Primary Immune Deficiency DiseasesBacteriophageNCT01617122
Evaluate Bacteriophage as a Useful Immunogen in Patients With Primary Immune Deficiency Diseases (PIDD)
A study testing Bacteriophage OX174 in people with Primary Immune Deficiency Diseases, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Immune Deficiency Diseases
- What is being tested?
- Bacteriophage OX174
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1995to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- subject/parent or guardian willing to sign consent and adhere to study schedule
- known or suspected primary immune deficiency
Who cannot join
- pregnancy
- breastfeeding
- unwilling to sign consent or adhere to study schedule
- < 2 yrs of age or > 85 yrs of age
- previous reaction to vaccine
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Florida
St. Petersburg, Florida, 33701
Carla Duff, RN BSN CCRP, 727-553-3515, cduff@health.usf.edu
Amy Kramer, 727-553-1258, akramer@health.usf.edu
About this study
Official title: To Evaluate Bacteriophage OX174 Antigen as a Useful Immunogen in Patients With Immune Deficiency
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.
- Conditions
- Primary Immune Deficiency Diseases
- Being tested
- Bacteriophage OX174
- Keywords
- PID, PIDD, antibody deficiency, CVID, recurrent infections
- Medical subject headings
- Primary Immunodeficiency Diseases, Reinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacteriophage OX174Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Bacteriophage | Experimental | Subjects receive bacteriophage vaccinations and blood draws Receives: Biological: Bacteriophage OX174 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of capacity of switch from IgM to IgG.
Blood samples are obtained after each immunizition of Bacteriophage.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startOct 1995
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune Deficiency DiseasesStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John W Sleasman, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617122
- Sponsor's protocol ID
- ACH 03-0120
- Acronym
- Bacteriophage
- Status last verified
- Jul 2012
- First submitted
- 5 Aug 2010
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate Bacteriophage OX174 Antigen as a Useful Immunogen in Patients With Immune Deficiency
- ClinicalTrials.gov ID
- NCT01617122
- Acronym / sponsor ID
- Bacteriophage / ACH 03-0120
- Conditions
- Primary Immune Deficiency Diseases
- Keywords
- PID, PIDD, antibody deficiency, CVID, recurrent infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Oct 1995
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bacteriophage | Experimental | Biological: Bacteriophage OX174Subjects receive bacteriophage vaccinations and blood draws |
Who may qualify
- Ages
- 2 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- subject/parent or guardian willing to sign consent and adhere to study schedule
- known or suspected primary immune deficiency
Key exclusion criteria (5 listed)
- pregnancy
- breastfeeding
- unwilling to sign consent or adhere to study schedule
- < 2 yrs of age or > 85 yrs of age
- previous reaction to vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacteriophage OX174Give 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. | Biological | Bacteriophage |
Primary outcome
Evidence of capacity of switch from IgM to IgG.
Time frame: 12 weeks
Blood samples are obtained after each immunizition of Bacteriophage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Sleasman, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacteriophage OX174 in people with Primary Immune Deficiency Diseases, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carla Duff, RN BSN CCRP (727-553-3515, cduff@health.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of capacity of switch from IgM to IgG. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2012.