Plague Pipeline

Needle- and adjuvant-free; 100% of macaques survived aerosol challenge

University of Texas Medical Branch, Galveston National Laboratory. A human adenovirus 5 vector that carries three antigens at once: YscF, a protein from the needle of the type III secretion system, plus F1 and LcrV. The construct is described as needle-free and adjuvant-free. In the reported study, every macaque challenged by aerosol survived. The briefing dates the work to 2016–2021. It is not in human trials here.

Stage chart

Preclinical

Phase 1

Phase 2

Phase 3

Licensed

Preclinical · primates. Phase 3 is empty here, as it is for every programme in the set.

Years on the record

2016–2021. Labelled “2016–2021” on the briefing. Not a forecast.

Analyst card

Challenge: Aerosol challenge in macaques. That is a pneumonic model. Bubonic challenge is not the result cited here.
F1-negative strains: Not reported as its own arm. YscF, F1, and LcrV are all in the vector.
Adjuvant: None. Adenovirus 5 is the delivery.
Route: Described as needle-free.
Stability: Formulation and cold-chain requirement are not stated.
Time to protection: Not reported. No time-to-protection figure is in the briefing.
Other threats: Plague only.
Survival figure: Every macaque in the reported aerosol study survived. Group size and challenge dose are not restated here.
Animal Rule: A primate aerosol survival study is the kind of evidence 21 CFR 601 Subpart H asks for. This briefing does not record an FDA Animal Rule designation or a correlate of protection.

Pipeline record

Lab: University of Texas Medical Branch, Galveston National Laboratory.
Vector: Human adenovirus 5 expressing three antigens: YscF from the type III secretion needle, plus F1 and LcrV.
Delivery: Described as needle-free and adjuvant-free.
Evidence: In the reported study, every macaque challenged by aerosol survived. Dated 2016–2021. Not in human trials in this set.

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Platform: Viral vector
A virus that does not cause plague carries genes for plague antigens. One candidate uses ChAdOx1, the same chimpanzee adenovirus as Oxford's COVID-19 vaccine. Another is an adenovirus construct still in primates.
Who is paying: US — UTMB Galveston National Laboratory
Country: United States
What was tested: Primates · aerosol
Stage: Preclinical · primates
Date: 2016–2021
Antigens named: YscFF1V / LcrV