Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation of a Cell-Cultured Smallpox Vaccine Compared to Dryvax®

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Cell-Cultured Smallpox Vaccine compared to Dryvax®

About this trial

This is an interventional prevention trial for Smallpox focused on measuring Smallpox, Smallpox Vaccine, Vaccinia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Kentucky Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00042094

First Posted

July 23, 2002

Last Updated

June 29, 2011

Sponsor

DynPort Vaccine Company LLC, A GDIT Company

1. Study Identification

Unique Protocol Identification Number

NCT00042094

Brief Title

Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation of a Cell-Cultured Smallpox Vaccine Compared to Dryvax®

Official Title

A Phase 1 Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation (Take Rate) of a Cell-Cultured Smallpox Vaccine (CCSV) Compared to a Calf Lymph Vaccine (Dryvax®)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

March 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

DynPort Vaccine Company LLC, A GDIT Company

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smallpox

Keywords

Smallpox, Smallpox Vaccine, Vaccinia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

350 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Cell-Cultured Smallpox Vaccine compared to Dryvax®

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of Kentucky Medical Center

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536-0084

Country

United States

Smallpox

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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