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

Smallpox Clinical Trial

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®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00042094
• Other study ID #: SMPX-001
• Status: Completed
• Phase: Phase 1
• First received: July 23, 2002
• Last updated: June 29, 2011
• Start date: March 2002
• Est. completion date: March 2003

Study information

• Verified date: June 2011
• Source: DynPort Vaccine Company LLC, A CSC Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: March 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smallpox

Intervention

Biological:
• Cell-Cultured Smallpox Vaccine compared to Dryvax®

Locations

Country	Name	City	State
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
DynPort Vaccine Company LLC, A CSC Company

Country where clinical trial is conducted

United States,