Expanded Dryvax Dilution Study in Previously Vaccinated Adults

NCT00050505 | Completed Phase 2

• 1 other identifier: 02-007
• Study Type: interventional
• Target: 927
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine the safety and effect of diluting smallpox vaccine, making a larger number of doses in case smallpox is released into the environment. A total of up to 927 healthy adults between the ages of 32 and 70 years who were already vaccinated against smallpox (but not since 1989) will volunteer for this study for up to 34 weeks and receive different strengths of vaccine. Some subjects may participate for longer if they choose to be revaccinated because the first vaccination does not take. The vaccine will be given by making small cuts in the skin and putting the vaccine into these cuts. After the screening visit, volunteers will be followed through study visits and follow up phone calls. Blood will be collected during some study visits to look at the immune system (body system that fights infection) response.

Conditions

Smallpox

Keywords

smallpox, Dryvax, vaccine, dilution

Outcome Measures

Primary Outcomes (1)

• Proportion of vaccinees demonstrating a "take" 6 to 11 days after the first vaccination at each of the dose levels (undiluted and 1:5 and 1:10).

  6 to 11 days after the first vaccination at each of the dose levels (undiluted and 1:5 and 1:10).

Study Arms (3)

Cohort C

EXPERIMENTAL

N=100 to 110 subjects receives 1:10 diluted dose of Dryvax vaccine on Day 0 and 1:5 revaccination dose on Day 56

Biological: Live vaccinia virus vaccine

Cohort B

EXPERIMENTAL

N=571 to 581 subjects receives 1:5 diluted dose of Dryvax vaccine on Day 0 and 1:5 revaccination dose on Day 56

Biological: Live vaccinia virus vaccine

Cohort A

EXPERIMENTAL

N=226 to 236 subjects receives undiluted dose Dryvax vaccine on Day 0 and 1:5 revaccination dose on Day 56

Biological: Live vaccinia virus vaccine

Interventions

Live vaccinia virus vaccine BIOLOGICAL

Dryvax undiluted. Cohort A receives undiluted dose of Dryvax vaccine

Cohort A

Eligibility Criteria

• Age: 32 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 32 to 70 years.
• 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 26 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 within 56 days post vaccination. (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.
• 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; and WBC \> 2,500/mm3 and \< 11,000/mm3.

You may not qualify if:

• Smallpox vaccination in 1990 or more recently.
• 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 responsibilities that preclude subject compliance with the protocol.
• History of "illegal" injection drug use.
• Inactivated vaccine 14 days prior to vaccination
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (7)

Kaiser Permanente Vaccine Study Center

Oakland, California, 94612, United States

Location

Stanford University

Stanford, California, 94305-5208, United States

Location

UCLA Center For Vaccine Research

Torrance, California, 90502, United States

Location

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Duke Health Center

Durham, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

Smallpox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 10, 2002
• First Posted: December 11, 2002
• Study Start: October 1, 2002
• Study Completion: December 1, 2003
• Last Updated: December 5, 2014

Record last verified: 2009-07

Locations

US (7)