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Virus Therapy

Bacteriophage for Primary Immunodeficiency (Bacteriophage Trial)

N/A
Waitlist Available
Led By John W Sleasman, MD
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Primary Immunodeficiency

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evidence of capacity of switch from IgM to IgG.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BacteriophageExperimental Treatment1 Intervention
Subjects receive bacteriophage vaccinations and blood draws

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Who is running the clinical trial?

University of South FloridaLead Sponsor
425 Previous Clinical Trials
190,275 Total Patients Enrolled
John W Sleasman, MDPrincipal InvestigatorUniversity of South Florida
~7 spots leftby Nov 2025
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