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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-05-31

Brief Summary

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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

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

Conditions

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Healthy

Keywords

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volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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RiVax

vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

31 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Ellen Vitetta

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lubin, Dr.

Role: PRINCIPAL_INVESTIGATOR

Lubin Clinic

Locations

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Hampton Roads Center For Clinical Research

Chesapeake, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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1R01FD003369-01A1

Identifier Type: FDA

Identifier Source: secondary_id

View Link

3369-01

Identifier Type: -

Identifier Source: org_study_id