Plague Pipeline

Phase 2a n=240; Phase 2b two-regimen trial

Native F1 plus recombinant V, adsorbed on alum. Run by the Lanzhou Institute of Biological Products with the Jiangsu CDC. A Phase 2a enrolled about 240 people, and a Phase 2b is comparing two regimens. It is in humans and is not a marketed product in this briefing. Lanzhou sits inside China National Biotec Group, part of the unlisted state parent. Hong Kong-listed Sinopharm Group (1099) is a distributor, not the maker.

Stage chart

Preclinical

Phase 1

Phase 2

Phase 3

Licensed

Phase 2a → Phase 2b. Phase 3 is empty here, as it is for every programme in the set.

Years on the record

2014–2026. Labelled “2014–now” on the briefing. Not a forecast.

Analyst card

Challenge: Human immunogenicity and safety. No challenge form is in the trial records used here.
F1-negative strains: Not reported. Native F1 and recombinant V are both in the shot.
Adjuvant: Aluminium hydroxide.
Route: Intramuscular, deltoid. Phase 2b uses 30 µg of each antigen in 1.0 ml.
Stability: Liquid in saline. Thermostability is not stated.
Time to protection: Antibodies were still up at month 12 in the Phase 2a. Days-to-protection is not reported.
Other threats: Plague only.
Survival figure: No challenge survival figure. Phase 2a compared 15 µg and 30 µg. The higher dose raised more antibody.
Animal Rule: Chinese clinical development. Not an FDA Animal Rule file.

Pipeline record

What is in it: Native F1, extracted from a live attenuated Y. pestis strain, plus recombinant V made in E. coli, mixed 1:1 in saline and adsorbed on alum.
Doses tested: 15 µg or 30 µg of each antigen, in 1.0 ml. In the Phase 2a, 30 µg raised higher antibodies than 15 µg, and both were still up at month 12.
Phase 1: ChiCTR-ONRC-13003766, registered 7 November 2013. Single centre, healthy adults 18 to 55. Lanzhou made it; Jiangsu CDC led the clinical work.
Phase 2b: CTR20200846. Target 720 adults aged 18 to 55. Two schedules, months 0/1/6 and 0/2/6, each dose 30 µg of F1 and 30 µg of V, injected into the deltoid.
Where it sits: Lanzhou Institute of Biological Products, 888 Yanchang Road. Inside unlisted China National Biotec Group. Hong Kong 1099 is not this vaccine.

Registries

ChiCTR-ONRC-13003766 · ChiCTR · Lanzhou Phase 1Registered 7 November 2013. Single centre. Adults 18 to 55. Native F1 plus recombinant V. Safety and tolerability.
CTR20200846 · Chinese clinical trial registry · Lanzhou Phase 2bTarget 720 adults aged 18 to 55. Schedules at months 0/1/6 and 0/2/6. Each dose is 30 µg F1 and 30 µg V in 1.0 ml, into the deltoid. No stable English protocol URL is attached here.

News

Checking today’s headlines.

Latest intel

Checking Europe PMC.

PubMed

Checking today’s index.

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: China — Lanzhou Inst. Biological Products + Jiangsu CDC
Listed company: None. Lanzhou Institute of Biological Products sits inside China National Biotec Group, part of the state Sinopharm parent. That parent is not quoted. Hong Kong-listed Sinopharm Group (1099) distributes medicines; it does not make this vaccine.
Country: China
What was tested: Human · Phase 2
Stage: Phase 2a → Phase 2b
Date: 2014–now
Antigens named: F1V / LcrV