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

Phase 1 Study of the Safety and Immunogenicity of RiVax With Alum in Healthy Adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00812071

Acronym

FDA-OPD

Enrollment

Registered

2008-12-19

Start date

2008-03-31

Completion date

2012-05-31

Last updated

2013-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

volunteers

Brief 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.

Detailed description

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

Interventions

BIOLOGICALRiVax

vaccine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 31 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
assess the safety of 3 dose levels	one year

Secondary

Measure	Time frame
determine the immunogenicity of the 3 dose levels	one year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026