Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00053482

Purpose

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.

Condition	Intervention	Phase
Smallpox	Biological: ACAM2000 Smallpox Vaccine Biological: Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	The Effect of Dose on Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination

Resource links provided by NLM:

MedlinePlus related topics: Smallpox

Drug Information available for: PANVAC-V

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Day 30 post-vaccination ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 30 post-vaccination ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	357
Study Start Date:	January 2003
Study Completion Date:	October 2003
Primary Completion Date:	April 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1: ACAM2000 Participants will receive dose 1 of the ACAM2000 smallpox vaccine	Biological: ACAM2000 Smallpox Vaccine 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
Experimental: Group 2: ACAM2000 Participants will receive dose 2 of the ACAM2000 smallpox vaccine	Biological: ACAM2000 Smallpox Vaccine 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
Experimental: Group 3: ACAM2000 Participants will receive dose 3 of the ACAM2000 smallpox vaccine	Biological: ACAM2000 Smallpox Vaccine 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
Experimental: Group 4: ACAM2000 Participants will receive dose 4 of the ACAM2000 smallpox vaccine	Biological: ACAM2000 Smallpox Vaccine 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
Active Comparator: Group 5: Dryvax® Participants will receive dose 1 of Dryvax® smallpox vaccine.	Biological: Vaccinia virus (calf lymph) smallpox vaccine: Dryvax® Group 5 dose: 1.0x10-8th PFU/ml Other Name: Dryvax®

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:
1. the proportion of subjects at each dose level who develop a major cutaneous reaction
2. 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.

Eligibility

Ages Eligible for Study:	28 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053482

Locations

United States, Kansas
PRA International
Lenexa, Kansas, United States, 66219
United States, Missouri
Bio-Kinetic Clinical Applications
Springfield, Missouri, United States, 65802
United States, Rhode Island
Memorial Hospital of Rhode Island Division of Infectious Diseases
Pawtucket, Rhode Island, United States, 02860

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc.

More Information

Additional Information:

sanofi pasteur's web site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Director, Sanofi pasteur Inc
ClinicalTrials.gov Identifier:	NCT00053482 History of Changes
Other Study ID Numbers:	H-400-003
Study First Received:	January 30, 2003
Results First Received:	January 3, 2011
Last Updated:	February 10, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Smallpox vaccines
Dryvax®
Orthopoxvirus
Vaccinia virus
ACAM2000

Additional relevant MeSH terms:

Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on February 12, 2012