Evaluate Bacteriophage as a Useful Immunogen in Patients With Primary Immune Deficiency Diseases (PIDD)
- Conditions
- Primary Immune Deficiency Diseases
- Interventions
- Biological: Bacteriophage OX174
- Registration Number
- NCT01617122
- Lead Sponsor
- University of South Florida
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- subject/parent or guardian willing to sign consent and adhere to study schedule
- known or suspected primary immune deficiency
- pregnancy
- breastfeeding
- unwilling to sign consent or adhere to study schedule
- < 2 yrs of age or > 85 yrs of age
- previous reaction to vaccine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bacteriophage Bacteriophage OX174 Subjects receive bacteriophage vaccinations and blood draws
- Primary Outcome Measures
Name Time Method Evidence of capacity of switch from IgM to IgG. 12 weeks Blood samples are obtained after each immunizition of Bacteriophage.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of South Florida
🇺🇸St. Petersburg, Florida, United States