Safety, Immunogenicity, And Efficacy Of Ndv-3a Against Staphylococcus Aureus Colonization: A Phase 2 Vaccine Trial Among Us Army Infantry Trainees
2021 05 27
Journal Article
Authors:
Millar, E.V.;
Bennett, J.W.;
Barin, B.;
Carey, P.M.;
Law, N.N.;
English, C.E.;
Schwartz, M.M.;
Cochrane, T.;
Ellis, M.W.;
Tribble, D.R.;
Cooke, T.;
Hennessey, J.P.
Secondary:
Vaccine
Volume:
39
Pagination:
3179-3188
Issue:
23
PMID:
33962841
URL:
https://pubmed.ncbi.nlm.nih.gov/33962841/https://www2.emmes.com/publications/3053
DOI:
10.1016/j.vaccine.2021.04.031
Keywords:
CRID; Humans; Immunogenicity, Vaccine; Military Personnel; Staphylococcal Infections; Staphylococcal Vaccines; Staphylococcus aureus; Vaccines
Abstract:
BACKGROUND: Military trainees are at increased risk for Staphylococcus aureus colonization and infection. Disease prevention strategies are needed, but a S. aureus vaccine does not currently exist.METHODS: We enrolled US Army Infantry trainees (Fort Benning, GA) in a phase 2, randomized, double-blind, placebo-controlled trial of NDV-3A, a vaccine containing a recombinant adhesin/invasion protein of Candida albicans that has structural similarity to the S. aureus protein clumping factor A. Study participants received one intramuscular dose of NDV-3A or placebo (adjuvant alone) within 72 h of arrival on base. Longitudinal nasal and oral (throat) swabs were collected throughout the 14-week Infantry training cycle. Safety, immunogenicity, and efficacy of NDV-3A against S. aureus nasal / oral acquisition were the endpoints.RESULTS: The NDV-3A candidate had minimal reactogenicity and elicited robust antigen-specific B- and T-cell responses. During the 56-day post-vaccination period, there was no difference in the incidence of S. aureus nasal acquisition between those who were randomized to receive NDV-3A vs. placebo (25.6% vs. 29.1%; vaccine efficacy [VE]: 12.1%; p = 0.31). In time-to-event analysis, there was no difference between study groups with respect to the S. aureus colonization-free interval (VE: 13%; p = 0.29). Similarly, the efficacy of NDV-3A against S. aureus oral acquisition was poor (VE: 2.4%; p = 0.52).CONCLUSIONS: A single dose of NDV-3A did not prevent nasal nor oral acquisition of S. aureus in a population of military trainees at high risk for colonization.
