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OpenTrials
Completed

NCT Number: NCT00812071

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

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.

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Key information

Conditions

Healthy

Age range

18 year–31 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hampton Roads Center For Clinical Research

Chesapeake, Virginia, 23320, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RiVax

Biological

vaccine

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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Acronym: FDA-OPD

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 19, 2008
Registry last updated
Aug 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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