Official Title
A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26COVS1 in Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older
Brief Summary

The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort in healthy adults aged greater than or equal to (>=) 18 to less than or equal to (= 65 years in good health with or without stable underlying conditions. The purpose of the study is also to assess the safety and reactogenicity of Ad26.COV2.S administered as ad hoc booster vaccination in healthy adults aged >= 18 to = 65 years in good health with or without stable underlying conditions.

Completed
COVID-19 Prevention

Biological: Ad26.COV2.S

Participants will receive intramuscular (IM) injection of Ad26.COV2.S.
Other Name: Array

Biological: Placebo

Participants will receive Placebo.

Eligibility Criteria

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

- All female participants of childbearing potential must have a negative highly
sensitive urine pregnancy test at screening; and have a negative highly sensitive
urine pregnancy test immediately prior to each study vaccine administration

- Participant must have a body mass index (BMI) less than or equal to (<=) 30.0
kilograms per square meter (kg/m^2)

- 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 coronavirus disease-2019
(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 (participants may have medical conditions of mild
severity (according to the Toxicity Grading Scale), 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, for example, thiazides, Beta blockers, Alpha blockers at the same effective
dose).

Exclusion criteria:

- Participant has a clinically significant acute illness (this does not include minor
illnesses such as diarrhea or mild upper respiratory tract infection) or temperature
greater than or equal to (>=) 38.0 degree Celsius 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

- 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 history of any neurological disorders or seizures including
Guillain-Barre syndrome, with the exception of febrile seizures during childhood

- Participant has a positive diagnostic test result for SARS-CoV-2 infection confirmed
by polymerase chain reaction (PCR) at screening

- Participants with comorbidities that are or might be associated with an increased risk
of progression to severe COVID-19, that is, 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 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/m^2);
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 (according to the Toxicity Grading Scale), 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, for example, thiazides, Beta blockers, Alpha blockers at the same
effective dose)

- Applicable to Cohorts 1 and 3 only: Participant currently working in an occupation
with a high risk of exposure to SARS-CoV-2 (for example, health care worker or
emergency response personnel) or considered at the investigator's discretion to be at
increased risk to acquire COVID-19 for any other reason

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Belgium
United States
Locations

Optimal Research
San Diego, California, United States

Optimal Research
Melbourne, Florida, United States

Optimal Research
Peoria, Illinois, United States

Optimal Research
Rockville, Maryland, United States

Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States

AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
Knoxville, Tennessee, United States

Optimal Research
Austin, Texas, United States

Universiteit Antwerpen - Centrum voor de Evaluatie van Vaccinaties (CEV)
Edegem, Belgium

UZA-SGS
Edegem, Belgium

Center for Vaccinology (CEVAC)
Gent, Belgium

UZ Leuven
Leuven, Belgium

Clinical Pharmacology Unit
Merksem, Belgium

Janssen Vaccines & Prevention B.V. Clinical Trial, Study Director
Janssen Vaccines & Prevention B.V.

Janssen Vaccines & Prevention B.V.
NCT Number
Keywords
Covid-19
Ad26COVS1
Ad26.COV2.S
SARS CoV 2
Vaccine
MeSH Terms
COVID-19