Simultaneous mRNA COVID-19 and IIV4 Vaccination Study

  • STATUS
    Recruiting
  • days left to enroll
    73
  • participants needed
    450
  • sponsor
    Duke University
Updated on 9 April 2022
Accepts healthy volunteers

Summary

This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID vaccine either simultaneously or sequentially, 14 days apart. A second dose of mRNA COVID vaccine will be administered either 3 or 4 weeks following the first dose, depending upon the mRNA COVID vaccine received for participants receiving their initial dose of mRNA COVID vaccine. For those receiving a third dose of mRNA COVID vaccine, there will not be a second dose. Solicited symptoms of reactogenicity will be assessed on vaccination day and daily during the 7 days following each Vaccination Visit using either electronic or paper symptoms diaries, depending on study participant preference. Quality of life data will be collected using electronic or paper diaries on day of Vaccination Visit 1 and daily during the 7 days following the visit. Serious adverse events and adverse events of special interest will be collected throughout the duration of the study. Serum samples from participants will be collected for determination of COVID-19 seropositivity at baseline. Serum samples will be taken throughout the study to determine IIV4 immunogenicity and for potential future studies.

Details
Condition Pain, Quality of Life, Injection Site Reaction, Adverse Drug Event
Treatment Placebo, IIV4, Simultaneous administration of mRNA COVID-19 and IIV4, mRNA COVID-19
Clinical Study IdentifierNCT05028361
SponsorDuke University
Last Modified on9 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Persons aged ≥12 years if receiving primary two-dose mRNA COVID-19 vaccine series or persons aged ≥18 years if receiving a third mRNA COVID-19 vaccine dose according to FDA authorization or approval and ACIP recommendation. Note: receipt of an mRNA COVID-19 vaccine within 8 hours of enrollment is permitted
English or Spanish literate
Intention of receiving influenza vaccine and COVID-19 vaccine based on ACIP-CDC guidelines
Willing to provide written informed consent
Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and clinic visits

Exclusion Criteria

Currently pregnant, planning to become pregnant within the first three months of the study per participant self-report or likely to be pregnant per screening criteria as defined in Section 5.1 at Visit 1
Prior receipt of IIV4 during the 2021-2022 influenza season
Prior receipt of non-mRNA COVID-19 vaccine
Documented COVID-19 infection within 6 weeks prior to enrollment confirmed by either medical history or lab testing
Prior receipt of more than 2 mRNA COVID-19 vaccines
History of severe allergic reaction after a previous dose of any influenza vaccine; or to an influenza vaccine component, including egg protein
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of an mRNA vaccine
Receipt of any licensed inactivated vaccine within 2 weeks prior to enrollment in this study, receipt of any licensed live vaccine within 4 weeks prior to enrollment in this study, or receipt of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) or HEPLISAV-B (Hepatitis B Vaccine (Recombinant), Adjuvanted) vaccine within 6 weeks prior to enrollment in this study or planning receipt of any vaccines following enrollment until 6 weeks after receipt of the second dose of mRNA COVID-19 vaccine
Has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematologic malignancy
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
Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating intramuscular injection (a daily aspirin may be acceptable)
Has immunosuppression as a result of an underlying illness or medications, such as antirejection/transplant regimens or immunomodulatory agents. Stable HIV disease is permitted per the following parameters
Confirmed stable HIV disease defined as document viral load <50 copies/mL and CD4 count >200 within 6 months before enrollment, and on stable antiretroviral therapy for at least 6 months
Has known hepatitis B (HBV) or hepatitis C (HBC). Stable HBV or HBC are permitted per
the following parameters
If known HBV: confirmed inactive chronic HBV infection: HBsAg present for ≥6 months and HBeAg negative, anti-HBe positive; serum HBV DNA <2000 IU/mL; persistently normal ALT or AST levels; in those who had liver biopsy, findings that confirm absence of significant necroinflammation
Use of oral, parenteral, or high-dose inhaled glucocorticoids
If known HCV: evidence of sustained virological response for ≥12 weeks after treatment or without evidence of HCV RNA viremia (undetectable HCV RNA)
For definition of high-dose inhaled glucocorticoids, reference Appendix B
Anyone who is already enrolled or plans to enroll in another clinical trial with an investigational product during the study period
History of Guillain-Barré syndrome
Per protocol, co-enrollment in observational or behavioral intervention studies are permitted at any time. An investigational product may be permitted for therapy of an illness condition that occurs during the study period e.g. COVID-19 illness
Hearing loss determined by the investigators to prevent successful communication over the phone
History of myocarditis or pericarditis
History of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A)
Has injury or other reason why deltoid site on both arms cannot be used for vaccinations
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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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