ACAM 3000 MVA at Harvard Medical School

Summary

The purpose of this study is to assess the safety of an experimental smallpox vaccine (MVA: Modified Vaccinia Ankara) and to compare the body's immune (system that fights disease) response to this vaccine. Participants will be assigned to 1 of 6 study groups. Each group will include 12 subjects, 10 will receive the modified smallpox vaccine and two will receive placebo, an inactive substance. The vaccine will be administered in 1 of 3 ways: under the skin; in the muscle; or between the muscle and the skin. Groups A and B will receive Dryvax® 6-15 months after the initial MVA vaccine; groups C, D, E, and F will receive Dryvax® 6 months after the initial MVA vaccine. Study procedures will include documenting side effects for 14 days after each vaccination, electrocardiogram (picture of the hearts activity) and blood samples. Participants will be involved in study related procedures for up to 18 months.

Conditions

• Smallpox

Interventions

BIOLOGICAL

MVA Smallpox Vaccine

MVA smallpox vaccine (ACAM3000 MVA) administered in two doses approximately 28 days apart in the following dose/route combination: 10\^7 or 10\^8 TCID50 intramuscularly (IM).

BIOLOGICAL

MVA Smallpox Vaccine

MVA smallpox vaccine (ACAM3000 MVA) administered in two doses approximately 28 days apart in the following dose/route combination: 10\^7 or 10\^8 TCID50 subcutaneously (SC).

OTHER

Placebo

Sterile saline (0.9%) volume of 0.5 ml intradermally in the deltoid.

OTHER

Placebo

Sterile saline (0.9%) volume of 0.5 ml subcutaneously in the deltoid.

BIOLOGICAL

MVA Smallpox Vaccine

MVA smallpox vaccine (ACAM3000 MVA) administered in two doses approximately 28 days apart in the following dose/route combination: 10\^6 or 10\^7 TCID50 intradermally (ID).

BIOLOGICAL

Live vaccinia virus vaccine

Dryvax® smallpox vaccine administered at approximately day 180, dosage 10\^8 pfu/ml.

OTHER

Placebo

Sterile saline (0.9%) volume of 0.5 ml intramuscularly in the deltoid.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

38 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2005-10-31

Primary Completion

2008-04-30

Completion

2008-04-30

Countries

• United States

Study Locations