Simultaneous RZV and aIIV4 Vaccination

NCT ID: NCT05007041

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 267 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-21
• Study Completion Date: 2023-06-08

Brief Summary

The overall aim of the study is to compare the safety of simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Quadrivalent Influenza Vaccine, Adjuvanted (FLUAD®) versus simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Fluzone® High-Dose Quadrivalent vaccine in persons age ≥65 years. A prospective, randomized, blinded clinical trial that will be conducted during the 2021/2022 and 2022/2023 influenza seasons. Over the course of these two influenza seasons, approximately 220 older adults will be enrolled at Duke University Medical Center, and 180 older adults at Johns Hopkins University Medical Center. Eligible subjects will be randomized to receive either simultaneous RZV/FLUAD® or RZV/Fluzone® High-Dose vaccines. All subjects will be assessed for 7 days post-injection and safety and tolerability compared between the two groups. Serious adverse events and adverse events of clinical interest will be assessed 42 days post-vaccination and compared between the two groups. Health-related quality of life will be assessed pre-vaccination Day 1 through Day 8. Serious Adverse Events and Adverse Events of Clinical Interest were also assessed throughout the study period.

Detailed Description

Intention-to-Treat (ITT) Population: Defined as all subjects who are randomized and vaccinated.

Modified Intention-to-Treat (mITT) Population: Defined as all subjects who are randomized, vaccinated, and provide at least one day of complete data on the symptom diary.

Conditions

Pain; Quality of Life; Injection Site Reaction; Adverse Drug Event

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine (FLUAD®)

In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the adjuvanted influenza vaccine (FLUAD® Quadrivalent) simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6.

Group Type: ACTIVE_COMPARATOR

FLUAD® Quadrivalent

Intervention Type: BIOLOGICAL

Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

SHINGRIX®

Intervention Type: BIOLOGICAL

Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

Zoster Vaccine Recombinant (RZV) and High-Dose Quadrivalent Influenza Vaccine (Fluzone®)

In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the (Fluzone® HD Quadrivalent) influenza vaccine simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6.

Group Type: ACTIVE_COMPARATOR

Fluzone® High-Dose Quadrivalent

Intervention Type: BIOLOGICAL

Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

SHINGRIX®

Intervention Type: BIOLOGICAL

Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

Interventions

FLUAD® Quadrivalent

Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

Intervention Type: BIOLOGICAL

Fluzone® High-Dose Quadrivalent

Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

Intervention Type: BIOLOGICAL

SHINGRIX®

Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

Intervention Type: BIOLOGICAL

Other Intervention Names

Influenza Vaccine, Adjuvanted (Quadrivalent); aIIV4; High-Dose Quadrivalent Influenza Vaccine; HD-IIV4; Zoster Vaccine Recombinant, Adjuvanted (RZV)

Eligibility Criteria

Inclusion Criteria

1. Male or female age ≥ 65 years

2. Intention of receiving IIV and RZV based on ACIP-CDC guidelines

3. Able to speak English

4. Willing to provide written informed consent

5. Living in the community

6. Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and clinic visits.

7. If HIV positive, HIV should be clinically stable.

Exclusion Criteria

1. IIV or recombinant influenza vaccine (RIV) receipt during the respective 2021-2022 or 2022-2023 influenza season prior to study enrollment

2. Prior receipt of recombinant zoster vaccine (SHINGRIX®)

3. For non-COVID-19 Vaccines:

• Receipt of any inactivated vaccine within 2 weeks prior to enrollment in this study
• Receipt of any live vaccine within 4 weeks prior to enrollment in this study
• Planning receipt of any non-COVID-19 vaccine during the entire period

4. For COVID-19 Vaccines:

• Receipt of COVID-19 vaccine within 2 weeks prior to enrollment in this study. For those who have initiated a COVID-19 vaccine series, enrollment is not allowed until 2 weeks after the final dose of a COVID-19 vaccine is completed.
• Planning receipt of a COVID-19 vaccine within 2 weeks after administration of study influenza and first dose recombinant zoster study vaccines.

5. Have acute illness or exacerbation of chronic illness within 72 hours of study vaccination

6. Hospitalization within the last 30 days for any reason

7. History of febrile illness (> 100.0°F or 37.8°C) within the past 24 hours prior to IIV administration

8. Has immunosuppression as a result of an underlying illness or treatment, or use of chemotherapy or radiation therapy within the preceding 12 months

9. Has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) *Participants with a history of malignancy may be included if, after previous treatment by surgical excision, chemotherapy or radiation therapy, the participant has been observed for a period that in the investigator's estimation provides a reasonable assurance of sustained cure

10. A history of autoimmune disease, that requires immunosuppressive agents or any other chronic medical condition considered clinically significant by the investigator

11. Use of chronic oral or intravenous administration (≥14 days) of immunosuppressive doses of steroids, i.e., prednisone >10 mg per day, immunosuppressants or other immune-modifying drugs within 30 days of starting this study. (Use of topical, nasal, or inhaled steroids is permitted)

12. Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating intramuscular injection (a daily aspirin may be acceptable)

13. Contraindication to IIV receipt including history of severe allergic reaction after a previous dose of any influenza vaccine; or to a vaccine component, including egg protein

14. Contraindication to RZV including history of a severe allergic reaction to any component of the RZV vaccine (including saponin or polysorbate 80) or to dose 2 of RZV

15. History of Guillain-Barré syndrome

16. History of Hepatitis C or active Hepatitis B

17. Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination

18. Dementia, any cognitive condition, or substance abuse that could interfere with study compliance

19. Anyone who is already enrolled or plans to enroll in another clinical trial with an investigational product within 28 days of vaccine receipt. Co-enrollment in observational or behavioral intervention studies are allowed at any time while enrollment in a clinical trial involving an investigational product (other than vaccine) may occur after 28 days following vaccine receipt

20. Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives

21. Anyone who is a relative of any research study personnel

22. Anyone who is an employee of any research study personnel

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Schmader, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Duke University

Durham, North Carolina, United States

Countries

United States

References

Schmader KE, Walter EB, Talaat KR, Rountree W, Poniewierski M, Randolph E, Leng SX, Wunderlich B, McNeil MM, Museru O, Broder KR. Safety of Simultaneous Vaccination With Adjuvanted Zoster Vaccine and Adjuvanted Influenza Vaccine: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2440817. doi: 10.1001/jamanetworkopen.2024.40817.

Reference Type: DERIVED

PMID: 39446325 (View on PubMed)

de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.

Reference Type: DERIVED

PMID: 37781954 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00108456

Identifier Type: -

Identifier Source: org_study_id