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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00038987
First received: June 6, 2002
Last updated: August 26, 2010
Last verified: December 2003
  Purpose

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.


Condition Intervention Phase
Smallpox
Biological: Wetvax (APSV)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 330
Study Start Date: May 2002
Estimated Study Completion Date: August 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years to 32 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038987

Locations
United States, California
Kaiser Permanente Vaccine Study Center
Oakland, California, United States, 94611
United States, Iowa
University of Iowa - Iowa City IA
Iowa City, Iowa, United States, 52242
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232-26
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00038987     History of Changes
Other Study ID Numbers: 02-009
Study First Received: June 6, 2002
Last Updated: August 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Smallpox
APSV
Aventis Pasteur Smallpox Vaccine
vaccinia-naive

Additional relevant MeSH terms:
Vaccinia
Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 19, 2014