coronavirus COVID-19
Conditions
Interventions
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 64 Years
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 65 years of age, inclusive, on the day of signing the ICF. 4. 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 COVID-19b, except for smoking, which is allowed (see also exclusion criterion 19). 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.
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 within 24 hours prior to the planned study vaccination; 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the safety and reactogenicity of Ad26.COV2.S 5x10^10 vp per 0.3 mL versus 5x10^10 vp per 0.5 mL. 2. To demonstrate non-inferiority (NI) of the immune responses (Geometric mean concentration (GMC)) 28 days after vaccination with Ad26.COV2.S 5x10^10 vp per 0.3 mL versus 5x10^10 vp per 0.5 mL, as measured by S enzyme-linked immunosorbent assay (S-ELISA) using a NI margin of 2/3 for the GMC ratio (GMC of 5x10^10 vp in 0.3 mL/GMC 5x10^10 vp in 0.5 mL). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the humoral immune response to Ad26.COV2.S across both groups, at all blood collection timepoints. 2. To further assess the humoral immune response to Ad26.COV2.S in a subset of participants across both groups, at selected blood collection timepoints. | — |
Countries
Netherlands
Outcome results
None listed