# NIH grant: New cryovials with integral septum for cryopreservation of PfSPZ vaccine and PfSPZ challenge products. (1SB1AI195021-01) — retained record

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NIH grant 1SB1AI195021-01: New cryovials with integral septum for cryopreservation of PfSPZ vaccine and PfSPZ challenge products.
Institute: {'code': 'AI', 'abbreviation': 'NIAID', 'name': 'National Institute of Allergy and Infectious Diseases', 'admin_org_id': '12500003', 'admin_funding_url': ''}. PI: STEPHEN LEV HOFFMAN. Award: $1000000.
Start: 2026-09-18T00:00:00.
ABSTRACT
Sanaria's mission is to produce, license and market Plasmodium falciparum (Pf) sporozoite (SPZ) vaccines
against malaria that prevent malaria infection and transmission in individuals, including travelers, and can be
used in malaria elimination programs. The goal of this proposal is the production of new cryovials for PfSPZ to
facilitate the mission. Despite annual investments of >$4B in malaria control, malaria killed more people
annually in Africa in 2020-2023 than did COVID-19. In 2023 there were 263M clinical cases and 597,000
deaths caused by malaria worldwide. RTS,S/ AS01 malaria vaccine was recommended in 2021 by WHO on
the basis of preventing hospitalizations (17%), severe malaria (32%), and deaths (9%) in a pilot
implementation program. R21, a biosimilar, is considered by WHO to provide similar protection. These existing
tools are inadequate: there is an urgent need for a vaccine with high vaccine efficacy (VE) that prevents
malaria infection to support malaria elimination. Our 1st generation radiation-attenuated vaccine, Sanaria®
PfSPZ Vaccine, was safe and well tolerated in 5-month- to 61-year-olds in 21 clinical trials in 9 countries, 6 in
Africa. It induced 92%-100% VE against controlled human malaria infection and significant VE against intense
Pf transmission in field trials in Africa for at least 18-21 months without boosting, including in women who
became pregnant. Sanaria's 2nd generation chemo-attenuated vaccine, PfSPZ-CVac, is 5-8 times more potent
than PfSPZ Vaccine, but has safety issues. Sanaria's 3rd generation genetically attenuated vaccine, PfSPZ-
LARC2 Vaccine, is expected to be safe and 5-10 times more potent and less expensive than PfSPZ Vaccine.
Final steps in manufacturing of all PfSPZ vaccines are addition of final product to vials and cryopreservation.
PfSPZ products are vialed in screwcap cryovials. Post-thaw handling of screwcap cryovials for dilution and
preparation of syringes must occur in an aseptic environment like a biological safety cabinet. This is not
suitable nor acceptable for a commercialized malaria vaccine. No available cryovial meets specifications for
PfSPZ products. We designed a novel cryovial that, like standard vaccine vials, has a septum, enabling use
anywhere, and that can be stored at cryogenic temperatures. For a previous version of this vial, we
successfully filed a patent application, submitted a Drug Master File (for vials) to FDA, filled vials with vaccine
and initiated clinical trials. However, the vials produced for us by SiO2 Materials Science had a particulates
problem unacceptable to FDA and were associated with less infectious/potent PfSPZ than PfSPZ in screwcap
vials (discovered in clinical trials). SiO2 filed for bankruptcy and is no longer involved. In this project we will
work with both primary and back-up companies, incorporate design improvements, manufacture vials and caps
that do not have a particulates problem and support PfSPZ potency like current screwcap vials. With critical
funding not typically supported by Phase II/IIB grants, this CRPP grant will facilitate development, production,
and use of the integral septum cryovials needed for saving lives of those at risk of malaria.
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