Influenza
Conditions
Keywords
Flu Vaccine, Intestinal Microbiome, Antibiotics
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
Interventions
DRUGIIV Flu Vaccine
This is an FDA approved and tested Inactivated Flu Vaccine.
DRUGMetronidazole
This is a standard antibiotic
DRUGNeomycin
This is a standard antibiotic.
DRUGVancomycin
This is a standard antibiotic.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30 | At day 30 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IIV Flu Vaccine With Antibiotics This arm will receive antibiotics prior and after IIV administration.
Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.
Metronidazole: This is a standard antibiotic
Neomycin: This is a standard antibiotic.
Vancomycin: This is a standard antibiotic. | 16 |
| IIV Flu Vaccine This arm will not take antibiotics in conjunction with IIV.
Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine. | 17 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | enrolled but not vaccinated | 1 | 0 |
| Overall Study | Pregnancy | 1 | 0 |
Baseline characteristics
| Characteristic | IIV Flu Vaccine With Antibiotics | IIV Flu Vaccine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 17 Participants | 33 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 8 Participants | 16 Participants |
| Region of Enrollment United States | 16 Participants | 17 Participants | 33 Participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 17 |
| other Total, other adverse events | 6 / 16 | 3 / 17 |
| serious Total, serious adverse events | 0 / 16 | 0 / 17 |
Outcome results
Primary
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
Time frame: At day 30
Population: The Overall Number of Participants analyzed for IIV Flu Vaccine with Antibiotics is 15, as one participant received antibiotics and did not receive vaccine. The study personnel were unable to draw blood on her at the vaccination day- therefore she was part of the safety population and not the immunogenicity population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IIV Flu Vaccine With Antibiotics | Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30 | 15 Participants |
| IIV Flu Vaccine | Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30 | 17 Participants |