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Hum Vaccin. 2010 Dec;6(12):1007-15. Epub 2010 Dec 1.

First in humans: a new molecularly defined vaccine shows excellent safety and strong induction of long-lived Mycobacterium tuberculosis-specific Th1-cell like responses.

Author information

1
Leiden University Medical Center, Dept. of Infectious Diseases, Leiden, The Netherlands. t.h.m.ottenhoff@lumc.nl

Abstract

Tuberculosis (TB) remains a major killer worldwide. The only available TB-vaccine, the nearly century-old Mycobacterium bovis BCG, has had only a limited effect on TB incidence. Therefore, developing new TB vaccines is a key priority, and the first new generation TB vaccines are now being tested in clinical trials. Here we describe the development and first testing in humans of a novel, wholly synthetic TB subunit vaccine. This vaccine has proven safe and highly immunogenic in all species in which it was tested, including mice, guinea pigs, non-human primates and humans. Most encouragingly, following vaccination in humans, strong IFN-γ responses persisted through at least 2½ years of follow-up, indicating induction of a substantial memory response by this new TB vaccine. These findings encourage further preclinical and clinical studies with TB subunit vaccines and cellular immunity-stimulating new adjuvants.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01003093.

PMID:
21178394
DOI:
10.4161/hv.6.12.13143
[Indexed for MEDLINE]

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