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Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics

NCT02154061 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2018-08-15

Study results available
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Summary

The purpose of the study is to better understand how 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 IIV (seasonal flu) vaccine.

In particular, the investigators will be looking at certain markers in blood after vaccination with IIV (seasonal flu vaccine) with or without the use of antibiotics before vaccination.

There will be two randomized groups. Group A will start taking antibiotic by mouth 3 days prior to vaccination and continue taking antibiotics the day of vaccination and one day after vaccination for a total of 5 days. Group B will only receive the IIV (seasonal flu vaccine) and will not take any antibiotics.

The investigators hope to enroll 50 subjects at Emory.

Conditions

Interventions

DRUG

IIV Flu Vaccine

This is an FDA approved and tested Inactivated Flu Vaccine.

DRUG

Metronidazole

This is a standard antibiotic

DRUG

Neomycin

This is a standard antibiotic.

DRUG

Vancomycin

This is a standard antibiotic.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Nadine Rouphael, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-05-26
Completion
2017-05-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02154061 on ClinicalTrials.gov