Clinical trial NCT04908722: A Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19 Prevention
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2021-06-01
Enrollment: 1609
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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
timeFrame: 28 days after first vaccination (at Day 29)
measure: 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
timeFrame: 14 days after second vaccination (at Day 71)
Secondary outcomes:
measure: Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA
timeFrame: Day 29, Day 57, Day 71, Week 32, and Week 60
measure: Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA
timeFrame: Day 29, Day 57, Day 71, Week 32, and Week 60
measure: Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination
timeFrame: 7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])
measure: Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination
timeFrame: 7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])
measure: Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination
timeFrame: 28 days after each vaccination (first vaccination [at Day 29], second vaccination [at Day 85])
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
measure: Number of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
measure: Number of Participants With AEs Leading to Study Discontinuation
timeFrame: Up to 60 weeks
measure: Number of Participants With Medically-Attended Adverse Events (MAAEs)
timeFrame: 6 months after second vaccination (up to 32 weeks)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Baptist Health Center For Clinical Research
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research Centers, Inc.
state: California
city: San Diego
country: United States
facility: Wr McCr Llc
state: California
city: Tustin
country: United States
facility: Ark Clinical Research
state: California
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute
state: Florida
city: Metairie
country: United States
facility: Medpharmics, LLC
state: Louisiana
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates, LLC
state: North Carolina
city: Yukon
country: United States
facility: Tekton Research Inc.
state: Oklahoma
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Keller
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Plano
country: United States
facility: Research Your Health
state: Texas
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Belo Horizonte
country: Brazil
facility: Universidade Federal De Minas Gerais - Hospital das Clínicas
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
city: Boa Vista
country: Brazil
facility: CECOR Centro OncolOgico de Roraima
city: Campinas
country: Brazil
facility: Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
city: Ceará
country: Brazil
facility: Núcleo de Medicina Tropical - Universidade Federal do Ceará
city: Criciúma
country: Brazil
facility: Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
city: Natal
country: Brazil
facility: Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN
city: Ribeirao Preto
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
city: Rio de Janeiro
country: Brazil
facility: Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu
city: Sao Paulo
country: Brazil
facility: Centro de Referencia E Treinamento Dst/Aids
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica LTDA ME
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Hamburg
country: Germany
facility: Clinical Research HamburggmbH
city: Hannover
country: Germany
facility: Klinische Forschung Hannover-Mitte GmbH
city: Leipzig
country: Germany
facility: Synexus Clinical Research GmbH
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock
city: Gdansk
country: Poland
facility: Gdanskie Centrum Zdrowia
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Cape Town
country: South Africa
facility: Synexus Helderberg Clinical Research Centre
city: Dennilton
country: South Africa
facility: Ndlovu Elandsdoorn Site
city: Mamelodi East
country: South Africa
facility: Stanza Clinical Research Centre : Mamelodi
city: Port Elizabeth
country: South Africa
facility: PHOENIX PHARMA (Pty) Ltd
city: Pretoria
country: South Africa
facility: Gct Sunnyside
city: Soshanguve
country: South Africa
facility: Setshaba Research Centre
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: