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APSV in Vaccinia Naive Adults

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ClinicalTrials.gov Identifier: NCT00050518
Recruitment Status : Completed
First Posted : December 13, 2002
Last Update Posted : August 27, 2010
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE December 11, 2002
First Posted Date  ICMJE December 13, 2002
Last Update Posted Date August 27, 2010
Study Start Date  ICMJE Not Provided
Actual Primary Completion Date February 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
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 Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE APSV in Vaccinia Naive Adults
Official Title  ICMJE A Multicenter, Double-Blind, Randomized Study of the Safety and Efficacy of Aventis Pasteur's Smallpox Vaccine, USP (APSV) in Vaccinia-Naive Adults.
Brief Summary The study seeks to define, with precision, the safety and efficacy of APSV, two dose potencies of one lot in vaccinia-naive adults. The ability of this vaccine to induce a classic �take� as defined by formation of a lesion at the injection site consistent with the �Jennerian� process (see Appendix A) and vaccine specific immune responses will be assessed. The local cutaneous lesion is considered to be a surrogate for clinical effectiveness of live, replicating smallpox vaccines. Neutralizing antibody formation has been correlated with takes for the Dryvax vaccine and is considered to be cross-protective for other orthopoxviruses, including variola. The study also seeks to characterize preliminarily the cell mediated immune (CMI) response to APSV (as compared to Dryvax).
Detailed Description A Multicenter, double blind, randomized trial in which each volunteer will receive one of 2 dose concentrations of one of two lots of Aventis Pasteur Smallpox Vaccine as a single vaccination (undiluted, 1:5 dilution). Volunteers without a take at day 7 - 9 will be offered a vaccination with Dryvax at the end of the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Condition  ICMJE Smallpox
Intervention  ICMJE Biological: Aventis Pasteur Smallpox Vaccine
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
444
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2003
Actual Primary Completion Date February 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION CRITERIA:

  • Adequate renal function defined as a serum creatinine 1.5 mg/dL; urine protein < 100mg/ dL or trace or negative proteinuria (by dipstick), and a calculated creatinine clearance >55 mL/min. Formula for calculations is contained within the Manual of Procedures.

(Note: Renal function is measured to ensure that subjects could meet criteria for use of cidofovir if needed).

  • Age 18-32 (children are excluded due to concerns of safety, including autoinoculation).
  • Willing to sign informed consent.
  • Availability for follow-up for planned duration of the study (56 days following the last vaccination).
  • Acceptable medical history by screen evaluation form and brief assessment.
  • Absence of a typical vaccinia scar and negative history of smallpox vaccination.
  • Negative urine or serum pregnancy test for women of childbearing potential.
  • If the volunteer is female and of childbearing potential, she agrees to use 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 negative Western blot for subjects who have a positive ELISA and have participated in an HIV vaccine trial.
  • Negative hepatitis B surface antigen and negative antibody to hepatitis C virus.
  • Negative urine glucose by dipstick.
  • ALT < 1.5 times institutional upper limit of normal.

EXCLUSION CRITERIA:

  • Allergies to any component of the vaccines (e.g., polymyxin B sulfate, dihydrostreptomycin sulfate, chlorotetracycline hydrochloride).
  • History of immunodeficiency.
  • Serology positive for HIV, hepatitis B, or hepatitis C at the screening visit.
  • Known or suspected impairment of immunologic function including, but not limited to clinically significant liver disease.
  • Diabetes mellitus.
  • Moderate to severe kidney impairment.
  • Malignancy with the exception of squamous cell or basal cell skin cancer.
  • Autoimmune disease.
  • Use of immunosuppressive medication.
  • Corticosteroid nasal sprays are permissible.
  • Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol.
  • History of illegal injection drug use.
  • Live attenuated vaccines within 60 days of study.
  • Use of experimental agents within 30 days prior to study.
  • Any history of vaccination with any vaccinia vectored or other pox vectored experimental vaccine.
  • Smallpox vaccination since 1990 (Vaccinia experience cohorts).
  • Typical vaccinia scar or history of smallpox vaccination (Vaccinia naive cohorts only).
  • Receipt of blood products or immunoglobulin in the past 6 months.
  • Recent donation of the equivalent of a pint of blood within the 30 days prior to enrollment.
  • Acute febrile illness (100.5 F) on the day of vaccination.
  • Pregnant or lactating women.
  • Eczema of any degree or history of eczema.
  • History of exfoliative skin disorders/conditions.
  • Any acute skin disorders of large magnitude, e.g., laceration requiring sutures, burn greater than 2x2 cm.
  • Household contacts/sexual contacts with, or close and frequent occupational exposure to, any of the following: pregnant women, children < 12 months of age, people with eczema or history of eczema, people with any of the skin disorders/conditions previously listed, people with immunodeficiency disease or use of immunosuppressive medications.
  • Any condition which, in the opinion of the investigator, might interfere with study objectives.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 32 Years   (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 NCT00050518
Other Study ID Numbers  ICMJE 02-054
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date March 2010

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