Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.

During the large Ebola outbreak that affected West Africa in 2014 and 2015, studies were launched to evaluate potential treatments for the disease. A clinical trial to evaluate the effectiveness of the antiviral drug favipiravir was conducted in Guinea. This paper describes the main challenges of the implementation of the trial in the Ebola treatment center of Guéckédou. Following the principles of the Good Clinical Research Practices, we explored the aspects of the community's communication and engagement, ethical conduct, trial protocol compliance, informed consent of participants, ongoing benefit/risk assessment, record keeping, confidentiality of patients and study data, and roles and responsibilities of the actors involved. We concluded that several challenges have to be addressed to successfully implement a clinical trial during an international medical emergency but that the potential for collaboration between research teams and humanitarian organizations needs to be highlighted.

Reduced Antibody Response to Infant Measles Vaccination: Effects Based on Type and Timing of the First Vaccine Dose Persist After the Second Dose.

Background: The effect of age at first dose on the immunogenicity of a 2-dose pediatric schedule of measles-mumps-rubella (MMR) or measles-mumps-rubella-varicella (MMRV) vaccine was assessed in children born to mostly vaccinated mothers. Methods: Immunogenicity data among children given their first measles vaccine dose between 11 and 22 months of age were pooled from 5 randomized controlled trials conducted in Europe and the United States between 2004 and 2010. Measles antibody titers were measured by enzyme-linked immunosorbent assay before and after each dose; geometric mean concentrations (GMCs) and the proportion seronegative (GMC <150 mIU/mL) were derived by age at first dose. Results: Among 5542 children given a first measles vaccine dose at 11, 12, 13-14, and 15-22 months of age, the proportion seronegative decreased from 8.5% to 3.2%, 2.4%, and 1.5%, respectively (P < .001), whereas GMCs increased with older age measles vaccine initiation (P < .001). MMRV induced higher GMCs than MMR (P < .001). First and second dose GMCs were highly correlated (Spearman coefficient = 0.8). Conclusions: As previously noted among infants born to mothers with history of wild-type measles, antibody responses among children born to vaccinated mothers were reduced based on earlier administration of their first measles vaccine dose at ≤12 vs ≥15 months of age. Negative effects of earlier age at first measles vaccine dose persisted after the second dose. The measles elimination goal may require a careful balance between earlier infant protection and the risk of reduced antibody responses and secondary vaccine failure among successive birth cohorts systematically initiated to measles vaccination <15 months of age.