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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Safety, tolerability, and immunogenicity of the novel antituberculous vaccine RUTI: Randomized, placebo-controlled phase II clinical trial in patients with latent tuberculosis infection
PLoS ONE, Volume 9, No. 2, Article e89612, Year 2014
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Description
Objectives: To evaluate the safety, tolerability and immunogenicity of three different doses (5, 25 and 50 μg) of the novel antituberculous vaccine RUTI compared to placebo in subjects with latent tuberculosis infection. Methods and Findings: Double-blind, randomized, placebo-controlled Phase II Clinical Trial (95 patients randomized). Three different RUTI doses and placebo were tested, randomized both in HIV-positive (n = 47) and HIV-negative subjects (n = 48), after completion of one month isoniazid (INH) pre-vaccination. Each subject received two vaccine administrations, 28 Days apart. Five patients withdrew and 90 patients completed the study. Assessment of safety showed no deaths during study. Two subjects had serious adverse events one had a retinal detachment while taking INH and was not randomized and the other had a severe local injection site abscess on each arm and was hospitalized; causality was assessed as very likely and by the end of the study the outcome had resolved. All the patients except 5 (21%) patients of the placebo group (3 HIV+ and 2 HIV-) reported at least one adverse event (AE) during the study. The most frequently occurring AEs among RUTI recipients were (% in HIV+/-): injection site reactions [erythema (91/92), induration (94/92), local nodules (46/25), local pain (66/75), sterile abscess (6/6), swelling (74/83), ulcer (20/11), headache (17/22) and nasopharyngitis (20/5)]. These events were mostly mild and well tolerated. Overall, a polyantigenic response was observed, which differed by HIV- status. The best polyantigenic response was obtained when administrating 25 μg RUTI, especially in HIV-positive subjects which was not increased after the second inoculation. Conclusion: This Phase II clinical trial demonstrates reasonable tolerability of RUTI. The immunogenicity profile of RUTI vaccine in LTBI subjects, even being variable among groups, allows us considering one single injection of one of the highest doses in future trials, preceded by an extended safety clinical phase. © 2014 Nell et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC3935928/bin/pone.0089612.s001.tif
https://efashare.b-cdn.net/share/pmc/articles/PMC3935928/bin/pone.0089612.s002.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3935928/bin/pone.0089612.s003.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3935928/bin/pone.0089612.s004.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3935928/bin/pone.0089612.s005.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3935928/bin/pone.0089612.s006.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3935928/bin/pone.0089612.s007.pdf
Authors & Co-Authors
Nell, Andre S.
United States, Waltham
Parexel International
D'Lom, Eva
United States, Waltham
Parexel International
Bouic, Patrick J.D.
South Africa, Cape Town
Synexa Life Sciences Pty Ltd
Sabaté, Montserrat
Spain, Barcelona
Tfs Develop
Bosser, Ramon
Spain, Barcelona
Janus Developments
Picas, Jordi
Spain, Badalona
Archivel Farma
Amat, Mercè
Spain, Badalona
Archivel Farma
Churchyard, Gavin John
South Africa, Johannesburg
The Aurum Institute
Cardona, Pere Joan
Spain, Badalona
Archivel Farma
Spain, Cerdanyola Del Valles
Universitat Autònoma de Barcelona
Statistics
Citations: 97
Authors: 9
Affiliations: 7
Identifiers
Doi:
10.1371/journal.pone.0089612
e-ISSN:
19326203
Research Areas
Disability
Health System And Policy
Infectious Diseases