A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2

Last updated: January 31, 2025
Sponsor: Janssen Vaccines & Prevention B.V.
Overall Status: Completed

Phase

2

Condition

Corona Virus

Coronavirus

Treatment

Ad26.COV2.S

Clinical Study ID

NCT04999111
CR109060
VAC31518COV2008
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purposes of this study are to demonstrate the non-inferiority (NI) of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels, administered greater than or equal to (>=) 6 months after single-dose primary vaccination with Ad26.COV2.S, compared to the neutralizing antibody response to the original strain induced by single-dose primary vaccination with Ad26.COV2.S; To demonstrate the NI of the neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 510^10 virus particle (vp) dose level, administered >= 6 months after single-dose primary vaccination with Ad26.COV2.S (510^10 vp dose level), compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by single-dose primary vaccination with Ad26.COV2.S at the 510^10 vp dose level, if feasible; To demonstrate the NI of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels administered >=6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the original strain induced by 2-dose primary vaccination with Pfizer BNT162b2; To demonstrate the NI of neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 510^10 vp dose level, administered >= 6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by 2-dose primary vaccination with Pfizer BNT162b2, if feasible.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cohort 1: Participant received Ad26.COV2.S in VAC31518COV3001. The interval betweenthe Ad26.COV2.S primary vaccination should preferably be greater than or equal to (>=) 6 months prior to study vaccination on VAC31518COV2008, however a window ofmaximum -20 days is allowed; Cohort 2: Participant completed primary vaccinationwith a 2-dose regimen of BNT162b2 vaccine. The last dose of BTN162b2 shouldpreferably be >=6 months prior to study vaccination on COV2008, however a window ofa maximum of -20 days is allowed

  • Participant must provide consent indicating that he or she understands the purpose,procedures and potential risks and benefits of the study, and is willing toparticipate in the study

  • Participant agrees to not donate bone marrow, blood, and blood products from thestudy vaccine administration until 3 months after receiving the study vaccine

  • Participant must be willing to provide verifiable identification, has means to becontacted and to contact the investigator during the study

  • Participant must be able to read, understand, and complete questionnaires in theelectronic clinical outcome assessment (eCOA) (that is, the Coronavirus disease (COVID-19) signs and symptoms surveillance question, the e-Diary, and the electronicpatient-reported outcomes (ePROs). Participants with visual impairment are eligiblefor study participation and may have caregiver assistance in completing the eCOAquestionnaires

Exclusion

Exclusion Criteria:

  • Participant has a clinically significant acute illness (this does not include minorillnesses such as diarrhea or mild upper respiratory tract infection) or temperature >= 38.0 degree Celsius (C) (100.4 degree Fahrenheit [F]) within 24 hours prior tothe planned study vaccination; randomization at a later date is permitted at thediscretion of the investigator. Please notify the sponsor (or medical monitor) ofthis decision

  • Participant has a known or suspected allergy or history of anaphylaxis or otherserious adverse reactions to vaccines or their excipients (including specificallythe excipients of the study vaccine

  • Participant received treatment with immunoglobulins (Ig) in the 3 months orexogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans toreceive such treatment during the study

  • Participant has a known history of confirmed severe acute respiratory syndromecoronavirus-2 (SARS-CoV-2) infection

  • Participant has a history of heparin-induced thrombocytopenia or thrombosis incombination with thrombocytopenia

  • Participant has a history of acute polyneuropathy (example. Guillain-Barre syndrome)

  • History of capillary leak syndrome

Study Design

Total Participants: 1541
Treatment Group(s): 1
Primary Treatment: Ad26.COV2.S
Phase: 2
Study Start date:
August 06, 2021
Estimated Completion Date:
November 22, 2022

Connect with a study center

  • Central Phoenix Medical Clinic

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Synexus Clinical Research US Inc

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Anaheim Clinical Trials, LLC

    Anaheim, California 92801
    United States

    Site Not Available

  • Ark Clinical Research

    Long Beach, California 90815
    United States

    Site Not Available

  • Velocity Clinical Research

    North Hollywood, California 91606
    United States

    Site Not Available

  • Velocity Clinical Research, Denver

    Denver, Colorado 80209
    United States

    Site Not Available

  • Velocity Clinical Research, Hallandale Beach

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Research Centers of America, LLC

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Synexus Clinical Research US Inc

    Orlando, Florida 32806
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc

    Orlando, Florida 32806
    United States

    Site Not Available

  • Synexus Clinical Research US Inc

    The Villages, Florida 32162
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc

    The Villages, Florida 32162
    United States

    Site Not Available

  • Optimal Research

    Peoria, Illinois 61614
    United States

    Site Not Available

  • Johnson County Clin-Trials

    Lenexa, Kansas 66219
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Clinical Trials Management, LLC

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Rochester Clinical Research, Inc

    Rochester, New York 14609
    United States

    Site Not Available

  • Velocity Clinical Research, Anderson

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Accellacare US Inc

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Crofoot Research Center

    Houston, Texas 77098
    United States

    Site Not Available

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah 84088
    United States

    Site Not Available

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