Healthy Volunteers, with or without comorbidities (Prevention of SARS-CoV-2-mediated COVID-19) MedDRA version: 23.1 Level: LLT Classification code 10084465 Term: COVID-19 vaccination System Organ Class: 100000004865
Conditions
Interventions
Product Name: Ad26.COV2.S
Product Code: VAC31518
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Not available
Current Sponsor code: VAC31518
Other descriptive name: Ad26.COV2.S (al
Sponsors
Janssen Vaccines & Prevention B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is =18 to =65 years) yes F.1.3.1 Number of subjects for this age range 9000
Exclusion criteria
Exclusion criteria: 1. Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature =38.0ºC (100.4°F) within 24 hours prior to the planned 1st dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor. 2. 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). 3. Participant has abnormal function of the immune system resulting from: a. Clinical conditions (eg, autoimmune disease or potential immune mediated disease or known or suspected immunodeficiency, or patient on hemodialysis) expected to have an impact on the immune response of the study vaccine. Participants with clinical conditions stable under non-immunomodulator treatment (eg, autoimmune thyroiditis, autoimmune inflammatory rheumatic disease such as rheumatoid arthritis) may be enrolled at the discretion of the investigator. Non-immunomodulator treatment is allowed as well as steroids at a non-immunosuppressive dose or route of administration. b. Chronic (>10 days) or recurrent use of systemic corticosteroids within 6 months before administration of the 1st dose of study vaccine and during the study. A substantially immunosuppressive steroid dose is considered to be =2 weeks of daily receipt of 20 mg of prednisone or equivalent. Ocular, topical or inhaled steroids are allowed. c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 6 months before administration of the 1st dose of study vaccine and during the study. 4. Participant received treatment with Ig in the 3 months or blood products in the 4 months before the planned administration of the 1st dose of study vaccine or has any plans to receive such treatment during the study. 5. Participant received or plans to receive: a. Licensed live attenuated vaccines – within 28 days before or after planned administration of the 1st or subsequent study vaccinations. b. Other licensed (not live) vaccines – within 14 days before or after planned administration of the 1st or subsequent study vaccinations. 6. Participant previously received a coronavirus vaccine. 7. Participant received an investigational drug within 30 days(including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational Ig or investigational monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine (including investigational Adenoviral-vectored vaccines) within 6 months before the planned administration of the 1st dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study. 8. Participant is pregnant or planning to become pregnant within 3 months after the last dose of study vaccine. 9. Participant has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the wellbeing) or that could prevent, limit, or confound the protocol-specified assessments. 10. Stage 1: Participants with comor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed, moderate to severe/critical COVID-19, as compared to placebo, in SARS-CoV-2 seronegative adults;Secondary Objective: - To demonstrate the efficacy of Ad26.COV2.S in the prevention of moderate to severe/critical COVID-19 in adults regardless of their serostatus - To evaluate the efficacy of Ad26.COV2.S in the prevention of moderate to severe/critical COVID-19 - To assess the effect of Ad26.COV2.S on: 1. COVID-19 requiring medical intervention 2. SARS-CoV-2 viral RNA load for moderate to severe/critical COVID-19 3. Mild COVID-19 4. COVID-19 as defined by the US FDA harmonized case definition 5. All molecularly confirmed symptomatic COVID-19 6. Occurrence of confirmed asymptomatic or undetected infections with SARS-CoV-2 - To assess the efficacy of Ad26.COV2.S in the prevention of SARS-CoV-2 infection - To evaluate safety in terms of SAEs, MAAEs, and MAAEs leading to study discontinuation - In a subset of participants, to evaluate the safety and reactogenicity (local & systemic AEs, unsolicited AEs), and immunogenicity of Ad26.COV2.S as compared to placebo;Primary end point(s): First occurrence of molecularly confirmed, moderate to severe/critical COVID-19, with onset at least 14 days after the 2nd vaccination (Day 71);Timepoint(s) of evaluation of this end point: day 71 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: First occurrence of molecularly confirmed, moderate to severe/critical COVID-19, with onset -1 day after the 1st vaccination -at least 14 days after the 2nd vaccination (Day 71) -14 days after the 1st vaccination (Day 15) Safety: Occurrence and relationship of SAEs (during the entire study), MAAEs (until 6 months after the last vaccination), and MAAEs leading to study discontinuation (during the entire study) for all participants Immunogenicity: -Analysis of antibodies binding to the SARS-CoV-2 S protein by ELISA -SARS-CoV-2 neutralization as measured by virus neutralization assay (VNA; wildtype virus and/or pseudovirion expressing SARS-CoV-2 S protein);Timepoint(s) of evaluation of this end point: Efficacy: Day 2, day 15, day 71 Safety: throughout the study | — |
Countries
France, Germany, Italy, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen Research & Development
Outcome results
None listed