ClinicalTrials.gg
CompletedNCT02262819Updated Mar 30, 2021

Human Immunity Against Staphylococcus Aureus Skin Infection

A Phase 1 interventional study of S. aureus in Staphylococcus Aureus Skin Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 2 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-30.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Apr 2019, 7 years 6 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
49
Allocation
Not applicable
Ages
2 Years to 65 Years
Sex
All
01

Study summary

Background:

  • Staphylococcus aureus, or staph, is commonly found on the skin and in the respiratory system. Sometimes people who get sick with staph infection do not get better with standard treatment. These staph infections can be serious and even deadly. Researchers want to find out why some people are more likely to get the infection.

Objectives:

  • To look at the immune response of the skin when it is exposed to bacteria.

Eligibility:

  • People age 2 65 with hyper IgE syndrome (HIES) and those with recurrent staph infections.
  • Healthy volunteers.

Design:

  • Participants will be screened with medical history, physical exam, and blood tests.
  • Over 1 5 days, participants may have blood tests and a skin and nasal swab. They may have additional tests if needed. If they had a recent biopsy, researchers may ask for a sample from it.
  • Some participants will spend the night at the clinic. Their vital signs will be taken and they will have blood drawn. Some participants will take aspirin or ibuprofen starting 2 days before their stay.
  • Some participants will have blisters created on the inside of their forearm. Suction will pull a layer of skin from their arm. Skin will be removed. Different solutions will be applied to the blisters. Up to 3 biopsies may be taken.
  • Children will not have blood tests or biopsies.
  • Participants will be called every day for 10 days, then at 30 days after the procedure.
  • Participants will have a follow-up visit 10 days after the procedure.
  • Participants who did not get blisters or biopsies will not have any follow-up appointments.
Read the detailed description

The incidence of community-associated (CA) staphylococcal infections, especially those caused by methicillin-resistant Staphylococcus aureus (MRSA), has increased dramatically in recent years. Skin and soft tissues are the primary site for most of these infections, and skin or mucosal colonization increases the risk of disseminated disease. Many patients without apparent underlying immune dysfunction suffer from recurrent and persistent skin infections with MRSA. Additionally, patients with conditions such as atopic dermatitis and Hyper IgE (or Job s) Syndrome (HIES) are disproportionately affected. Although underlying host molecular defects responsible for some of these predisposing conditions have been uncovered in recent years (e.g. STAT3 mutations in HIES), the skin immune response to S. aureus infections has not been elucidated in either healthy controls or susceptible populations. In this protocol, we will perform exploratory evaluations of anti-staphylococcal immune responses in healthy subjects, subjects with STAT3 mutations, and otherwise healthy subjects with a history of recurrent staphylococcal skin infections. An additional group of subjects with other underlying conditions of interest may be included.

The primary objective of this research is to perform in vivo and ex vivo challenges with killed bacteria through the use of the skin blister model and keratinocyte cultures to evaluate skin immune responses. Occasionally, a commensal fungi, such as Candida species may also be used. We will use three experimental approaches to complete this objective: 1) evaluation of in vivo responses in skin blisters to killed microbe exposure, 2) ex vivo evaluation of anti-microbial responses through derivation of keratinocyte cultures from skin blisters or biopsies, and 3) evaluation of function and immune-stimulatory ability of commensal organisms.

Specifically, a suction blister device will be used to induce a skin blister on the forearm. The tops of the blisters will be removed, and solutions of killed S. aureus, commensal coagulase-negative staphylococcal species, or other Gram-negative commensals as well as commensal fungi, such as Candida species will be applied to the blisters to stimulate inflammatory responses. The blister fluid will then be collected at various time points over 24 hours for laboratory analysis. Baseline skin and/or nasal swabs, skin biopsies, and blood draws will also be performed (The skin and nasal swabs may be performed at the screening or baseline visit.). Pediatric participants may be enrolled for baseline skin and/or nasal swabs. All research procedures will be performed at the National Institutes of Health Clinical Center. We anticipate that the research will provide critical new information on the human skin immune response to S. aureus that has direct relevance for the development of vaccines, diagnostics, and therapeutics.

02

Conditions studied

  • Staphylococcus Aureus Skin Infection

Browse trials for

Keywords

  • Skin Blister
  • Immune Response
  • Suction Device
  • Anti-Microbial
  • Killed Microbe
03

In context

Blister

36 studies on the registry are indexed under Blister; 3 are open to participants now.

This study's enrollment of 49 is below the median of 65 across 24 interventional studies indexed under Blister.

Browse Blister studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

Participants must either:

  1. Have documentation of a proven or suspected immune defect or a history of invasive infection or recurrent (2 or more) skin infections with S. aureus (patient population); or
  2. Not have evidence of an immune defect or history of invasive or recurrent S. aureus infections (healthy volunteers).

    • Participants must be between 2 and 65 years old (inclusive).
    • Participants must be willing to allow storage of blood, DNA, RNA, bacterial and fungal cultures, and other tissue samples for future research. Some research blood may not be required of healthy volunteers, except at the discretion of the Principal Investigator (PI).

Exclusion criteria

EXCLUSION CRITERIA:

The following exclusion criteria apply to all participants:

  • Current chemotherapy or underlying .
  • Current oral .
  • Individuals with any condition that, in the opinion of the investigator, contraindicates participation in the study will be excluded.

The following exclusion criteria apply to adult participants in the blister portion of the study (Arm 1) only:

  • Viral or C. Test results, including those from an outside facility or lab, within the prior 6 months will be accepted.
  • positive. Test results, including those from an outside facility or lab, within the prior 6 months will be accepted.
  • Individuals on anticoagulant or anti- therapy (other than aspirin or NSAIDs as described in the protocol).
  • Pregnancy.
Terms in these criteria, in plain language(5)

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
49 participants (actual)

Interventions

  • DrugS. aureus

    S. aureus, commensal coagulase-negative staphylococcal species, and Gram-negative commensals, such as Roseomonas and Pseudomonas species

06

What researchers measure

Primary outcomes

  1. Evaluate the local in vivo skin immune response to bacteria.

    Time frame: 4 years

  2. Evaluate the keratinocyte responses to bacterial challenge.

    Time frame: 4 years

Secondary outcomes

  1. Determine if abnormalities in specific immune pathways, such as IL-17 and vitamin D metabolism, are present in subjects with recognized susceptibility to S. aureus infections.

    Time frame: 4 years

  2. Characterize cultured skin bacteria (S. aureus, S. epidermidis, and other skin commensals) with molecular and functional studies.

    Time frame: 4 years

  3. Assess the impact of non-steroidal anti-inflammatory drugs (NSAIDs) on skin immune function.

    Time frame: 4 years

  4. Characterize blood immune parameters in a cohort of patients with invasive and/or recurrent skin and soft tissue S. aureus infections.

    Time frame: 4 years

07

Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
08

References and documents

Publications

  • Gough P, Ganesan S, Datta SK. IL-20 Signaling in Activated Human Neutrophils Inhibits Neutrophil Migration and Function. J Immunol. 2017 Jun 1;198(11):4373-4382. doi: 10.4049/jimmunol.1700253. Epub 2017 Apr 19. PubMed 28424238 ↗
  • Sastalla I, Williams KW, Anderson ED, Myles IA, Reckhow JD, Espinoza-Moraga M, Freeman AF, Datta SK. Molecular Typing of Staphylococcus aureus Isolated from Patients with Autosomal Dominant Hyper IgE Syndrome. Pathogens. 2017 Jun 6;6(2):23. doi: 10.3390/pathogens6020023. PubMed 28587312 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2014, a primary completion of Apr 2019 and a completion of Apr 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2014
First posted
Oct 13, 2014
Start
Oct 10, 2014
Primary completionActual
Apr 24, 2019
CompletionActual
Apr 24, 2019
Last update
Mar 30, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02262819
Responsible party
Sponsor
First posted
Oct 13, 2014
Start date
Oct 10, 2014
Primary completion
Apr 24, 2019
Completion
Apr 24, 2019
Last update
Mar 30, 2021

Study contacts

Ian A Myles, M.D.
principal investigator · National Institute of Allergy and Infectious Diseases (NIAID)

Oversight

FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion