Safety and Immunogenicity of the Recombinant Mycobacterium bovis BCG Vaccine VPM1002 in HIV-Unexposed Newborn Infants in South Africa

• DOI: 10.1128/cvi.00439-16
• Publication Date: 2017-01-09T14:28:45Z
• Authors: André G. Loxton; Julia K. Knaul; Leander Grode; Andrea Gutschmidt; Christiane Meller; Bernd Eisele; Hilary Johnstone; Gian van der Spuy; Jeroen Maertzdorf; Stefan H. E. Kauf...; Anneke C. Hesseling; Gerhard Walzl; Mark F. Cotton
• Keywords: BCG vaccine; Tuberculosis vaccines

ABSTRACT Tuberculosis is a global threat to which infants are especially vulnerable. Effective vaccines required protect from this devastating disease. VPM1002, novel recombinant Mycobacterium bovis bacillus Calmette-Guérin (BCG) vaccine previously shown be safe and immunogenic in adults, was evaluated for safety its intended target population, namely, newborn region with high prevalence of tuberculosis. A total 48 newborns were vaccinated intradermally VPM1002 ( n = 36) or BCG Danish strain 12) phase II open-labeled, randomized trial 6-month follow-up period. Clinical laboratory measures during time. In addition, vaccine-induced immune responses mycobacteria analyzed whole-blood stimulation proliferation assays. The parameters immunogenicity comparable the two groups. Both induced interleukin-17 (IL-17) responses; however, vaccination led an increase CD8 + IL-17 T cells at week 16 month 6 time points. incidence abscess formation lower than BCG. We conclude that safe, well-tolerated, infants, confirming results previous trials adults. These strongly support further evaluation efficacy larger studies. (This study has been registered ClinicalTrials.gov under registration no. NCT01479972.)