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Smallpox clinical trials

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NCT ID: NCT00189956 Completed - Smallpox Clinical Trials

Dose-finding Study to Evaluate Immunogenicity of Three Different Dose Levels of the IMVAMUNE (MVA-BN) Smallpox Vaccine.

Start date: April 2003
Phase: Phase 2
Study type: Interventional

The objective of the study is to find the optimal dose for the smallpox candidate vaccine IMVAMUNE (MVA-BN). For this purpose the study compares IMVAMUNE (MVA-BN) administered at three different dose levels.

NCT ID: NCT00189943 Completed - Smallpox Clinical Trials

Study on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects

Start date: April 2001
Phase: Phase 1
Study type: Interventional

The purpose of this study is to collect information on the safety, tolerability and immunogenicity of an investigational smallpox vaccine at different doses and using different routes of administration in vaccinia-naive and vaccinated healthy volunteers

NCT ID: NCT00189917 Completed - Dermatitis, Atopic Clinical Trials

Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in Patients With Atopic Disorders

Start date: April 2004
Phase: Phase 1
Study type: Interventional

The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in populations with atopic disorders.

NCT ID: NCT00189904 Completed - HIV Infections Clinical Trials

Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in HIV Infected Patients

Start date: July 2005
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations.

NCT ID: NCT00133575 Completed - Smallpox Clinical Trials

ACAM 3000 MVA at Harvard Medical School

Start date: October 2005
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT00123396 Completed - Smallpox Clinical Trials

VHA Clinicians and Bioterror Events: Interactive Web-based Learning

Start date: August 2004
Phase: N/A
Study type: Interventional

Our 4-year project uses public domain software and content developed by a University of Alabama at Birmingham (UAB) team and updates, refines, and tailors it to the unique clinician populations and electronic educational applications of VAMCs We are testing an innovative, web-based intervention adapted specifically for the VA to increase syndromic recognition, treatment, and post-exposure prophylaxis of biological warfare agents at multiple VA sites via a randomized controlled trial (RCT). Ultimately, we will disseminate the intervention throughout the entire VA system.

NCT ID: NCT00082446 Completed - Smallpox Clinical Trials

Combination Study With MVA BN and Dryvax

Start date: May 2004
Phase: Phase 1
Study type: Interventional

The overall goals of this study are to expand the available data on the safety and immunogenicity of MVA-BN in vaccinia-naive adults and to determine the optimum dose of MVA-BN to induce immune responses and attenuate Dryvax take reactions. Participants will include 90 healthy volunteers, ages 18-32 years. Participants will be randomly assigned to 1 of 6 study groups (groups A-F). Participants will be involved in study related procedures for up to 2 years. During this time, volunteers will return periodically for blood draws to check immune responses.

NCT ID: NCT00079820 Completed - Smallpox Clinical Trials

Safety, Tolerability, and Immune Response of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Adults

Start date: April 2004
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT00068198 Completed - Smallpox Clinical Trials

Human Immune Responses Smallpox

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to attempt to identify the immune response of healthy adults to an investigational dilution of the Dryvax smallpox vaccine. In addition, we will try to determine whether certain genetic characteristics influence the size of the sore around the vaccination site, and use blood samples from subjects in the study to make a new form of antibody that could be given to people with vaccine side effects.

NCT ID: NCT00063856 Completed - Smallpox Clinical Trials

Dressing Preparations for Smallpox

Start date: July 2003
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of this study is to find out the risk of spreading the vaccine virus, vaccinia, from the smallpox vaccination site when different types of bandages are used to cover the site. The study will also look at how each bandage type affects the healing of the sore. Study participants will include healthy individuals, 18-50 years old, who have not previously received a smallpox vaccine and healthy individuals, 18-50 years old, who have received a previous smallpox vaccine. All participants will receive the smallpox vaccine and be randomly assigned to 1 of 3 different bandage groups to cover the vaccine site: standard gauze dressing attached with paper tape, Opsite gauze-impregnanted occlusive dressing (attached by paper tape and waterproof), and Allevyn hydropolymer dressing (which is self-adhesive and highly absorbent). Volunteers will be involved in study related procedures for up to 252 days.