Evaluate Bacteriophage as a Useful Immunogen in Patients With Primary Immune Deficiency Diseases (PIDD)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||To Evaluate Bacteriophage OX174 Antigen as a Useful Immunogen in Patients With Immune Deficiency|
- Evidence of capacity of switch from IgM to IgG. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Blood samples are obtained after each immunizition of Bacteriophage.
|Study Start Date:||October 1995|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Subjects receive bacteriophage vaccinations and blood draws
Biological: Bacteriophage OX174
Give first dose of bacteriophage (2 x 109 PFU/kg body weight (0.02 ml/kg)) at visit one. Obtain labs prior to vaccine, 15 minutes, 1 week, 2 weeks, and 4 weeks after vaccine. 6 weeks after 1st vaccine, obtain blood, give 2nd dose of bacteriophage, obtain labs 15 minutes, 1 week, 2 weeks, and 4 weeks after vaccine. Selected patients may receive a tertiary vaccine.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617122
|Contact: Carla Duff, RN BSN CCRPemail@example.com|
|Contact: Amy Kramerfirstname.lastname@example.org|
|United States, Florida|
|University of South Florida||Recruiting|
|St. Petersburg, Florida, United States, 33701|
|Contact: Carla Duff, RN BSN CCRP 727-553-3515 email@example.com|
|Contact: Amy Kramer 727-553-1258 firstname.lastname@example.org|
|Principal Investigator:||John W Sleasman, MD||University of South Florida|