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

A Randomized, Double-blind, Phase 3 Study to Evaluate 6 Dose Levels of Ad26.COV2.S Administered As a Two-Dose Schedule in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Prevention
• Intervention / Treatment: Biological: Ad26.COV2.S

• Study Type: Interventional
• Enrollment (Actual): 1609
• Phase: Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Brazil
  • Belo Horizonte, Brazil, 30150-221
    • Santa Casa de Misericórdia de Belo Horizonte
  • Belo Horizonte, Brazil, 30130-100
    • Universidade Federal De Minas Gerais - Hospital das Clínicas
  • Boa Vista, Brazil, 69304-415
    • CECOR - Centro Oncológico de Roraima
  • Campinas, Brazil, 13060-904
    • Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro
  • Ceará, Brazil, 60430-160
    • Núcleo de Medicina Tropical - Universidade Federal do Ceará
  • Criciúma, Brazil, 88811-508
    • Sociedade Literaria e Caritativa Santo Agostinho - Hospital Sao Jose
  • Natal, Brazil, 59025-050
    • Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN
  • Ribeirao Preto, Brazil, 14048-900
    • Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
  • Rio de Janeiro, Brazil, 26030-380
    • Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu
  • Sao Paulo, Brazil, 04121-000
    • Centro de Referência e Treinamento DST/AIDS
  • São Paulo, Brazil, 01228-000
    • CPQuali Pesquisa Clinica LTDA ME
• Germany
  • Berlin, Germany, 10787
    • Klinische Forschung Berlin-Mitte GmbH
  • Hamburg, Germany, 22143
    • Clinical Research HamburggmbH
  • Hannover, Germany, 30159
    • Klinische Forschung Hannover-Mitte GmbH
  • Leipzig, Germany, 04103
    • Synexus Clinical Research GmbH
  • Rostock, Germany, 18057
    • Universitaetsmedizin Rostock
• Poland
  • Gdansk, Poland, 80-542
    • Gdanskie Centrum Zdrowia
  • Rzeszow, Poland, 35-055
    • Centrum Medyczne Medyk
  • Skorzewo, Poland, 60-185
    • Centrum Medyczne Pratia Poznan
• South Africa
  • Cape Town, South Africa, 7130
    • Synexus Helderberg Clinical Research Centre
  • Dennilton, South Africa, 0485
    • Ndlovu Elandsdoorn Site
  • Mamelodi East, South Africa, 122
    • Stanza Clinical Research Centre : Mamelodi
  • Port Elizabeth, South Africa, 6001
    • Phoenix Pharma (Pty) Ltd
  • Pretoria, South Africa, 0002
    • Gct Sunnyside
  • Soshanguve, South Africa, 152
    • Setshaba Research Centre
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center for Clinical Research
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Long Beach, California, United States, 90815
      • Ark Clinical Research
    • Redding, California, United States, 96001
      • Paradigm Clinical Research Centers, Inc.
    • San Diego, California, United States, 92120
      • Wr-McCr, Llc
    • Tustin, California, United States, 92780
      • Ark Clinical Research
  • Florida
    • Hallandale Beach, Florida, United States, 33009
      • Velocity Clinical Research, Hallandale Beach
    • Miami, Florida, United States, 33179
      • Floridian Research Institute
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • MedPharmics, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Clinical Research Center of Nevada
  • New York
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
    • Wilmington, North Carolina, United States, 28403
      • Trial Management Associates, LLC
  • Oklahoma
    • Yukon, Oklahoma, United States, 73099
      • Tekton Research Inc.
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Texas
    • Keller, Texas, United States, 76248
      • Ventavia Research Group, LLC
    • Plano, Texas, United States, 75093
      • Research Your Health
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Clinical Research Partners, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: Ad26.COV2.S; Participants will receive intramuscular (IM) injections of Ad26.COV2.S.; Other Names: JNJ-78436735; Ad26COVS1; VAC31518
Experimental: 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.	Biological: Ad26.COV2.S; Participants will receive intramuscular (IM) injections of Ad26.COV2.S.; Other Names: JNJ-78436735; Ad26COVS1; VAC31518
Experimental: 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.	Biological: Ad26.COV2.S; Participants will receive intramuscular (IM) injections of Ad26.COV2.S.; Other Names: JNJ-78436735; Ad26COVS1; VAC31518
Experimental: 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.	Biological: Ad26.COV2.S; Participants will receive intramuscular (IM) injections of Ad26.COV2.S.; Other Names: JNJ-78436735; Ad26COVS1; VAC31518
Experimental: 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.	Biological: Ad26.COV2.S; Participants will receive intramuscular (IM) injections of Ad26.COV2.S.; Other Names: JNJ-78436735; Ad26COVS1; VAC31518
Experimental: 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.	Biological: Ad26.COV2.S; Participants will receive intramuscular (IM) injections of Ad26.COV2.S.; Other Names: JNJ-78436735; Ad26COVS1; VAC31518

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main Study: Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Concentration Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination	SARS-CoV-2 S protein binding antibodies concentration measured by ELISA will be reported.	28 days after first vaccination (Day 29)
Main Study: ELISA Geometric Mean Concentrations (GMCs) 28 Days After First Vaccination	Non-inferiority (NI) will be assessed in terms of humoral immune response expressed by the GMCs of S-ELISA.	28 days after first vaccination (Day 29)
Main Study: SARS-CoV-2 S Protein Binding Antibodies Concentration Measured by ELISA 14 Days After Second Vaccination	SARS-CoV-2 S protein binding antibodies concentration measured by ELISA will be reported.	14 days after second vaccination (Day 71)
Main Study: ELISA GMCs 14 Days After Second Vaccination	NI will be assessed in terms of humoral immune response expressed by the GMCs of S-ELISA.	14 days after second vaccination (Day 71)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main and Sub Study: Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA	Serological response to vaccination to SARS-COV-2 S protein as measured by ELISA will be reported.	Up to 60 weeks
Main and Sub Study: SARS-CoV-2 S Protein Binding Antibody GMCs as Measured by ELISA or Equivalent Assay	SARS-CoV-2 S protein binding antibody GMCs as measured by ELISA or equivalent assay will be reported.	Up to 60 weeks
Main and Sub Study: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination	Solicited local AEs include injection site pain/tenderness, erythema and swelling at the study vaccine injection site and the extent (largest diameter) of any erythema and swelling (using the ruler supplied) will be noted in the participant diary after 7 days after each vaccination.	7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 57 (up to Day 64)
Main and Sub Study: Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination	Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary after 7 days of each vaccination.	7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 57 (up to Day 64)
Main and Sub Study: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination	Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.	28 days after first vaccination on Day 1 (up to Day 29); 28 days after second vaccination on Day 57 (up to Day 85)
Main and Sub Study: Number of Participants with Serious Adverse Events (SAEs)	SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.	Up to 60 weeks
Main and Sub Study: Number of Participants with Adverse Events of Special Interest (AESIs)	Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.	Up to 60 weeks
Main and Sub Study: Number of Participants with Medically-Attended Adverse Events (MAAEs)	MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.	6 months after second vaccination (up to 32 weeks)
Main Study: Number of Participants with AEs Leading to Study Discontinuation	Number of participants with AEs leading to study discontinuation will be reported.	Up to 60 weeks

Collaborators and Investigators

• Sponsor: Janssen Vaccines & Prevention B.V.
• Investigators: Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial, Janssen Vaccines & Prevention B.V.

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2021
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): July 10, 2023

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CR108960; 2020-005801-14 (EudraCT Number); VAC31518COV3003 (Other Identifier: Janssen Vaccines & Prevention B.V.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes