Vaccinia Virus Vaccine (APSV) in Vaccinia- Naive Subjects: PILOT

NCT00038987 | Completed Phase 1

• 1 other identifier: 02-009
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 4

Brief Summary

To define the safety of vaccination with APSV as determined by the reactogenicity of the vaccine and the development of expected and un-expected adverse events associated with vaccination. To assess the proportion of individuals who respond to vaccination with a "take" (those who form a visible lesion at the injection site) 6 to 8 days after the vaccination.

Conditions

Smallpox

Keywords

Smallpox; APSV; Aventis Pasteur Smallpox Vaccine; vaccinia-naive

Interventions

Wetvax (APSV) BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-32 (Volunteers over 32 years of age are not included since they usually are not vaccinia-naive.) Children are excluded due to concerns of safety, including autoinoculation.
• Acceptable medical history by screening evaluation form and brief assessment.
• Negative urine pregnancy test for women.
• Negative history of smallpox vaccination.
• Negative ELISA for HIV or negative Western blot for volunteers who have a positive ELISA and have participated in an HIV vaccine trial.
• Availability for follow-up for planned duration of the study (6 months). Note: Stage 1 - clinic visit at Day 180+/-15 days, Stage 2 - phone call at Day 180 +/- 15 days.
• If the volunteer is female, she agrees to use acceptable contraception and not become pregnant for the duration of the study.
• Willing to sign informed consent.
• Adequate renal functions as defined as a serum creatinine of 1.5 mg/dL, urine protein \< 100 mg/dL or negative proteinuria, and a calculated creatinine clearance \> 55 mL/min based on the following formulas: For males ((140 minus age in years) x weight in kg)/72 x serum creatinine). For females: 0.85 x ((140 minus age in years) x weight in kg)/72 x serum creatinine). Note: Renal function is measured to ensure subjects could meet criteria for use of cidofovir if needed.

You may not qualify if:

• 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, other than 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 that 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.
• Typical vaccinia scar without known history of vaccination.

Sponsors & Collaborators

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

Study Sites (4)

Kaiser Permanente Vaccine Study Center

Oakland, California, 94611, United States

Location

University of Iowa - Iowa City IA

Iowa City, Iowa, 52242, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232-26, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, 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 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: June 10, 2002
• Study Start: May 1, 2002
• Study Completion: August 1, 2002
• Last Updated: August 27, 2010

Record last verified: 2003-12

Locations

US (4)