A Study of Ad26.COV2.S in Healthy Adults (COVID-19)

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: Ad26.COV2.S

Study type

Interventional

Funder types

Industry

Identifiers

NCT04894305

VAC31518COV1003 (Other Identifier)

CR109013

2021-001374-30 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S (0.3 milliliter [mL] versus 0.5 mL) and to demonstrate non-inferiority (NI) of Ad26.COV2.S (0.3 mL versus 0.5 mL), 28 days after vaccination.

Enrollment

380 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participant must sign an informed consent form (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
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 coronavirus disease-2019 (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
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 on the day of and prior to study vaccine administration
Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the study vaccine
Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study

Exclusion criteria

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)
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)
Participant has a history of any neurological disorders or seizures including Guillain-barre syndrome, with the exception of febrile seizures during childhood
Participant has a history of chronic urticaria (recurrent hives), eczema or adult atopic dermatitis
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 study vaccine or has any plans to receive such treatment during the study
Upper limit of body mass index (BMI) range should not be considered in participants with comorbidities that are or might be associated with an increased risk of progression to severe COVID-19. 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, example, thiazides, beta blockers, alpha blockers at the same effective dose)
Participant who is an employee of the sponsor, investigator or study site with direct involvement in the proposed study or other studies under the direction of that investigator or study site, including the family members of those employees or the investigator