Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by University of South Florida
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01617122
First received: August 5, 2010
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Primary Immune Deficiency Diseases
Biological: Bacteriophage OX174

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: To Evaluate Bacteriophage OX174 Antigen as a Useful Immunogen in Patients With Immune Deficiency

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Evidence of capacity of switch from IgM to IgG. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Blood samples are obtained after each immunizition of Bacteriophage.


Estimated Enrollment: 200
Study Start Date: October 1995
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bacteriophage
Subjects receive bacteriophage vaccinations and blood draws
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.

  Eligibility

Ages Eligible for Study:   2 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617122

Contacts
Contact: Carla Duff, RN BSN CCRP 727-553-3515 cduff@health.usf.edu
Contact: Amy Kramer 727-553-1258 akramer@health.usf.edu

Locations
United States, Florida
University of South Florida Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Carla Duff, RN BSN CCRP    727-553-3515    cduff@health.usf.edu   
Contact: Amy Kramer    727-553-1258    akramer@health.usf.edu   
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: John W Sleasman, MD University of South Florida
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01617122     History of Changes
Other Study ID Numbers: ACH 03-0120
Study First Received: August 5, 2010
Last Updated: July 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of South Florida:
PID
PIDD
antibody deficiency
CVID
recurrent infections

Additional relevant MeSH terms:
Deficiency Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on November 27, 2014