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

120 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Recombinant Zoster Vaccine for shingles?

Research shows that the Recombinant Zoster Vaccine (RZV) is effective in preventing shingles and its complications, like postherpetic neuralgia, especially in older adults and those with weakened immune systems. Studies have demonstrated that RZV significantly boosts the body's immune response, making it a strong option for preventing shingles. ^{1 2 3 4 5}

Is the recombinant zoster vaccine (Shingrix) safe for humans?

The recombinant zoster vaccine (Shingrix) is generally considered safe for humans, with most people experiencing mild reactions like pain or redness at the injection site and fever. Serious side effects are rare, and no unexpected safety issues have been found in large studies. However, there is a rare case of severe muscle breakdown (rhabdomyolysis) reported, so it's important to discuss any concerns with a healthcare provider. ^{6 7 8 9 10}

How is the recombinant zoster vaccine treatment different from other shingles treatments?

The recombinant zoster vaccine (Shingrix) is unique because it is the first shingles vaccine approved for use in immunocompromised individuals, offering protection to those with weakened immune systems. It is a two-dose vaccine that uses a specific protein from the virus combined with an adjuvant (a substance that enhances the body's immune response) to provide strong and lasting immunity. ^{3 7 11 12 13}

What is the purpose of this trial?

This goal of this study is to assess the safety and immunogenicity of recombinant zoster virus in young adult solid organ transplant recipients. In this study, participants will receive the recombinant zoster vaccine. They will be monitored for adverse events and tested for antibody and cellular immunity.

Research Team

Ravi Jhaveri, MD

Principal Investigator

Ann and Robert H Lurie Children's Hospital

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of the Recombinant Zoster Vaccine for Herpes Zoster Ophthalmicus in the United States. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Post-licensure zoster vaccine effectiveness against herpes zoster and postherpetic neuralgia in older adults: a systematic review and meta-analysis. [2022]

3. United States 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. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of the adjuvanted recombinant zoster vaccine in adults aged 50 years or older. A phase IIIB, non-randomized, multinational, open-label study in previous ZOE-50 and ZOE-70 placebo recipients. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of adjuvanted recombinant subunit herpes zoster vaccine in lung transplant recipients. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) - United States, October 2017-June 2018. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of Recombinant Zoster Vaccine in Rheumatology Patients. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Active Postlicensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Rhabdomyolysis after recombinant zoster vaccination: a rare adverse reaction. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Safety of recombinant zoster vaccine: a retrospective study of 622 rheumatology patients. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Recombinant varicella-zoster virus vaccines as platforms for expression of foreign antigens. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

A phase 1/2 clinical trial evaluating safety and immunogenicity of a varicella zoster glycoprotein e subunit vaccine candidate in young and older adults. [2022]