This is a phase 1b, open-label study in adult healthy participants. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 \[E1-, E2b-, E3-\] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity.
Khayelitsha Clinical Research Site
Khayelitsha, South Africa
Number of Participants With Medically Attended Adverse Events (MAAE)
Number of Participants with MAAEs through 1 week post final vaccine administration
Time frame: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants With Solicited Local Reactogenicity AEs
Number of Participants with solicited local reactogenicity AEs through 1 week post final vaccine administration
Time frame: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants With Solicited Systemic Reactogenicity AEs
Number of Participants with solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Time frame: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants With Unsolicited AEs
Number of Participants with unsolicited AEs through 1 week post final vaccine administration
Time frame: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants With Medically Attended Adverse Events (MAAE)
Number of Participants with MAAEs through 30 days post final vaccine administration
Time frame: From first dose of study treatment through 30 days post final vaccine administration; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6.
Number of Participants With Unsolicited AEs
Number of Participants with unsolicited AEs through 30 days post final vaccine administration
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Time frame: From first dose of study treatment through 30 days post final vaccine administration; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6.
Number of Participants With Medically Attended Adverse Events (MAAE)
Number of Participants with MAAEs through 6 months post final vaccine administration
Time frame: From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6.
Number of Participants With Unsolicited AEs
Number of Participants with unsolicited AEs through 6 months post final vaccine administration
Time frame: From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6.