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

NCT ID: NCT02154061

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-05-26

Brief 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.

Detailed Description

We will study using a system biology approach the immune responses to IIV alone vs. IIV with antibiotic administration

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

IIV Flu Vaccine with Antibiotics

This arm will receive antibiotics prior and after IIV administration.

Group Type: EXPERIMENTAL

IIV Flu Vaccine

Intervention Type: DRUG

This is an FDA approved and tested Inactivated Flu Vaccine.

Metronidazole

Intervention Type: DRUG

This is a standard antibiotic

Neomycin

Intervention Type: DRUG

This is a standard antibiotic.

Vancomycin

Intervention Type: DRUG

This is a standard antibiotic.

IIV Flu Vaccine

This arm will not take antibiotics in conjunction with IIV.

Group Type: ACTIVE_COMPARATOR

IIV Flu Vaccine

Intervention Type: DRUG

This is an FDA approved and tested Inactivated Flu Vaccine.

Interventions

IIV Flu Vaccine

This is an FDA approved and tested Inactivated Flu Vaccine.

Intervention Type: DRUG

Metronidazole

This is a standard antibiotic

Intervention Type: DRUG

Neomycin

This is a standard antibiotic.

Intervention Type: DRUG

Vancomycin

This is a standard antibiotic.

Intervention Type: DRUG

Other Intervention Names

Fluzone; Flagyl; Vancocin

Eligibility Criteria

Inclusion Criteria

1. Healthy individuals aged 18-40 years.

2. Able to understand and give informed consent.

3. 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 30 days before and 30 days after TIV vaccination

Exclusion Criteria

• You received blood product within 3 months of enrolling in the study or a live attenuated vaccine within 4 weeks or inactivated vaccines within 2 weeks.
• You received the 2014-2015 flu vaccine or had a confirmed case of influenza during 2014-2015.
• You received any antibiotics 6 months prior to enrolling in the study or expect to take antibiotics one month after vaccination.
• You received probiotics or prebiotics 3 months prior before enrolling in the study or expect to take one month after vaccination.
• You received proton pump inhibitors, H2 blocker receptors, or antacids 3 months regularly before enrolling in the study or one month after
• You had an allergic response or sensitivity to past vaccinations.
• You have health conditions that weaken your body's ability to fight infections or you are taking drugs like steroids that weaken your body's ability to fight infections.(Some nasal and topical steroids are allowed.).
• You have a chronic medical problem including (but not limited to) insulin dependent diabetes, severe heart disease including arrhythmias, severe lung disease, auto immune diseases and or grade 4 uncontrolled hypertension.
• Chronic neurological conditions such as seizure disorder, Parkinson disease, myasthenia gravis, neuropathy, or histories of encephalopathy, meningitis or ototoxicity.
• Any history of gastrointestinal disease, kidney or liver diseases.
• Alcohol or drug abuse or psychiatric conditions that in the opinion of the investigator would compromise your participation in this trial.
• Pregnant or are breast feeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Nadine Rouphael

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadine Rouphael, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Vaccine Center

Atlanta, Georgia, United States

Countries

United States

References

Wimmers F, Donato M, Kuo A, Ashuach T, Gupta S, Li C, Dvorak M, Foecke MH, Chang SE, Hagan T, De Jong SE, Maecker HT, van der Most R, Cheung P, Cortese M, Bosinger SE, Davis M, Rouphael N, Subramaniam S, Yosef N, Utz PJ, Khatri P, Pulendran B. The single-cell epigenomic and transcriptional landscape of immunity to influenza vaccination. Cell. 2021 Jul 22;184(15):3915-3935.e21. doi: 10.1016/j.cell.2021.05.039. Epub 2021 Jun 25.

Reference Type: DERIVED

PMID: 34174187 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00074239

Identifier Type: -

Identifier Source: org_study_id