Evaluate Bacteriophage as a Useful Immunogen in Patients With Primary Immune Deficiency Diseases (PIDD)
This study is currently recruiting participants.
Verified July 2012 by University of South Florida
Sponsor:
University of South Florida
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
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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 |
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:
- subject/parent or guardian willing to sign consent and adhere to study schedule
- known or suspected primary immune deficiency
Exclusion Criteria:
- pregnancy
- breastfeeding
- unwilling to sign consent or adhere to study schedule
- < 2 yrs of age or > 85 yrs of age
- previous reaction to vaccine
Contacts and Locations
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 Malnutrition Nutrition Disorders |
ClinicalTrials.gov processed this record on May 21, 2013