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Trial record 1 of 27 for:    acam2000 | Smallpox | Phase 2
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Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults

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ClinicalTrials.gov Identifier: NCT00053482
Recruitment Status : Completed
First Posted : January 31, 2003
Results First Posted : February 11, 2011
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Emergent BioSolutions

Tracking Information
First Submitted Date  ICMJE January 30, 2003
First Posted Date  ICMJE January 31, 2003
Results First Submitted Date  ICMJE January 3, 2011
Results First Posted Date  ICMJE February 11, 2011
Last Update Posted Date August 13, 2018
Study Start Date  ICMJE January 2003
Actual Primary Completion Date April 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2011)
  • The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Day 30 post-vaccination ]
    The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 14, 2011)
  • Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Days 0 to 30 post-vaccination ]
  • Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Days 0 (Baseline) and 15 post-vaccination ]
  • Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Days 0 (Baseline) and 15 post-vaccination ]
  • Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Days 0 (Baseline) and 15 post-vaccination ]
  • Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Days 0 (Baseline) and 15 post-vaccination ]
Original Other Pre-specified Outcome Measures Not Provided
 
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:

  1. 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.
  2. 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.
  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 at least 28 years of age, with a history of smallpox vaccination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Smallpox
Intervention  ICMJE
  • Biological: ACAM2000 Smallpox Vaccine
    Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml
  • Biological: Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®
    Group 5 dose: 1.0x10-8th PFU/ml
    Other Name: Dryvax®
Study Arms  ICMJE
  • Experimental: Group 1: ACAM2000
    Participants will receive dose 1 of the ACAM2000 smallpox vaccine
    Intervention: Biological: ACAM2000 Smallpox Vaccine
  • Experimental: Group 2: ACAM2000
    Participants will receive dose 2 of the ACAM2000 smallpox vaccine
    Intervention: Biological: ACAM2000 Smallpox Vaccine
  • Experimental: Group 3: ACAM2000
    Participants will receive dose 3 of the ACAM2000 smallpox vaccine
    Intervention: Biological: ACAM2000 Smallpox Vaccine
  • Experimental: Group 4: ACAM2000
    Participants will receive dose 4 of the ACAM2000 smallpox vaccine
    Intervention: Biological: ACAM2000 Smallpox Vaccine
  • Active Comparator: Group 5: Dryvax®
    Participants will receive dose 1 of Dryvax® smallpox vaccine.
    Intervention: Biological: Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2008)
357
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
350
Actual Study Completion Date  ICMJE October 2003
Actual 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 Human immunodeficient 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
  • innoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 28 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00053482
Other Study ID Numbers  ICMJE H-400-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emergent BioSolutions
Study Sponsor  ICMJE Emergent BioSolutions
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Emergent BioSolutions
PRS Account Emergent BioSolutions
Verification Date August 2018

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