Evaluate Bacteriophage as a Useful Immunogen in Patients With Primary Immune Deficiency Diseases (PIDD)
NCT ID: NCT01617122
Last Updated: 2012-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
1995-10-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Bacteriophage
Subjects receive bacteriophage vaccinations and blood draws
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.
Interventions
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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 Criteria
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Inclusion Criteria
2. known or suspected primary immune deficiency
Exclusion Criteria
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
2 Years
85 Years
ALL
Yes
Sponsors
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University of South Florida
OTHER
Responsible Party
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Principal Investigators
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John W Sleasman, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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University of South Florida
St. Petersburg, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Carla Duff, RN BSN CCRP
Role: primary
Amy Kramer
Role: backup
Other Identifiers
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ACH 03-0120
Identifier Type: -
Identifier Source: org_study_id