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

Completed · Phase 2

Conditions studied: Coronavirus Disease

In brief

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 5\*10\^10 virus particle (vp) dose level, administered \>= 6 months after single-dose primary vaccination with Ad26.COV2.S (5\*10\^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 5\*10\^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 5\*10\^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.

Key facts

Study ID: NCT04999111
Run by: Janssen Vaccines & Prevention B.V.
People needed: 1541
Starts: 2021-08-06
Expected to finish: 2022-11-22
Last updated by the study team: 2025-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Cohort 1: Participant received Ad26.COV2.S in VAC31518COV3001. The interval between the Ad26.COV2.S primary vaccination should preferably be greater than or equal to (>=) 6 months prior to study vaccination on VAC31518COV2008, however a window of maximum -20 days is allowed; Cohort 2: Participant completed primary vaccination with a 2-dose regimen of BNT162b2 vaccine. The last dose of BTN162b2 should preferably be >=6 months prior to study vaccination on COV2008, however a window of a 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 to participate in the study
Participant agrees to not donate bone marrow, blood, and blood products from the study vaccine administration until 3 months after receiving the study vaccine
Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Participant must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the Coronavirus disease (COVID-19) signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs). Participants with visual impairment are eligible for study participation and may have caregiver assistance in completing the eCOA questionnaires

You may not qualify if…

Participant has a clinically significant acute illness (this does not include minor illnesses 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 to the planned study vaccination; randomization at a later date is permitted at the discretion of the investigator. Please notify the sponsor (or medical monitor) of this decision
Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine
Participant received treatment with immunoglobulins (Ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study
Participant has a known history of confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection
Participant has a history of heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia
Participant has a history of acute polyneuropathy (example. Guillain-Barre syndrome)
History of capillary leak syndrome

Where it is running

Central Phoenix Medical Clinic — Phoenix, Arizona, United States
Synexus Clinical Research US Inc — Tucson, Arizona, United States
Anaheim Clinical Trials, LLC — Anaheim, California, United States
Ark Clinical Research — Long Beach, California, United States
Velocity Clinical Research — North Hollywood, California, United States
Velocity Clinical Research, Hallandale Beach — Hallandale, Florida, United States
Research Centers of America, LLC — Hollywood, Florida, United States
Synexus Clinical Research US Inc — Orlando, Florida, United States
Synexus Clinical Research US Inc — The Villages, Florida, United States
Optimal Research — Peoria, Illinois, United States
Johnson County Clin-Trials — Lenexa, Kansas, United States
University of Kentucky — Lexington, Kentucky, United States
Clinical Trials Management, LLC — Metairie, Louisiana, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Rochester Clinical Research, Inc — Rochester, New York, United States
Velocity Clinical Research, Anderson — Anderson, South Carolina, United States
Accellacare US Inc — Mt. Pleasant, South Carolina, United States
Coastal Carolina Research Center — North Charleston, South Carolina, United States
Crofoot Research Center — Houston, Texas, United States
Velocity Clinical Research, Salt Lake City — West Jordan, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.