APSV in Vaccinia Naive Adults

NCT00050518 | Completed Phase 2

• 1 other identifier: 02-054
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 4

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).

Conditions

Smallpox

Keywords

Smallpox; Aventis Pasteur; Vaccine

Interventions

Aventis Pasteur Smallpox Vaccine BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

University of Iowa - Iowa City IA

Iowa City, Iowa, 52242, United States

Location

Cincinnati Children's Hospital Med Ctr

Cincinnati, Ohio, 45229, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-05, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232-26, United States

Location

MeSH Terms

Conditions

Smallpox

Interventions

Aventis Pasteur smallpox vaccine

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 11, 2002
• First Posted: December 13, 2002
• Primary Completion: February 1, 2003
• Study Completion: February 1, 2003
• Last Updated: August 27, 2010

Record last verified: 2010-03

Locations

US (4)