Implementing an Ebola Vaccine Study - Sierra Leone.

In October 2014, the College of Medicine and Allied Health Sciences of the University of Sierra Leone, the Sierra Leone Ministry of Health and Sanitation, and CDC joined the global effort to accelerate assessment and availability of candidate Ebola vaccines and began planning for the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE). STRIVE was an individually randomized controlled phase II/III trial to evaluate efficacy, immunogenicity, and safety of the recombinant vesicular stomatitis virus Ebola vaccine (rVSV-ZEBOV). The study population was health care and frontline workers in select chiefdoms of the five most affected districts in Sierra Leone. Participants were randomized to receive a single intramuscular dose of rVSV-ZEBOV at enrollment or to receive a single intramuscular dose 18-24 weeks after enrollment. All participants were followed up monthly until 6 months after vaccination. Two substudies separately assessed detailed reactogenicity over 1 month and immunogenicity over 12 months. During the 5 months before the trial, STRIVE and partners built a research platform in Sierra Leone comprising participant follow-up sites, cold chain, reliable power supply, and vaccination clinics and hired and trained at least 350 national staff. Wide-ranging community outreach, informational sessions, and messaging were conducted before and during the trial to ensure full communication to the population of the study area regarding procedures and current knowledge about the trial vaccine. During April 9-August 15, 2015, STRIVE enrolled 8,673 participants, of whom 453 and 539 were also enrolled in the safety and immunogenicity substudies, respectively. As of April 28, 2016, no Ebola cases and no vaccine-related serious adverse events, which by regulatory definition include death, life-threatening illness, hospitalization or prolongation of hospitalization, or permanent disability, were reported in the study population. Although STRIVE will not produce an estimate of vaccine efficacy because of low case frequency as the epidemic was controlled, data on safety and immunogenicity will support decisions on licensure of rVSV-ZEBOV.The activities summarized in this report would not have been possible without collaboration with many U.S. and international partners (http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/partners.html).

Rates of caesarean section and total volume of surgery in Sierra Leone: a retrospective survey.

BACKGROUND: Surgical services are essential components of health-care systems. Monitoring of surgical activity is important, but resource demanding. Simpler tools to estimate surgical volume, particularly in low-income countries, are needed. Previous work hypothesises that the relative frequency of caesarean sections, expressed as a proportion of total operative procedures, could serve as a proxy measure of surgical capacity. We aimed to establish nationwide and district-wide rates of surgery and caesarean sections, and to explore correlations between districts rates for caesarean sections and corresponding rates for total volume of surgery in Sierra Leone in 2012. METHODS: A nationwide, exhaustive, retrospective, facility-based study of all surgical providers and surgical procedures was performed in Sierra Leone. Between Jan 14, and May 20, 2013, four teams of 12 medical students collected data on the characteristics of the institutions and of the surgeries performed in 2012. Data were retrieved from operation, anaesthesia, and delivery logbooks. FINDINGS: Of 60 facilities performing surgery, complete annual data for 2012 was collected from 58 (97%) institutions. 24 152 surgical procedures identified, gave a national rate of 400 surgeries per 100 000 inhabitants (district range 32-909 per 100 000 [IQR 95-502 per 100 000]). National caesarean section rate was 2·1% (district range 0·3-4·0% [IQR 0·8-2·1]). District caesarean sections rate significantly correlated with the rate of total surgical procedures per 100 000 population (p<0·01). With known caesarean section rate, total volume of surgeries per 100 000 can be calculated with the equation: -9·8 + 4·68 × caesarean sections per 100 000. INTERPRETATION: The close correlation between rate of caesarean section and population rates of total volume of surgery at district level in Sierra Leone indicates that rate of caesarean section should be further explored as a proxy indicator for overall surgical volume in low performing settings. By collecting data from three sources, missing procedures was considered less likely. FUNDING: Norwegian University of Science and Technology.