NCT04780035

Study of the Tolerability, Safety, Immunogenicity and Preventive Efficacy of the EpiVacCorona Vaccine for the Prevention of COVID-19

Completed Phase 3 Last updated 16 March 2022

What this trial tests

Phase 3 trial testing EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) in COVID-19 in 3,000 participants. Completed in 20 December 2021.

Timeline

27 November 2020

Primary endpoint
31 August 2021

20 December 2021

Quick facts

Lead sponsor	Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	3,000
Start date	27 November 2020
Primary completion	31 August 2021
Estimated completion	20 December 2021
Sites	8 locations across Russia

Drugs / interventions tested

• EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) — full drug profile →
• Placebo (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections)

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" — full company profile →

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of the clinical study is to evaluate the tolerability, safety, immunogenicity and prophylactic efficacy of the EpiVacCorona vaccine in volunteers aged 18 and above.

The study tasks are to:

* evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly;
* evaluate the tolerability of the EpiVacCorona vaccine when administered twice intramuscularly;
* identify any adverse events to the administration of the EpiVacCorona vaccine;
* investigate the humoral immune response following two doses of the EpiVacCorona vaccine;
* investigate the cell-mediated immune response following two doses of the EpiVacCorona vaccine;
* evaluate the prophylactic efficacy of the EpiVacCorona vaccine when administered twice intramuscularly.

Publications & conference data

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

1. Progress of the COVID-19 vaccine effort: viruses, vaccines and variants versus efficacy, effectiveness and escape.
   Tregoning JS, Flight KE, Higham SL, Wang Z, et al · · 2021 · cited 827× · PMID 34373623 · DOI 10.1038/s41577-021-00592-1
2. 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
3. Efficacy and safety of COVID-19 vaccines.
   Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
4. COVID-19: Unmasking Emerging SARS-CoV-2 Variants, Vaccines and Therapeutic Strategies.
   Raman R, Patel KJ, Ranjan K. · · 2021 · cited 139× · PMID 34356617 · DOI 10.3390/biom11070993
5. An overview of current COVID-19 vaccine platforms.
   Nagy A, Alhatlani B. · · 2021 · cited 113× · PMID 33936564 · DOI 10.1016/j.csbj.2021.04.061
6. The impact of spike mutated variants of SARS-CoV2 [Alpha, Beta, Gamma, Delta, and Lambda] on the efficacy of subunit recombinant vaccines.
   Mohammadi M, Shayestehpour M, Mirzaei H. · · 2021 · cited 99× · PMID 34428473 · DOI 10.1016/j.bjid.2021.101606
7. Mini-Review Discussing the Reliability and Efficiency of COVID-19 Vaccines.
   Doroftei B, Ciobica A, Ilie OD, Maftei R, et al · · 2021 · cited 93× · PMID 33804914 · DOI 10.3390/diagnostics11040579
8. COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials.
   Yan ZP, Yang M, Lai CL. · · 2021 · cited 89× · PMID 33923054 · DOI 10.3390/ph14050406