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Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults

Primary Purpose

Smallpox

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ACAM2000 Smallpox Vaccine
Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®
Sponsored by
Emergent BioSolutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smallpox focused on measuring Smallpox vaccines, Dryvax®, Orthopoxvirus, Vaccinia virus, ACAM2000

Eligibility Criteria

28 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: have a history of previous smallpox vaccination greater than 10 years previous to the date of screening and presence of a vaccination scar. females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children. agree to be available for the entire study and agree to comply with all requirements. exclusion criteria: children 1 year of age or younger in the household or be in close contact smallpox vaccination within ten years known or suspected Human immunodeficient virus (HIV) infection, primary immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use of immunosuppressive or anti-neoplastic drugs or have a household member or intimate contact with the conditions listed above. renal disease current or past history of eczema or a household member or direct contact who has eczema. known allergy or past allergic reactions to latex gloves or to antibiotics which include neomycin, streptomycin, chlortetracycline, and polymyxin B known allergy or past allergic reaction to blood products. known allergy to cidofovir or sulfa-containing drugs. history of allergic phenomena following smallpox vaccination in the past, including urticaria, erythema multiforme, or Stevens-Johnson syndrome. transfusion of blood or treatment with any blood product. current or history of drug or alcohol abuse innoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.

Sites / Locations

  • PRA International
  • Bio-Kinetic Clinical Applications
  • Memorial Hospital of Rhode Island Division of Infectious Diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group 1: ACAM2000

Group 2: ACAM2000

Group 3: ACAM2000

Group 4: ACAM2000

Group 5: Dryvax®

Arm Description

Participants will receive dose 1 of the ACAM2000 smallpox vaccine

Participants will receive dose 2 of the ACAM2000 smallpox vaccine

Participants will receive dose 3 of the ACAM2000 smallpox vaccine

Participants will receive dose 4 of the ACAM2000 smallpox vaccine

Participants will receive dose 1 of Dryvax® smallpox vaccine.

Outcomes

Primary Outcome Measures

The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50)
Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine

Secondary Outcome Measures

Full Information

First Posted
January 30, 2003
Last Updated
August 9, 2018
Sponsor
Emergent BioSolutions
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1. Study Identification

Unique Protocol Identification Number
NCT00053482
Brief Title
Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults
Official Title
The Effect of Dose on Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emergent BioSolutions

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age and previously vaccinated against smallpox.
Detailed Description
Specifically, the objectives of this study are to: Compare the safety and tolerability of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age and previously vaccinated to smallpox. 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 four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age by comparing: the proportion of subjects at each dose level who develop a major cutaneous reaction 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 ACAM2000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age, with a history of smallpox vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smallpox
Keywords
Smallpox vaccines, Dryvax®, Orthopoxvirus, Vaccinia virus, ACAM2000

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group 1: ACAM2000
Arm Type
Experimental
Arm Description
Participants will receive dose 1 of the ACAM2000 smallpox vaccine
Arm Title
Group 2: ACAM2000
Arm Type
Experimental
Arm Description
Participants will receive dose 2 of the ACAM2000 smallpox vaccine
Arm Title
Group 3: ACAM2000
Arm Type
Experimental
Arm Description
Participants will receive dose 3 of the ACAM2000 smallpox vaccine
Arm Title
Group 4: ACAM2000
Arm Type
Experimental
Arm Description
Participants will receive dose 4 of the ACAM2000 smallpox vaccine
Arm Title
Group 5: Dryvax®
Arm Type
Active Comparator
Arm Description
Participants will receive dose 1 of Dryvax® smallpox vaccine.
Intervention Type
Biological
Intervention Name(s)
ACAM2000 Smallpox Vaccine
Intervention Description
Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml
Intervention Type
Biological
Intervention Name(s)
Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®
Other Intervention Name(s)
Dryvax®
Intervention Description
Group 5 dose: 1.0x10-8th PFU/ml
Primary Outcome Measure Information:
Title
The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Description
The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50)
Time Frame
Day 30 post-vaccination
Title
Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Time Frame
Day 30 post-vaccination
Title
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Time Frame
Days 0 to 30 post-vaccination
Other Pre-specified Outcome Measures:
Title
Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Time Frame
Days 0 to 30 post-vaccination
Title
Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Time Frame
Days 0 (Baseline) and 15 post-vaccination
Title
Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Time Frame
Days 0 (Baseline) and 15 post-vaccination
Title
Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Time Frame
Days 0 (Baseline) and 15 post-vaccination
Title
Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Time Frame
Days 0 (Baseline) and 15 post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: have a history of previous smallpox vaccination greater than 10 years previous to the date of screening and presence of a vaccination scar. females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children. agree to be available for the entire study and agree to comply with all requirements. exclusion criteria: children 1 year of age or younger in the household or be in close contact smallpox vaccination within ten years known or suspected Human immunodeficient virus (HIV) infection, primary immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use of immunosuppressive or anti-neoplastic drugs or have a household member or intimate contact with the conditions listed above. renal disease current or past history of eczema or a household member or direct contact who has eczema. known allergy or past allergic reactions to latex gloves or to antibiotics which include neomycin, streptomycin, chlortetracycline, and polymyxin B known allergy or past allergic reaction to blood products. known allergy to cidofovir or sulfa-containing drugs. history of allergic phenomena following smallpox vaccination in the past, including urticaria, erythema multiforme, or Stevens-Johnson syndrome. transfusion of blood or treatment with any blood product. current or history of drug or alcohol abuse innoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Emergent BioSolutions
Official's Role
Study Director
Facility Information:
Facility Name
PRA International
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Bio-Kinetic Clinical Applications
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
Memorial Hospital of Rhode Island Division of Infectious Diseases
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States

12. IPD Sharing Statement

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Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults

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