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NCT05420077

Safety and Immunogenicity of RVM-V001 in Healthy Individuals Previously Vaccinated With BNT162b2 and mRNA-1273

Terminated Phase 1 Last updated 27 June 2023
What this trial tests

Phase 1 trial testing RVM-V001 10 µg in Infectious Disease in 13 participants. Terminated before completion.

Timeline
12 September 2022
Primary endpoint
2 June 2023
2 June 2023

Quick facts

Lead sponsorRVAC Medicines (US), Inc.
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingnone
Primary purposeprevention
Enrollment13
Start date12 September 2022
Primary completion2 June 2023
Estimated completion2 June 2023
Sites2 locations across Australia

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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:

Other recruiting trials for Infectious Disease

Currently open trials in the same condition.

Other RVAC Medicines (US), Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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