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

NCT02154061 | Completed Results

• 1 other identifier: IRB00074239
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Flu Vaccine, Intestinal Microbiome, Antibiotics

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30

  Number of participants with four fold rise in HAI titers or HAI 1:40 and above in each group at D30 will be recorded based on immunologic testing of blood samples

  At day 30

Study Arms (2)

IIV Flu Vaccine with Antibiotics

EXPERIMENTAL

This arm will receive antibiotics prior and after IIV administration.

Drug: IIV Flu Vaccine; Drug: Metronidazole; Drug: Neomycin; Drug: Vancomycin

IIV Flu Vaccine

ACTIVE COMPARATOR

This arm will not take antibiotics in conjunction with IIV.

Drug: IIV Flu Vaccine

Interventions

IIV Flu Vaccine DRUG

This is an FDA approved and tested Inactivated Flu Vaccine.

Also known as: Fluzone

IIV Flu Vaccine; IIV Flu Vaccine with Antibiotics

Metronidazole DRUG

This is a standard antibiotic

Also known as: Flagyl

IIV Flu Vaccine with Antibiotics

Neomycin DRUG

This is a standard antibiotic.

IIV Flu Vaccine with Antibiotics

Vancomycin DRUG

This is a standard antibiotic.

Also known as: Vancocin

IIV Flu Vaccine with Antibiotics

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals aged 18-40 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 30 days before and 30 days after TIV vaccination

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Vaccine Center

Atlanta, Georgia, 30030, United States

Location

Related Publications (1)

• 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.

  PMID: 34174187 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; Metronidazole; Neomycin; Vancomycin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 3, 2014
• Study Start: April 1, 2015
• Primary Completion: May 26, 2017
• Study Completion: May 26, 2017
• Last Updated: August 15, 2018
• Results First Posted: June 27, 2018

Record last verified: 2018-07

Locations

US (1)