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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 30, 2003

Last Updated Date

January 14, 2009

Start Date ^†

January 2003

Current Primary Outcome Measures ^†

The primary endpoint was the proportion of subjects in each vaccine group with a successful vaccination, where successful vaccination was defined as a major cutaneous reaction [ Time Frame: days 7-15 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00053495 on ClinicalTrials.gov Archive Site

Current 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 between treatment groups. [ Time Frame: days 0-30 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

The Effect of Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination

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

The objective of this study is to 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 18-29 years of age and naïve to smallpox vaccine. 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 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 four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults 18-29 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 18-29 years of age and naïve to smallpox vaccine.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Smallpox

Intervention ^†

Biological: vaccinia virus: ACAM2000 smallpox vaccine
Biological: vaccinia virus (calf lymph): 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 ^†

Completed

Enrollment ^†

353

Completion Date

November 2003

Primary Completion Date

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

Eligibility Criteria ^†

inclusion criteria:

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:

military service prior to 1989.
history of previous smallpox vaccination.
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
inoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.

Gender

Both

Ages

18 Years to 29 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00053495

Responsible Party

Medical Director, Sanofi Pasteur Inc.

Secondary IDs ^††

Study Sponsor ^†

Sanofi-Aventis

Collaborators ^††

Investigators ^†

Study Director:

Midical Director

Sanofi Pasteur Inc

Information Provided By

Sanofi-Aventis

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.