PfSPZ-GA1 Malaria Vaccine Description
PfSPZ-GA1 Malaria Vaccine candidate is a Plasmodium falciparum SPZ vaccine attenuated by the deletion of b9 and slarp.
These scientists engineered attenuated PfSPZ by deletion of two genes encoding slarp and b9, each governing independent and critical processes for successful liver-stage development (12). Pf double-knockout (Pf∆b9∆slarp) SPZ were capable of invading primary human hepatocytes in vitro, but arrested growth early after an invasion and were not detected at days 2 to 7 after infection, similar to PfSPZ Vaccine.
Manufacture of aseptic, purified and cryopreserved Pf∆b9∆slarp PfSPZ (Sanaria PfSPZ-GA1 Vaccine) was performed in compliance with Good Manufacturing Practice.
PfSPZ-GA1 Malaria Vaccine Indication
PfSPZ-GA1 Malaria Vaccine candidate is indicated to induce protection against malaria infection. All immunized groups showed a significant increase in antibody titers against PfCSP between pre-immunization and pre-CHMI time points.
PfSPZ-GA1 Malaria Vaccine Dosage
Dosage of PfSPZ-GA1 Malaria Vaccine is being evaluated in ongoing clinical trials.
In the current study, immunization with 4.5 × 105 PfSPZ of PfSPZ Vaccine and PfSPZ-GA1 Vaccine-induced similar anti-PfCSP antibody titers, whereas immunization with 9.0 × 105 PfSPZ of PfSPZ-GA1 Vaccine produced significantly higher anti-PfCSP titers [Fig. 4A; one-way analysis of variance (ANOVA) Tukey post hoc mean difference, 5573; 95% confidence interval (CI), 332 to 30,823; P = 0.04].
PfSPZ-GA1 Malaria Vaccine News
May 20, 2020 - A double-blind, placebo-controlled phase 1/2a trial of the genetically attenuated malaria vaccine PfSPZ-GA1.
April 10, 2019 – Sanaria Inc. and the Government of Equatorial Guinea signed an agreement that continues their joint commitment to develop Sanaria PfSPZ Vaccine as a tool for malaria elimination. This follows a new, broader agreement between the Government of Equatorial Guinea (EG) and industry partners, Marathon Oil Corporation, Noble Energy Inc. and Atlantic Methanol Production Company (AMPCO), to sponsor clinical development of Sanaria® PfSPZ Vaccine, including the Phase 3 clinical program starting in 2020.
November 8, 2017 - Building upon publication of clinical trial results in Nature, PNAS, Lancet Infectious Diseases, and JCI Insight in 2017, Sanaria Inc. is highlighting the work of its many collaborators at a symposium entitled “Moving Toward a PfSPZ Malaria Vaccine for Protecting Travelers and Use in Elimination Campaigns” (session 133) at the 66th meeting of the American Society of Tropical Medicine and Hygiene in Baltimore, and then at the second 2017 International PfSPZ Consortium meeting held at the University of Maryland School of Medicine.
December 1, 2015 - The March Toward Malaria Vaccines.
PfSPZ-GA1 Malaria Vaccine Clinical Trials
Clinical Trial NCT03163121: Safety and Protective Efficacy of Genetically Attenuated PfSPZ-GA1 Vaccine in Healthy Dutch Volunteers
- This is a first-in-human, randomized clinical trial of PfSPZ-GA1 Vaccine (genetically attenuated PfSPZ) in healthy malaria-naïve adult volunteers.
- The administration and efficacy data of the live, injectable, nonreplicating, genetically attenuated PfSPZ, PfSPZ-GA1 Vaccine.
- PfSPZ-GA1 Vaccine was safe and well-tolerated, and no blood-stage infections were observed in 45 volunteers after 97 injections, totaling more than 6 × 107 PfSPZ administered by DVI.
- The PfSPZ-GA1 Vaccine was immunogenic and induced both antibody and CD4+ and CD8+ T cell responses, with a potency analogous to the comparator PfSPZ Vaccine.
- The current trial underscores the clinical potential of genetically attenuated vaccines, boosting further development of such malaria vaccine strategies.