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

Tracking Information

First Received Date ^ICMJE

January 30, 2003

Last Updated Date

January 14, 2009

Start Date ^ICMJE

September 2002

Primary Completion Date

March 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00053508 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Smallpox

Intervention ^ICMJE

Biological: ACAM1000
Biological: vaccinia virus (calf lymph) smallpox vaccine: Dryvax

Study Arms / Comparison Groups

Experimental: ACAM1000
Active Comparator: Dryvax

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

274

Completion Date

September 2003

Primary Completion Date

March 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 29 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00053508

Responsible Party

Medical Director, Sanofi Pasteur Inc.

Study ID Numbers ^ICMJE

H-300-002

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Director

Sanofi Pasteur Inc

Information Provided By

Sanofi-Aventis

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP