A Unique Public-Private Partnership to Eradicate Malaria in Equatorial Guinea: Part 2 of the ASTMH Blog Series

One example of the ability of public-private partnerships to establish and strengthen research capacity is the Equatorial Guinea Malaria Initiative (EGMVI), which began within the larger Bioko Island Malaria Control Project (BIMCP). Last year, the two were combined into the Bioko Island Malaria Elimination Project (BIMEP). Dr Stephen Hoffman from Sanaria, Inc. shared details of the BIMEP with us at FHI Clinical’s ASTMH dinner event. FHI Clinical has also had the privilege of being involved in studies conducted by the EGMVI (now BIMEP).

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Below is a brief history about how the BIMEP team evolved from the two original organizations.

BIMCP

The BIMCP was established in 2003 by a consortium of the Government of Equatorial Guinea (EG) and nonprofit, public and academic organizations to fund local malaria control efforts and reduce malaria- related morbidity and mortality. From 2004 to 2018, the project focused on control interventions — indoor residual spraying, long-lasting insecticide-treated nets, improved diagnosis and treatment, a focus on pregnant women, better antenatal care, communication strategies for behavior change within communities, community outreach, comprehensive monitoring and evaluation, capacity building and institutional development to transfer management to the National Malaria Control Program.

By 2016, malaria transmission was reduced by nearly 76% among children 2-14 years old, with all-cause mortality reduced by 64% in children <5 years old. Parasite prevalence was also reduced by 81%, from 45% in 2004 to 8.5% in 2016, with elimination of one of the three main malaria vector species (Anopheles funestus). However, the rate of success plateaued — an additional malaria control tool was needed.

EGMVI
To achieve further significant reductions in malaria transmission, a vaccine would be needed. However, EG lacked the infrastructure to conduct clinical trials of potential vaccines. That is where the EGMVI came in. Starting in 2012, the Government of EG and Sanaria partnered to evaluate the feasibility and desirability of conducting the first-ever clinical trial in EG to establish the safety, tolerability, immunogenicity and protective efficacy of a Sanaria sporozoite-based malaria vaccine.
Sanaria, a biotechnology company, is developing vaccines that have been shown to be highly protective against preventing Plasmodium falciparum infection to humans. Their innovative approach uses P. falciparum (Pf) sporozoites (SPZ) as the platform technology. Their lead candidate, PfSPZ Vaccine, had recently been evaluated by the Ifakara Health Institute in Tanzania and was a promising vaccine option for EG.

Following their evaluation of the feasibility and desirability for clinical trials, the Government of EG authorized funding for a series of clinical trials to evaluate Sanaria’s PfSPZ Vaccine. The BIMCP consortium provided financing, and a vaccine implementation team was established, including local Equatoguineans, personnel from Ifakara Health Institute, Sanaria and La Paz Malabo Medical Center in Malabo, EG.

Their challenge was to build research capacity to prepare for the first-ever clinical trial in the country: establish a National Ethics Committee (Comité Ético Nacional de Guinea Ecuatorial – CENGE), engage regulatory authorities to review and approve the importation of the vaccine for research purposes and train a team of Equatoguinean nationals to conduct clinical trials.

EG successfully overcame these challenges preparing for its first-ever clinical trial and has since conducted multiple clinical trials, including a phase 2 clinical trial for which we provided data and site monitoring support. A phase 3 clinical trial will begin this year with the aim of submitting data to US and European regulatory agencies for licensing. FHI Clinical is proud to be providing on-site and remote data monitoring, training and additional site support during these trials — helping to eradicate a disease that is highly prevalent and a significant cause of mortality in EG — and all of Africa.

To date, there have been no serious adverse events (SAEs) worldwide for the more than 1,600 research subjects, ranging in age from infants to the elderly, who have been administered the PfSPZ Vaccine in more than 19 different clinical trials in the US, Europe and 6 African countries.
BIMEP
The combination of BIMCP and EGMVI into BIMEP has led to the establishment of two goals. The first is to eliminate malaria from Bioko Island, including EG’s capital city Malabo, and then to eliminate malaria from mainland EG, where the malaria prevalence has increased since 2015. An impressive list of implementation partners are participating in this project: the Ministry of Health and Social Welfare and the Ministry of Mines and Hydrocarbons (Republic of Equatorial Guinea), Sanaria, Inc., Ifakara Health Institute, Swiss TPH, London School of Hygiene and Tropical Medicine, Liverpool School of Tropical Medicine, Texas A&M University, George Mason University Department of Global and Community Health, University of Washington School of Medicine, University of Washington Institute for Health Metrics and Evaluation, and University of Southern Maine Department of Computer Science.
The BIMEP team’s efforts to achieve its ambitious goals resulted in it winning the 2019 Concordia P3 Impact Award and the 2019 Audience Choice Award.

FHI Clinical thanks Dr Hoffman for sharing his experiences during ASTMH.

For more than 10 years, the FHI Clinical project team has partnered with companies developing and deploying vaccines, treatments and preventive devices for malaria in more than 30 countries worldwide. Learn more.

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