HPV-Clinical

HPV-Clinical Trial

Human Papillomavirus (HPV) infection is responsible for >95% of cervical cancers worldwide. Both HPV 16 & 18 linked cervical cancer have been reported worldwide and account for ~70% of the cases. Peak of HPV infection coincides with the onset of sexual activity in girls and young women. Approx. 500,000  women are diagnosed with cervical cancer each year, about 80% of which are in developing countries. Over half of the women diagnosed with cervical cancer die from the disease, and 85% of those deaths occur in the developing world where cancer screening is uncommon. Currently there is no drug treatment for HPV infection.

The primary problem is with the availability of low cost, safe and efficacious vaccines which would be available in volumes of ~ 50M doses per annum.

GCI is supporting a Phase II/III clinical trial for testing SII’s quadrivalent vaccine in india. SII plans to establish commercial scale facility of > 50M doses for this vaccine in order to take care of the continuous supply of low cost high quality vaccines for global mass vaccination. SIIPL would establish the manufacturing facility, scale up from 100L to 4x1000L scale. The clinical evaluation would primarily focus on immunological noninferiority when compared to licensed Quadrivalent Gardasil (Merck vaccine). This program also involves integration of WHO IARC right from the beginning of clinical design to ensure high quality clinical data are generated.  This would ensure acceptability by regulators.