NCT00053508

Brief Summary

The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
274

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2002

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2003

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

6 months

First QC Date

January 30, 2003

Last Update Submit

January 17, 2014

Conditions

Smallpox

Outcome Measures

Primary Outcomes (1)

  • The proportion of subjects in each treatment group who develop a major cutaneous reaction on Day 7, Day 10, and/or Day 15.

    Day 7, Day 10, and/or Day 15

Secondary Outcomes (1)

  • 1.The comparison of treatment groups for the proportion of subjects developing a >fourfold rise in neutralizing antibodies. 2. neutralizing antibody response. 3. geometric mean neutralizing titer on day 31 will be compared between treatment groups.

    days 0 and 30, day 31

Study Arms (4)

Group 1

EXPERIMENTAL

ACAM1000

Biological: ACAM1000

Group 2

EXPERIMENTAL

ACAM1000

Biological: ACAM1000

Group 3

EXPERIMENTAL

ACAM1000

Biological: ACAM1000

Group 4

ACTIVE COMPARATOR

Dryvax

Biological: vaccinia virus (calf lymph) smallpox vaccine: Dryvax

Interventions

ACAM1000BIOLOGICAL

Group 1 dose: 1.4 x 10-8th PFU/ml (350,000 PFU) Group 2 dose: 2.8 x 10-7th PFU/ml (70,000 PFU) Group 3 dose: 5.6 x 10-6th PFU/ml (14,000 PFU)

Group 1Group 2Group 3
vaccinia virus (calf lymph) smallpox vaccine: DryvaxBIOLOGICAL

group 4 dose: 1.6 x 10-8th PFU/ml (250,000 PFU)

Also known as: brand name = Dryvax
Group 4

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • in good general health.
  • not pregnant and using effective birth control
  • agreed to participate in entire study and comply with protocol requirements.

You may not qualify if:

  • military service prior to 1989.
  • no previous smallpox vaccination.
  • no contact with with children 1 year of age or younger
  • immunodeficiency individuals or close contacts who are immunodeficient
  • past history or current renal disease
  • diagnosis or past history of eczema
  • known allergy or past allergic reactions to latex gloves or to some antibiotics (neomycin, streptomycin, chlortetracycline, and polymyxin B).
  • known allergy or past allergic to blood products.
  • known allergy or past allergic reaction to cidofovir or sulfa-containing drugs.
  • transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit.
  • serology positive for HIV, hepatitis B or hepatitis C.
  • current diagnosis or history within six months of drug or alcohol abuse disorders, psychiatric illness.
  • inoculation with any other live vaccine within 30 days of Day 0 or participation in another drug or vaccine trial within 30 days of Day 0.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Orlando Clinical Research Center

Orlando, Florida, 32806, United States

Location

Mayo Vaccine Research Group

Rochester, Minnesota, 55905, United States

Location

Radiant Research

Cincinnati, Ohio, 45236, United States

Location

Related Links

MeSH Terms

Conditions

Smallpox

Interventions

DryVax vaccine

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Medical Director

    Sanofi Pasteur Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2003

First Posted

January 31, 2003

Study Start

September 1, 2002

Primary Completion

March 1, 2003

Study Completion

September 1, 2003

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

US(3)