CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 349 enrolled
Drug / intervention
SARS-CoV-2 VLP Vaccine-Wuhan +2 morebiological
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.

Search/NCT04962893
NCT04962893Phase 2Completed
CompareCT.gov

Phase II Study to Assess the Safety, Efficacy, and Immunogenicity of Authentic SARS-CoV-2 or Alpha Variant Spike Containing VLP Vaccines and Their Combination for the Prevention of COVID-19 in Healthy Adult Volunteers (SAVE STUDY)

Ihsan GURSEL, PhD, Prof.·interventional·Posted Jul 15, 2021·Updated May 31, 2022

In Brief

A Phase 2 clinical trial evaluating SARS-CoV-2 VLP Vaccine-Wuhan, SARS-CoV-2 VLP Vaccine-Alpha (British) variant, and 1 other intervention for Covid19. Completed, enrolled 349 participants across 3 sites.

Detailed Summary

This is a randomized, parallel dose assigned, double blind, multi center, Phase II study assessing the efficacy, safety, and immunogenicity of VLP vaccine (Authentic and Alpha variants) in adults between 18 and 59 years who are healthy or have medically stable chronic diseases and who have no known history of SARS-CoV-2 infection

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesTurkey (Türkiye)
CollaboratorsThe Scientific and Technological Research Council of Turkey, Nobel Pharmaceuticals, MonitorCRO

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJul 15, 2021
Enrollment StartJun 26, 2021
Primary CompletionJan 16, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.0 years ago

Interventions

SARS-CoV-2 VLP Vaccine-Wuhanbiological

Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus

SARS-CoV-2 VLP Vaccine-Alpha (British) variantbiological

Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus

SARS-CoV-2 VLP Vaccine-Wuhan+Alpha variantbiological

Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the Wuhan or Alpha variants