Dryvax Seropositives #2 (Expanded Trial)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00050505
First received: December 10, 2002
Last updated: August 26, 2010
Last verified: May 2006
  Purpose

The study seeks to further 1) evaluate safety in previously vaccinated adults between the ages of 32-70 who are vaccinated with undiluted Dryvax, and 1:5 and 1:10 dilutions; 2) define with very high precision the proportion of individuals who respond with a "take" 6-11 days after vaccination with undiluted Dryvax and Dryvax diluted 1:5; 3) define with good precision the proportion of individuals who respond with a "take" with a 1:10 dilution of Dryvax and; 4) explore correlations between "takes/no takes" and immune responses in all vaccine dilution groups.


Condition Intervention Phase
Smallpox
Biological: Dryvax
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: A Multicenter, Double Blind, Randomized Dose-Response Study of Dryvax Vaccine Against Smallpox in Previously Vaccinated Adults

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 927
Estimated Study Completion Date: October 2004
Detailed Description:

This study will evaluate the safety and immunogenicity of Dryvax vaccine against smallpox and its dilutions (1:5 and 1:10) in previously, but remotely, vaccinated adults. Both serologic and cell-mediated immune responses will be evaluated (the latter on a small subgroup of volunteers). The study will be conducted at five clinics in the U.S., commencing at the University of Rochester in New York. Approximately 927 volunteers between the ages of 32 and 70 years who were previously vaccinated against smallpox (but not since 1989) will be randomized to receive Dryvax vaccine undiluted, diluted 1:5 or diluted 1:10. Subjects will be involved in the trial for 8 to 16 weeks.

  Eligibility

Ages Eligible for Study:   32 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Negative urine glucose by dipstick.
  • Adequate renal function defined as a serum creatinine less than or equal to 1.5 mg/dL, urine protein < 100 mg/dL or trace or negative proteinuria by dipstick, and a calculated creatinine clearance > 55 ml/min based on the formulas in the manual of procedures.
  • Hematocrit > 34% for females, >38% for males, platelets > 150,000/mm3, WBC > 2500/mm3 and < 11000/mm3.
  • Typical vaccinia scar or validated documentation (e.g., military record, international travel certificate) of a smallpox vaccination, but not since 1989.
  • Willing to sign informed consent.
  • Availability for follow-up for the planned duration of the study at least 8 weeks after vaccination.
  • Acceptable medical history by screening evaluation and brief clinical assessment.
  • Negative urine or serum pregnancy test for women of childbearing potential.
  • If the subject is female and of childbearing potential, she must use an acceptable contraception and not become pregnant for the duration of the study. (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner).
  • Negative ELISA for HIV or indeterminant Western blot or other assay confirming that the serostatus does not reflect HIV infection.
  • ALT < 1.5 times institutional upper limit of normal.
  • Negative hepatitis B surface antigen and negative antibody to hepatitis C virus.
  • Age 32 to 70 years.

Exclusion Criteria:

  • Any acute skin disorders of large magnitude, e.g., laceration requiring sutures, burn greater than 2x2 cm.
  • Household contacts/sexual contacts with, or frequent and/or prolonged exposure to, any of the following: Pregnant women, children < 12 months of age, people with or history of eczema, people with chronic exfoliative skin disorders/conditions or any acute skin disorders of large magnitude, e.g., laceration requiring sutures, burn greater than 2x2 cm or people with immunodeficiency disease or use of immunosuppressive medications.
  • Any condition that, in the opinion of the investigator, might interfere with study objectives.
  • Known allergies to any component of the vaccine (e.g., polymyxin B sulfate, dihydrostreptomycin sulfate, chlortetracycline hydrochloride, neomycin sulfate).
  • Known allergies to any known component of the diluent (i.e., glycerin and phenol).
  • Known allergies to any known component of VIG, i.e., thimerosal or previous allergic reaction to immunoglobulins.
  • Known allergies to cidofovir or probenecid.
  • Live attenuated vaccines within 60 days of study.
  • Use of investigational agents within 30 days prior to study.
  • Receipt of blood products or immunoglobulin in the past 6 months.
  • Acute febrile illness on the day of vaccination.
  • Pregnant or lactating women.
  • Eczema of any degree or history of eczema.
  • History of chronic exfoliative skin disorders/conditions.
  • Smallpox vaccination in 1990 or more recently.
  • Inactivated vaccine 14 days prior to vaccination.
  • History of immunodeficiency.
  • Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease, diabetes mellitus, moderate to severe kidney impairment.
  • Malignancy, other than squamous cell or basal cell skin cancer.
  • Active Autoimmune disease.
  • Use of immunosuppressive medication.
  • Medical or psychiatric condition or occupational responsibilites that preclude subject compliance with the protocol.
  • History of "illegal" injection drug use.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00050505     History of Changes
Other Study ID Numbers: 02-007
Study First Received: December 10, 2002
Last Updated: August 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
smallpox
Dryvax vaccine
immunogenicity
previously vaccinated

Additional relevant MeSH terms:
Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 16, 2014