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Safety and immunogenicity of the recombinant BCG vaccine VPM1002 in HIV-unexposed newborn infants in South Africa.

Safety and immunogenicity of the recombinant BCG vaccine VPM1002 in HIV-unexposed newborn infants in South Africa.
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Loxton AG, Knaul JK, Grode L, Gutschmidt A, Meller C, Eisele B, Johnstone H, van der Spuy G, Maertzdorf J, Kaufmann SH, Hesseling AC, Walzl G, Cotton MF, ,


Loxton AG, Knaul JK, Grode L, Gutschmidt A, Meller C, Eisele B, Johnstone H, van der Spuy G, Maertzdorf J, Kaufmann SH, Hesseling AC, Walzl G, Cotton MF, , (click to view)

Loxton AG, Knaul JK, Grode L, Gutschmidt A, Meller C, Eisele B, Johnstone H, van der Spuy G, Maertzdorf J, Kaufmann SH, Hesseling AC, Walzl G, Cotton MF, ,

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Clinical and vaccine immunology : CVI 2016 12 14() pii

Abstract
BACKGROUND
Tuberculosis is a global threat to which infants are especially vulnerable. Effective vaccines are required to protect infants from this devastating disease. VPM1002, a novel recombinant Bacille Calmette-Guérin (BCG) vaccine, previously shown to be safe and immunogenic in adults, was evaluated for safety in its intended target population, namely newborn infants in a region with high prevalence of tuberculosis.

METHODS
A total of forty-eight newborns were vaccinated intradermally with VPM1002 (n=36) or BCG Danish strain (n=12) in a Phase II open-labelled, randomized trial with a 6 month follow-up period. Clinical and laboratory measures of safety were evaluated during this time. In addition, vaccine-induced immune responses to mycobacteria were analyzed in whole blood stimulation and proliferation assays.

RESULTS
Safety parameters and immunogenicity were comparable in the two groups. Both vaccines induced IL-17 responses; however, VPM1002 vaccination led to an increase of CD8(+)IL-17(+) T-cells at week 16 and month 6 time points. The incidence of abscess formation was lower for VPM1002 than for BCG.

CONCLUSIONS
VPM1002 is a safe, well tolerated and immunogenic vaccine in newborn infants, confirming results from previous trials in adults. These results strongly support further evaluation of the safety and efficacy of this vaccination in larger studies.

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