AzTrials
AzTrials

Staphylococcus AureusPhase 2NCT03455309

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

A Phase 2 study testing NDV-3A in people with Staphylococcus Aureus, run by NovaDigm Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 17 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Staphylococcus Aureus
What is being tested?
NDV-3A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
382 participants
Where
1 siteUnited States
Study dates
30 Jan 2018to 15 Oct 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.)
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fort Benning

    Fort Benning, Georgia, 31905

Other trials in United States

About this study

Official title: A Phase 2 Double-blind Placebo-controlled Study to Evaluate the Safety, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing S. Aureus Colonization

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

Read the 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 acquisition of S. aureus among a population of military recruits at increased risk for S. aureus colonization and disease. Colonization is a risk factor for skin and soft tissue infection (SSTI), and the anterior nares is an important reservoir for S. aureus. Use of S. aureus nasal colonization (specifically, incident nasal colonization with S. aureus post-vaccination) as a primary endpoint will allow the investigators to pursue a statistically-valid and meaningful parameter related to S. aureus SSTI. The proposed trial may yield evidence to warrant evaluation of NDV-3A efficacy against SSTI in a large-scale, Phase 2/3 trial in this high risk population.

Being tested
NDV-3A, Placebo
Keywords
Als3, SSTI, vaccine, NDV-3A, incident nasal colonization
Medical subject headings
Staphylococcal Infections, Amyotrophic Lateral Sclerosis 3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NDV-3ABiological

    Single dose administered by intramuscular injection

  • PlaceboBiological

    Single dose administered by intramuscular injection

Study groups in NCT03455309
Study groupRoleWhat they receive
NDV-3AActive comparator0.5 mL dose containing 300 micrograms of recombinant Als3 protein in phosphate-buffered saline and 0.5 mg aluminum as aluminum hydroxide
Receives: Biological: NDV-3A
PlaceboPlacebo comparator0.5 mL dose containing phosphate-buffered saline and 0.5 mg aluminum as aluminum hydroxide
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 56 days post-vaccination

Secondary outcomes (12)

  1. Evaluation of the efficacy of the NDV-3A vaccine

    Describe SSTI rates within the training company as defined by the development of skin and soft tissue infection (SSTI) over the training period as compared to other companies in the battalion as well as historical data

    Measured: 0-90 days

  2. Evaluation of the efficacy of the NDV-3A vaccine

    Describe NDV-3A-associated delay in time to first nasal acquisition of S. aureus colonization

    Measured: 0-90 days

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

    Describe reduction in cross-sectional prevalence of S. aureus nasal/oral colonization

    Measured: 0-90 days

  4. Evaluation of safety and tolerability in all subjects

    Occurrence of solicited adverse events (AE) over a 7-day follow-up period following vaccination

    Measured: 0-7 days

  5. Evaluation of safety and tolerability in all subjects

    Occurrence of unsolicited AEs over a 28-day follow-up period following vaccination

    Measured: 0-28 days

  6. Evaluation of safety and tolerability in all subjects

    Occurrence of serious adverse events (SAE) or Adverse Events of Special Interest (AESI) at any time during the study period (enrollment to final in-person follow-up visit)

    Measured: 0-90 days

  7. Measurement and characterization of immunogenicity of NDV-3A

    Describe the humoral immune response induced by NDV-3A using ELISA analysis of serum

    Measured: 0-90 days

  8. Measurement and characterization of immunogenicity of NDV-3A

    Describe the cell mediated immune responses induced by NDV-3A using ELISpot analysis of PBMCs

    Measured: 0-14 days

  9. Describe the impact of NDV-3A on S. aureus acquisition and transmission

    Following determination of taxonomy (via sequencing of 16S rRNA), determine the relative abundance and distribution of, and change in, bacterial species colonizing the nose and throat (i.e. nasal/oral microbiome) of military trainees during the training period.

    Measured: 0-90 days

  10. Describe the impact of NDV-3A on S. aureus acquisition and transmission

    Compare the compositions of the nasal/oral microbiome between study groups to assess the impact of NDV-3A vaccine on the nasal/oral microbiome.

    Measured: 0-90 days

  11. Describe the impact of NDV-3A on S. aureus acquisition and transmission

    Utilize a combination of epidemiologic, microbiologic, and genomic data on colonization isolates to describe the intra-class transmission dynamics of S. aureus among congregate military trainees

    Measured: 0-90 days

  12. Describe the impact of NDV-3A on S. aureus acquisition and transmission

    Conduct whole genome sequencing on isolates to describe the intra- and inter-host concordance of infecting and colonizing strains of S. aureus

    Measured: 0-90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2018
  2. Study start30 Jan 2018
  3. Primary completion19 Jul 2019
  4. Study completion15 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
double-blind, placebo-controlled, randomized study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
382 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03455309
Sponsor's protocol ID
NDV3A-006
Other IDs
IDCRP-104
Status last verified
Jan 2020
First submitted
13 Feb 2018
Last updated
29 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25489065

  • 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.

    PubMed 23099329

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NDV-3A in people with Staphylococcus Aureus, run by NovaDigm Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevent acquisition of incident Staphylococcus aureus nasal colonization (time frame: 56 days post-vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03455309, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in