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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 : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Emergent BioSolutions

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.

Condition or disease Intervention/treatment Phase
Smallpox Biological: ACAM2000 Smallpox Vaccine Biological: Vaccinia virus (calf lymph) smallpox vaccine: Dryvax® Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Dose on Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination
Study Start Date : January 2003
Actual Primary Completion Date : April 2003
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smallpox

Arm Intervention/treatment
Experimental: Group 1: ACAM2000
Participants will receive dose 1 of the ACAM2000 smallpox vaccine
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

Experimental: Group 2: ACAM2000
Participants will receive dose 2 of the ACAM2000 smallpox vaccine
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

Experimental: Group 3: ACAM2000
Participants will receive dose 3 of the ACAM2000 smallpox vaccine
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

Experimental: Group 4: ACAM2000
Participants will receive dose 4 of the ACAM2000 smallpox vaccine
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

Active Comparator: Group 5: Dryvax®
Participants will receive dose 1 of Dryvax® smallpox vaccine.
Biological: Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®
Group 5 dose: 1.0x10-8th PFU/ml
Other Name: Dryvax®




Primary Outcome Measures :
  1. 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)

  2. 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 ]
  3. 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 ]

Other Outcome Measures:
  1. Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Days 0 to 30 post-vaccination ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]


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Ages Eligible for Study:   28 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053482


Locations
United States, Kansas
PRA International
Lenexa, Kansas, United States, 66219
United States, Missouri
Bio-Kinetic Clinical Applications
Springfield, Missouri, United States, 65802
United States, Rhode Island
Memorial Hospital of Rhode Island Division of Infectious Diseases
Pawtucket, Rhode Island, United States, 02860
Sponsors and Collaborators
Emergent BioSolutions
Investigators
Study Director: Medical Director Emergent BioSolutions

Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT00053482     History of Changes
Other Study ID Numbers: H-400-003
First Posted: January 31, 2003    Key Record Dates
Results First Posted: February 11, 2011
Last Update Posted: February 23, 2018
Last Verified: January 2018

Keywords provided by Emergent BioSolutions:
Smallpox vaccines
Dryvax®
Orthopoxvirus
Vaccinia virus
ACAM2000

Additional relevant MeSH terms:
Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs