Clinical Trial

Rabies Vaccine

Study Description

Systems Biology of Inactivated Rabies Vaccine in Healthy Adults With or Without Use of Broad Spectrum Antibiotics

The study is a prospective randomized, unblinded study looking to enroll 54 subjects at Emory University. The use of antibiotics changes micro-organisms in the intestines. The change to micro-organisms in the intestines may change 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 certain markers (immune responses) in blood and lymph nodes after rabies vaccination with or without the use of antibiotics from day of vaccination to 28 days post vaccination in both groups.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Biological - Rabies Vaccine

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

Drug - Metronidazole

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.

Drug - Vancomycin

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.

Drug - Neomycin Sulfate

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.

Additional Information

Official Study Title

A Prospective Randomized Open Label Trial to Study the Systems Biology of Inactivated Rabies Vaccine in Healthy Adults With or Without Use of Broad Spectrum Antibiotics

Clinical Trial ID

NCT03557008

ParticipAid ID

DdwM8a