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NCT00097396
A Phase 1, Open-Label, Dose-Escalating Study to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant Plague Vaccine rF1V in Healthy Volunteers
Phase 1 trial testing rF1V vaccine in Pneumonic Plague in 40 participants. Completed in 1 September 2006.
1 July 2006
Quick facts
| Lead sponsor | DynPort Vaccine Company LLC, A GDIT Company |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 November 2004 |
| Primary completion | 1 July 2006 |
| Estimated completion | 1 September 2006 |
| Sites | 1 location across United States |
Drugs / interventions tested
- rF1V vaccine — full drug profile →
Conditions studied
- Pneumonic Plague — all drugs for Pneumonic Plague →
- Preventive Therapy — all drugs for Preventive Therapy →
Sponsor
DynPort Vaccine Company LLC, A GDIT Company — full company profile →
Who can join
Adults 18 to 40, any sex, with Pneumonic Plague or Preventive Therapy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- To evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an IM injection at four ascending dose-levels.
Sponsor's own description
The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels. The purpose of the Cohort 4 Extension is to evaluate the safety and tolerability of a third intramuscular (IM) dose of 160 ug rF1V in healthy volunteers who have previously been vaccinated with the same concentration of rF1V vaccine.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Biological threat preparedness through vaccine development and stockpiling: challenges and strategic implications.
Lee J. · · 2025 · cited 1× · PMID 40529698 · DOI 10.3389/fpubh.2025.1614626
Verify or expand the search:
- PubMed search for NCT00097396
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of rF1V vaccine
Trials testing the same drug.
- NCT05506969 — Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine · Phase 2 · 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 NCT00097396 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 DynPort Vaccine Company LLC, A GDIT Company
- Last refreshed: 29 June 2011
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/NCT00097396.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing