Malaria Control and Elimination - Malaria Vaccine Trials

Background

MCDI and partners Sanaria Inc., Ifakara Health Institute (IHI) and Swiss Tropical and Public Health Institute (SwissTPH), are currently implementing the vaccine component of the Bioko Island Elimination Project (BIMEP), which was preceeded by the Equatoguinean Malari Vaccine Initiative (EGMVI, 2013-2018). The objective of the EGMVI was to carry out a series of clinical trials of new candidate whole sporozoite malaria vaccines manufactured by Sanaria, the PfSPZ Vaccine and PfSPZ C-Vac. The first stage of the EGMVI involved educating the Government of Equatorial Guinea about the prospects of the PfSPZ Vaccine and the potential benefits and risks of participating in clinical trials for this product. Because no clinical trials had ever been conducted in Equatorial Guinea, MCDI and Sanaria engaged WHO, WHO-AFRO, the IHI, SwissTPH, the Ministry of Health of Mali and others in providing the Government of Equatorial Guinea with an opportunity to learn firsthand what would be involved and required to participate in clinical trials for the PfSPZ Vaccine. Based on the information and guidance obtained during Stage I, the Government of Equatorial Guinea committed to providing considerable financial support for conducting a series of clinical trials on Bioko Island with the operational support of MCDI.


The second stage of the EGMVI involved establishing the pre-requisites necessary for conducting clinical trials in EG including:

  • Providing technical assistance for the establishment of a first Ethics Committee in Equatorial Guinea,
  • Providing technical assistance to a newly constituted drug regulatory authority to review and authorize the importation of the vaccine;
  • Selection and training of five local staff to work on the first clinical trial
  • Formulation and approval of a study protocol for the first trial
  • Procurement and set-up of all laboratory and clinical equipment needed to carry-out the trial.

Phase III of the EGMVI involved the first ever clinical trial of 33 health adult male adult subjects between the ages of 18 and 35 years to evaluate the safety of the PfSPZ Vaccine was successfully completed in January of 2016. A second trial involving approximately 130 subjects ranging from 6 months to 65 years of age was completed in 2017, and was the first clinical trial in Africa to compare Sanaria’s two candidate vaccines in adult subjects. The phase III efficacy trial on an estimated 3000 subjects occurred in 2018.


In 2019, the Bioko Island Malaria Control Program (BIMCP) merged with the EGMVI to form the Bioko Island Malaria Elimination Project (BIMEP). The objective of the BIMEP is to develop and implement a realistic, evidence-based program for malaria elimination for Bioko Island.


The main activities of the BIMEP include:

  • Continuation of the highly effective vector control, surveillance, case management, and social behavior change communication activities of the BIMCP
  • Implementation of a Phase 3 trial to support licensure of the PfSPZ vaccine (beginning January 2020)
  • Implementation of a Phase 4 trial aimed at measuring public health impact of mass vaccination in combination with optimized malaria control program, measured by a cluster randomized trial of the island
  • Island-wide immunization, using a step-wedge approach that will evolve into a full implementation and control program
  • Vaccination program established to protect travelers from the mainland of Equatorial Guinea who travel to Bioko Island, reducing malaria importation
  • Establishing an ongoing surveillance program to flag imported malaria cases