search
Back to results

APSV in Vaccinia Naive Adults

Primary Purpose

Smallpox

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aventis Pasteur Smallpox Vaccine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smallpox focused on measuring Smallpox, Aventis Pasteur, Vaccine

Eligibility Criteria

18 Years - 32 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Iowa - Iowa City IA
  • Cincinnati Children's Hospital Med Ctr
  • University of Cincinnati
  • Vanderbilt University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 11, 2002
Last Updated
August 26, 2010
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00050518
Brief Title
APSV in Vaccinia Naive Adults
Official Title
A Multicenter, Double-Blind, Randomized Study of the Safety and Efficacy of Aventis Pasteur's Smallpox Vaccine, USP (APSV) in Vaccinia-Naive Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
February 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smallpox
Keywords
Smallpox, Aventis Pasteur, Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
444 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Aventis Pasteur Smallpox Vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
32 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Iowa - Iowa City IA
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Cincinnati Children's Hospital Med Ctr
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-05
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-26
Country
United States

12. IPD Sharing Statement

Learn more about this trial

APSV in Vaccinia Naive Adults

We'll reach out to this number within 24 hrs