A study to evaluate safety, reactogenicity and immunogenicity of Ad26COVS1 in adults

Phase 1

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

• Registration Number: EUCTR2020-001483-28-BE
• 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: 2020-06-30
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1045

Inclusion Criteria

1. Applicable to Cohorts 1 and 2 only: Participant is male or female and 18 to 55 years of age, inclusive, on the day of signing the ICF.
Applicable to Cohort 3 only: Participant is male or female and 65 years of age or older on the day of signing the ICF. For study sites in Belgium, participant is 65 to 75 years of age, inclusive, on the day of signing the ICF.

2. Participant must have a body mass index (BMI) <30.0 kg/m2.

3. Applicable to Cohorts 1 and 2 only: Participant must be healthy, in the investigator’s clinical judgment, as confirmed by medical history, physical examination, clinical laboratory assessments, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe COVID-19.
Applicable to Cohort 3 only: In the investigator’s clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hyperlipoproteinemia or hypothyroidism, as long as their symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe COVID-19. If they are 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. Participants will be included on the basis of physicalnexamination, clinical laboratory assessments, medical history, and vital signs.

4. All female 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 670
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 375

Exclusion Criteria

1. Participant has a clinically significant acute illness or temperature =38.0ºC (100.4°F) within 24 hours prior to the planned first dose of study vaccine.
2. Participant has a history of malignancy within 5 years before screening.
3. Participant has a history of any neurological disorders or seizures including Guillain-Barré syndrome, with the exception of febrile seizures during childhood.
4. Participant previously received a coronavirus vaccine.
5. Participant has a positive diagnostic test result for SARS-CoV-2 infection, confirmed by PCR, at screening.
6. Seropositive participants are enrolled in specific circumstances.
7. Participants with comorbidities that are or might be associated with an increased risk of progression to severe COVID-19, ie, participants with moderateto-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 or 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); smoking; end stage renal disease; organ transplantation; cancer; HIV infection and other immunodeficiencies; hepatitis B infection; and sleep apnea.
Applicable to Cohort 3 only: 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).

Study & Design

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