Responses to Rabies Vaccine in Adults With or Without Antibiotics

NCT03557008 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00101567
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

The use of antibiotics changes micro-organisms in the intestines which may impact the body's vaccine immune response and alter the effectiveness of the rabies vaccine. There will be two randomized groups (1:1 randomization). Group A will start taking an antibiotic regimen by mouth 3 days prior to vaccination and continue taking antibiotics the day of rabies vaccination and one day after vaccination for a total of 5 days. Group B will only receive the rabies vaccination and will not take any antibiotics. The dosage of each antibiotic is taken from their respective package inserts and does not exceed the maximum dose allowed for each antibiotic. The purpose of the study is to look at immune response after rabies vaccination with or without the use of antibiotics from day of vaccination to 28 days post vaccination in both groups.

Conditions

Rabies Human

Keywords

Rabies Vaccine; Antibiotics; Biopsy

Outcome Measures

Primary Outcomes (2)

• Antibody Titers

  Antibody titers are examined by direct comparison of antibody titers in the blood. Rabies specific Immunoglobulin G (IgG) endpoint titer was measured by ELISA. The endpoint titer is defined as the reciprocal of the highest plasma dilution that gives a reading above the cutoff values. The cutoff is set based on the average plus 3 times the standard deviation of the reading of 1:160 dilution of baseline plasma.

  Day 28

• Proportion of Participants Achieving Seroprotection

  Participants are categorized as achieving seropositivity if rabies specific IgG endpoint titer is present.

  Day 28

Study Arms (2)

Rabies Vaccine with Antibiotics

ACTIVE COMPARATOR

Participants in this group will receive the rabies vaccines as well as an antibiotic regimen consisting of metronidazole, vancomycin, and neomycin sulfate.

Biological: Rabies Vaccine; Drug: Metronidazole; Drug: Vancomycin; Drug: Neomycin Sulfate

Rabies Vaccine

ACTIVE COMPARATOR

Participants in this group will receive the rabies vaccine.

Biological: Rabies Vaccine

Interventions

Rabies Vaccine BIOLOGICAL

A 1.0 milliliter (mL) dose of Imovax® will be given to participants on Day 0 and Day 28 of the study.

Also known as: Imovax

Rabies Vaccine; Rabies Vaccine with Antibiotics

Metronidazole DRUG

The antibiotic regimen will be given for five days beginning 3 days prior to vaccination, on the vaccination day, and one day after vaccination for a total for 5. The regimen will include 500 milligrams (mg) of Flagyl taken by mouth three times a day.

Also known as: Flagyl

Rabies Vaccine with Antibiotics

Vancomycin DRUG

The antibiotic regimen will be given for five days beginning 3 days prior to vaccination, on the vaccination day, and one day after vaccination for a total for 5. The regimen will include 125 mg of Vancocin taken by mouth four times a day.

Also known as: Vancocin

Rabies Vaccine with Antibiotics

Neomycin Sulfate DRUG

The antibiotic regimen will be given for five days beginning 3 days prior to vaccination, on the vaccination day, and one day after vaccination for a total for 5. The regimen will include 500 milligrams (mg) of Neomycin sulfate taken by mouth three times a day.

Also known as: Mycifradin

Rabies Vaccine with Antibiotics

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals aged 18-49 years.
• Able to understand and give informed consent.
• Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 28 days before and 28 days after Rabies vaccination.

You may not qualify if:

• Receipt of the following:
• Receipt of blood products 3 months prior to vaccination or expected receipt through 12 months after vaccination.
• Receipt of any live virus vaccines within 28 days prior to vaccination or expected receipt within 28 days after vaccination.
• Receipt of any inactivated vaccine within 14 days or expected receipt within 14 days after vaccination.
• Receipt of any antibiotic 3 months prior to vaccination or expected receipt 28 days after vaccination.
• Receipt of probiotics and prebiotics 3 months prior to vaccination or expected receipt 28 days after vaccination.
• Receipt of proton pump inhibitors, H2 receptor blockers, or antacids 3 months prior to vaccination or expected receipt 28 days after vaccination.
• Presence of co-morbidities or immunosuppressive states such as:
• Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease (including arrhythmias), severe lung disease, auto immune diseases, thrombocytopenia and grade 4 hypertension. Grade 4 hypertension per CTCAE criteria is defined as Life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive).
• Chronic neurologic conditions including seizure disorder, Parkinson's disease, myasthenia gravis, neuropathy, or history of encephalopathy, meningitis or ototoxicity.
• Any history of gastrointestinal disease including (but not only): documented bacterial gastroenteritis or gastroenteritis associated with fever or associated with presence of blood/mucus in stools in the last 3 months, inflammatory bowel disease, and/or gastrointestinal surgery.
• Any history of kidney or liver diseases.
• Alcohol abuse, drug abuse, or psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data.
• Any history of lymphoma involving axillary nodes or any history of breast cancer.
• Impaired immune function or known chronic infections including, but not limited to, known HIV, tuberculosis, hepatitis B or C; organ transplantation (bone marrow, hematopoietic stem cell, or solid organ transplant); immunosuppression due to cancer; current and/or expected receipt of chemotherapy, radiation therapy, steroids (i.e., more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days, or high dose inhaled corticosteroids); and any other immunosuppressive therapies, functional or anatomic asplenia, or congenital immunodeficiency. Subjects receiving \> 20 mg/day of prednisone or its equivalent daily or on alternate days for more than 2 weeks may enter the study after therapy has been discontinued for more than 3 months and Subjects are excluded if on high dose intranasal steroids defined as \> 960 mcg/day of beclomethasone dipropionate or equivalent.

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

The Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030, United States

Location

MeSH Terms

Interventions

Rabies Vaccines; Metronidazole; Vancomycin; Neomycin

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Aminoglycosides; Glycosides

Results Point of Contact

• Title: Nadine Rouphael, MD
• Organization: Emory University

nroupha@emory.edu

404-712-1435

Study Officials

• Nadine Rouphael, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Longitudinal and Randomized

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 14, 2018
• Study Start: July 5, 2018
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: June 8, 2023
• Results First Posted: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)