Plague Pipeline

TLR5-ligand adjuvanted F1/V fusion protein

An NIH / NIAID programme. Flagellin, a bacterial protein that triggers TLR5, is fused to F1 and V and given as two intramuscular doses. The Phase 1 trial NCT01381744 ran from 2012 to 2014 and found dose-dependent antibodies and no vaccine-related serious adverse events. The briefing still files it as Phase 1. It is not licensed, and no company owns it.

Stage chart

Preclinical

Phase 1

Phase 2

Phase 3

Licensed

Phase 1. Phase 3 is empty here, as it is for every programme in the set.

Years on the record

2009–2026. Labelled “2009–now” on the briefing. Not a forecast.

Analyst card

Challenge: Designed for pneumonic plague. The Phase 1 measured antibodies, not protection after challenge.
F1-negative strains: Not reported. F1 and V are both in the fusion.
Adjuvant: Flagellin, a TLR5 agonist, fused to the antigens.
Route: Intramuscular on day 0 and day 28. Doses of 1, 3, 6, or 10 micrograms.
Stability: Liquid in phosphate-buffered saline, pH 6.2.
Time to protection: Antibodies were measured over 13 months. Time-to-protection is not reported.
Other threats: Plague only.
Survival figure: No challenge. After two 10 µg doses, peak anti-F1 IgG was 260 and anti-V IgG was 984 in the 2017 paper. Those are titers, not a correlate of protection.
Animal Rule: No FDA Animal Rule designation is recorded. Human plague challenge is not done; a US licence would need animal efficacy under 21 CFR 601 Subpart H, plus a correlate of protection. Neither is established here.

Pipeline record

Product: Flagellin fused to F1 and V, in phosphate-buffered saline at pH 6.2. Flagellin triggers TLR5.
Trial: NCT01381744, also called DMID 08-0066. Sponsor: NIAID. Phase 1, randomised, placebo-controlled, dose escalation.
Regimen: 1, 3, 6, or 10 micrograms, intramuscularly on day 0 and day 28. Aimed at pneumonic plague.
What happened: The registry lists 48 people; the 2017 paper reports 60 enrolled. No vaccine-related serious adverse events. Antibodies to F1 and V rose with dose. The authors said higher doses might be worth testing. Ran from February 2012 to August 2014.
Where it stopped: The briefing still files it as Phase 1. No later licence appears in this set, and no company is named as the owner.

Registries

NCT01381744 · ClinicalTrials.gov · Flagellin/F1/V dose escalationPhase 1. NIAID, DMID 08-0066. February 2012 to August 2014. Registry enrollment 48. Intramuscular on day 0 and day 28, at 1, 3, 6, or 10 µg.

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Platform: Subunit
Purified pieces of the bacterium — here, usually capsule antigen F1 and the V antigen, LcrV — instead of a living organism. This is the only platform in the set with a new marketing authorisation.
Who is paying: US — NIH / NIAID
Country: United States
What was tested: Human · Phase 1
Stage: Phase 1
Date: 2009–now
Antigens named: F1V / LcrV