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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
First human challenge testing of a pneumococcal vaccine: Double-blind randomized controlled trial
American Journal of Respiratory and Critical Care Medicine, Volume 192, No. 7, Year 2015
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Description
Rationale: New vaccines are urgently needed to protect the vulnerable from bacterial pneumonia. Clinical trials of pneumonia vaccines are slow and costly, requiring tens of thousands of patients. Studies of pneumococcal vaccine efficacy against colonization have been proposed as a novel method to down-select between vaccine candidates. Objectives: Using our safe and reproducible experimental human pneumococcal colonization model, we aimed to determine the effect of 13-valent pneumococcal conjugate vaccine (PCV) on colonization. Methods: A total of 100 healthy participants aged 18-50 years were recruited into this double-blind randomized placebocontrolled trial. They were randomly assigned to PCV (n = 49) or hepatitis A (control, n = 50) vaccination and inoculated with 80,000 CFU/100 μl of Streptococcus pneumoniae (6B) per naris. Measurements and Main Results: Participants were followed up for 21days todetermine pneumococcal colonization by culture ofnasal wash. The PCV group had a significantly reduced rate of 6B colonization (10% [5 of 48]) compared with control subjects (48% [23 of 48]) (risk ratio, 0.22; confidence interval, 0.09-0.52; P < 0.001). Density of colonization was reduced in the PCV group compared with the control group following inoculation. The area under the curve (density vs. day) was significantly reduced in the PCV compared with control group (geometric mean, 259 vs. 11,183; P = 0.017). Conclusions: PCV reduced pneumococcal colonization rate, density, and duration in healthy adults. The experimental human pneumococcal colonization model is a safe, cost-effective, and efficient method to determine the protective efficacy of new vaccines on pneumococcal colonization;PCVprovides a gold standard against which to test these novel vaccines. Copyright © 2015 by the American Thoracic Society.
Authors & Co-Authors
Collins, Andrea M.
United Kingdom, Liverpool
Liverpool University Hospitals Nhs Foundation Trust
United Kingdom, Liverpool
Liverpool School of Tropical Medicine
Wright, Angela D.
United Kingdom, Liverpool
Liverpool School of Tropical Medicine
Mitsi, Elena
United Kingdom, Liverpool
Liverpool School of Tropical Medicine
Gritzfeld, Jenna F.
United Kingdom, Liverpool
Liverpool School of Tropical Medicine
Hancock, Carole A.
United Kingdom, Liverpool
Liverpool University Hospitals Nhs Foundation Trust
Pennington, Shaun Harry
United Kingdom, Liverpool
Liverpool School of Tropical Medicine
Wang, Duolao
United Kingdom, Liverpool
Liverpool School of Tropical Medicine
Morton, Ben
United Kingdom, Liverpool
Liverpool School of Tropical Medicine
Ferreira, Daniela Mulari
United Kingdom, Liverpool
Liverpool School of Tropical Medicine
Gordon, Stephen B.
United Kingdom, Liverpool
Liverpool School of Tropical Medicine
Statistics
Citations: 61
Authors: 10
Affiliations: 2
Identifiers
Doi:
10.1164/rccm.201503-0542OC
ISSN:
1073449X
Research Areas
Disability
Infectious Diseases
Study Design
Randomised Control Trial
Study Approach
Quantitative