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

Primary Immune Deficiency Diseases Clinical Trial

— Bacteriophage  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01617122
• Other study ID #: ACH 03-0120
• Status: Recruiting
• Phase: N/A
• First received: August 5, 2010
• Last updated: July 16, 2012
• Start date: October 1995
• Est. completion date: December 2015

Study information

• Verified date: July 2012
• Source: University of South Florida
• Contact: Carla Duff, RN BSN CCRP
• Phone: 727-553-3515
• Email: cduff[@]health.usf.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 85 Years

Eligibility

Inclusion Criteria:

1. subject/parent or guardian willing to sign consent and adhere to study schedule

2. known or suspected primary immune deficiency

Exclusion Criteria:

1. pregnancy

2. breastfeeding

3. unwilling to sign consent or adhere to study schedule

4. < 2 yrs of age or > 85 yrs of age

5. previous reaction to vaccine

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Deficiency Diseases
• Immunologic Deficiency Syndromes
• Primary Immune Deficiency Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of South Florida	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of capacity of switch from IgM to IgG.	Blood samples are obtained after each immunizition of Bacteriophage.	12 weeks	No