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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by University of South Florida.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01617122
First Posted: June 12, 2012
Last Update Posted: July 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of South Florida
  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: None (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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01617122     History of Changes
Other Study ID Numbers: ACH 03-0120
First Submitted: August 5, 2010
First Posted: June 12, 2012
Last Update Posted: July 17, 2012
Last Verified: July 2012

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

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