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ACAM3000 MVA Vaccine

Ensayo de Sanofi en Viruela.

Más ensayos de: Viruela.

Fase

Fase 1

Estado

Completado

Participantes

110

previstos

Centros

2

Fin del objetivo primario

oct 2006

fecha real

Título oficial en el registro (en inglés): Safety, Tolerability, and Immune Response of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Adults

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en abr 2004.

De principio a fin

1. Empieza el ensayo (abr 2004)
2. Lectura de resultados oct 2006 (real)
3. Hoy

Los cambios los anota PivotalWire desde agosto de 2026; lo anterior no lo tenemos. El historial completo, versión a versión, está en ClinicalTrials.gov.

Qué mide

Safety (Study Completion) (del registro, en inglés)

Qué se prueba

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

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Ficha completa en ClinicalTrials.gov (NCT00079820), actualizada en ene 2014.