Adult Disease

This study is a multicentric double-blind placebo-controlled dose escalation trial of a CD40HVac vaccine (humanized anti-CD40 mAb fused to HPV16 E6/E7 oncoproteins) adjuvanted with poly-ICLC (Hiltonol) in patients with HPV16 oropharyngeal carcinoma with no evidence of residual or recurrent disease after surgery and/or radiochemotherapy. The primary objective is to determine the recommended phase 2 dose (RP2D) of a poly-ICLC(Hiltonol)-adjuvanted CD40HVac vaccine according to the safety and the capacity to elicit immune responses of different doses Two dose levels of poly-ICLC-adjuvanted CD40.HVac will be explored * 1st dose level: CD40.HVac 1.0 mg, with 1.0 mg poly-ICLC * 2nd dose level: CD40.HVac 3.0 mg, with 1.0 mg poly-ICLC The safety data will be reviewed by an IDSMB that will give recommendations.

This is a prospective study aimed at recruiting 30,000 individuals, aged 40-70 years old, and following them longitudinally for 25 years with repeated measurements. The basic follow-up frame will include a visit to the Clinical Test Center (CTC) every two years and a phone interview every other year (on uneven years). Sample collection and biobanking will be performed every two years and online questionnaires will be filled out on an annual basis. The primary goals are to study the variation observed across different individuals in disease susceptibility, clinical phenotypes, and therapeutic responses. The study aims at studying the complex interplay and relative contribution of different omics, physiological characteristics and lifestyle on disease pathogenesis and progression and to evaluate how these effects are mediated.