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

Janssen Vaccines & Prevention B.V.1,609 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,609

Conditions

COVID-19 Prevention

Interventions

Ad26.COV2.SBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (43)

Outcomes

Primary Outcomes

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.

Time frame: 28 days after first vaccination (at Day 29)

Time frame: 14 days after second vaccination (at Day 71)

Secondary Outcomes

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

Percentage of participants with serological response to vaccination to SARS-COV-2 S protein as measured by ELISA were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) the baseline (pre-dose 1) sample value was less than or equal to (\<=) lower limit of quantification (LLOQ) and the post-baseline sample was greater than (\>) LLOQ; (2) the baseline sample (pre-dose 1) value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>=4-fold) increase from the baseline sample value. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.

Time frame: 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

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

Data from ClinicalTrials.gov

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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

...and 33 more locations

Time frame: 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

An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participant in their e-diary for 7 days after each vaccination. Solicited local AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.

Time frame: 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

An AE was any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) were noted in the subject diary after 7 days of each vaccination. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.

Time frame: 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

Unsolicited AEs were all AEs for which the subject was not specifically questioned in the subject diary. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.

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

Number of Participants With Serious Adverse Events (SAEs)

SAE was any untoward medical occurrence that at any dose may results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.

Time frame: From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)

Number of Participants With Adverse Events of Special Interest (AESIs)

AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with thrombocytopenia syndrome were considered to be an AESI. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.

Time frame: From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)

Number of Participants With AEs Leading to Study Discontinuation

Number of participants with AEs leading to study discontinuation were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.

Time frame: Up to 60 weeks

Number of Participants With Medically-Attended Adverse Events (MAAEs)

MAAEs were 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 were not considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.

Time frame: 6 months after second vaccination (up to 32 weeks)