The Equatoguinean Malaria Vaccine Initiative: From the Launching of a Clinical Research Platform to Malaria Elimination Planning in Central West Africa.

Fifteen years of investment in malaria control on Bioko Island, Equatorial Guinea (EG), dramatically reduced malaria-associated morbidity and mortality, but the impact has plateaued. To progress toward elimination, EG is investing in the development of a malaria vaccine. We assessed the unique public-private partnership that has had such a significant impact on malaria on Bioko Island and now added a major effort on malaria vaccine development. As part of a $79M commitment, the EG government (75%) and three American energy companies (25%) have invested since 2012 greater than $55M in the Equatoguinean Malaria Vaccine Initiative (EGMVI) to support clinical development of Sanaria® PfSPZ vaccines (Sanaria Inc., Rockville, MD). In turn, the vaccine development program is building human capital and physical capacity. The EGMVI established regulatory and ethical oversight to ensure compliance with the International Conference on Harmonization and Good Clinical Practices for the first importation of investigational product, ethical approval, and conduct of a clinical trial in Equatoguinean history. The EGMVI has completed three vaccine trials in EG, two vaccine trials in Tanzania, and a malaria incidence study, and initiated preparations for a 2,100-volunteer clinical trial. Personnel are training for advanced degrees abroad and have been trained in Good Clinical Practices and protocol-specific methods. A new facility has established the foundation for a national research institute. Biomedical research and development within this visionary, ambitious public-private partnership is fostering major improvements in EG. The EGMVI plans to use a PfSPZ Vaccine alongside standard malaria control interventions to eliminate Pf malaria from Bioko, becoming a potential model for elimination campaigns elsewhere.

Advancing Global Health through Development and Clinical Trials Partnerships: A Randomized, Placebo-Controlled, Double-Blind Assessment of Safety, Tolerability, and Immunogenicity of PfSPZ Vaccine for Malaria in Healthy Equatoguinean Men.

Equatorial Guinea (EG) has implemented a successful malaria control program on Bioko Island. A highly effective vaccine would be an ideal complement to this effort and could lead to halting transmission and eliminating malaria. Sanaria® PfSPZ Vaccine (Plasmodium falciparum sporozoite Vaccine) is being developed for this purpose. To begin the process of establishing the efficacy of and implementing a PfSPZ Vaccine mass vaccination program in EG, we decided to conduct a series of clinical trials of PfSPZ Vaccine on Bioko Island. Because no clinical trial had ever been conducted in EG, we first successfully established the ethical, regulatory, quality, and clinical foundation for conducting trials. We now report the safety, tolerability, and immunogenicity results of the first clinical trial in the history of the country. Thirty adult males were randomized in the ratio 2:1 to receive three doses of 2.7 × 105 PfSPZ of PfSPZ Vaccine (N = 20) or normal saline placebo (N = 10) by direct venous inoculation at 8-week intervals. The vaccine was safe and well tolerated. Seventy percent, 65%, and 45% of vaccinees developed antibodies to Plasmodium falciparum (Pf) circumsporozoite protein (PfCSP) by enzyme-linked immunosorbent assay, PfSPZ by automated immunofluorescence assay, and PfSPZ by inhibition of sporozoite invasion assay, respectively. Antibody responses were significantly lower than responses in U.S. adults who received the same dosage regimen, but not significantly different than responses in young adult Malians. Based on these results, a clinical trial enrolling 135 subjects aged 6 months to 65 years has been initiated in EG; it includes PfSPZ Vaccine and first assessment in Africa of PfSPZ-CVac. ClinicalTrials.gov identifier: NCT02418962.

Impact of military conflict on a civilian receiving hospital in a war zone.

OBJECTIVE: To study the impact of war on the workload/finances of a community hospital adjacent to the front. SUMMARY BACKGROUND DATA: Community hospitals located nearby/within military conflict zones treat trauma casualties while providing routine surgical services to the community. METHODS: Observational study conducted in Ziv hospital (1 of 3 designated receiving hospitals during the second Lebanon War (12/7/2006-14/8/2006). Data were documented in real-time and retrieved retrospectively from computerized databases. RESULTS: Ziv treated 1509 military/civilian casualties. Seven percent were at least moderately injured. 27.5% of the casualties required admission, preferentially to surgical wards. Critical mortality rate was 7%. There were 48 secondary transfers, half from the department of emergency medicine (ED) and half after in-hospital stabilization/emergency surgery including 7 to free intensive care (ICU) beds to accommodate expected casualties. The General Surgery department (GSD) performed 81 operating room (OR) procedures, including explorations/debridements for casualties (n = 24, 0-3 per-day), laparotomies for acute abdomen (n = 33) and cancer surgery (n = 11).Compared with previous/later years, there were 23% more trauma casualties presenting to the ED and an increased OR workload for Orthopedic surgery. Decreases occurred in the number of elective and emergency admissions (10%), obstetric deliveries (28%), OR procedures (33%), GSD OR procedures (44%), hospital revenues (up to 43%), yearly hospitalization days (7%), number of hospitalized patients, bed occupancy rates, and visits to outpatient clinics (all 5%). CONCLUSIONS: Treatment of civilian/military casualties resulted in reorganization of hospital operations with significantly decreased accrued revenue. The bulk of the GSD workload shifts from the OR to the ED/wards while Orthopedic procedures and ICU beds become bottlenecks to patient flow during war.