Subpart D Panel Review of DMID Protocol 01-650 "A Multicenter, Randomized Dose Response Study of the Safety, Clinical and Immune Responses of Dryvax Administered to Children 2 to 5 Years of Age"*

Please note that information in the following documents that is exempt from disclosure under existing Federal statutes has been redacted.
  1. Note from NIAID, NIH, releasing for public disclosure DMID Protocol 01-650 and Investigator's Brochure for Vaccinia Immune Globulin
  2. Protocol "A Multicenter, Randomized Dose Response Study of the Safety, Clinical and Immune Responses of Dryvax Vaccine Administered to Children 2 to 5 Years of Age"
  3. Site-specific protocol application reviewed by The Harbor - UCLA Medical Center IRB
  4. Sample parental permission document
  5. Package Inserts
    1. Dryvax
    2. Cidofovir (Vistide)
    3. Viroptic
  6. Investigator's Brochure:  Vaccinia Immune Globulin
  7. Vaccinia (Smallpox) Vaccine Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2001
  8. HHS Bioterrorism Preparedness Testimony
    1. Centers for Disease Control and Prevention
    2. National Institutes of Health
  9. Harbor-UCLA Medical Center IRB Review of DMID 01-650 Protocol: Excerpt from Minutes
  10. Cincinnati Children's Hospital Medical Center IRB review of DMID Protocol 01-650
    1. Excerpt from IRB minutes July 16, 2002
    2. Excerpt from IRB minutes July 30, 2002
  11. Kaiser Permanente Southern California IRB review of DMID Protocol 01-650
  12. Individual expert reports solicited pursuant to HHS regulations at 45 CFR 46.407 and FDA regulations at 21 CFR 50.54
    1. Expert #1
    2. Expert #2
    3. Expert #3
    4. Expert #4
    5. Expert #5
    6. Expert #6
    7. Expert #7
    8. Expert #8
    9. Expert #9
    10. Expert #10
  13. Letter to Harbor-UCLA Medical Center regarding HHS Secretary's and FDA Commissioner's determination

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Updated January 24, 2003