The International PfSPZ Consortium (I-PfSPZ-C)
Sanaria Inc. hosted the semi-annual International PfSPZ consortium (I-PfSPZ-C) meeting at Tulane University School of Public Health and Tropical Medicine in New Orleans, on November 1st and 2nd. This meeting was attended by 128 attendees from 43 institutions present in 16 countries, and more joining online from around the world, all to collaborate and strategize regarding Sanaria’s PfSPZ program.
Sanaria’s entire research portfolio was covered throughout the 2-day meeting, discussing the latest results from unpublished and ongoing studies, as well as plans for upcoming trials and strategies, in a highly interactive and communal forum. Much of the discussion centered around Sanaria’s transition to Phase 3 trials in Equatorial Guinea, elsewhere in Africa, and Europe since the results from these trials will be the critical source of clinical data for vaccine licensure in the USA (FDA), Europe (EMA) and Africa (country specific regulatory authorities). A representative from WHO was also present to discuss WHO requirements and processes regarding PfSPZ policy development and recommendations of use after PfSPZ licensure. Further discussion and emphasis was placed on the cluster randomized trial in Equatorial Guinea to demonstrate community effects of PfSPZ Vaccine.
Additionally, the use of PfSPZ Vaccine in malaria elimination campaigns was modeled and discussed in the context of Bioko Island, Equatorial Guinea, where malaria prevalence has plateaued. With the Vice-minister of Health present, operational considerations were discussed with the roll out of mass vaccinations campaigns with PfSPZ Vaccine in conjunction with the government’s standard control intervention strategies and the possibility of eliminating malaria from Bioko Island and expanding into mainland Africa.
Other areas of discussion were other potential versions of PfSPZ Vaccine for licensure, such as PfSPZ-CVac, malaria challenge given with anti-malaria prophylaxis, and PfSPZ-GA1, the genetically attenuated version PfSPZ. Results from the study in PfSPZ Vaccine safety in HIV positive volunteers was reviewed. Further emphasis was put on the need to develop assays that accurately predict T-cells correlated with vaccine efficacy.
Key takeaways from the consortium was the ever-expanding presence of collaborators, partners and institutions contributing to the development of the PfSPZ malaria vaccine. Continued evidence was provided attesting to the safety and tolerability of Sanaria PfSPZ products. Although there are questions that remain to be answered, the pathway forward is clear and steps are being taken to provide a safe, tolerable and efficacious vaccine that could lead us closer to malaria elimination.
