NCT05084989: ReCOV

Safety, and Immunogenicity Study of the Recombinant Two-component COVID-19 Vaccine (CHO Cell)

Completed Phase 2 Last updated 29 February 2024

What this trial tests

Phase 2 trial testing Part1:Recombinant two-component COVID-19 vaccine (CHO cell) in COVID-19 in 948 participants. Completed in 9 February 2023.

Timeline

31 January 2022

Primary endpoint
18 August 2022

9 February 2023

Quick facts

Lead sponsor	Jiangsu Rec-Biotechnology Co., Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	948
Start date	31 January 2022
Primary completion	18 August 2022
Estimated completion	9 February 2023
Sites	1 location across Philippines

Drugs / interventions tested

• Part1:Recombinant two-component COVID-19 vaccine (CHO cell) — full drug profile →
• Part1: Placebo
• Part2: Recombinant two-component COVID-19 vaccine (CHO cell) — full drug profile →
• Part2: COVID-19 Vaccine, mRNA — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Jiangsu Rec-Biotechnology Co., Ltd. — full company profile →

Who can join

Adults 18 to 80, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Part 1: Primary Vaccination in Adults Part 1 will evaluate the safety and immunogenicity of the recombinant two component COVID-19 vaccine (CHO cell) (ReCOV for short) in adults aged 18 years and older, when administered as 2 intramuscular doses, 21 days apart.

Part 2: Booster Vaccination in Adults Part 2 will evaluate the immunogenicity and safety and of one booster dose of ReCOV in adult participants who have received primary vaccination with 2 doses of an inactivated COVID-19 vaccine (CoronaVac®). COMIRNATY®, an mRNA COVID-19 vaccine will be used as the active control.

Publications & conference data

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

1. 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
2. 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
3. A Narrative Review of COVID-19 Vaccines.
   Eroglu B, Nuwarda RF, Ramzan I, Kayser V. · · 2021 · cited 38× · PMID 35062723 · DOI 10.3390/vaccines10010062
4. Nanoparticles in clinical trials of COVID-19: An update.
   Rauf A, Abu-Izneid T, Khalil AA, Hafeez N, et al · · 2022 · cited 22× · PMID 35953020 · DOI 10.1016/j.ijsu.2022.106818
5. An overview of current drugs and prophylactic vaccines for coronavirus disease 2019 (COVID-19).
   Alagheband Bahrami A, Azargoonjahromi A, Sadraei S, Aarabi A, et al · · 2022 · cited 18× · PMID 35562685 · DOI 10.1186/s11658-022-00339-3
6. Advanced biopolymeric materials and nanosystems for RNA/DNA vaccines: a review.
   Pereira LFT, Tredus JGR, Corá LO, Novacki LL, et al · · 2024 · cited 2× · PMID 39110059 · DOI 10.1080/17435889.2024.2382077
7. Safety and Immunogenicity of a Recombinant Two-Component SARS-CoV-2 Protein Vaccine: Randomized, Double-Blind, Placebo-Controlled Phase I and Phase II Studies.
   Wynne C, Balgos A, Li J, Hamilton P, et al · · 2024 · cited 1× · PMID 38103161 · DOI 10.1007/s40121-023-00896-w
8. Immunogenicity and safety of boosting with a recombinant two-component SARS-CoV-2 vaccine: two randomized, parallel-controlled, phase 2 studies.
   Balgos A, Hannawi S, Chen WL, Abuquta A, et al · · 2024 · PMID 38529685 · DOI 10.1080/14760584.2024.2334423