A phase 1, randomized, observer-blind study to compare the safety, reactogenicity, and Immunogenicity of Ad26.COV2.S at a single Dose of 5x10^10 vp in 2 different volumes in healthy adults

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 380

Inclusion Criteria

1. Participant must sign an 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.
2. Participant is willing and able to adhere to the prohibitions and
restrictions specified in this
protocol.
3. Participant is 18 to 65 years of age, inclusive, on the day of signing the
ICF.
4. 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
COVID-19b, except for
smoking, which is allowed (see also exclusion criterion 19). 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.

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
within 24 hours
prior to the planned study vaccination; 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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. To assess the safety and reactogenicity of Ad26.COV2.S 5x10^10 vp per 0.3 mL<br /><br>versus 5x10^10 vp per 0.5 mL.<br /><br>2. To demonstrate non-inferiority (NI) of the immune responses (Geometric mean<br /><br>concentration (GMC)) 28 days after vaccination with Ad26.COV2.S 5x10^10 vp per<br /><br>0.3 mL versus 5x10^10 vp per 0.5 mL, as measured by S enzyme-linked<br /><br>immunosorbent assay (S-ELISA) using a NI margin of 2/3 for the GMC ratio (GMC<br /><br>of 5x10^10 vp in 0.3 mL/GMC 5x10^10 vp in 0.5 mL).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To assess the humoral immune response to Ad26.COV2.S across both groups, at<br /><br>all blood collection timepoints.<br /><br>2. To further assess the humoral immune response to Ad26.COV2.S in a subset of<br /><br>participants across both groups, at selected blood collection<br /><br>timepoints.</p><br>