For the desk
Challenge form, antigen, adjuvant, and what this set does not know. Empty cells stay empty. No survival curve was invented to fill them.
Aerosol and systemic counts include programmes tested on both routes. “No challenge” means a human study or a paper that never named a form of plague.
Where plague already lives in animals and people. Cross-checked against deployment, not against a live case feed.
Regional markers, not case coordinates, and not a live outbreak feed. Amber means EV76 is already in use.
Only identifiers this briefing actually holds. The other programmes have no public trial number here.
Reading ClinicalTrials.gov where an NCT exists.
No bioreactor yield and no CDMO. Cold chain is unstated for every candidate, including the RNA ones. −80 °C is not assigned.
| Programme | What is known |
|---|---|
| 03 rF1V + CpG 1018 | DoD rF1V antigen from USAMRIID. Adjuvant CpG 1018. Parenteral. Host, yield, CDMO, and cold chain are not stated. |
| 04 Native F1 + rV in alum | Recombinant V made in E. coli. Native F1 extracted from an attenuated strain. Alum in saline, 15 or 30 µg of each antigen in 1.0 ml. No yield, CDMO, or cold-chain figure. |
| 07 F1 mRNA-LNP — single dose | mRNA in a lipid nanoparticle. Ultra-cold storage is not stated. No host yield or CDMO. |
| 08 Bivalent F1 + LcrV mRNA-LNP | Two mRNAs in lipid nanoparticles, including an Fc design. Ultra-cold storage is not stated. |
| 09 Self-amplifying RNA-LNP, F1 + V | Self-amplifying RNA in lipid nanoparticles. Ultra-cold storage is not stated. |
The other 16 programmes do not name a production host, a formulation, or a plant.
One non-dilutive figure is on the record. No SBIR, DTRA, BARDA, or CEPI identifier is attached to these 21.
0 of 21 report a challenge with a streptomycin-resistant or multidrug-resistant Y. pestis. Imperial’s RNA work used a Madagascar clinical isolate and did not call it resistant.
F1 is the capsule. V is LcrV, the tip of the type III secretion needle. YscF is another needle protein. Pla is not a column: two live strains delete it to weaken the bacterium. It is not an antigen in this set.
| Programme | F1 | V / LcrV | YscF | Whole organism | With anthrax |
|---|---|---|---|---|---|
| 01 EV76-NIIEG | — | — | — | Yes | — |
| 02 PMMM — microencapsulated rF1 + rV | Yes | Yes | — | — | — |
| 03 rF1V + CpG 1018 | Yes | Yes | — | — | — |
| 04 Native F1 + rV in alum | Yes | Yes | — | — | — |
| 05 ChAdOx1 Plague (F1 + V) | Yes | Yes | — | — | — |
| 06 rF1V + flagellin adjuvant | Yes | Yes | — | — | — |
| 07 F1 mRNA-LNP — single dose | Yes | — | — | — | — |
| 08 Bivalent F1 + LcrV mRNA-LNP | Yes | Yes | — | — | — |
| 09 Self-amplifying RNA-LNP, F1 + V | Yes | Yes | — | — | — |
| 10 Ad5-YFV — YscF / F1 / LcrV | Yes | Yes | Yes | — | — |
| 11 CO92 ΔlppΔmsbBΔail / Δpla (LMA, LMP) | — | — | — | Yes | — |
| 12 CO92 Δpgm / ΔpPst · ΔyscN | — | — | — | Yes | — |
| 13 EV76-B-SHUΔpla | — | — | — | Yes | — |
| 14 VTnF1 — oral, single dose | Yes | — | — | — | — |
| 15 Outer-membrane vesicles + modified LPS | — | Yes | — | — | — |
| 16 Salmonella Typhimurium — F1 / Psn / V | Yes | Yes | — | — | — |
| 17 F. tularensis LVS — F1 / LcrV + anthrax PA | Yes | Yes | — | — | Yes |
| 18 Bacteriophage T4 nanoparticle — F1-V + PA | Yes | Yes | — | — | Yes |
| 19 Polyanhydride nanovaccine — rF1V | Yes | Yes | — | — | — |
| 20 DNA fusion vaccine — anthrax / plague | — | — | — | — | Yes |
| 21 Peptidoglycan-free bacterial ghosts | — | — | — | — | — |
People are not challenged with Y. pestis. A US licence for a plague vaccine would use the Animal Rule, 21 CFR 601 Subpart H: animal efficacy, plus a correlate of protection that predicts the human response. This briefing records neither an Animal Rule approval nor a correlate. The only primate aerosol result in the set is the UTMB adenovirus, where every macaque in the reported study survived. That is evidence of the kind the rule asks for. It is not a designation.
The flagellin Phase 1 published peak IgG titers after two 10 microgram doses. Those numbers are immunogenicity, not a protective threshold.
The only contract amount in the set is the US Department of Defense award to Dynavax, about $22 million, announced on 4 October 2021, to run a Phase 2 of rF1V with CpG 1018. That bought development, not a stockpile.
The United States has no FDA-approved plague vaccine, so none of these 21 is a licensed Strategic National Stockpile product. No Project BioShield purchase, CEPI award, or EU HERA procurement is recorded here. EV76 is the one in actual campaigns: laboratory staff and enzootic populations in Russia and Kazakhstan, and Mongolia since 2002.