coronavirus SARS-CoV-2
Conditions
Interventions
Adults:
Vaccination of Ad26.COV2.S in 1-and 2-dose vaccination regimens followed by
antigen presentation after 4 months (2-dose regimen) or 6 months (single-dose
regimen). Participants who received
Sponsors
Janssen-Cilag
Eligibility
Age
12 Years to 64 Years
Inclusion criteria
Inclusion criteria: Adults: 1. Participant is 18 to 55 years of age, inclusive, or 65 years of age or older on the day of signing the ICF. 2. Participant must have a body mass index (BMI)
Exclusion criteria
Exclusion criteria: Adults: 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. 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 blood products 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 is a woman who is pregnant, breastfeeding, or planning to become pregnant within 3 months after the last dose of study vaccine. 9. Participant has chronic active hepatitis B or hepatitis C infection per medical history. 10. Participant previously received a coronavirus vaccine. 11. Participant has a positive diagnostic test result for past (serological testing) or current (PCR based viral RNA detection) SARS-CoV-2 infection at screening. 12. Participants with comorbidities that are or might be associated with an increased risk of progression to severe COVID-19, ie, participants with moderate-to severe asthma; chronic lung diseases such as chronic obstructive pulmonary disease (COPD) (including emphysema and chronic bronchitis), idiopathic pulmonary fibrosis and cystic fibrosis; diabetes (including type 1, type 2, or gestational); serious heart conditions, including heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and pulmonary hypertension or high blood pressure; obesity (BMI >= 30 kg/m2); chronic liver disease,including cirrhosis; sickle cell disease; thalassemia; cerebrovascular disease; neurologic conditions (dementia); and participants who live in nursing homes or long-term care facilities. This list is consistent with the list of conditions that increase the risk of progression to severe COVID19 available at the CDC website at the time of writing of this protocol, except for smoking, which is allowed. Applicable only to participants 65 years of age and older: Participants may have hypertension of mild severity as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, eg, thiazides, Beta blockers, Alpha blockers at the same effective dose). 13. Participant who is currently working in an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adults: - Serological response to vaccination as measured by virus neutralization assay (VNA) titers and enzyme-linked immunosorbent assay (ELISA), 28days after Vaccination 2. - Antibody geometric mean titers (GMTs) and geometric mean concentrations (GMCs), 28days after Vaccination 2. - Serological response to vaccination as measured by VNA titers and ELISA, 28days after Vaccination 1. - Antibody GMTs and GMCs, 28days after Vaccination 1. - Serological response to vaccination as measured by VNA titers and ELISA, 28days after Vaccination 2. - Antibody GMTs and GMCs, 28days after Vaccination 2 - Solicited local and systemic AEs for 7 days after each vaccination. - Unsolicited AEs for 28 days after each vaccination. - Serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study (from first vaccination until end of the study). Adolescents: - Solicited local and systemic AEs for 7 days after each vaccination. - Unsolicited AEs for 28 days after each vaccination. - SAEs and AESIs throughout the study (from first vaccination until end of the study). - Serological response to vaccination as measured by psVNA titer, 28 days post-dose 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adults: - Serological response to vaccination as measured by VNA titers and ELISA, 7 days after antigen presentation. - Antibody GMTs and GMCs, 7 days after antigen presentation. - Solicited local and systemic AEs for 7 days after antigen presentation. - Unsolicited AEs for 28 days after antigen presentation. - SAEs and AESIs throughout the study (from antigen presentation until end of the study). - Neutralizing antibody titers to the wild-type SARS-CoV-2 virus and/or pseudovirion expressing S protein as measured by VNA, at all blood collection timepoints - Binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins (eg, Sprotein) as measured by ELISA, at all blood collection timepoints. Adolescents: - Serological response to vaccination as measured by VNA titers and ELISA, 28 days after Vaccination. - Antibody GMTs (VNA) and GMCs, 28 days after Vaccination. - Serological response to vaccination as measured by VNA titers and ELISA, 7 days after the booster vaccination - Antibody GMTs (VNA) and GMCs, 7 days after the booster vaccination. - Solicited local and systemic AEs for 7 days after the booster vaccination - Unsolicited AEs for 28 days after the booster vaccination - SAEs and AESIs throughout the study (from booster dose until end of the study). | — |
Countries
Netherlands
Outcome results
None listed