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:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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 primary endpoint is the proportion of subjects in each treatment group who develop a major cutaneous reaction on Study Day 3, Day 7, Day 10, and/or Study Day 15. [ Time Frame: Days 3, 7, 10, and/or 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

1) comparison of treatment groups for the proportion of subjects developing a >fourfold rise in neutralizing antibodies 2) neutralizing antibody response (mean fold-increase in 50% PRNT titer) 3) geometric mean neutralizing titer among treatment groups. [ Time Frame: days 0-30 ] [ 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
Group 1: Experimental Group 1: ACAM2000	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
Group 2: Experimental Group 2: ACAM2000	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
Group 3: Experimental Group 3: ACAM2000	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
Group 4: Experimental Group 4: ACAM2000	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
Group 5: Active Comparator Group 5: Dryvax	Biological: Vaccinia virus (calf lymph) smallpox vaccine: Dryvax Group 5 dose: 1.0x10-8th PFU/ml

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 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:

Acambis Web Page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi pasteur Inc ( Medical Director )
Study ID Numbers:	H-400-003
Study First Received:	January 30, 2003
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00053482 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Smallpox, vaccines, Dryvax, Orthopoxvirus, Vaccinia virus

Additional relevant MeSH terms:

Virus Diseases
Smallpox
Poxviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on November 27, 2009