NCT00812071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

August 20, 2013

Status Verified

August 1, 2013

Enrollment Period

3.8 years

First QC Date

December 15, 2008

Last Update Submit

August 19, 2013

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

  • assess the safety of 3 dose levels

    one year

Secondary Outcomes (1)

  • determine the immunogenicity of the 3 dose levels

    one year

Interventions

RiVaxBIOLOGICAL

vaccine

Eligibility Criteria

Age18 Years - 31 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers aged 18-31, m or f

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hampton Roads Center For Clinical Research

Chesapeake, Virginia, 23320, United States

Location

MeSH Terms

Interventions

RiVax

Study Officials

  • Lubin, Dr.

    Lubin Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 15, 2008

First Posted

December 19, 2008

Study Start

March 1, 2008

Primary Completion

January 1, 2012

Study Completion

May 1, 2012

Last Updated

August 20, 2013

Record last verified: 2013-08

Locations

US(1)