To Evaluate Bacteriophage OX174 Antigen as a Useful Immunogen in Patients With Immune Deficiency
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of South Florida
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Evidence of capacity of switch from IgM to IgG.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 85 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •subject/parent or guardian willing to sign consent and adhere to study schedule
- •known or suspected primary immune deficiency
Exclusion Criteria
- •breastfeeding
- •unwilling to sign consent or adhere to study schedule
- •< 2 yrs of age or > 85 yrs of age
- •previous reaction to vaccine
Outcomes
Primary Outcomes
Evidence of capacity of switch from IgM to IgG.
Time Frame: 12 weeks
Blood samples are obtained after each immunizition of Bacteriophage.
Secondary Outcomes
No secondary outcomes reported