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 Stage III of the Equatorial Guinea Malaria Vaccine Initiative (EGMVI). The objective of the EGMVI is 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.

MCDI and its partners are currently in Phase III of the EGMVI. 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 is currently underway (February 2017), and will be the first clinical trial in Africa to compare Sanaria’s two candidate vaccines in adult subjects. This will be followed by a phase three efficacy trial on an estimate 3000 subjects beginning in 2018.


Should a licensed highly effective PfSPZ vaccine come on the market, the objective is to include the vaccine along with standard control measures to demonstrate that it is possible to eliminate malaria from Bioko Island and then other highly endemic areas such as the continental region of Equatorial Guinea.


Visit the EGMVI website