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NCT05408312
Phase I Clinical Trial of GEN2-Recombinant COVID-19 Vaccine (CHO Cells) in Healthy People Aged 18 and Above
Phase 1 trial testing Experimental Vaccine 1 in COVID-19 Pneumonia in 234 participants. Completed in 28 February 2024.
28 February 2024
Quick facts
| Lead sponsor | National Vaccine and Serum Institute, China |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 234 |
| Start date | 18 June 2022 |
| Primary completion | 28 February 2024 |
| Estimated completion | 28 February 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Experimental Vaccine 1 — full drug profile →
- Experimental Vaccine 2 — full drug profile →
- Experimental Vaccine 3 — full drug profile →
- placebo
Conditions studied
- COVID-19 Pneumonia — all drugs for COVID-19 Pneumonia →
Sponsor
National Vaccine and Serum Institute, China
Who can join
18 and older, any sex, with COVID-19 Pneumonia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
phase I study will evaluate the safety and tolerability of GEN2-Recombinant COVID-19 Vaccine (CHO cells) in healthy people aged 18 years and older. A total of 234 subjects were enrolled, of which 126 were enrolled in the 18-59-year-old group, and were randomly assigned to receive experimental vaccine 1, experimental vaccine 2, experimental vaccine 3 and placebo in a ratio of 2:2:2:1; 60- A total of 54 people were enrolled in the 69-year-old and ≥70-year-old groups, and were randomly assigned to receive the experimental vaccine 1 and placebo according to the ratio of 2:1.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05408312
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for COVID-19 Pneumonia
Currently open trials in the same condition.
- NCT06601998 — Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19. · recruiting
- NCT06501599 — AI-based System for Assessing Suspected Viral Pneumonia Related Lung Changes · recruiting
- NCT06402318 — Passive Detection- SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) for Operational Medicine · recruiting
- NCT05765396 — SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies · active not recruiting
- NCT06927622 — Corona Virus Disease 2019 Cohort Study · recruiting
Other National Vaccine and Serum Institute, China trials
Trials by the same sponsor.
- NCT05916326 — Phase III Clinical Trial to Evaluate the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula Polymorpha) · Phase 3 · completed
- NCT04941261 — Clinical Trial to Evaluate the Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenula Polymorpha) · Phase 2 · unknown
- NCT04869592 — A Clinical Trial to Evaluate the Recombinant SARS-CoV-2 Vaccine (CHO Cell) for COVID-19 · Phase 1, PHASE2 · completed
- NCT04436133 — Immunogenicity AND Safety Study of the 11 Valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) · Phase 2 · completed
- NCT04188691 — A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05408312 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Vaccine and Serum Institute, China
- Last refreshed: 16 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05408312.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing