Imperial College London
Portrait Picture

Professor Christl Donnelly CBE FMedSci FRS

Faculty of Medicine, School of Public Health

Visiting Professor
 
 
 
//

Contact

 

c.donnelly Website

 
 
//

Location

 

School of Public HealthWhite City Campus

//

Summary

 

Publications

Citation

BibTex format

@article{Longini:2022,
author = {Longini, IM and Yang, Y and Fleming, TR and Munoz-Fontela, C and Wang, R and Ellenberg, SS and Qian, G and Halloran, ME and Nason, M and De, Gruttola V and Mulangu, S and Huang, Y and Donnelly, C and Henao, Restrepo A-M},
journal = {Clinical Trials},
pages = {647--654},
title = {A platform trial design for preventive vaccines against Marburg virus and other emerging infectious disease threats},
url = {http://hdl.handle.net/10044/1/97727},
volume = {19},
year = {2022}
}
Download

RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Background:The threat of a possible Marburg virus disease outbreak in Central and Western Africa is growing.  While no Marburg virus vaccines are currently available for use, several candidates are in the pipeline.  Building on knowledge and experiences in the designs of vaccine efficacy trials against other pathogens including SARS-CoV-2, we develop designs of randomized phase 3 vaccine efficacy trials for Marburg virus vaccines. Methods:A core protocol approach will be used, allowing multiple vaccine candidates to be tested against controls.  The primary objective of the trial will be to evaluate the effect of each vaccine on the rate of virologically confirmed Marburg virus disease, although Marburg infection, assessed via seroconversion could be the primary objective in some cases.  The overall trial design will be a mixture of individually and cluster randomized designs, with individual randomization done whenever possible.  Clusters will consist of either contacts and contacts of contacts of index cases, i.e., ring vaccination, or other transmission units.  Results:The primary efficacy endpoint will be analysed as a time-to-event outcome.  A vaccine will be considered successful if its estimated efficacy is greater than 50% and has sufficient precision to rule out that true efficacy is less than 30%.  This will require approximately 150 total endpoints, i.e., cases of confirmed Marburg virus disease, per vaccine/comparator combination  Interim analyses will be conducted after 50 and after 100 events.  Statistical analysis of the trial will be blended across the different types of designs.  Under the assumption of a 6-month attack rate of 1%  of the of the participants in the placebo arm for both the individually and cluster randomize populations, the most likely sample size is about 20,000 participants per armConclusions:This event-driven design takes into the account the potentially sporadic spread of Marburg virus.    The proposed trial design may be applica
AU  - Longini,IM
AU  - Yang,Y
AU  - Fleming,TR
AU  - Munoz-Fontela,C
AU  - Wang,R
AU  - Ellenberg,SS
AU  - Qian,G
AU  - Halloran,ME
AU  - Nason,M
AU  - De,Gruttola V
AU  - Mulangu,S
AU  - Huang,Y
AU  - Donnelly,C
AU  - Henao,Restrepo A-M
EP  - 654
PY  - 2022///
SN  - 1740-7745
SP  - 647
TI  - A platform trial design for preventive vaccines against Marburg virus and other emerging infectious disease threats
T2  - Clinical Trials
UR  - http://hdl.handle.net/10044/1/97727
VL  - 19
ER  -
Download