Evidence map›Paper›PMID 33073737›Full record

Trial reportGlobal health action2020

Implementation of accelerated research: strategies for implementation as applied in a phase 1 Ad26.ZEBOV, MVA-BN-Filo two-dose Ebola vaccine clinical trial in Uganda.

Jonathan Kitonsa, Abu-Baker Ggayi, Zacchaeus Anywaine, Eva Kisaakye, Laura Nsangi, Vincent Basajja, Mary Nyantaro, Deborah Watson-Jones, Georgi Shukarev, Ine Ilsbroux and 2 more

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Global health action, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
0.2field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 13 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 4 countries.

Jonathan KitonsaMedical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit , Entebbe, Uganda.
Abu-Baker GgayiMedical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit , Entebbe, Uganda.
Zacchaeus AnywaineMedical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit , Entebbe, Uganda.
Eva KisaakyeMedical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit , Entebbe, Uganda.
Laura NsangiMedical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit , Entebbe, Uganda.
Vincent BasajjaMedical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit , Entebbe, Uganda.
Mary NyantaroMedical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit , Entebbe, Uganda.
Deborah Watson-JonesLondon School of Hygiene and Tropical Medicine , London, UK.
Georgi ShukarevJanssen Vaccines and Prevention B.V., Clinical Development , Leiden, The Netherlands.
Ine IlsbrouxJanssen Research & Development, Portfolio Delivery Operations, Global Development , Beerse, Belgium.
Cynthia RobinsonJanssen Vaccines and Prevention B.V., Clinical Development , Leiden, The Netherlands.
Pontiano KaleebuMedical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit , Entebbe, Uganda.
Uganda Virus Research Institute · UGJanssen (Netherlands) · NLJanssen (Belgium) · BELondon School of Hygiene & Tropical Medicine · GB

Funding

Medical Research Council MC_UU_00027/1
6 · The paper itself

Abstract

backgroundThe 2013-2016 Ebola epidemic in West Africa is the worst ever caused by

objectiveWe report on the strategies utilised by the Unit and sponsor in ensuring expedited clinical trial approval and accelerated conduct.

methodsJanssen Vaccines and Prevention B.V. conducted a phase 1 trial to evaluate the safety, tolerability, and immunogenicity of heterologous two-dose vaccination regimens using Ad26.ZEBOV and MVA-BN-Filo, in healthy adults in Africa. Accelerated implementation strategies are hereby presented.

resultsStrategies included: holding the African Vaccine Regulatory Forum (AVAREF) joint review meeting; expedited review by institutional ethics and country-specific regulatory bodies; competitive recruitment between sites; electronic data capture (EDC); frequent study monitoring schedule; involvement of a community advisory board (CAB); and utilization of a 'phased' study information-sharing approach in community engagement and participant recruitment. These strategies enabled the site to acquire approvals within 2 months and enrol 47 participants within a spurn of five. The same milestone is usually acquired in at least 1 year without accelerated implementation.

conclusionThe use of well-thought strategies by sponsors and research sites can enable the implementation of accelerated research. We recommend the use of similar strategies in other settings.

Indexed as

Research DesignAdolescentAdultAfrica, WesternEbola VaccinesEbolavirusEpidemicsFemaleHemorrhagic Fever, EbolaHumansMaleMiddle AgedSingle-Blind MethodUgandaYoung AdultEbola Vaccinesaccelerated conductEbola virus diseaseexpedited approvalvaccine research

Identifiers

PMID33073737
PMCPMC7594841
OpenAlexW3093418507

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.