NCT04904471

A Global Phase III Clinical Trial of Recombinant COVID- 19 Vaccine (Sf9 Cells)

Completed Phase 3 Last updated 26 March 2025

What this trial tests

Phase 3 trial testing Recombinant COVID-19 vaccine (Sf9 cells) in COVID-19 in 39,663 participants. Completed in 1 November 2023.

Timeline

15 June 2021

Primary endpoint
31 January 2022

1 November 2023

Quick facts

Lead sponsor	WestVac Biopharma Co., Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	39,663
Start date	15 June 2021
Primary completion	31 January 2022
Estimated completion	1 November 2023
Sites	24 locations across Indonesia, Mexico, Philippines, Kenya, Nepal

Drugs / interventions tested

• Recombinant COVID-19 vaccine (Sf9 cells) — full drug profile →
• Placebo control

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

WestVac Biopharma Co., Ltd. — 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

This Phase III study is a global multicenter, randomized, double-blind,placebo controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of therecombinant COVID-19 vaccine (Sf9 cells) in 40,000 participants aged 18 years and older who do not have a known history of SARS-CoV-2 infection but whose locations or circumstances put them at appreciable risk of acquiring COVID-19 or SARS-CoV-2 infection.

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. Scientific rationale for developing potent RBD-based vaccines targeting COVID-19.
   Kleanthous H, Silverman JM, Makar KW, Yoon IK, et al · · 2021 · cited 118× · PMID 34711846 · DOI 10.1038/s41541-021-00393-6
4. A comprehensive review on COVID-19 vaccines: development, effectiveness, adverse effects, distribution and challenges.
   Rahman MM, Masum MHU, Wajed S, Talukder A. · · 2022 · cited 74× · PMID 35127995 · DOI 10.1007/s13337-022-00755-1
5. Vaccines for COVID-19: A Systematic Review of Immunogenicity, Current Development, and Future Prospects.
   Zhang Z, Shen Q, Chang H. · · 2022 · cited 44× · PMID 35572592 · DOI 10.3389/fimmu.2022.843928
6. A Narrative Review of COVID-19 Vaccines.
   Eroglu B, Nuwarda RF, Ramzan I, Kayser V. · · 2021 · cited 38× · PMID 35062723 · DOI 10.3390/vaccines10010062
7. 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
8. Counting on COVID-19 Vaccine: Insights into the Current Strategies, Progress and Future Challenges.
   Kandimalla R, Chakraborty P, Vallamkondu J, Chaudhary A, et al · · 2021 · cited 19× · PMID 34829969 · DOI 10.3390/biomedicines9111740