NCT04710303

COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	hAd5-S-Fusion+N-ETSD vaccine	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.

Timeline

• Start date: 2021-03-02
• Primary completion: 2022-08-02
• Completion: 2022-08-02
• First posted: 2021-01-14
• Last updated: 2024-11-15
• Results posted: 2024-11-15

Locations

1 site across 1 country: South Africa

Regulatory

• FDA-regulated drug study