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Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination

Primary Purpose

Smallpox

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ACAM1000
vaccinia virus (calf lymph) smallpox vaccine: Dryvax
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smallpox

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Orlando Clinical Research Center
  • Mayo Vaccine Research Group
  • Radiant Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

ACAM1000

ACAM1000

ACAM1000

Dryvax

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 30, 2003
Last Updated
January 17, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00053508
Brief Title
Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Official Title
The Effect of Dose On Safety, Tolerability, and Immunogenicity of ACAM1000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination A Phase 2, Randomized, Double-Blind, Dose-Response Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
CDC's decision to down-select vaccine development to single candidate, ACAM2000
Study Start Date
September 2002 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
September 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
In addition to assessment of safety parameters, the objective of this study is to determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine. Specifically, the objectives of this study are to: Compare the safety and tolerability of three dose levels of ACAM1000 and a standard dose of Dryvax® in healthy adults 18-29 years of age and naïve to smallpox vaccine. Safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis. Determine the immunogenicity of three dose levels of ACAM1000 and a standard dose of Dryvax® in healthy adults 18-29 years of age by comparing: (a)the proportion of subjects at each dose level who develop a major cutaneous reaction; (b)the proportion of subjects in each treatment group who develop neutralizing antibodies, including the fold-increase in antibody titer between Baseline and Day 30 sera; and the geometric mean vaccinia neutralizing antibody titer on Day 30. Determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
ACAM1000
Arm Title
Group 2
Arm Type
Experimental
Arm Description
ACAM1000
Arm Title
Group 3
Arm Type
Experimental
Arm Description
ACAM1000
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
Dryvax
Intervention Type
Biological
Intervention Name(s)
ACAM1000
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
vaccinia virus (calf lymph) smallpox vaccine: Dryvax
Other Intervention Name(s)
brand name = Dryvax
Intervention Description
group 4 dose: 1.6 x 10-8th PFU/ml (250,000 PFU)
Primary Outcome Measure Information:
Title
The proportion of subjects in each treatment group who develop a major cutaneous reaction on Day 7, Day 10, and/or Day 15.
Time Frame
Day 7, Day 10, and/or Day 15
Secondary Outcome Measure Information:
Title
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.
Time Frame
days 0 and 30, day 31

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: in good general health. not pregnant and using effective birth control agreed to participate in entire study and comply with protocol requirements. Exclusion criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc
Official's Role
Study Director
Facility Information:
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Mayo Vaccine Research Group
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

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Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination

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