NCT04530396: RESIST

Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19

Status unknown Phase 3 Last updated 22 January 2021

What this trial tests

Phase 3 trial testing Gam-COVID-Vac in Covid19 Prevention in 33,758 participants. Status unknown.

Timeline

7 September 2020

Primary endpoint
1 May 2021

1 May 2021

Quick facts

Lead sponsor	Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	33,758
Start date	7 September 2020
Primary completion	1 May 2021
Estimated completion	1 May 2021
Sites	23 locations across Russia

Drugs / interventions tested

• Gam-COVID-Vac — full drug profile →
• placebo

Conditions studied

• Covid19 Prevention — all drugs for Covid19 Prevention →

Sponsor

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Who can join

Adults 18 to 111, any sex, with Covid19 Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia.
   Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, et al · · 2021 · cited 1136× · PMID 33545094 · DOI 10.1016/s0140-6736(21)00234-8
2. Viral targets for vaccines against COVID-19.
   Dai L, Gao GF. · · 2021 · cited 836× · PMID 33340022 · DOI 10.1038/s41577-020-00480-0
3. SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates.
   Kyriakidis NC, López-Cortés A, González EV, Grimaldos AB, et al · · 2021 · cited 507× · PMID 33619260 · DOI 10.1038/s41541-021-00292-w
4. SARS-CoV-2 immunity: review and applications to phase 3 vaccine candidates.
   Poland GA, Ovsyannikova IG, Kennedy RB. · · 2020 · cited 463× · PMID 33065034 · DOI 10.1016/s0140-6736(20)32137-1
5. COVID-19 vaccine development: milestones, lessons and prospects.
   Li M, Wang H, Tian L, Pang Z, et al · · 2022 · cited 298× · PMID 35504917 · DOI 10.1038/s41392-022-00996-y
6. Role of Structural and Non-Structural Proteins and Therapeutic Targets of SARS-CoV-2 for COVID-19.
   Yadav R, Chaudhary JK, Jain N, Chaudhary PK, et al · · 2021 · cited 294× · PMID 33917481 · DOI 10.3390/cells10040821
7. Coronavirus vaccine development: from SARS and MERS to COVID-19.
   Li YD, Chi WY, Su JH, Ferrall L, et al · · 2020 · cited 242× · PMID 33341119 · DOI 10.1186/s12929-020-00695-2
8. COVID-19 vaccines: rapid development, implications, challenges and future prospects.
   Kashte S, Gulbake A, El-Amin Iii SF, Gupta A. · · 2021 · cited 240× · PMID 33677814 · DOI 10.1007/s13577-021-00512-4