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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.
We will study using a system biology approach the immune responses to IIV alone vs. IIV with antibiotic administration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IIV Flu Vaccine with Antibiotics | Experimental | This arm will receive antibiotics prior and after IIV administration. |
|
| IIV Flu Vaccine | Active Comparator | This arm will not take antibiotics in conjunction with IIV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IIV Flu Vaccine | Drug | This is an FDA approved and tested Inactivated Flu Vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadine Rouphael, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Vaccine Center | Atlanta | Georgia | 30030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34174187 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Count of Participants | Participants | At day 30 |
|
365 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadine Rouphael, MD | Emory University | 404-712-1435 | nroupha@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2016 | May 30, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D008795 | Metronidazole |
| D009355 | Neomycin |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Metronidazole | Drug | This is a standard antibiotic |
|
|
| Neomycin | Drug | This is a standard antibiotic. |
|
| Vancomycin | Drug | This is a standard antibiotic. |
|
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 6 |
| 16 |
| EG001 | 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. | 0 | 17 | 0 | 17 | 3 | 17 |
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| abdominal pain | General disorders | Non-systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| anal itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| URI | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D009593 |
| Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |