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Simultaneous RZV and aIIV4 Vaccination

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ClinicalTrials.gov Identifier: NCT05007041
Recruitment Status : Recruiting
First Posted : August 16, 2021
Last Update Posted : September 14, 2022
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Johns Hopkins University
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE August 9, 2021
First Posted Date  ICMJE August 16, 2021
Last Update Posted Date September 14, 2022
Actual Study Start Date  ICMJE September 21, 2021
Estimated Primary Completion Date March 8, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2021)
Number of participants with at least one severe (Grade 3) solicited local or systemic reactogenicity event after SHINGRIX® dose 1 in each study group [ Time Frame: Up to 8 days post-vaccination ]
Modified Intention-to-Treat (mITT) Population
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2021)
  • Number of participants with at least one severe (Grade 3) solicited local reactogenicity event after SHINGRIX® dose 1 in each study group [ Time Frame: Up to 8 days post-vaccination ]
    Modified Intention-to-Treat (mITT) Population
  • Number of participants with at least one severe (Grade 3) solicited systemic reactogenicity after SHINGRIX® dose 1 in each study group [ Time Frame: Up to 8 days post-vaccination ]
    Modified Intention-to-Treat (ITT) Population
  • Number of participants with at least one serious adverse event or adverse event of clinical interest after SHINGRIX® dose 1 in each study group [ Time Frame: Up 42 days post-vaccination ]
    Intention-to-Treat (ITT) Population
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simultaneous RZV and aIIV4 Vaccination
Official Title  ICMJE Safety of Simultaneous Vaccination With Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Inactivated Influenza Vaccine (aIIV4)
Brief Summary The overall aim of the study is to compare the safety of simultaneous RZV (SHINGRIX®) and inactivated adjuvanted influenza vaccine aIIV4 (FLUAD®) versus simultaneous RZV (SHINGRIX®) and inactivated influenza HD-IIV4 (Fluzone® HD) vaccine in persons ≥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/aIIV4 or RZV/HD-IIV4 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Subjects, study coordinators, and investigators will be blinded to the type of flu vaccine administered in conjunction with the Shingrix vaccine.
Primary Purpose: Prevention
Condition  ICMJE
  • Pain
  • Quality of Life
  • Injection Site Reaction
  • Adverse Drug Event
Intervention  ICMJE
  • Biological: FLUAD® Quadrivalent
    Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
    Other Name: Influenza Vaccine, Adjuvanted (Quadrivalent)
  • Biological: Fluzone® HD Quadrivalent
    Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
    Other Name: High-dose quadrivalent influenza vaccine
  • Biological: SHINGRIX®
    Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
    Other Name: Zoster vaccine recombinant, adjuvanted
Study Arms  ICMJE
  • Active Comparator: Recombinant Zoster Vaccine (RZV) and Quadrivalent adjuvanted influenza vaccine
    In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the quadrivalent adjuvanted influenza vaccine (FLUAD® Quadrivalent) simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6.
    Interventions:
    • Biological: FLUAD® Quadrivalent
    • Biological: SHINGRIX®
  • Active Comparator: Recombinant Zoster Vaccine (RZV) and high-dose quadrivalent influenza vaccine
    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.
    Interventions:
    • Biological: Fluzone® HD Quadrivalent
    • Biological: SHINGRIX®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 9, 2021)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 12, 2023
Estimated Primary Completion Date March 8, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kenneth Schmader, MD 919 660-7572 kenneth.schmader@duke.edu
Contact: Emily Randolph 919 385-5785 emily.randolph@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05007041
Other Study ID Numbers  ICMJE Pro00108456
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Duke University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Duke University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Centers for Disease Control and Prevention
  • Johns Hopkins University
Investigators  ICMJE
Principal Investigator: Kenneth Schmader, MD Duke University
PRS Account Duke University
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP