Calendario›INO›VGX-3100

VGX-3100

Phase I of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation for CIN 2 or 3

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

Fase

Fase 1

Estado

Completado

Participantes

18

previstos

Centros

4

Fin del objetivo primario

ene 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en may 2008.

Qué mide

Safety and tolerability of escalating doses of VGX-3100, administered by IM injection with EP to adult female subjects post surgical or ablative treatment of grade 2 or 3 CIN. (Through Month 4) (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, we have developed our DNA vaccine, VGX-3100, to include plasmids targeting E6 and E7 proteins of both HPV subtypes 16 and 18. We 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. The vaccine is proposed to be given to patients with a history of CIN 2 and 3 that have been treated by surgery. We will determine which dose the DNA vaccine will be the best tolerated and elicit the strongest immune response.

Más ensayos de INO

Todos los de INO, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00685412), actualizada en sep 2017.