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Lessons from the First Clinical Trial of a Non-licensed Vaccine among Ugandan Adolescents: A Phase II Field Trial of the Tuberculosis Candidate Vaccine, MVA85A

Lessons from the First Clinical Trial of a Non-licensed Vaccine among Ugandan Adolescents: A Phase II Field Trial of the Tuberculosis Candidate Vaccine, MVA85A

Author: 
Anne Wajja
Milly Namutebi
Barbara Apule
Gloria Oduru
Samuel Kiwanuka
Mirriam Akello
Beatrice Nassanga
Joyce Kabagenyi
Juma Mpiima
Samantha Vermaak
Alison Lawrie
Iman Satti
Jaco Verweij
Stephen Cose
Jonathan Levin
Pontiano Kaleebu
Edridah Tukahebwa
Helen McShane
Alison M. Elliott
Publication Date
Wednesday, September 19, 2018
Affiliation: 

MRC/UVRI and LSHTM Uganda Research Unit (Wajja, Namutebi, Apule, Oduru, Kiwanuka, Akello, Nassanga, Kabagenyi, Cose, Levin, Kaleebu, Elliott); Ministry of Health of Uganda (Mpiima); University of Oxford (Vermaak, Lawrie, Satti, McShane); St. Elisabeth Hospital (Verweij); London School of Hygiene & Tropical Medicine (Cose, Elliott); University of the Witwatersrand (Levin)

"Engagement with the community and all stakeholders was critical for successful implementation of the trial."

Despite the importance of immunisation in adolescence, and the relative ease of access via school, immunisation in late primary school is not always routine in Sub Saharan African (SSA) countries. The only licensed tuberculosis (TB) vaccine, Bacille Calmette-Guérin (BCG), prevents severe disease in childhood but does not protect against pulmonary TB among adolescents and adults in tropical latitudes. This article shares experiences and lessons learned when implementing a clinical trial of an unlicensed vaccine among adolescents in Uganda: MVA85A, a candidate TB vaccine. A key insight is that sufficient time and resources should be planned for community preparation and sensitisation to ensure buy-in and acceptance of a project of this kind.

  <div class="field button"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6338128.1/" 0="s:6:&quot;a:0:{}&quot;;" target="_blank">Click here to read the article online or to download it in PDF format (16 pages).</a></div>
Contacts (user reference): 
Source: 

Wellcome Open Research, v.3; 2018PMC6338128.1. Image credit: MRC/UVRI and LSHTM Uganda Research Unit

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