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

Primary Purpose

Smallpox

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Wetvax (APSV)
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, APSV, Aventis Pasteur Smallpox Vaccine, vaccinia-naive

Eligibility Criteria

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

INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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. History of smallpox vaccination. Acute febrile illness on the day of vaccination. Pregnant or lactating women. Eczema or 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. Receipt of blood products or immunoglobulin in the past 6 months. Household contacts/sexual contacts with, or occupational exposure to (other than minimal contact), people with any of the following: pregnancy, < 12 months of age, eczema or history of eczema, previously listed skin disorders/conditions, immunodeficiency disease or use of immunosuppressive medications. Allergies to any component of the vaccines (e.g. polymyxin B sulfate, dihydrostreptomycin sulfate, chlortetracycline hydrochloride, neomycin sulfate). Allergies to any known component of the diluent. Allergies to any known component of VIG, i.e., thimerosal or previous allergic reaction to immunoglobulins. Allergies to cidofovir or probenicid. Blood donation within the past 55 days (stage 1 only).

Sites / Locations

  • Kaiser Permanente Vaccine Study Center
  • University of Iowa - Iowa City IA
  • Vanderbilt University
  • Baylor College of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2002
Last Updated
August 26, 2010
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00038987
Brief Title
Vaccinia Virus Vaccine (APSV) in Vaccinia- Naive Subjects: PILOT
Official Title
A Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of Various Concentrations of Aventis Pasteur's Smallpox Vaccine, USP (APSV) in Vaccinia-naive Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

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.
Detailed Description
The study will be a four-center, randomized, dose finding trial to evaluate safety, preliminary efficacy, and immunogenicity of Aventis Pasteur smallpox vaccine (APSV) in healthy, vaccinia-naive adults. Four concentrations of APSV, derived from 2 lots of vaccine, will be tested; ranging from 10 (exponent 6 pfu per ml) to 10 (exponent 7.5 pfu per ml). Four concentrations of Dryvax (ranging from 10 exp 6 per ml to 10 exp 8 per ml) will be evaluated as a positive control. This study is designed to assess the feasibility of the use of APSV and dilutions of APSV in an emergency vaccination scenario. The study will be conducted in two phases. The initial phase will consist of a single-center, randomized, open-label study in 45 subjects to evaluate the safety and approximate the take rate of undiluted APSV (two lots APSV plus a Dryvax control arm: n=15 per arm). A 14 day post vaccination safety follow-up will be completed for all subjects vaccinated in the initial phase prior to initiation of the second phase of the study with an additional 285 subjects. All subjects will be followed for 56 days post vaccination with a clinic visit at day 180 for stage 1 subjects and a follow-up phone call at day 180 for stage 2 subjects. The expansion phase of the study will be conducted at three additional sites.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
330 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Wetvax (APSV)

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: 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. EXCLUSION CRITERIA: 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. History of smallpox vaccination. Acute febrile illness on the day of vaccination. Pregnant or lactating women. Eczema or 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. Receipt of blood products or immunoglobulin in the past 6 months. Household contacts/sexual contacts with, or occupational exposure to (other than minimal contact), people with any of the following: pregnancy, < 12 months of age, eczema or history of eczema, previously listed skin disorders/conditions, immunodeficiency disease or use of immunosuppressive medications. Allergies to any component of the vaccines (e.g. polymyxin B sulfate, dihydrostreptomycin sulfate, chlortetracycline hydrochloride, neomycin sulfate). Allergies to any known component of the diluent. Allergies to any known component of VIG, i.e., thimerosal or previous allergic reaction to immunoglobulins. Allergies to cidofovir or probenicid. Blood donation within the past 55 days (stage 1 only).
Facility Information:
Facility Name
Kaiser Permanente Vaccine Study Center
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
University of Iowa - Iowa City IA
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-26
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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