Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin (FDA-OPD)

The University of Texas System (UT)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: RiVax

Study type: Interventional

Funder types: Other

Identifiers

NCT00812071

1R01FD003369-01A1

3369-01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 31 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers aged 18-31, m or f

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)