Evaluate Bacteriophage as a Useful Immunogen in Patients With Primary Immune Deficiency Diseases (PIDD)



Status:Completed
Conditions:Other Indications, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:2 - 85
Updated:4/2/2016
Start Date:October 1995
End Date:December 2015
Contact:Carla Duff, RN BSN CCRP
Email:cduff@health.usf.edu
Phone:727-553-3515

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Trial Summary
Trial Overview
Inclusion Criteria

To Evaluate Bacteriophage OX174 Antigen as a Useful Immunogen in Patients With Immune Deficiency

This protocol is designed to ascertain whether the bacteriophage 0X174 neoantigen is safe
and effective as an antigen used in the evaluation of primary and secondary immune
responses. Bacteriophage 0X174 is given intravenously 2 billion PFU/Kg of body weight; small
blood specimens of 3-5 ml (about 1 teaspoon) are collected after 15 minutes, 7 days, 14
days, and 28 days. Blood is collected at intervals following the administration of the
bacteriophage and the number of phage/ml is determined by the agar overlay method using
suspension of E. coli C and serially diluted patient's serum. Phage-specific IgG and IgM are
measured by neutralization assay. Capacity of switch from IgM to IgG is determined.


Inclusion Criteria:

1. subject/parent or guardian willing to sign consent and adhere to study schedule

2. known or suspected primary immune deficiency

Exclusion Criteria:

1. pregnancy

2. breastfeeding

3. unwilling to sign consent or adhere to study schedule

4. < 2 yrs of age or > 85 yrs of age

5. previous reaction to vaccine
We found this trial at
1
site
University of South Florida
St. Petersburg, Florida 33701
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mi
from
St. Petersburg, FL
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