A Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy Adults

NCT ID: NCT04908722

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1609 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-18
• Study Completion Date: 2023-07-10

Brief Summary

The purpose of this study is to demonstrate non-inferiority (NI) in terms of humoral immune responses after 6 dose levels of Ad26.COV2.S.

Conditions

COVID-19 Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Ad26.COV2.S Dose Level 1

Participants in the main study and sub study will receive intramuscular (IM) injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 1 on Days 1 and 57.

Group Type: EXPERIMENTAL

Ad26.COV2.S

Intervention Type: BIOLOGICAL

Participants will receive intramuscular (IM) injections of Ad26.COV2.S.

Group 2: Ad26.COV2.S Dose Level 2

Participants will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 2 on Days 1 and 57 in the main study.

Group Type: EXPERIMENTAL

Ad26.COV2.S

Intervention Type: BIOLOGICAL

Participants will receive intramuscular (IM) injections of Ad26.COV2.S.

Group 3: Ad26.COV2.S Dose Level 3

Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 3 on Days 1 and 57.

Group Type: EXPERIMENTAL

Ad26.COV2.S

Intervention Type: BIOLOGICAL

Participants will receive intramuscular (IM) injections of Ad26.COV2.S.

Group 4: Ad26.COV2.S Dose Level 4

Participants will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 4 on Days 1 and 57 in the main study.

Group Type: EXPERIMENTAL

Ad26.COV2.S

Intervention Type: BIOLOGICAL

Participants will receive intramuscular (IM) injections of Ad26.COV2.S.

Group 5: Ad26.COV2.S Dose Level 5

Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 5 on Days 1 and 57.

Group Type: EXPERIMENTAL

Ad26.COV2.S

Intervention Type: BIOLOGICAL

Participants will receive intramuscular (IM) injections of Ad26.COV2.S.

Group 6: Ad26.COV2.S Dose Level 6

Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 6 on Days 1 and 57.

Group Type: EXPERIMENTAL

Ad26.COV2.S

Intervention Type: BIOLOGICAL

Participants will receive intramuscular (IM) injections of Ad26.COV2.S.

Interventions

Ad26.COV2.S

Participants will receive intramuscular (IM) injections of Ad26.COV2.S.

Intervention Type: BIOLOGICAL

Other Intervention Names

JNJ-78436735; Ad26COVS1; VAC31518

Eligibility Criteria

Inclusion Criteria

• Participant must sign an informed consent form (ICF) 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 must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe Coronavirus disease 2019 (COVID-19), except for smoking, which is allowed. If on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participant will be included on the basis of physical examination, medical history, and vital signs
• All female participants of childbearing potential must: a) have a negative highly sensitive urine pregnancy test at screening; b) have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration
• Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine
• Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study

Exclusion Criteria

• Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (C) (100.4 degree Fahrenheit [F]) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
• 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 or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccinations; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of the first or subsequent study vaccinations
• Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study
• Participant previously received a coronavirus vaccine

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Vaccines & Prevention B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Vaccines & Prevention B.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Vaccines & Prevention B.V.

Locations

Baptist Health Center For Clinical Research

Little Rock, Arkansas, United States

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Ark Clinical Research

Long Beach, California, United States

Paradigm Clinical Research Centers, Inc.

Redding, California, United States

Wr McCr Llc

San Diego, California, United States

Ark Clinical Research

Tustin, California, United States

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, United States

Floridian Research Institute

Miami, Florida, United States

Medpharmics, LLC

Metairie, Louisiana, United States

Clinical Research Center of Nevada

Las Vegas, Nevada, United States

Rochester Clinical Research, Inc

Rochester, New York, United States

Wake Research Associates

Raleigh, North Carolina, United States

Trial Management Associates, LLC

Wilmington, North Carolina, United States

Tekton Research Inc.

Yukon, Oklahoma, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Ventavia Research Group, LLC

Keller, Texas, United States

Research Your Health

Plano, Texas, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, , Brazil

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, , Brazil

CECOR Centro OncolOgico de Roraima

Boa Vista, , Brazil

Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

Campinas, , Brazil

Núcleo de Medicina Tropical - Universidade Federal do Ceará

Ceará, , Brazil

Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose

Criciúma, , Brazil

Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN

Natal, , Brazil

Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

Ribeirão Preto, , Brazil

Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu

Rio de Janeiro, , Brazil

CPQuali Pesquisa Clinica LTDA ME

São Paulo, , Brazil

Centro de Referencia E Treinamento Dst/Aids

São Paulo, , Brazil

Klinische Forschung Berlin-Mitte GmbH

Berlin, , Germany

Clinical Research HamburggmbH

Hamburg, , Germany

Klinische Forschung Hannover-Mitte GmbH

Hanover, , Germany

Synexus Clinical Research GmbH

Leipzig, , Germany

Universitaetsmedizin Rostock

Rostock, , Germany

Gdanskie Centrum Zdrowia

Gdansk, , Poland

Centrum Medyczne Medyk

Rzeszów, , Poland

Centrum Medyczne Pratia Poznan

Skorzewo, , Poland

Synexus Helderberg Clinical Research Centre

Cape Town, , South Africa

Ndlovu Elandsdoorn Site

Dennilton, , South Africa

Stanza Clinical Research Centre : Mamelodi

Mamelodi East, , South Africa

PHOENIX PHARMA (Pty) Ltd

Port Elizabeth, , South Africa

Gct Sunnyside

Pretoria, , South Africa

Setshaba Research Centre

Soshanguve, , South Africa

Countries

United States; Brazil; Germany; Poland; South Africa

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-005801-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VAC31518COV3003

Identifier Type: OTHER

Identifier Source: secondary_id

CR108960

Identifier Type: -

Identifier Source: org_study_id