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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00053495
First received: January 30, 2003
Last updated: May 7, 2012
Last verified: May 2012

January 30, 2003
May 7, 2012
January 2003
June 2003   (final data collection date for primary outcome measure)
  • Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Days 0 to 30 post-vaccination ] [ Designated as safety issue: No ]
    The severity of each reported adverse event was classified by the investigator according to the following definitions. None - no symptom; Mild - awareness of sign or symptoms, but easily tolerated; Moderate - discomfort enough to cause interference with usual activity; and Severe - incapacitating with inability to work or perform usual activity.
  • Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. [ Time Frame: Day 30 post-vaccination ] [ Designated as safety issue: No ]
  • Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. [ Time Frame: Day 30 post-vaccination ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00053495 on ClinicalTrials.gov Archive Site
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Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
The Effect of Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination

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

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:

  1. 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.
  2. 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.
  3. 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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Smallpox
  • Biological: Vaccinia virus: ACAM2000 smallpox vaccine
    Group 1 dose: 1.0x10-8th PFU/ml Group 2 dose: 2.0x10-8th PFU/ml Group 3 dose: 1.0x10-7th PFU/ml Group 4 dose: 5.0x10-6th PFU/ml
  • Biological: vaccinia virus (calf lymph): Dryvax
    Group 5 dose: 1.0x10-8th PFU/ml
    Other Name: Dryvax®
  • Experimental: Group 1: ACAM2000 Dose 1
    Participants will receive a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0.
    Intervention: Biological: Vaccinia virus: ACAM2000 smallpox vaccine
  • Experimental: Group 2: ACAM2000 Dose 2
    Participants will receive a single dose of ACAM2000 smallpox vaccine, 2.0x10-8th plaque-forming units/mL on Day 0.
    Intervention: Biological: Vaccinia virus: ACAM2000 smallpox vaccine
  • Experimental: Group 3: ACAM2000 Dose 3
    Participants will receive a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
    Intervention: Biological: Vaccinia virus: ACAM2000 smallpox vaccine
  • Experimental: Group 4: ACAM2000 Dose 4
    Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
    Intervention: Biological: Vaccinia virus: ACAM2000 smallpox vaccine
  • Active Comparator: Group 5: Dryvax® Vaccine
    Participants will receive a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
    Intervention: Biological: vaccinia virus (calf lymph): Dryvax
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
353
November 2003
June 2003   (final data collection date for primary outcome measure)

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 human immunodeficiency virus (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.
Both
18 Years to 29 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00053495
H-400-005
Yes
Sanofi
Sanofi
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc
Sanofi
May 2012

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