Healthy VolunteerPhase 1/2NCT07605806
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
A Phase 1/2 study testing Vancomycin (IV) in people with Healthy Volunteer and Hypersensitivity Reactions, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Hypersensitivity Reactions, Vancomycin
- What is being tested?
- Vancomycin (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2026to 30 Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
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
- Conditions
- Healthy Volunteer, Hypersensitivity Reactions, Vancomycin
- Being tested
- Vancomycin (IV)
- Keywords
- non-IgE-mediated hypersensitivity reaction, Healthy volunteer, vancomycin
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin (IV)Drug
single infusion of vancomycin in healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin | Experimental | single infusion of vancomycin in healthy volunteers Receives: Drug: Vancomycin (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum vancomycin concentration (mg/mL)
The concentration of vancomycin in serum (in mg/mL) associated with an infusion reaction
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start21 May 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Dispenza, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605806
- Sponsor's protocol ID
- IRB00358755
- Other IDs
- R21AI182531
- Status last verified
- Oct 2026
- First submitted
- 5 May 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
- ClinicalTrials.gov ID
- NCT07605806
- Acronym / sponsor ID
- IRB00358755
- Conditions
- Healthy Volunteer, Hypersensitivity Reactions, Vancomycin
- Keywords
- non-IgE-mediated hypersensitivity reaction, Healthy volunteer, vancomycin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 21 May 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vancomycin | Experimental | Drug: Vancomycin (IV)single infusion of vancomycin in healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycin (IV)single infusion of vancomycin in healthy volunteers | Drug | Vancomycin |
Primary outcome
Serum vancomycin concentration (mg/mL)
Time frame: 30 minutes
The concentration of vancomycin in serum (in mg/mL) associated with an infusion reaction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Dispenza, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vancomycin (IV) in people with Healthy Volunteer and Hypersensitivity Reactions, run by Johns Hopkins University 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 12 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
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?
Serum vancomycin concentration (mg/mL) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.