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

NCT04908722 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: CR1089602020-005801-14VAC31518COV3003
• Study Type: interventional
• Target: 1,609
• Locations: 5 countries
• Sites: 43

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

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination

  Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.

  28 days after first vaccination (at Day 29)

• Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination

  Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.

  14 days after second vaccination (at Day 71)

Secondary Outcomes (9)

• Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA

  Day 29, Day 57, Day 71, Week 32, and Week 60

• Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA

  Day 29, Day 57, Day 71, Week 32, and Week 60

• Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination

  7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])

• Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination

  7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])

• Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination

  28 days after each vaccination (first vaccination [at Day 29], second vaccination [at Day 85])

Study Arms (6)

Group 1: Ad26.COV2.S Dose Level 1

EXPERIMENTAL

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.

Biological: Ad26.COV2.S

Group 2: Ad26.COV2.S Dose Level 2

EXPERIMENTAL

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.

Biological: Ad26.COV2.S

Group 3: Ad26.COV2.S Dose Level 3

EXPERIMENTAL

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.

Biological: Ad26.COV2.S

Group 4: Ad26.COV2.S Dose Level 4

EXPERIMENTAL

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.

Biological: Ad26.COV2.S

Group 5: Ad26.COV2.S Dose Level 5

EXPERIMENTAL

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.

Biological: Ad26.COV2.S

Group 6: Ad26.COV2.S Dose Level 6

EXPERIMENTAL

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.

Biological: Ad26.COV2.S

Interventions

Ad26.COV2.S BIOLOGICAL

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

Also known as: JNJ-78436735, Ad26COVS1, VAC31518

Group 1: Ad26.COV2.S Dose Level 1; Group 2: Ad26.COV2.S Dose Level 2; Group 3: Ad26.COV2.S Dose Level 3; Group 4: Ad26.COV2.S Dose Level 4; Group 5: Ad26.COV2.S Dose Level 5; Group 6: Ad26.COV2.S Dose Level 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (43)

Baptist Health Center For Clinical Research

Little Rock, Arkansas, 72205, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Ark Clinical Research

Long Beach, California, 90815, United States

Location

Paradigm Clinical Research Centers, Inc.

Redding, California, 96001, United States

Location

Wr McCr Llc

San Diego, California, 92120, United States

Location

Ark Clinical Research

Tustin, California, 92780, United States

Location

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, 33009, United States

Location

Floridian Research Institute

Miami, Florida, 33179, United States

Location

Medpharmics, LLC

Metairie, Louisiana, 70006, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89106, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Trial Management Associates, LLC

Wilmington, North Carolina, 28403, United States

Location

Tekton Research Inc.

Yukon, Oklahoma, 73099, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Ventavia Research Group, LLC

Keller, Texas, 76248, United States

Location

Research Your Health

Plano, Texas, 75093, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

Location

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, 30130-100, Brazil

Location

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, 30150-221, Brazil

Location

CECOR Centro OncolOgico de Roraima

Boa Vista, 69304-415, Brazil

Location

Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

Campinas, 13060-904, Brazil

Location

Núcleo de Medicina Tropical - Universidade Federal do Ceará

Ceará, 60430-160, Brazil

Location

Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose

Criciúma, 88811-508, Brazil

Location

Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN

Natal, 59025-050, Brazil

Location

Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

Ribeirão Preto, 14048-900, Brazil

Location

Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu

Rio de Janeiro, 26030-380, Brazil

Location

CPQuali Pesquisa Clinica LTDA ME

São Paulo, 01228-000, Brazil

Location

Centro de Referencia E Treinamento Dst/Aids

São Paulo, 04121-000, Brazil

Location

Klinische Forschung Berlin-Mitte GmbH

Berlin, 10787, Germany

Location

Clinical Research HamburggmbH

Hamburg, 22143, Germany

Location

Klinische Forschung Hannover-Mitte GmbH

Hanover, 30159, Germany

Location

Synexus Clinical Research GmbH

Leipzig, 04103, Germany

Location

Universitaetsmedizin Rostock

Rostock, 18057, Germany

Location

Gdanskie Centrum Zdrowia

Gdansk, 80-542, Poland

Location

Centrum Medyczne Medyk

Rzeszów, 35-055, Poland

Location

Centrum Medyczne Pratia Poznan

Skorzewo, 60 185, Poland

Location

Synexus Helderberg Clinical Research Centre

Cape Town, 7130, South Africa

Location

Ndlovu Elandsdoorn Site

Dennilton, 0485, South Africa

Location

Stanza Clinical Research Centre : Mamelodi

Mamelodi East, 122, South Africa

Location

PHOENIX PHARMA (Pty) Ltd

Port Elizabeth, 6001, South Africa

Location

Gct Sunnyside

Pretoria, 0002, South Africa

Location

Setshaba Research Centre

Soshanguve, 152, South Africa

Location

MeSH Terms

Interventions

Ad26COVS1

Intervention Hierarchy (Ancestors)

COVID-19 Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Global Medical Head
• Organization: Janssen Vaccines & Prevention B.V.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 1, 2021
• Study Start: June 18, 2021
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: February 4, 2025
• Results First Posted: May 23, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

ZA (6); BR (11); PL (3); DE (5); US (18)