A Phase 2 interventional study of NDV-3A and Placebo in Staphylococcus Aureus, sponsored by NovaDigm Therapeutics, Inc.. Completed at 1 site in United States. Open to male participants aged 17 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by NovaDigm Therapeutics, Inc. · Phase 2, Interventional, and Prevention
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Among 125 studies in Staphylococcal Infections with a site in United States — 6 open to participants now, 11 under way, none of them phase 3. Staphylococcal Infections · United States.
Among the 125 studies in Staphylococcal Infections with a site in United States, this one is the 23rd largest by enrollment of the 92 interventional ones that give a count, is one of 3 that started in 2018, is one of 19 in phase 2, and was the 101st registered.
303 studies on the registry are indexed under Staphylococcal Infections; 34 are open to participants now.
Browse Staphylococcal Infections studies →6 of the 125 studies in Staphylococcal Infections with a site in United States are open now. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 2–120
Johns Hopkins University · Sites in United States
Ages 0–60 · Healthy volunteers
University of Virginia · Sites in United States
Ages 18–65
University of Melbourne · Sites in United States, Australia, Canada and 10 more countries
Texas Woman's University · Sites in United States
Ages 18–45 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 22 Staphylococcal Infections studies recruiting now, 16 (73%) set no upper age limit and 4 (18%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.
This study: 17 Years to 35 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
125 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 26 · Phase 3 15 · Phase 4 16
First in 2000; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 382 is above the median of 124 across 198 interventional studies indexed under Staphylococcal Infections.
Median enrollment 158 across the 92 interventional studies, 217 across the 32 observational. Of the 105 that completed or were terminated, 44 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
38 of 125 have an industry lead sponsor. The 10 most frequent:
NovaDigm Therapeutics, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
NovaDigm Therapeutics, Inc. has 3 studies filed under Staphylococcal Infections — fewer than ten, so there is no comparison to draw.
3 of the studies in Staphylococcal Infections with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06749457AstraZenecaA Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa) | 2027-03-08 |
| NCT01879761University of ChicagoImmune Resolution After Staphylococcus Aureus Bacteremia | 2027-06 |
| NCT06805994Johns Hopkins UniversityAdministering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment | 2027-09-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 125 studies in Staphylococcal Infections with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
0.5 mL dose containing phosphate-buffered saline and 0.5 mg aluminum as aluminum hydroxide
Biological: Placebo
Single dose administered by intramuscular injection
Single dose administered by intramuscular injection
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
Time frame: 56 days post-vaccination
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
Time frame: 0-90 days
Evaluation of the efficacy of the NDV-3A vaccine
Describe NDV-3A-associated delay in time to first nasal acquisition of S. aureus colonization
Time frame: 0-90 days
Evaluation of the efficacy of the NDV-3A vaccine
Describe reduction in cross-sectional prevalence of S. aureus nasal/oral colonization
Time frame: 0-90 days
Evaluation of safety and tolerability in all subjects
Occurrence of solicited adverse events (AE) over a 7-day follow-up period following vaccination
Time frame: 0-7 days
Evaluation of safety and tolerability in all subjects
Occurrence of unsolicited AEs over a 28-day follow-up period following vaccination
Time frame: 0-28 days
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)
Time frame: 0-90 days
Measurement and characterization of immunogenicity of NDV-3A
Describe the humoral immune response induced by NDV-3A using ELISA analysis of serum
Time frame: 0-90 days
Measurement and characterization of immunogenicity of NDV-3A
Describe the cell mediated immune responses induced by NDV-3A using ELISpot analysis of PBMCs
Time frame: 0-14 days
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.
Time frame: 0-90 days
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.
Time frame: 0-90 days
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
Time frame: 0-90 days
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
Time frame: 0-90 days
Plan to share: No
Ran from Jan 2018 to primary completion in Jul 2019, 17 months.
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NovaDigm Therapeutics, Inc.