Challenges and prospects of clinical trials in Nigeria - Lessons from the WHO COVID-19 solidarity plus trial.

Conducting randomized clinical trials (RCTs) during a pandemic is essential for obtaining timely evidence on safe and effective treatments, but it presents numerous obstacles. During the COVID-19 pandemic, the World Health Organization (WHO) sponsored multinational RCTs investigating repurposed drugs among hospitalized COVID-19 patients across countries with varying clinical research capacities. In Nigeria, several challenges hindered our progress, including inadequate infrastructure, initial insufficient investigator certification and expertise, and delays in securing regulatory approvals due to bureaucratic hurdles.

The promise, problems, and pitfalls of including pregnant women in clinical trials of Lassa fever vaccine: a qualitative assessment of sub-Sahara Africa investigators' perception.

Introduction: Lassa fever runs a uniquely severe course in pregnancy. There are plans for Lassa fever vaccine clinical trials in endemic West African countries. We assessed the perception of West African investigators to include pregnant women in these studies.

Adopting an heterologous prime-boost strategy in COVID-19 vaccination: the need for locally generated evidence in Africa.

The reduction in the severity and prevalence of COVID-19 has been largely due to the rapid development and deployment of COVID-19 vaccines. Consequently, WHO, in partnership with the Coalition for Epidemic Preparedness Innovation, GAVI, the Vaccine Alliance, set up the COVID-19 Vaccines Global Access (COVAX) Initiative. The goal of this initiative is to prevent discrimination between high and low-income/middle-income countries and ensure equitable vaccine distribution.

Tracking the uptake and trajectory of COVID-19 vaccination coverage in 15 West African countries: an interim analysis.

The African Union Bureau of Heads of State and Government endorsed the COVID-19 Vaccine Development and Access Strategy to vaccinate at least 60% of each country's population with a safe and efficacious vaccine by 2022, to achieve the population-level immunity needed to bring the pandemic under control. Using publicly available, country-level population estimates and COVID-19 vaccination data, we provide unique insights into the uptake trends of COVID-19 vaccinations in the 15 countries that comprise the Economic Community of West Africa States (ECOWAS). Based on the vaccination rates in the ECOWAS region after three months of commencing COVID-19 vaccinations, we provide a projection of the trajectory and speed of vaccination needed to achieve a COVID-19 vaccination coverage rate of at least 60% of the total ECOWAS population.

Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results.

Background: World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with coronavirus disease 2019 (Covid-19).

Methods: We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug).

A systematic scorecard-based approach to site assessment in preparation for Lassa fever vaccine clinical trials in affected countries.

Background: We sought to develop and test an objective scorecard-based system for assessing and categorizing available research sites in Lassa fever-affected countries based on their preparedness and capability to host Lassa fever vaccine clinical trials.

Methods: We mapped available clinical research sites through interrogation of online clinical trial registries and relevant disease-based consortia. A structured online questionnaire was used to assess the capability of clinical trial sites to conduct Lassa fever vaccine clinical trials.

Meeting report: WHO consultation on accelerating Lassa fever vaccine development in endemic countries, Dakar, 10-11 September 2019.

At the time of writing in 2019, there have been 754 confirmed cases of Lassa fever in Nigeria, 21% of whom have died. Lassa is on the priority pathogen list for WHO's R&D Blueprint for Action to Prevent Epidemics. In September 2019, WHO convened 67 scientists, regulators, ethicists, public health officials, funders and vaccine developers to discuss the end-to-end clinical development plan for Lassa fever vaccines.

A review of Lassa fever vaccine candidates.

Lassa fever is a zoonotic disease caused by the Lassa virus, a rodent-borne arenavirus endemic to West Africa. Recent steady increase in reported cases of the disease in Nigeria, where 123 deaths occurred in 546 confirmed cases in 2019 has further underlined the need to accelerate the development of vaccines for preventing the disease. Intensified research and development of Lassa fever medical countermeasures have yielded some vaccine candidates with preclinical scientific plausibility using predominantly novel technology.

Is chronic malnutrition associated with an increase in malaria incidence? A cohort study in children aged under 5 years in rural Gambia.

Background: Malnutrition is common in children in sub-Saharan Africa and is thought to increase the risk of infectious diseases, including malaria. The relationship between malnutrition and malaria was examined in a cohort of 6-59 month-old children in rural Gambia, in an area of seasonal malaria transmission. The study used data from a clinical trial in which a cohort of children was established and followed for clinical malaria during the 2011 transmission season.

Correction to: Emergence of knock-down resistance in the Anopheles gambiae complex in the Upper River Region, The Gambia, and its relationship with malaria infection in children.

Unfortunately, the original article [1] contained an error mistakenly carried forward by the Production department handling this article whereby some figures and their captions were interchanged. The correct figures (Figs. 1, 2, 3, 4, 5) and captions are presented in this erratum.

Emergence of knock-down resistance in the Anopheles gambiae complex in the Upper River Region, The Gambia, and its relationship with malaria infection in children.

Background: Insecticide resistance threatens malaria control in sub-Saharan Africa. Knockdown resistance to pyrethroids and organochlorines in Anopheles gambiae sensu lato (s.l.

Efficacy of indoor residual spraying with dichlorodiphenyltrichloroethane against malaria in Gambian communities with high usage of long-lasting insecticidal mosquito nets: a cluster-randomised controlled trial.

Background: Although many malaria control programmes in sub-Saharan Africa use indoor residual spraying with long-lasting insecticidal nets (LLINs), the two studies assessing the benefit of the combination of these two interventions gave conflicting results. We aimed to assess whether the addition of indoor residual spraying to LLINs provided a significantly different level of protection against clinical malaria in children or against house entry by vector mosquitoes.

Methods: In this two-arm cluster, randomised, controlled efficacy trial we randomly allocated clusters of Gambian villages using a computerised algorithm to LLINs alone (n=35) or indoor residual spraying with dichlorodiphenyltrichloroethane plus LLINs (n=35).

Scientific and popular health knowledge in the education work of community health agents in Rio de Janeiro shantytowns.

Health education for socially marginalized populations challenges the efficacy of existing strategies and methods, and the pertinence of the educational and philosophical principles that underpin them. The Brazilian Community Health Agents Initiative (CHAI) hires residents of deprived marginalized communities to undertake health promotion and education in their communities. The ultimate goal of the CHAI is to connect populations with the public healthcare system by promoting social re-affiliation, protecting civil rights and enhancing equity of access to health services.