25 Participants NeededMy employer runs this trial

Vancomycin for Allergies

PA
JH
Overseen ByJennifer Hoffmann
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how vancomycin, administered through infusion, affects individuals without traditional allergy markers. Researchers aim to identify new blood markers that emerge during a reaction to the drug. The study targets generally healthy individuals who have never taken vancomycin and do not have certain medical conditions, such as allergies to similar drugs or ongoing infections. Participants will undergo a skin allergy test for vancomycin and receive a single infusion of the drug. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants an opportunity to contribute to groundbreaking research.

Do I need to stop taking my current medications for the trial?

You will need to stop taking antihistamines one week before joining the study and cannot take them during the trial. If you are using beta-blockers, immunomodulatory therapies, oral corticosteroids, or biologics, you may not be eligible to participate.

Is there any evidence suggesting that vancomycin is likely to be safe for humans?

Research has shown that vancomycin, an antibiotic, can cause different reactions in some people. In a large study, about 0.3% of patients reported an allergy or sensitivity to vancomycin. This means that out of over 4 million patients, only a small number experienced some kind of reaction.

The most common reaction is a vancomycin infusion reaction (VIR), occurring in 3.7% to 47% of people receiving the drug. VIR can cause symptoms like skin redness and itching. In rare cases, more serious reactions like anaphylaxis, a severe allergic reaction, have occurred, but these are less common.

Overall, most people do not have a true allergy to vancomycin. Many reactions are not caused by the immune system, so they are not typical allergies. While there are risks, these reactions can often be managed by slowing the infusion or providing supportive care.12345

Why are researchers excited about this trial's treatment for allergies?

Vancomycin is unique because it is being explored as an unconventional treatment for allergies, which is different from the usual antihistamines and corticosteroids. Typically used as an antibiotic, vancomycin's potential lies in its ability to modulate the microbiome, which might influence allergic responses. Researchers are excited about this approach because it targets the underlying microbiological factors, offering a fresh perspective on allergy management.

What evidence suggests that vancomycin might be an effective treatment for allergies?

Research has shown that vancomycin can cause various unexpected allergic reactions, known as hypersensitivity reactions. These reactions may occur immediately or take time to appear, with about 42% of cases showing immediate signs. The most common reaction is the vancomycin infusion reaction (VIR), occurring in up to 47% of patients. However, many patients (about 86%) who exhibit symptoms do not have a true allergy, meaning their reactions are not immune system-related. This trial will involve a single infusion of vancomycin in healthy volunteers to study these reactions. Identifying specific biomarkers, detectable signs in the blood, during these reactions is crucial for understanding how and why they occur. This could help doctors determine who might experience these reactions and how to prevent them.12346

Who Is on the Research Team?

MD

Melanie Dispenza, MD, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults who are either healthy or have a known allergy to folinic acid, and may have had reactions to vancomycin. Participants should not have conditions that would make the study unsafe for them.

Inclusion Criteria

Ability to clearly understand and speak English at an 8th grade reading level for safety reasons due to need for clear and timely communication with investigators and study team
Women of child bearing potential must agree to a reliable form of highly effective contraception prior to study entry, for the duration of study participation, and for 7 days following completion of vancomycin therapy
My kidney function is normal based on recent blood tests.
See 2 more

Exclusion Criteria

I am able to stop taking antihistamines before and during the study.
I have taken vancomycin before, either by mouth or through an IV.
I currently have trouble hearing.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Allergy Skin Testing

Participants undergo allergy skin testing for vancomycin

1 day
1 visit (in-person)

Treatment

Participants receive an infusion of vancomycin to investigate biomarkers of non-IgE-mediated immediate hypersensitivity reactions

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the vancomycin infusion

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Vancomycin

Trial Overview

The study tests how people react to an IV infusion of vancomycin and looks for new blood markers linked to immediate allergic-type reactions. All participants get skin testing and then receive vancomycin by IV.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: VancomycinExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+

Citations

Vancomycin Hypersensitivity Reactions Documented in ... - PMC

Vancomycin causes diverse adverse reactions, including common (e.g., RMS) and severe (e.g., DRESS) reactions entered as DAL free-text. Anaphylaxis comprised 6% ...

Vancomycin Hypersensitivity: It Is Not Always What It Seems

Of the 18,761 documented suspected vancomycin HSRs, 42% were determined likely immediate and 20% likely nonimmediate on the basis of signs and symptoms ...

Vancomycin Infusion Reaction: A Clinical and Therapeutic ...

VIR is the most common hypersensitivity reaction associated with vancomycin use.1 The incidence of VIR is estimated to be 3.7% to 47% in patients who receive ...

Vancomycin Infusion Reaction

Approximately 86% of patients in our review did not have a true vancomycin allergy, defined as immune-mediated or hypersensitivity reactions ...

Vancomycin Flushing Syndrome Mimicking an Allergic ...

Rapid recognition and cessation of the vancomycin infusion led to prompt resolution of symptoms. Clinicians should be aware that VFS is a common ...

#PharmToExamTable: Vancomycin Allergy and Cross ...

Clinical cross-reactivity between glycopeptides remains controversial, with varied reports suggesting possible immunological cross-reactivity.