At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 41 enrolled
Drug / intervention
hAd5-S-Fusion+N-ETSD vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of a Prophylactic COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults (ProVIVA-SA-1)
In Brief
A Phase 1 clinical trial evaluating hAd5-S-Fusion+N-ETSD vaccine for Covid19. Completed, enrolled 41 participants across 1 site.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesSouth Africa
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedJan 2021
Enrollment StartMar 2021
Primary CompletionAug 2022
TodayJul 2026
First PostedJan 14, 2021
Enrollment StartMar 2, 2021
Primary CompletionAug 2, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.5 years ago
Interventions
hAd5-S-Fusion+N-ETSD vaccinebiological
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.