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NCT05420077
Safety and Immunogenicity of RVM-V001 in Healthy Individuals Previously Vaccinated With BNT162b2 and mRNA-1273
Phase 1 trial testing RVM-V001 10 µg in Infectious Disease in 13 participants. Terminated before completion.
2 June 2023
Quick facts
| Lead sponsor | RVAC Medicines (US), Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 13 |
| Start date | 12 September 2022 |
| Primary completion | 2 June 2023 |
| Estimated completion | 2 June 2023 |
| Sites | 2 locations across Australia |
Drugs / interventions tested
- RVM-V001 10 µg — full drug profile →
- RVM-V001 30 µg — full drug profile →
- RVM-V001 60 µg — full drug profile →
Conditions studied
- Infectious Disease — all drugs for Infectious Disease →
- COVID-19 — all drugs for COVID-19 →
Sponsor
RVAC Medicines (US), Inc. — full company profile →
Who can join
Adults 18 to 65, any sex, with Infectious Disease or COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phase 1, open-label, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of RVM-V001 administered as a single intramuscular injection in healthy adults. Three dose levels will be evaluated, with progression from low- to high-dose level based on the assessment of safety and tolerability. The study will be conducted at one or more sites in Australia.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
mRNA vaccines: A novel weapon to control infectious diseases.
Tian Y, Deng Z, Yang P. · · 2022 · cited 14× · PMID 36267192 · DOI 10.3389/fmicb.2022.1008684 -
Race with virus evolution: The development and application of mRNA vaccines against SARS-CoV-2.
Lee KM, Lin SJ, Wu CJ, Kuo RL. · · 2023 · cited 9× · PMID 36642222 · DOI 10.1016/j.bj.2023.01.002 -
Research progress of mRNA vaccines for infectious diseases.
Zhang Z, Du J, Zhang D, Han R, et al · · 2025 · cited 5× · PMID 40847375 · DOI 10.1186/s40001-025-03060-x -
Comparative analysis of the effectiveness difference of SARS-COV-2 mRNA vaccine in different populations in the real world: A review.
Cai S, Chang C, Zhang X, Qiao W. · · 2023 · cited 4× · PMID 37653835 · DOI 10.1097/md.0000000000034805
Verify or expand the search:
- PubMed search for NCT05420077
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Infectious Disease
Currently open trials in the same condition.
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- NCT07069400 — An International Observational Study of Adults With Acute Infection · recruiting
- NCT06422338 — A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients) · NA · recruiting
- NCT06510699 — Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial · Phase 2 · recruiting
- NCT05972772 — Rickettsia Clearance Study · Phase 2, PHASE3 · recruiting
Other RVAC Medicines (US), Inc. trials
Trials by the same sponsor.
- NCT05788185 — Safety & Immunogenicity of RVM-V001/RVM-V002 or RVMV001+RVMV002 (Co Administered as Separate Injections) in Healthy Indi · Phase 1, PHASE2 · terminated
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 NCT05420077 (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 RVAC Medicines (US), Inc.
- Last refreshed: 27 June 2023
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/NCT05420077.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing