Status:
COMPLETED
Evaluation of NDV-3A Vaccine in Preventing S. Aureus Colonization
Lead Sponsor:
NovaDigm Therapeutics, Inc.
Collaborating Sponsors:
Infectious Diseases Clinical Research Program
Uniformed Services University of the Health Sciences
Conditions:
Staphylococcus Aureus
Eligibility:
MALE
17-35 years
Phase:
PHASE2
Brief 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
Detailed Description
The investigators will conduct a Phase 2 clinical trial to evaluate the safety, immunogenicity, and efficacy of candidate vaccine NDV-3A (NovaDigm Therapeutics, Inc.) to prevent incident nasal acquisi...
Eligibility Criteria
Inclusion
- Active duty, male subject, 17-35 years of age, inclusive, at the time of screening.
- Assigned to one of the selected companies/battalions
- Informed of the nature of the study and has agreed to and is able to read, review, and sign the informed consent document prior to screening.
- Free of known significant health problems as established by the requirements to be enrolled in a military training program before entering into the study.
- Agrees to be reachable by phone, email or letter at 6 months post-vaccination.
Exclusion
- Reports receiving any investigational drug, investigational vaccine, or investigational device within 30 days prior to dosing; subjects will be allowed to receive routine vaccinations associated with training and any other prescribed medications not in the exclusion criteria.
- Presence of clinically significant SSTI (e.g., cellulitis, abscess) at screening or other skin or skin structure infections that would confound the interpretation of clinical response.
- Reports a history of allergic response(s), anaphylaxis, or other serious reactions to previous vaccinations.
- Reports a history of allergies to yeast
- Reports a history of anaphylaxis or other serious reactions to aluminum.
- Reports a history of autoimmune disease (psoriasis, etc.)
- Seropositive for HIV antibody.
- Reports the use of any immunosuppressive drugs, including systemic corticosteroids (more than 14 days at a dose of \>20 mg/day prednisone or equivalent), within 4 weeks prior to dosing.
- Reports receiving any blood products within 3 months prior to dosing.
- Reports donating blood/plasma within 28 days prior to dosing.
- Illness causing temperature ≥ 100.4°F
- Evidence of abnormal, unresolved laboratory results in the subject's medical record for the following tests: hemoglobin, white blood cell count, platelet count, creatinine, and alanine aminotransferase
- Any other medical and/or social reason which, in the opinion of the investigator(s), would increase the subject's risk of having an adverse reaction as a result of participation in the study.
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2019
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT03455309
Start Date
January 30 2018
End Date
October 15 2019
Last Update
January 29 2020
Active Locations (1)
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1
Fort Benning
Fort Benning, Georgia, United States, 31905