Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic E... | NCT00812071

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

NCT00812071

Sponsor

University of Texas Southwestern Medical Center

Status

Completed

Last Update Posted

Aug 20, 2013Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

RiVax

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01FD003369-01A1	U.S. FDA Grant/Contract		View source

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Jan 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Dec 15, 2008

First Submission Date that Met QC Criteria

Dec 18, 2008

First Posted Date

Dec 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2013

Last Update Posted Date

Aug 20, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ellen Vitetta, Director, University of Texas Southwestern Medical CenterPrincipal Investigator

Lead Sponsor

University of Texas Southwestern Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Name	Type	Description	Arm Group Labels	Other Names
RiVax	Biological	vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
assess the safety of 3 dose levels		one year

Secondary Outcomes

Measure	Description	Time Frame
determine the immunogenicity of the 3 dose levels		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

31 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lubin, Dr.	Lubin Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hampton Roads Center For Clinical Research		Chesapeake	Virginia	23320	United States

Intervention Browse Module

MeSH Terms

ID	Term
C509236	RiVax

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided