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NCT06642558
Safety and Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and Above
Phase 1, PHASE2 trial testing Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose) in Respiratory Syncytial Virus (RSV) in 522 participants. Participants enrolled and being followed up; not accepting new ones.
30 June 2025
Quick facts
| Lead sponsor | MAXVAX Biotechnology Limited Liability Company |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 522 |
| Start date | 13 November 2024 |
| Primary completion | 30 June 2025 |
| Estimated completion | 28 February 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose) — full drug profile →
- Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose) — full drug profile →
- Placebo (Saline solution)
Conditions studied
- Respiratory Syncytial Virus (RSV) — all drugs for Respiratory Syncytial Virus (RSV) →
Sponsor
MAXVAX Biotechnology Limited Liability Company — full company profile →
Who can join
18 and older, any sex, with Respiratory Syncytial Virus (RSV). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the safety and immunogenicity of two dose levels of the single dose Recombinant RSV vaccine(CHO cells), when administered intramuscularly (IM) in healthy adults aged 18 years and older.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Respiratory Syncytial Virus (RSV): A Comprehensive Overview From Basic Biology to Clinical Prevention and Control.
Shi J, Huang X, Ye C, Lu Y, et al · · 2026 · PMID 41261734 · DOI 10.1002/med.70025
Verify or expand the search:
- PubMed search for NCT06642558
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Respiratory Syncytial Virus (RSV)
Currently open trials in the same condition.
- NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
- NCT06851806 — Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease · NA · recruiting
- NCT07249320 — Evaluating ABRYSVO Maternal Vaccine Effectiveness Among Infants · active not recruiting
- NCT07272434 — Phase III Clinical Trial of the Recombinant Respiratory Syncytial Virus Vaccine ( CHO Cell) · Phase 3 · recruiting
- NCT07106918 — A Clinical Trial of SIBP-A16 Injection in Healthy Adults · EARLY_PHASE1 · recruiting
Other MAXVAX Biotechnology Limited Liability Company trials
Trials by the same sponsor.
- NCT07492706 — Safety, Tolerability and Immunogenicity of a Maternal Respiratory Syncytial Virus (RSV) Vaccine (MKK900) in Healthy Adul · Phase 1 · not yet recruiting
- NCT07293065 — A Phase III Clinical Trial to Evaluate Long-Term Protective Efficacy of Recombinant Zoster Vaccine (CHO Cell) · Phase 3 · active not recruiting
- NCT07272434 — Phase III Clinical Trial of the Recombinant Respiratory Syncytial Virus Vaccine ( CHO Cell) · Phase 3 · recruiting
- NCT06654700 — Phase III Clinical Trial of Lot-to-lot Consistency of Recombinant Herpes Zoster Vaccine (CHO Cell). · Phase 3 · not yet recruiting
- NCT05856084 — Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above · Phase 2 · active not recruiting
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 NCT06642558 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MAXVAX Biotechnology Limited Liability Company
- Last refreshed: 6 June 2025
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/NCT06642558.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing