HealthyPhase 1FDA-OPDNCT00812071
Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin
A Phase 1 study testing RiVax in people with Healthy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Dose escalation study: 3 dose groups. 5 patients in each dose group, then 15 more patients in "best" group. 3 vaccinations in volunteers, at 0 6 and 16 weeks. Read more about this study
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 to 31 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers aged 18-31, m or f
Who cannot join
- immunodeficiency
- pregnant
- chronic disease
- parental IgG
- abnormal labs
- drug use
Show all 9Show fewer
- hiv
- hep c
- hep b
Trial locations and contacts
1 site in 1 country.
United States1 site
Hampton Roads Center For Clinical Research
Chesapeake, Virginia, 23320
About this study
Official title: Phase 1 Study of the Safety and Immunogenicity of RiVax With Alum in Healthy Adults
Dose escalation study: 3 dose groups. 5 patients in each dose group, then 15 more patients in "best" group. 3 vaccinations in volunteers, at 0 6 and 16 weeks.
Read the detailed description
Final report was submitted to Dr. Karen Russell at FDA, Rockville on September 26, 2012.
- Conditions
- Healthy
- Being tested
- RiVax
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiVaxBiological
vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the safety of 3 dose levels
Measured: one year
Secondary outcomes (1)
determine the immunogenicity of the 3 dose levels
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Vitetta, University of Texas Southwestern Medical Center
- Investigators
- Lubin, Dr., Principal investigator, Lubin Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812071
- Sponsor's protocol ID
- 3369-01
- Other IDs
- 1R01FD003369-01A1
- Acronym
- FDA-OPD
- Status last verified
- Aug 2013
- First submitted
- 15 Dec 2008
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Safety and Immunogenicity of RiVax With Alum in Healthy Adults
- ClinicalTrials.gov ID
- NCT00812071
- Acronym / sponsor ID
- FDA-OPD / 3369-01
- Conditions
- Healthy
- Keywords
- volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 19 Dec 2008 (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.
Dose escalation study: 3 dose groups. 5 patients in each dose group, then 15 more patients in "best" group. 3 vaccinations in volunteers, at 0 6 and 16 weeks.
Detailed description
Final report was submitted to Dr. Karen Russell at FDA, Rockville on September 26, 2012.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 31 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers aged 18-31, m or f
Key exclusion criteria (9 listed)
- immunodeficiency
- pregnant
- chronic disease
- parental IgG
- abnormal labs
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 |
|---|---|---|
| RiVaxvaccine | Biological | – |
Primary outcome
assess the safety of 3 dose levels
Time frame: one year
1 secondary outcome
determine the immunogenicity of the 3 dose levels
Time frame: one year
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 20 Aug 2013.
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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.
Lubin, Dr. principal investigator
Lubin Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RiVax in people with Healthy, run by University of Texas Southwestern Medical Center 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 1 inclusion and 9 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 20 Aug 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
assess the safety of 3 dose levels (time frame: one year). 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 20 Aug 2013.