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VGX-3100

Fourth Dose of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + EP in Adult Females Previously Vaccinated With Three Doses of VGX-3100

Ensayo de INOVIO PHARMACEUTICALS, INC. en Human Papillomavirus (HPV) (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

14

previstos

Centros

3

Fin del objetivo primario

oct 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en jul 2010.

Qué mide

Safety and tolerability of a fourth dose of VGX-3100 (through Month 6 (end of study)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroDNA vaccines, which are small pieces of DNA also known as plasmids, have several advantages over traditional vaccines such as live attenuated virus and recombinant protein-based vaccines. DNA vaccines appear to be well tolerated in humans. Therefore, the investigators have developed our DNA vaccine, VGX-3100, to include plasmids targeting E6 and E7 proteins of both HPV subtypes 16 and 18. The investigators have chosen to deliver our candidate vaccines via electroporation (EP) using the CELLECTRA constant current device to deliver a small electric charge following intramuscular (IM) injection, since animal studies have shown that this delivery method increases the immune response to our DNA vaccine leading to a decrease in the size of tumors caused by HPV 16 and 18. In study HPV-001, the vaccine was given to subjects with a history of CIN 2 and 3 who had been previously treated by surgery. This study is proposed to vaccinate the same subjects with a fourth dose of the VGX-3100 to determine the safety and immune response.

Más ensayos de INO

Todos los de INO, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01188850), actualizada en ago 2018.