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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00053508

Purpose

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

Condition	Intervention	Phase
Smallpox	Biological: ACAM1000 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 ACAM1000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination A Phase 2, Randomized, Double-Blind, Dose-Response Study

Resource links provided by NLM:

MedlinePlus related topics: Smallpox

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

The proportion of subjects in each treatment group who develop a major cutaneuos reaction on Day 7, Day 10, and/or Day 15. [ Time Frame: Day 7, Day 10, and/or Day 15 ] [ Designated as safety issue: No ]

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. [ Time Frame: days 0 and 30, day 31 ] [ Designated as safety issue: No ]

Enrollment:	274
Study Start Date:	September 2002
Study Completion Date:	September 2003
Primary Completion Date:	March 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental ACAM1000	Biological: ACAM1000 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 2: Experimental ACAM1000	Biological: ACAM1000 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 3: Experimental ACAM1000	Biological: ACAM1000 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 4: Active Comparator Dryvax	Biological: vaccinia virus (calf lymph) smallpox vaccine: Dryvax group 4 dose: 1.6 x 10-8th PFU/ml (250,000 PFU)

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.

Eligibility

Ages Eligible for Study:	18 Years to 29 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053508

Locations

United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32806
United States, Minnesota
Mayo Vaccine Research Group
Rochester, Minnesota, United States, 55905
United States, Ohio
Radiant Research
Cincinnati, Ohio, United States, 45236

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc

More Information

Additional Information:

Acambis Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi Pasteur Inc. ( Medical Director )
Study ID Numbers:	H-300-002
Study First Received:	January 30, 2003
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00053508 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Virus Diseases
Smallpox
Poxviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on November 25, 2009