Evaluation of NDV-3A Vaccine in Preventing S. Aureus Colonization

NCT03455309 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: NDV3A-006IDCRP-104
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

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

Conditions

Staphylococcus Aureus

Keywords

Als3; SSTI; vaccine; NDV-3A; incident nasal colonization

Outcome Measures

Primary Outcomes (1)

• Prevent acquisition of incident Staphylococcus aureus nasal colonization

  Change in incident Staphylococcus aureus nasal colonization by study day 56 in a population of US Army trainees at Ft. Benning, GA

  56 days post-vaccination

Secondary Outcomes (12)

• Evaluation of the efficacy of the NDV-3A vaccine

  0-90 days

• Evaluation of the efficacy of the NDV-3A vaccine

  0-90 days

• Evaluation of the efficacy of the NDV-3A vaccine

  0-90 days

• Evaluation of safety and tolerability in all subjects

  0-7 days

• Evaluation of safety and tolerability in all subjects

  0-28 days

Study Arms (2)

NDV-3A

ACTIVE COMPARATOR

0.5 mL dose containing 300 micrograms of recombinant Als3 protein in phosphate-buffered saline and 0.5 mg aluminum as aluminum hydroxide

Biological: NDV-3A

Placebo

PLACEBO COMPARATOR

0.5 mL dose containing phosphate-buffered saline and 0.5 mg aluminum as aluminum hydroxide

Biological: Placebo

Interventions

NDV-3A BIOLOGICAL

Single dose administered by intramuscular injection

NDV-3A

Placebo BIOLOGICAL

Single dose administered by intramuscular injection

Placebo

Eligibility Criteria

• Age: 17 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NovaDigm Therapeutics, Inc.: lead
• Infectious Diseases Clinical Research Program: collaborator
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Fort Benning

Fort Benning, Georgia, 31905, United States

Location

Related Publications (2)

• 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.

  PMID: 25489065 BACKGROUND

• 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.

  PMID: 23099329 RESULT

MeSH Terms

Conditions

Staphylococcal Infections; Amyotrophic Lateral Sclerosis 3

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Jason W Bennett, MD

  USU IDCRP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor, principal investigator and study site are all blinded but can access key if safety issues require unblinding
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, placebo-controlled, randomized study

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 6, 2018
• Study Start: January 30, 2018
• Primary Completion: July 19, 2019
• Study Completion: October 15, 2019
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)