ClinicalTrials.gg
Active, not recruitingNCT07605806Updated Oct 27, 2026

Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions

A Phase 1/2 interventional study of Vancomycin (IV) in Healthy Volunteer, Hypersensitivity Reactions and Vancomycin, sponsored by Johns Hopkins University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Johns Hopkins University · Phase 1/2, Interventional, and Other

Updated Oct 27, 2026Now Active, not recruitingGo to Updates ↓

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Phase
Phase 1/2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 300 studies in Hypersensitivity with a site in United States — 32 open to participants now, 40 under way, 1 of them phase 3. Hypersensitivity · United States.

Planned enrollment
166th of 220
25 · median 60
Started
2026
with 9 others
Phase 1/2
13 of 300
none open now
Primary completion
2027-05
later than 14 of 38 live
Registered
298th of 300
by date
Lead sponsor
8 of 300
Johns Hopkins University

Among the 300 studies in Hypersensitivity with a site in United States, this one is the 166th largest by planned enrollment of the 220 interventional ones that give a count, is one of 10 that started in 2026, is one of 13 in phase 1/2, reaches primary completion later than 14 of the 38 other live ones, and was the 298th registered.

Hypersensitivity

1,056 studies on the registry are indexed under Hypersensitivity; 150 are open to participants now.

Browse Hypersensitivity studies →

Open to participants now

32 of the 300 studies in Hypersensitivity with a site in United States are open now. Recruiting first, the newest first:

27 more — sign in →

All 32 open studies →

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 →

Who these studies take

Of the 101 Hypersensitivity studies recruiting now, 37 (37%) set no upper age limit and 52 (51%) stop at 75 or younger; 56 take children under 18; 37 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study summary

The goal of this clinical trial is to investigate biomarkers of non-IgE-mediated immediate hypersensitivity reactions during infusion of intravenous vancomycin. The main question it aims to answer is:

  • Identifying novel biomarkers in blood that occur during infusion reaction

Participants will:

  • Have allergy skin testing for vancomycin
  • Receive an infusion of vancomycin
03

Conditions studied

  • Healthy Volunteer
  • Hypersensitivity Reactions
  • Vancomycin

Browse trials for

Keywords

  • non-IgE-mediated hypersensitivity reaction
  • Healthy volunteer
  • vancomycin
04

Who can participate

Ages eligible
18 Years and older
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

  • Male or female age ≥ 18 years.
  • Adequate kidney function as defined by creatinine level within normal institutional limits at the participant's first visit.
  • Women of child bearing potential must agree to a reliable form of highly effective (hormonal, device, or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 days following completion of vancomycin therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform the Principal Investigator and her treating physician immediately.
  • Ability to understand and the willingness to sign a written .
  • Ability to clearly understand and speak English at an 8th grade reading level. For safety reasons, participants must speak English due to the anticipated need for clear and timely communication with investigators and the study team in emergency situations, since the investigators and study team are English speaking.

Exclusion criteria

Exclusion Criteria:

  • Participants who have previously received vancomycin in any formulation, including oral or intravenous.
  • History of allergic reactions to study drug or reactions attributed to compounds of similar chemical or biologic composition to vancomycin, including active product or .
  • Concurrent use of medications thought to cause non-specific mast cell activation (e.g. opioids)
  • Baseline serum tryptase over 8.0 ng/mL and/or known mast cell disorder, including, but not limited to, mastocytosis, idiopathic mast cell activation syndrome, and hereditary alpha tryptasemia
  • Active infection or immunodeficiency
  • Unstable cardiovascular disease
  • Renal insufficiency
  • Current hearing deficit
  • Current use of beta-blockers
  • Use of immunomodulatory therapies or oral within the previous 1 month
  • Use of biologics in the previous 6 months, including omalizumab
  • Participants taking antihistamines must stop these drugs for one week prior to enrollment and must refrain from taking antihistamines during the duration of the study so as not to interfere with responses during drug challenge
Terms in these criteria, in plain language(4)

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.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

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.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Vancomycin

    single infusion of vancomycin in healthy volunteers

    Drug: Vancomycin (IV)

Interventions

06

What researchers measure

Primary outcomes

  1. Serum vancomycin concentration (mg/mL)

    The concentration of vancomycin in serum (in mg/mL) associated with an infusion reaction

    Time frame: 30 minutes

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2026 (actual). Primary completion is estimated for May 2027, 12 months after the start.

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

Registered
May 5, 2026
First posted
May 26, 2026
StartActual
May 21, 2026
Primary completionEst.
May 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Oct 27, 2026
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.
Status
Recruiting→Active, not recruiting
changed Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Recruiting→Active, not recruiting
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07605806
Responsible party
Sponsor
First posted
May 26, 2026
Start date
May 21, 2026
Primary completion
May 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Oct 27, 2026

Study contacts

Melanie Dispenza, MD, PhD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Vancomycin

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