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Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics (VAX-002)

Primary Purpose

Influenza

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

IIV Flu Vaccine

Metronidazole

Neomycin

Vancomycin

About this trial

This is an interventional other trial for Influenza focused on measuring Flu Vaccine, Intestinal Microbiome, Antibiotics

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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.

Sites / Locations

Emory Vaccine Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IIV Flu Vaccine with Antibiotics

IIV Flu Vaccine

Arm Description

This arm will receive antibiotics prior and after IIV administration.

This arm will not take antibiotics in conjunction with IIV.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02154061

First Posted

May 29, 2014

Last Updated

July 17, 2018

Sponsor

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT02154061

Brief Title

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

Acronym

VAX-002

Official Title

Systems Biology of Inactivated Influenza Vaccine (IIV) in Healthy Adults With or Without Use of Broad Spectrum Antibiotics

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

May 26, 2017 (Actual)

Study Completion Date

May 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Flu Vaccine, Intestinal Microbiome, Antibiotics

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IIV Flu Vaccine with Antibiotics

Arm Type

Experimental

Arm Description

This arm will receive antibiotics prior and after IIV administration.

Arm Title

IIV Flu Vaccine

Arm Type

Active Comparator

Arm Description

This arm will not take antibiotics in conjunction with IIV.

Intervention Type

Drug

Intervention Name(s)

IIV Flu Vaccine

Other Intervention Name(s)

Fluzone

Intervention Description

This is an FDA approved and tested Inactivated Flu Vaccine.

Intervention Type

Drug

Intervention Name(s)

Metronidazole

Other Intervention Name(s)

Flagyl

Intervention Description

This is a standard antibiotic

Intervention Type

Drug

Intervention Name(s)

Neomycin

Intervention Description

This is a standard antibiotic.

Intervention Type

Drug

Intervention Name(s)

Vancomycin

Other Intervention Name(s)

Vancocin

Intervention Description

This is a standard antibiotic.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

At day 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nadine Rouphael, MD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory Vaccine Center

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34174187

Citation

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.

Results Reference

derived

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

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