A Study to Evaluate Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older

Phase 1

• Conditions: Healthy Volunteers (Prevention of COVID-19); Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002584-63-ES
• Lead Sponsor: Janssen Vaccines & Prevention B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-16
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 550

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) <30.0 kg/m2.
3. Participant 18 to 55 years of age, inclusive: Participant must be healthy, in the investigator’s clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe COVID-19, except for smoking, which is allowed.
Participant 65 years of age and older: in the investigator’s clinical judgment, participant must be either in good or stable health. 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-19, except for smoking, which is allowed. 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. Participant will be included on the basis of physical examination, medical history, and vital signs.
4. All participants of childbearing potential must:
a. Have a negative highly sensitive urine pregnancy test at screening.
b. Have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration.
5. Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 367
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 183

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 while enrolled in this study or 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 COVID-19 available at the CDC website at the time of writing of this protocol, except for smoking, which is allowed.
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 close contact with SARS-CoV-2 infected patients) or considered at the investigator’s discretion to be at increased risk to acquire COVID-19 for any other reason.
14. Participant who has had a known exposure to an individual with confirmed COVID-19 or SARS-CoV-2 infection within the past 2 weeks.
15. History of confirmed SARS or MERS.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified