Evaluate Bacteriophage as a Useful Immunogen in Patients With Primary Immune Deficiency Diseases (PIDD)
Bacteriophage
To Evaluate Bacteriophage OX174 Antigen as a Useful Immunogen in Patients With Immune Deficiency
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 1995
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1995
CompletedFirst Submitted
Initial submission to the registry
August 5, 2010
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 17, 2012
July 1, 2012
20.2 years
August 5, 2010
July 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evidence of capacity of switch from IgM to IgG.
Blood samples are obtained after each immunizition of Bacteriophage.
12 weeks
Study Arms (1)
Bacteriophage
EXPERIMENTALSubjects receive bacteriophage vaccinations and blood draws
Interventions
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 Criteria
You may qualify if:
- subject/parent or guardian willing to sign consent and adhere to study schedule
- known or suspected primary immune deficiency
You may not qualify if:
- pregnancy
- breastfeeding
- unwilling to sign consent or adhere to study schedule
- \< 2 yrs of age or \> 85 yrs of age
- previous reaction to vaccine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of South Florida
St. Petersburg, Florida, 33701, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John W Sleasman, MD
University of South Florida
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2010
First Posted
June 12, 2012
Study Start
October 1, 1995
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
July 17, 2012
Record last verified: 2012-07