NCT00079820

Brief Summary

The purpose of this study is to gather information on the safety and the effectiveness of an investigational vaccine for the prevention of smallpox disease. Smallpox was one of the major causes of death and sickness through the first half of the 20th century, but a global program of smallpox eradication resulted in the elimination of the natural disease. The last cases of smallpox in the United States occurred in 1949 in Texas. Today, only laboratory workers who work with smallpox-related viruses, military personnel, and health care workers are vaccinated. Historically, individuals in the US were vaccinated with a product such as Dryvax®, which contains the virus vaccinia in the same family as smallpox. This virus could promote immunity to smallpox, but not produce the disease itself. Although effective, these vaccines are not safe to use in people with atopic dermatitis (eczema, allergic immune response to allergens), children less than 1 year of age, and people with a compromised immune system, occurring in certain diseases (HIV positive individuals and AIDS), and following treatment with certain types of drugs. It is important to find a safe vaccine that can be used to protect people who cannot receive routine vaccinia-based smallpox vaccine. The vaccine in this study is known as Modified Vaccinia Ankara or MVA vaccine. It is the objective of this study to find out if MVA vaccine is safe and effective in providing immunity to smallpox. The effectiveness of this vaccine will be measured in two ways. The first way is to find out if there are specific antibodies in your blood following MVA vaccination. Antibodies are chemicals your body produces to fight smallpox virus. The second way is to see whether or not there is a typical skin reaction following vaccination with a traditional smallpox vaccine, given about three months after vaccination with the MVA vaccine. The typical reaction in an unvaccinated person to smallpox vaccine is formation of a blister or "pox" which occurs at the site of vaccination. In a person with immunity to smallpox the skin reaction is much less, and typically consists of a little swelling at the site of vaccination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2004

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2004

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2004

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

January 13, 2014

Status Verified

January 1, 2014

Enrollment Period

2.5 years

First QC Date

March 15, 2004

Last Update Submit

January 9, 2014

Conditions

Smallpox

Keywords

SmallpoxSmallpox VaccineVariola virusSmallpox VirusMODIFIED VACCINIA ANKARAMVADryvaxDryvax vaccineProtection against smallpox

Outcome Measures

Primary Outcomes (1)

  • Safety

    Study Completion

Secondary Outcomes (1)

  • Immunogenicity

    Study Completion

Study Arms (5)

A

EXPERIMENTAL

MVA3000 Smallpox vaccine (1x10-8) with Dryvax Challenge at Day 112

Biological: ACAM3000 MVA Vaccine

B

EXPERIMENTAL

MVA3000 Smallpox vaccine (1x10-8) with no Challenge

Biological: ACAM3000 MVA Vaccine

C

PLACEBO COMPARATOR

Placebo

Biological: ACAM3000 MVA Vaccine

D

EXPERIMENTAL

MVA3000 Smallpox vaccine (1x10-7) with Dryvax challenge at Day 112

Biological: ACAM3000 MVA Vaccine

E

EXPERIMENTAL

MVA3000 Smallpox vaccine (1x10-6) with Dryvax challenge at Day 112

Biological: ACAM3000 MVA Vaccine

Interventions

ACAM3000 MVA VaccineBIOLOGICAL

Two subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days

Also known as: Dryvax smallpox vaccine
ABCDE

Eligibility Criteria

Age18 Years - 31 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects must meet the following to be eligible for the study:
  • adult males or females who provided informed consent for the study.
  • adults 18 and 31 years (inclusive).
  • good general health,
  • female subjects must not be pregnant or lactating and be on appropriate contraception or be a female unable to bear children.
  • subjects be available for participation during the entire study.

You may not qualify if:

  • military service prior to 1989 or after December 13th, 2002.
  • history of previous smallpox vaccination
  • known/suspected history of immunodeficiency, or with current radiation treatment or use of immunosuppressive or anti-neoplastic drugs.
  • subjects with a household member or intimate contact with the same conditions listed above.
  • known or suspected impairment of other immunologic function.
  • malignancy, including squamous cell or basal cell skin cancer at vaccination site
  • active autoimmune disease.
  • subjects with known eye diseases or other conditions that require the use of corticosteroid eye drops.
  • known/history of cardiac disease.
  • subjects who have been diagnosed with 3 or more of the following risk factors for ischemic coronary disease: a) high blood pressure b) elevated blood cholesterol levels c) diabetes or high blood sugar d) first degree relative (for example, mother, father, brother, or sister) who had a heart condition before the age of 50 e) smoke cigarettes
  • subjects with a history of palpitations or abnormalities of cardiac rhythm.
  • subjects with odd ECG patterns
  • subjects with a ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years.
  • positive or elevated creatinine kinase, CK-MB, or Troponin I laboratory test levels.
  • abnormalities of clinical laboratory assessments.
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

PRA International

Lenexa, Kansas, 66219, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536-0093, United States

Location

MeSH Terms

Conditions

Smallpox

Interventions

DryVax vaccine

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Medical Director

    Sanofi Pasteur Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2004

First Posted

March 17, 2004

Study Start

April 1, 2004

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

January 13, 2014

Record last verified: 2014-01

Locations

US(2)