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.
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.
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.
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.