drugset / Trial / NCT01617122

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

NCT01617122 ↗

Unknown 200 enrolled University of South Florida
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
1995-10
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bacteriophage OX174 Vaccine 2e+09 unknown Intravenous