Vaccitech plc announced topline interim data from the HPV001 study (NCT04607850), a Phase 1b/2 clinical trial of VTP-200 in women with low-grade cervical human papillomavirus (HPV) lesions. Data from the first 58 women enrolled who reached their 6-month timepoint in the HPV001 placebo-controlled study were reviewed internally and the trial will continue as planned to the 12-month primary endpoint. Immunogenicity results showed high responses, defined as an average greater than 1,000 spot-forming units per million peripheral blood mononuclear cells in an ELISPOT assay, especially to the E1, E2 and E6 antigens.

VTP-200 was generally well-tolerated with no product-related grade 3 unsolicited events and no product-related SAEs. Results were unblinded by group however, to preserve the integrity of these data, the results will not be fully reported until the trial is complete and the data are fully unblinded. These interim data will be presented orally at the upcoming International Papillomavirus Conference in Washington D.C., which is taking place 17-21 April 2023.

HPV001 (NCT04607850) is a fully-enrolled, randomized, placebo-controlled Phase 1b/2 multi-center trial evaluating the safety, efficacy and immunogenicity of VTP-200, which utilizes the ChAdOx1-HPV and MVA-HPV heterologous approach, in women with HPV-related low grade cervical lesions. The study consists of an open label, non-randomized, dose escalation lead-in phase of 9 participants, followed by a blinded, randomized main phase of approximately 96 participants with high-risk HPV.