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Trial record 31 of 61 for:    Neomycin sulfate

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02154061
Recruitment Status : Completed
First Posted : June 3, 2014
Results First Posted : June 27, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Nadine Rouphael, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Influenza
Interventions Drug: IIV Flu Vaccine
Drug: Metronidazole
Drug: Neomycin
Drug: Vancomycin
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IIV Flu Vaccine With Antibiotics IIV Flu Vaccine
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 16 17
Completed 14 17
Not Completed 2 0
Reason Not Completed
Pregnancy             1             0
enrolled but not vaccinated             1             0
Arm/Group Title IIV Flu Vaccine With Antibiotics IIV Flu Vaccine Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 16 17 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
17
 100.0%
33
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Female
7
  43.8%
9
  52.9%
16
  48.5%
Male
9
  56.3%
8
  47.1%
17
  51.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
American Indian or Alaska Native
1
   6.3%
0
   0.0%
1
   3.0%
Asian
0
   0.0%
1
   5.9%
1
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  37.5%
8
  47.1%
14
  42.4%
White
8
  50.0%
8
  47.1%
16
  48.5%
More than one race
1
   6.3%
0
   0.0%
1
   3.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 16 participants 17 participants 33 participants
16
 100.0%
17
 100.0%
33
 100.0%
1.Primary Outcome
Title Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title IIV Flu Vaccine With Antibiotics IIV Flu Vaccine
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 15 17
Measure Type: Count of Participants
Unit of Measure: Participants
15
 100.0%
17
 100.0%
Time Frame 365 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IIV Flu Vaccine With Antibiotics IIV Flu Vaccine
Hide Arm/Group Description

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.

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.

All-Cause Mortality
IIV Flu Vaccine With Antibiotics IIV Flu Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/17 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
IIV Flu Vaccine With Antibiotics IIV Flu Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/17 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IIV Flu Vaccine With Antibiotics IIV Flu Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/16 (37.50%)      3/17 (17.65%)    
Blood and lymphatic system disorders     
thrombocytopenia *  2/16 (12.50%)  2 0/17 (0.00%)  0
anemia *  3/16 (18.75%)  3 1/17 (5.88%)  1
neutropenia *  1/16 (6.25%)  1 0/17 (0.00%)  0
leukopenia *  1/16 (6.25%)  1 1/17 (5.88%)  1
Gastrointestinal disorders     
nausea *  1/16 (6.25%)  1 0/17 (0.00%)  0
diarrhea *  2/16 (12.50%)  2 0/17 (0.00%)  0
General disorders     
abdominal pain *  3/16 (18.75%)  3 0/17 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
URI *  0/16 (0.00%)  0 1/17 (5.88%)  1
Skin and subcutaneous tissue disorders     
anal itching *  1/16 (6.25%)  1 0/17 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Nadine Rouphael, MD
Organization: Emory University
Phone: 404-712-1435
Responsible Party: Nadine Rouphael, Emory University
ClinicalTrials.gov Identifier: NCT02154061     History of Changes
Other Study ID Numbers: IRB00074239
First Submitted: May 29, 2014
First Posted: June 3, 2014
Results First Submitted: May 30, 2018
Results First Posted: June 27, 2018
Last Update Posted: August 15, 2018