NCT00042094

Brief Summary

This study will evaluate the safety and efficacy of both Dryvax® and the new cell-cultured vaccine (CCSV) in a comparative fashion. Across 3 cohorts, 150 vaccinia-naive volunteers will be randomly assigned to receive either CCSV (100 volunteers) or Dryvax® (50 volunteers) in a blinded fashion. Subjects will be followed closely for up to 6 months and a subgroup of volunteers will be followed up to 3 years in order to evaluate the duration of immunity following vaccination. Another cohort will enroll 100 vaccinia-experienced volunteers and randomly assign them to receive either CCSV (50 volunteers) or Dryvax® (50 volunteers) and a sub group will be followed up to 3 years. A fifth cohort will enroll 100 vaccinia-naive volunteers and randomly assign them to receive different dilutions of CCSV (1:1, 1:5, 1:25, and 1:50).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2002

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2002

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

June 30, 2011

Status Verified

June 1, 2011

First QC Date

July 23, 2002

Last Update Submit

June 29, 2011

Conditions

Smallpox

Keywords

SmallpoxSmallpox VaccineVaccinia

Interventions

Cell-Cultured Smallpox Vaccine compared to Dryvax®BIOLOGICAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* Have never received smallpox vaccine or previously received an experimental smallpox vectored vaccine (for vaccinia-naive cohorts only) * Have been previously vaccinated within the last 10 years (vaccinia-experienced cohort only) * Must agree to have blood samples banked for future research testing * Have not participated in any clinical trial using investigational product within past month * No current or past history of exfoliative skin problems * Not have regular contact with children under 3 years of age until scab at site of vaccination has fallen off (around 21 days or 3 weeks after vaccination) * Do not have a positive test for HIV virus, hepatitis C virus, or hepatitis B surface antigen * Are not a health care worker caring for newborns, patients that are immunocompromised or have skin that is adversely altered * Will not engage in direct patient care until immunization scab falls off (around 21 days or 3 weeks after vaccination) if health care worker

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536-0084, United States

Location

MeSH Terms

Conditions

SmallpoxVaccinia

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 23, 2002

First Posted

July 26, 2002

Study Start

March 1, 2002

Study Completion

March 1, 2003

Last Updated

June 30, 2011

Record last verified: 2011-06

Locations

US(1)