Safety, reactogenicity, and immunogenicity of a 2-dose Ebola vaccine regimen of Ad26.ZEBOV followed by MVA-BN-Filo in healthy adult pregnant women: study protocol for a phase 3 open-label randomized controlled trial
This study is intended to support a label variation to relax restrictions on use in pregnant women, a vulnerable population with high medical need.Trial registrationClinicaltrials.govNCT04556526. September 21, 2020. (Source: Trials)
Source: Trials - June 20, 2022 Category: Research Source Type: clinical trials

Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone
This article explored the decisions taken by the Pharmacy Board of Sierra Leone through its Expert Committee on Medicine Safety and Clinical Trials regarding clinical trials oversight during the Ebola epidemic and the lessons learned. This independent expert committee assessed and provided scientific opinions to the Pharmacy Board of Sierra Leone to inform approval of all clinical trials within 10 –15 working days. We also requested for assisted review from the African Vaccine Regulatory Forum and support from the US Food and Drug Administration through a unilateral recognition and reliance memorandum of understanding. I...
Source: Trials - June 6, 2022 Category: Research Source Type: clinical trials

Surveillance of Vaccine-induced Immunity Against Ebola in Previously Vaccinated Health Care Workers
Condition:   Immune Response Intervention:   Sponsor:   Institute of Tropical Medicine, Belgium Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 6, 2022 Category: Research Source Type: clinical trials

A Study in Tanzania of a New Vaccine Against Two Types of Ebola
Condition:   Ebola Intervention:   Biological: ChAdOx1 biEBOV Sponsor:   University of Oxford Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - March 29, 2022 Category: Research Source Type: clinical trials