Expired Study
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Lexington, Kentucky 40536


Purpose:

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).


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


Study is Available At:


Original ID:

SMPX-001


NCT ID:

NCT00042094


Secondary ID:


Study Acronym:


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®)


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

DynPort Vaccine Company LLC, A CSC Company


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

350


Enrollment Type:


Study Dates

Start Date:March 2002
Completion Date:March 2003
Verification Date:June 2011
Last Changed Date:June 29, 2011
First Received Date:July 23, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:Cell-Cultured Smallpox Vaccine compared to Dryvax®

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:DynPort Vaccine Company LLC, A CSC Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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