drugset / Trial / NCT03455309
Evaluation of NDV-3A Vaccine in Preventing S. Aureus Colonization
Phase 2
Completed
382 enrolled
NovaDigm Therapeutics, Inc.
Infectious Diseases Clinical Research Program · collabUniformed Services University of the Health Sciences · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The proposed study aims to further evaluate the safety and immunogenicity of a candidate S. aureus vaccine NDV-3A, as well as its efficacy against acquisition of S. aureus
Timeline
- Start
- 2018-01-30
- Primary completion
- 2019-07-19
- Completion
- 2019-10-15
Publications
- Background Yeaman MR, Filler SG, Chaili S, Barr K, Wang H, Kupferwasser D, Hennessey JP Jr, Fu Y, Schmidt CS, Edwards JE Jr, Xiong YQ, Ibrahim AS. Mechanisms of NDV-3 vaccine efficacy in MRSA skin versus invasive infection. Proc Natl Acad Sci U S A. 2014 Dec 23;111(51):E5555-63. doi: 10.1073/pnas.1415610111. Epub 2014 Dec 8.
- Results Schmidt CS, White CJ, Ibrahim AS, Filler SG, Fu Y, Yeaman MR, Edwards JE Jr, Hennessey JP Jr. NDV-3, a recombinant alum-adjuvanted vaccine for Candida and Staphylococcus aureus, is safe and immunogenic in healthy adults. Vaccine. 2012 Dec 14;30(52):7594-600. doi: 10.1016/j.vaccine.2012.10.038. Epub 2012 Oct 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | NDV-3A | Vaccine | 300 ug | Intramuscular |