NCT07605806

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
12mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
May 2026Jun 2027

First Submitted

Initial submission to the registry

May 5, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

May 21, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 5, 2026

Last Update Submit

May 21, 2026

Conditions

Healthy VolunteerHypersensitivity ReactionsVancomycin

Keywords

non-IgE-mediated hypersensitivity reactionHealthy volunteervancomycin

Outcome Measures

Primary Outcomes (1)

  • Serum vancomycin concentration (mg/mL)

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

    30 minutes

Study Arms (1)

Vancomycin

EXPERIMENTAL

single infusion of vancomycin in healthy volunteers

Drug: Vancomycin (IV)

Interventions

Vancomycin (IV)DRUG

single infusion of vancomycin in healthy volunteers

Vancomycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 contraception (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 informed consent.
  • 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.

You may not qualify if:

  • 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 excipients.
  • 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 corticosteroids 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Hypersensitivity

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Melanie Dispenza, MD, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Hoffmann

CONTACT

4109551318jhoffm45@jh.edu

Pooja Akoijam

CONTACT

410-955-1201pakoija1@jh.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 26, 2026

Study Start

May 21, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

May 26, 2026

Record last verified: 2026-05

Locations

US(1)