Healthy Volunteers (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
Sponsors
Janssen Vaccines & Prevention B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Participant must sign an 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. 2. Participant is willing and able to adhere to the prohibitions and restrictions specified in this protocol. 3. Participant is 18 to 55 years of age, inclusive, on the day of signing the ICF. 4. Participant must have a BMI =65 years) no F.1.3.1 Number of subjects for this age range
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 first 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 history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence). 3.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). 4.Participant has abnormal function of the immune system resulting from: a.Clinical conditions (eg, autoimmune disease, potential immune mediated disease or known or suspected immunodeficiency, chronic kidney disease [with dialysis]) 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 or recurrent use of systemic corticosteroids within 6 months before administration of study vaccine and during the study. Note: Ocular, topical or inhaled steroids are allowed. c.Administration of antineoplastic and immunomodulating agents or radiotherapy within 6 months before administration of study vaccine and during the study. 5.Participant has a history of any neurological disorders or seizures including Guillain-Barré syndrome, with the exception of febrile seizures during childhood. 6.Participant has a history of chronic urticaria (recurrent hives), eczema or adult atopic dermatitis. 7.Participant received treatment with immunoglobulins in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study. 8.Participant received or plans to receive: c.Licensed live attenuated vaccines – within 28 days before or after planned administration of the first or subsequent study vaccinations d.Other licensed (not live) vaccines – within 14 days before or after planned administration of the first or subsequent study vaccinations. 9.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 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. 10.Participant is a woman who is pregnant or planning to become pregnant within 3 months after the last dose of study vaccine. 11.Participant has a history of an underlying clinically significant acute or chronic m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority (NI) in sequential order: • 1-dose 9x10^10 vp vs 1-dose 5x10^10 vp (release titer) • 1-dose 7x10^10 vp vs 1-dose 5x10^10 vp • 1-dose 3.5x10^10 vp vs 1-dose 5x10^10 vp • 1-dose 2.5x10^10 vp vs 1-dose 5x10^10 vp • 1 dose 1.25x10^10 vp vs 1-dose 5x10^10 vp To demonstrate NI in sequential order: • 2-doses 9x10^10 vp vs 1-dose 5x10^10 vp • 2-doses 9x10^10 vp vs 2-doses 5x10^10 vp • 2-doses 7x10^10 vp vs 1-dose 5x10^10 vp • 2-doses 7x10^10 vp vs 2-doses 5x10^10 vp • 2-doses 3.5x10^10 vp vs 1-dose 5x10^10 vp • 2-doses 3.5x10^10 vp vs 2-doses 5x10^10 vp •NI after 2-doses of Ad26.COV2.S 2.5x10^10 vp vs 1 dose of Ad26.COV2.S 5x10^10 vp •NI after 2-doses of Ad26.COV2.S 2.5x10^10 vp vs 2-doses of Ad26.COV2.S 5x10^10 vp •NI after 2-doses of Ad26.COV2.S 1.25x10^10 vp vs 1-dose of Ad26.COV2.S 5x10^10 vp •NI after 2-doses of Ad26.COV2.S 1.25x10^10 vp vs 2-doses of Ad26.COV2.S 5x10^10 vp ;Secondary Objective: 1.To assess the humoral immune response and durability to Ad26.COV2.S across all groups, at all blood collection timepoints. 2.To assess the seroconversion rate to 1 dose or 2 doses of Ad26.COV2.S across all groups, at all blood collection timepoints. 3.To assess the safety and reactogenicity of Ad26.COV2.S administered at several dose levels.;Primary end point(s): •Binding antibody concentrations to SARS CoV-2 S protein as measured by ELISA 28 days after vaccination •NI will be demonstrated in terms of humoral immune response expressed by the GMCs of S-ELISA, 28 days post-dose 1, using a NI margin of 2/3 for the GMC ratio (GMC 9x10^10 vp, 7x10^10 vp, 3.5x10^10 vp, 2.5x10^10 [or 1.25x10^10 vp]/GMC 5x10^10 vp) •Binding antibody concentrations to SARS CoV-2 S protein as measured by ELISA 14 days after vaccination 2 •NI will be demonstrated in terms of humoral immune response expressed by the GMCs of S-ELISA, 14 days post-dose 2 (9x10^10 vp, 7x10^10 vp, 3.5x10^10 vp, 2.5x10^10 vp or 1.25x10^10 vp) and 28 days post-dose 1 or 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Binding antibody concentrations to SARS CoV-2 S protein as measured by ELISA •Antibody GMCs (S-ELISA) •The proportion of subjects achieving seroconversion of serum antibody against the SARS-CoV-2 S protein by S-ELISA •Solicited local and systemic AEs for 7 days after each vaccination •Unsolicited AEs for 28 days after each vaccination •SAEs throughout the study (from first vaccination until end of the study) •Adverse event of special interest (AESIs [from first vaccination until end of the study]) •MAAEs (until 6 months post-dose 2) •AEs leading to study discontinuation (during the entire study) for all participants following vaccination ;Timepoint(s) of evaluation of this end point: until 6 months post vaccination | — |
Countries
Germany, Poland, United States
Contacts
Public ContactClinical Registry Group
Janssen Research & Development
Outcome results
None listed