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

Tracking Information

First Received Date ^ICMJE

January 30, 2003

Last Updated Date

January 14, 2009

Start Date ^ICMJE

January 2003

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00053482 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults

Official Title ^ICMJE

The Effect of Dose on Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination

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:
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.

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: ACAM2000 Smallpox Vaccine
Biological: Vaccinia virus (calf lymph) smallpox vaccine: Dryvax

Study Arms / Comparison Groups

Experimental: Group 1: ACAM2000
Experimental: Group 2: ACAM2000
Experimental: Group 3: ACAM2000
Experimental: Group 4: ACAM2000
Active Comparator: Group 5: 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

Completed

Enrollment ^ICMJE

357

Completion Date

October 2003

Primary Completion Date

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

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

28 Years and older

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

NCT00053482

Responsible Party

Medical Director, Sanofi pasteur Inc

Study ID Numbers ^ICMJE

H-400-003

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