Evaluate Bacteriophage as a Useful Immunogen in Patients With Primary Immune Deficiency Diseases (PIDD) (Bacteriophage)
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|ClinicalTrials.gov Identifier: NCT01617122|
Recruitment Status : Unknown
Verified July 2012 by University of South Florida.
Recruitment status was: Recruiting
First Posted : June 12, 2012
Last Update Posted : July 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Primary Immune Deficiency Diseases||Biological: Bacteriophage OX174||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||To Evaluate Bacteriophage OX174 Antigen as a Useful Immunogen in Patients With Immune Deficiency|
|Study Start Date :||October 1995|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
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.
- Evidence of capacity of switch from IgM to IgG. [ Time Frame: 12 weeks ]Blood samples are obtained after each immunizition of Bacteriophage.
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
|Contact: Carla Duff, RN BSN CCRPfirstname.lastname@example.org|
|Contact: Amy Krameremail@example.com|
|Principal Investigator:||John W Sleasman, MD||University of South Florida|