NCT01617122

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 2 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Primary Immune Deficiency Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 1995-10-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-06-12
• Last updated: 2012-07-17

Locations

1 site across 1 country: United States