Healthy Volunteers (Prevention of 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 (also known as Ad26COVS1)
Product Code: VAC31518
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Not available
Current Sponsor code: VAC31518
Other descrip
Sponsors
Janssen Vaccines & Prevention B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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) =65 years) yes F.1.3.1 Number of subjects for this age range 200
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. 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); 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); end stage renal disease; organ transplantation; cancer; HIV infection and other immunodeficiencies;hepatitis B infection; and sleep apnea. This list is consistent with the list of conditions that increase the risk of progression to severe COVID-19 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 occupation with a high risk of exposure to SARS-CoV-2 infection (eg, health care worker or emergency response personnel who work in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 7 or 28 days after each vaccination Safety endpoints - continuous throughout the study;Main Objective: 1.To assess the humoral immune response to 3 dose levels (5x10^10 virus particle (vp), 2.5x10^10 vp, 1.25x10^10 vp) of Ad26.COV2.S, administered intramuscularly (IM) as a 2-dose schedule at a 56-day interval, 28 days after Vaccination 2. 2.To assess the humoral immune response to 2 dose levels (1 x10^11 vp and 5x10^10 vp) of Ad26.COV2.S, administered IM as a single vaccination, 28 days after Vaccination 1. 3.To assess the humoral immune response to Ad26.COV2.S at the 5x10^10 vp dose level, administered IM as a 2-dose schedule at a 28-day and at an 84-day interval, 28 days after Vaccination 2. 4.To assess the safety and reactogenicity of Ad26.COV2.S, administered IM at several dose levels, as a 2-dose or a single-dose schedule. ;Secondary Objective: 1.To assess the anamnestic response to antigen presentation of Ad26.COV2.S at the 1.25x10^10 vp dose level, administered 4 months after Vaccination 2 (2-dose schedule) or 6 months after a Vaccination 1 (single-dose schedule), 7 days after antigen presentation (Groups 1-5, 7 and 9). 2.To assess the safety and reactogenicity of antigen presentation of Ad26.COV2.S at the 1.25x10^10 vp dose level, administered 4 months after Vaccination 2 (2-dose schedule) or 6 months after a Vaccination 1 (single-dose schedule)(Groups 1-5, 7 and 9). 3.To assess the humoral immune response to Ad26.COV2.S across all groups, at all blood collection timepoints ;Primary end point(s): 1a. Serological response to vaccination as measured by virus neutralization assay (VNA) titers and enzyme-linked immunosorbent assay (S-ELISA, ELISA Units/mL [EU/mL]), 28 days after Vaccination 2. 1b. Antibody geometric mean titers (GMTs) (VNA) and geometric mean concentrations (GMCs) (S-ELISA), 28 days after Vaccination 2. 2a. Serological response to vaccination as measured by VNA titers and ELISA (S-ELISA, EU/mL), 28 d | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1a. Serological response to vaccination as measured by VNA titers and ELISA (S-ELISA, EU/mL), 7 days after antigen presentation. 1b. Antibody GMTs (VNA) and GMCs (S-ELISA), 7 days after antigen presentation. 2a. Solicited local and systemic AEs for 7 days after antigen presentation. 2b. Unsolicited AEs for 28 days after antigen presentation. 2c. SAEs and AESIs throughout the study (from antigen presentation until end of the study). 3a. Neutralizing antibody titers to the wild-type SARS-CoV-2 virus expressing S protein as measured by VNA, at all blood collection timepoints. 3b. Binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins (eg, S protein) as measured by ELISA, at all blood collection timepoints. ;Timepoint(s) of evaluation of this end point: - 7 or 28 days after antigen presentation - at all blood collection timepoints | — |
Countries
Germany, Netherlands, Spain, United Kingdom
Contacts
Public ContactClinical Registry Group
Janssen Research & Development
Outcome results
None listed