Protocol for a phase 3 trial to evaluate the effectiveness and safety of a heterologous, two-dose vaccine for Ebola virus disease in the Democratic Republic of the Congo. Issue 3 (8th March 2022)

• Record Type: Journal Article
• Authors: Watson-Jones, Deborah; Kavunga-Membo, Hugo; Grais, Rebecca F; Ahuka, Steve; Roberts, Natalie; Edmunds, W John; Choi, Edward M; Roberts, Chrissy H; Edwards, Tansy; Camacho, Anton; Lees, Shelley; Leyssen, Maarten; Spiessens, Bart; Luhn, Kerstin; Douoguih, Macaya; Hatchett, Richard; Bausch, Daniel G; Muyembe, Jean-Jacques
• Other Names: author non-byline.; Watson-Jones Deborah author non-byline.; John Edmunds W author non-byline.; Choi Edward M author non-byline.; Roberts Chrissy H author non-byline.; Lees Shelley author non-byline.; Edwards Tansy author non-byline.; Manno Daniela author non-byline.; Smith Peter G author non-byline.; Greenwood Brian author non-byline.; Bausch Daniel G author non-byline.; Muyembe Jean-Jacques author non-byline.; Ahuka Steve author non-byline.; Kavunga-Membo Hugo author non-byline.; Grais Rebecca author non-byline.; Rattigan Susan author non-byline.; Camacho Anton author non-byline.; Mambula Grace author non-byline.; Roberts Natalie author non-byline.; Johnson John author non-byline.; Kighoma Patient Mumbere author non-byline.; Burton Marie author non-byline.; Leyssen Maarten author non-byline.; Douoguih Macaya author non-byline.; Spiessens Bart author non-byline.; Hatchett Richard author non-byline.; Imbault Nathalie author non-byline.; Voss Gerald author non-byline.; Saville Melanie author non-byline.; Delaporte Eric author non-byline.; Longini Ira M author non-byline.;
• Is Part Of: BMJ open. Volume 12:Issue 3(2022)
• Publication Date: 2022-03-08
• Subjects: public health -- Ebola -- vaccine -- infectious diseases -- tropical medicine; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2021-055596
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Ebola virus disease (EVD) continues to be a significant public health problem in sub-Saharan Africa, especially in the Democratic Republic of the Congo (DRC). Large-scale vaccination during outbreaks may reduce virus transmission. We established a large population-based clinical trial of a heterologous, two-dose prophylactic vaccine during an outbreak in eastern DRC to determine vaccine effectiveness. Methods and analysis: This open-label, non-randomised, population-based trial enrolled eligible adults and children aged 1 year and above. Participants were offered the two-dose candidate EVD vaccine regimen VAC52150 (Ad26.ZEBOV, Modified Vaccinia Ankara (MVA)-BN-Filo), with the doses being given 56 days apart. After vaccination, serious adverse events (SAEs) were passively recorded until 1 month post dose 2. 1000 safety subset participants were telephoned at 1 month post dose 2 to collect SAEs. 500 pregnancy subset participants were contacted to collect SAEs at D7 and D21 post dose 1 and at D7, 1 month, 3 months and 6 months post dose 2, unless delivery was before these time points. The first 100 infants born to these women were given a clinical examination 3 months post delivery. Due to COVID-19 and temporary suspension of dose 2 vaccinations, at least 50 paediatric and 50 adult participants were enrolled into an immunogenicity subset to examine immune responses following a delayed second dose. Samples collected predose 2 and at 21 days post dose 2 will be tested using the Ebola viruses glycoprotein Filovirus Animal Non-Clinical Group ELISA. For qualitative research, in-depth interviews and focus group discussions were being conducted with participants or parents/care providers of paediatric participants. Ethics and dissemination: Approved by Comité National d'Ethique et de la Santé du Ministère de la santé de RDC, Comité d'Ethique de l'Ecole de Santé Publique de l'Université de Kinshasa, the LSHTM Ethics Committee and the MSF Ethics Review Board. Findings will be presented to stakeholders and conferences. Study data will be made available for open access. Trial registration number: NCT04152486 .