Shingrix, is generally safe. Studies have found that adults, including those 18 and older, usually tolerate it well. The most common side effects are mild and include pain at the injection site, muscle pain, and tiredness, which typically resolve on their own within a few days.

Safety checks conducted after the vaccine's public release support these findings. Serious side effects are rare. The FDA approved the vaccine for preventing shingles in adults, indicating a strong safety record.

Overall, the recombinant zoster vaccine is considered safe for most people, with only minor side effects reported by most patients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The recombinant zoster vaccine, known as Shingrix, is unique because it uses a non-live, adjuvanted formula to prevent shingles, unlike traditional vaccines that often use a live, attenuated virus. This makes it a safer option for individuals with weakened immune systems. Researchers are excited about Shingrix because it has shown higher efficacy and longer-lasting protection against shingles compared to existing vaccines. By stimulating a stronger immune response, Shingrix offers a promising advancement in the fight against shingles.

What is the effectiveness track record for the recombinant zoster vaccine in preventing shingles?

Research shows that the Shingrix vaccine effectively prevents shingles. A large study found it to be 97% effective in stopping shingles in adults. This is important because shingles can cause painful rashes and other complications. Additionally, for those who do get shingles, the vaccine reduces the risk of long-term nerve pain, known as postherpetic neuralgia, by 47%. Already approved and used to prevent shingles in adults, this vaccine provides strong evidence of its effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Ravi Jhaveri, MD

Principal Investigator

Ann and Robert H Lurie Children's Hospital

Are You a Good Fit for This Trial?

This trial is for young adults who have had a solid organ transplant over a year ago, are on stable immunosuppressive meds for the last 6 months, and can follow up via phone or online. It's not for those with recent vaccine shots, shingles history, current pregnancy, fevers above 39°C, infections needing hospital care or drugs within two weeks before starting.

Inclusion Criteria

I can be contacted via phone, email, or patient portal for study follow-up.

My immunosuppressive medication has not changed in the last 6 months.

I will use effective birth control until 2 months after my last dose.

Exclusion Criteria

Any condition that, in the opinion of the investigator, may interfere with optimal participation in the study

I haven't had a fever of 39°C or higher or needed antibiotics in the last 14 days.

I am currently taking steroids or other drugs to suppress my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the first dose of the recombinant zoster vaccine and undergo pre-vaccine baseline Varicella Zoster Virus (VZV) anti-gE antibody testing

30-60 days

1 visit (in-person)

Second Dose and Immediate Follow-up

Participants receive the second dose of the vaccine and are monitored for adverse events and antibody responses

2 months

1 visit (in-person)

Extended Follow-up

Participants are monitored for safety and immunogenicity, including testing for antibody and cellular immunity at 1-2 months, 6 months, and 12-15 months after the second dose

12-15 months

Multiple visits (in-person, telephone, electronic)

What Are the Treatments Tested in This Trial?

Interventions

• Recombinant Zoster Vaccine

Trial Overview The study tests the safety and immune response to the recombinant zoster vaccine in these patients. They'll get vaccinated and then be checked for any negative reactions and their body's defense against shingles will be measured.

How Is the Trial Designed?

Group I: Recombinant Zoster Vaccine Administration and Testing Experimental Treatment 1 Intervention

all participants will receive 2 doses of recombinant zoster vaccine (Shingrix)

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

Shingrix, a recombinant zoster vaccine approved by the FDA on October 20, 2017, is designed to prevent herpes zoster (shingles) in adults aged 50 and older, requiring two doses administered 2-6 months apart.

The vaccine contains a novel adjuvant (AS01B) that enhances the immune response, making it a recommended option by the Advisory Committee on Immunization Practices for immunocompetent adults in the same age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines. Dooling, KL., Guo, A., Patel, 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]

In a study of 647,833 adults aged 50 and older who received the recombinant zoster vaccine (RZV), no sustained increased risk of serious health outcomes like stroke or Guillain-Barré syndrome was found compared to historical and contemporary vaccine recipients.

The study confirmed that while RZV may cause more systemic and local reactions than previous vaccines, it provides reassurance about its overall safety profile in preventing shingles and its complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Postlicensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data. Nelson, JC., Ulloa-Pérez, E., Yu, O., et al.[2023]

The Zoster Vaccine Recombinant, Adjuvanted (Shingrix) is effective in preventing herpes zoster in adults aged 50 and older, and its use has been expanded to include adults aged 18 and older who are immunocompromised, making it the first vaccine approved for this group.

With moderate to high efficacy and a good safety profile, Shingrix has the potential to significantly reduce the incidence of herpes zoster and its complications, as recommended by health authorities like the FDA and ACIP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2022. Anderson, TC., Masters, NB., Guo, A., et al.[2022]

Citations

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

SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) 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 who are ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38190712/

Effectiveness of Recombinant Zoster Vaccine Against ... A 2-dose series of recombinant zoster vaccine (RZV) was 97% effective against herpes zoster (HZ) in a pivotal clinical trial.

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

Effectiveness of the Adjuvanted Recombinant Zoster Vaccine ... human herpesvirus 3; immunocompromised host; vaccination; post-herpetic neuralgia; shingles vaccine; adjuvanted herpes zoster subunit vaccine ...

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

Effectiveness of Recombinant Herpes Zoster Vaccine in the ... Herpes zoster (HZ), commonly known as shingles, is a condition caused by reactivation of latent varicella-zoster virus. It causes painful rashes ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835162

Recombinant Zoster Vaccination and Risk of Postherpetic ... Among persons with herpes zoster, the risk of PHN was 47% (95% CI, 31%-59%) lower in those vaccinated vs unvaccinated. Against HZO, VE of full ...

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

Shingles (Herpes Zoster) Vaccine Safety Shingles (Herpes Zoster) Vaccine Safety. Safety Information by Vaccine | Page ... Active Post-Licensure Safety Surveillance for Recombinant Zoster Vaccine Using ...

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):. Page 3. 2. • in adults aged 50 years and older. • in adults aged 18 years and ...

8. shingrixhcp.com shingrixhcp.com/home-ic/efficacy-safety/adverse-reactions/

Safety Profile | SHINGRIX (Zoster Vaccine Recombinant, ... 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 who are ...

9. 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 ...

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 ...