RabiesNCT01063140
Rabies Immune Plasma Booster Study
An observational study of Rabies, run by CSL Behring at 10 sites in United States.
Trial summary
Rabies immune globulin is a product that is lifesaving to unvaccinated individuals exposed to the rabies virus. Rabies immune globulin is made from plasma from immune donors. Currently the only practical method to obtain this plasma is to immunize normal volunteer Source Plasma donors and collect their plasma while… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Rabies Vaccine (RabAvert) and Rabies Vaccine (Imovax)
- Type of treatment
- Vaccines
- How many people
- 491 participants
- Where
- 10 sitesUnited States
- Study dates
- Jan 2009to May 2010
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Source Plasma Donors. Donors must meet FDA and CSL Plasma requirements to be Source Plasma Donors. Donors had previously participated in CSL's rabies vaccine immunization program.
Who may be able to join
- Meet requirements for Source Plasma donors
- Completed initial series of rabies antibody injections with no serious adverse events for at least 90 days prior to enrollment
- Compliance with program requirements
- Signed informed consent
Who cannot join
- Failure to meet requirements to be Source Plasma donor
- Non-compliance with the program
- Experience a serious adverse reaction
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
CSL Donor Plasma Center
Cleveland, Ohio, 44109
CSL Donor Plasma Center
Knoxville, Tennessee, 37916
CSL Donor Plasma Center
Medord, Oregon, 97501
CSL Donor Plasma Center
Oak Park, Michigan, 48237
CSL Donor Plasma Center
Oklahoma City, Oklahoma, 73103
CSL Donor Plasma Center
Rock Island, Illinois, 61201
CSL Donor Plasma Center
Saint Paul, Minnesota, 55104
CSL Donor Plasma Center
Salt Lake City, Utah, 84115
CSL Donor Plasma Center
Springfield, Ohio, 45503
CSL Donor Plasma Center
Tempe, Arizona, 85282
About this study
Official title: Rabies Immune Plasma Booster Program - A Clinical Study Conducted as an Investigational New Drug Study
Rabies immune globulin is a product that is lifesaving to unvaccinated individuals exposed to the rabies virus. Rabies immune globulin is made from plasma from immune donors. Currently the only practical method to obtain this plasma is to immunize normal volunteer Source Plasma donors and collect their plasma while titers are adequate. The use of rabies vaccine for immunization of normal Source Plasma donors is currently limited to a level that, while protective for the individual, is unsuitable for production of rabies immune globulin.
The objective of this study is to obtain efficacy and safety data regarding the rabies boostering program to demonstrate that:
Read more
- Rabies immune plasma production can be substantially increased by giving booster doses to previously immunized donors whose titers are below 10.0 IU/mL.
- It is safe for normal Source Plasma donors to receive booster doses of rabies vaccine on a regular basis.
This study utilizes two rabies vaccines approved by the FDA, Imovax® (Sanofi-Pasteur) and RabAvert® (Novartis).
- Conditions
- Rabies
- Being tested
- Rabies Vaccine (RabAvert), Rabies Vaccine (Imovax)
- Keywords
- Rabies Immune Globulin, Source Plasma Donors, Booster Immunization
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabies Vaccine (RabAvert)Biological
Also called Rabipur
The initial booster immunization is given on Day 1; subsequent booster immunizations will be administered if the donor's titers fall below 10 IU/mL. A maximum of 4 booster immunizations may be administered over the 2 year study period.
Rabies Vaccine (Imovax)Biological
The initial booster immunization is given on Day 1; subsequent booster immunizations will be administered if the donor's titers fall below 10 IU/mL. A maximum of 4 booster immunizations may be administered over the 2 year study period.
| Study group | Role | What they receive |
|---|---|---|
| RabAvert | Not described Receives: Biological: Rabies Vaccine (RabAvert) | |
| Imovax | Not described Receives: Biological: Rabies Vaccine (Imovax) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer (GMT) for rabies plasma donations received after booster injections
Measured: 30-day intervals for the duration of the study (up to 2 years)
Secondary outcomes (1)
Adverse Event Reaction Rate
Measured: 30-35 days after each injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startJan 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RabiesStudies of the same condition, open and under way.
- More trials run by CSL BehringThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CSL Plasma
- Responsible party
- Sponsor
- Investigators
- Toby L. Simon, MD, Principal investigator, CSL Plasma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063140
- Sponsor's protocol ID
- ZLB 1
- Status last verified
- Sep 2015
- First submitted
- 4 Feb 2010
- Last updated
- 7 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rabies Immune Plasma Booster Program - A Clinical Study Conducted as an Investigational New Drug Study
- ClinicalTrials.gov ID
- NCT01063140
- Acronym / sponsor ID
- ZLB 1
- Conditions
- Rabies
- Keywords
- Rabies Immune Globulin, Source Plasma Donors, Booster Immunization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Collaborators
- CSL Plasma
- Study start
- Jan 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 Feb 2010 (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.
Rabies immune globulin is a product that is lifesaving to unvaccinated individuals exposed to the rabies virus. Rabies immune globulin is made from plasma from immune donors. Currently the only practical method to obtain this plasma is to immunize normal volunteer Source Plasma donors and collect their plasma while titers are adequate. The use of rabies vaccine for immunization of normal Source Plasma donors is currently limited to a level that, while protective for the individual, is unsuitable for production of rabies immune globulin.
The objective of this study is to obtain efficacy and safety data regarding the rabies boostering program to demonstrate that:
- Rabies immune plasma production can be substantially increased by giving booster doses to previously immunized donors whose titers are below 10.0 IU/mL.
- It is safe for normal Source Plasma donors to receive booster doses of rabies vaccine on a regular basis.
This study utilizes two rabies vaccines approved by the FDA, Imovax® (Sanofi-Pasteur) and RabAvert® (Novartis).
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RabAvert | – | Biological: Rabies Vaccine (RabAvert) |
| Imovax | – | Biological: Rabies Vaccine (Imovax) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Source Plasma Donors. Donors must meet FDA and CSL Plasma requirements to be Source Plasma Donors. Donors had previously participated in CSL's rabies vaccine immunization program.
Key inclusion criteria (4 listed)
- Meet requirements for Source Plasma donors
- Completed initial series of rabies antibody injections with no serious adverse events for at least 90 days prior to enrollment
- Compliance with program requirements
- Signed informed consent
Key exclusion criteria (3 listed)
- Failure to meet requirements to be Source Plasma donor
- Non-compliance with the program
- Experience a serious adverse reaction
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 |
|---|---|---|
| Rabies Vaccine (RabAvert)Also: RabipurThe initial booster immunization is given on Day 1; subsequent booster immunizations will be administered if the donor's titers fall below 10 IU/mL. A maximum of 4 booster immunizations may be administered over the 2 year study period. | Biological | RabAvert |
| Rabies Vaccine (Imovax)The initial booster immunization is given on Day 1; subsequent booster immunizations will be administered if the donor's titers fall below 10 IU/mL. A maximum of 4 booster immunizations may be administered over the 2 year study period. | Biological | Imovax |
Primary outcome
Geometric mean titer (GMT) for rabies plasma donations received after booster injections
Time frame: 30-day intervals for the duration of the study (up to 2 years)
1 secondary outcome
Adverse Event Reaction Rate
Time frame: 30-35 days after each injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
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Rabies (Healthy Volunteers)
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.
Toby L. Simon, MD principal investigator
CSL Plasma
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rabies, run by CSL Behring at 10 sites 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean titer (GMT) for rabies plasma donations received after booster injections (time frame: 30-day intervals for the duration of the study (up to 2 years)). 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 7 Sep 2015.