Simultaneous RZV and aIIV4 Vaccination

  • STATUS
    Recruiting
  • End date
    Apr 12, 2023
  • participants needed
    400
  • sponsor
    Duke University
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Updated on 30 September 2021
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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.

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.

Details
Condition adverse drug events, Acute Pain Service, drug reaction, ache, quality-of-life, overdose of drug with toxic effect, Injection Site Reaction, Pain (Pediatric), adverse drug reaction, adverse drug reactions, Post-Surgical Pain, Pain, Quality of life, injection site reactions
Treatment Shingrix®, FLUAD® Quadrivalent, Fluzone® HD Quadrivalent
Clinical Study IdentifierNCT05007041
SponsorDuke University
Last Modified on30 September 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female age 65 years
Intention of receiving IIV and RZV based on ACIP-CDC guidelines
Able to speak English
Willing to provide written informed consent
Living in the community
Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and clinic visits
If HIV positive, HIV should be clinically stable

Exclusion Criteria

IIV or recombinant influenza vaccine (RIV) receipt during the respective 2021-2022 or 2022-2023 influenza season prior to study enrollment
Prior receipt of recombinant zoster vaccine (SHINGRIX)
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
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
Have acute illness or exacerbation of chronic illness within 72 hours of study vaccination
Hospitalization within the last 30 days for any reason
History of febrile illness (> 100.0F or 37.8C) within the past 24 hours prior to IIV administration
Has immunosuppression as a result of an underlying illness or treatment, or use of chemotherapy or radiation therapy within the preceding 12 months
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
A history of autoimmune disease, that requires immunosuppressive agents or any other chronic medical condition considered clinically significant by the investigator
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)
Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating intramuscular injection (a daily aspirin may be acceptable)
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
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
History of Guillain-Barr syndrome
History of Hepatitis C or active Hepatitis B
Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination
Dementia, any cognitive condition, or substance abuse that could interfere with study compliance
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
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
Anyone who is a relative of any research study personnel
Anyone who is an employee of any research study personnel
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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