Skip to main content
OpenTrials
Completed

NCT Number: NCT00042094

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Smallpox DNA Virus Infections Infections Poxviridae Infections Vaccinia Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky Medical Center

Lexington, Kentucky, 40536-0084, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Cell-Cultured Smallpox Vaccine compared to Dryvax®

Biological

Sponsors and collaborators

Lead sponsor

DynPort Vaccine Company LLC, A GDIT Company

Industry

Registry information

Official study 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®)

Important dates

Study start
2002
Study completion
2003
First posted
Jul 26, 2002
Registry last updated
Jun 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.