A Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy Adults
- Registration Number
- NCT04908722
- Lead Sponsor
- Janssen Vaccines & Prevention B.V.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1609
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 4: Ad26.COV2.S Dose Level 4 Ad26.COV2.S 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 1: Ad26.COV2.S Dose Level 1 Ad26.COV2.S 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 2: Ad26.COV2.S Dose Level 2 Ad26.COV2.S 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 3: Ad26.COV2.S Dose Level 3 Ad26.COV2.S 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 5: Ad26.COV2.S Dose Level 5 Ad26.COV2.S 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 6: Ad26.COV2.S Dose Level 6 Ad26.COV2.S 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.
- Primary Outcome Measures
Name Time Method 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 14 days after second vaccination (at Day 71) 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.
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 28 days after first vaccination (at Day 29) 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.
- Secondary Outcome Measures
Name Time Method 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]) 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.
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 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.
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 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.
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]) 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.
Number of Participants With Serious Adverse Events (SAEs) From Day 1 (post-vaccination) up to end of the study (up to 60 weeks) 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.
Number of Participants With Adverse Events of Special Interest (AESIs) From Day 1 (post-vaccination) up to end of the study (up to 60 weeks) 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.
Number of Participants With AEs Leading to Study Discontinuation Up to 60 weeks 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.
Number of Participants With Medically-Attended Adverse Events (MAAEs) 6 months after second vaccination (up to 32 weeks) 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.
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]) 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.
Trial Locations
- Locations (42)
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
Clinical Research HamburggmbH
🇩🇪Hamburg, Germany
Klinische Forschung Hannover-Mitte GmbH
🇩🇪Hannover, Germany
Centrum Medyczne Pratia Poznan
🇵🇱Skorzewo, Poland
Synexus Clinical Research GmbH
🇩🇪Leipzig, Germany
Universitaetsmedizin Rostock
🇩🇪Rostock, Germany
Gdanskie Centrum Zdrowia
🇵🇱Gdansk, Poland
Centrum Medyczne Medyk
🇵🇱Rzeszow, Poland
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
🇧🇷Ribeirao Preto, Brazil
Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu
🇧🇷Rio de Janeiro, Brazil
Centro de Referencia E Treinamento Dst/Aids
🇧🇷Sao Paulo, Brazil
CPQuali Pesquisa Clinica LTDA ME
🇧🇷São Paulo, Brazil
Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN
🇧🇷Natal, Brazil
Klinische Forschung Berlin-Mitte GmbH
🇩🇪Berlin, Germany
Baptist Health Center For Clinical Research
🇺🇸Little Rock, Arkansas, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Ark Clinical Research
🇺🇸Tustin, California, United States
Paradigm Clinical Research Centers, Inc.
🇺🇸Redding, California, United States
Wr McCr Llc
🇺🇸San Diego, California, United States
Velocity Clinical Research, Hallandale Beach
🇺🇸Hallandale Beach, 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