CClinicalTrials.gg
CompletedNCT00812071FDA-OPDUpdated Aug 20, 2013

Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin

A Phase 1 interventional study of RiVax in Healthy, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 31 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-20.

Sponsored by University of Texas Southwestern Medical Center · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 31 Years
Sex
All
01

Study 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 the detailed description

Final report was submitted to Dr. Karen Russell at FDA, Rockville on September 26, 2012.

02

Conditions studied

  • Healthy

Keywords

  • volunteers
03

In context

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 31 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy volunteers aged 18-31, m or f

Exclusion criteria

Exclusion Criteria:

  • immunodeficiency
  • pregnant
  • chronic disease
  • parental IgG
  • abnormal labs
  • drug use
  • hiv
  • hep c
  • hep b
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Interventions

  • BiologicalRiVax

    vaccine

06

What researchers measure

Primary outcomes

  1. assess the safety of 3 dose levels

    Time frame: one year

Secondary outcomes

  1. determine the immunogenicity of the 3 dose levels

    Time frame: one year

07

Study locations

1 site
  • Hampton Roads Center For Clinical Research
    Chesapeake, Virginia 23320, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00812071
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Ellen Vitetta (Director, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Dec 19, 2008
Start date
Mar 2008
Primary completion
Jan 2012
Completion
May 2012
Last update
Aug 20, 2013

Study contacts

Lubin, Dr.
principal investigator · Lubin Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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