Immunogenicity and safety of a bivalent, adjuvant system 04-adjuvanted human papillomavirus vaccine in healthy female volunteers aged 15-25: a randomized, double-blind, phase III, noninferiority clinical trial.

Abstract

Vaccination is proven to significantly reduce the risk of human papillomavirus (HPV)-related complications, especially cervical cancer. This study aimed to assess the immunogenicity and safety of the investigational bivalent HPV vaccine (16/18), named Papilloguard (Noyan Pajouhan Biopharma, Tehran, Iran), in comparison with the reference product (Cervarix, bivalent HPV vaccine (16/18) manufactured by GlaxoSmithKline, Rixensart, Belgium) in a three-dose regimen. This trial was a randomized, controlled, double-blind, phase III study of two HPV vaccines in healthy female volunteers aged 15-25. The primary endpoint was to test the noninferiority of Papilloguard (Noyan Pajouhan Biopharma) to Cervarix (GlaxoSmithKline) as measured by the geometric mean titer (GMT) ratios of HPV-16 and HPV-18 7 months after the first vaccination. Secondary endpoints were the proportion of local and systemic solicited and unsolicited events, and the number of females with seroconversion against HPV-16 and HPV-18 7 months after the first vaccination. Out of 504 screened women, 218 were enrolled. Seven months after the first vaccination, GMT ratios of HPV-16 and HPV-18 were 0.59 and 0.93, respectively. The seroconversion rates of both Papilloguard (Noyan Pajouhan Biopharma) and Cervarix (GlaxoSmithKline) were more than 96%. Both vaccinated groups had a generally good profile of solicited and unsolicited adverse events (AEs). The most common AE was discomfort at the injection site, which was well tolerated. The result analysis of this study supports the noninferiority of Papilloguard (Noyan Pajouhan Biopharma) to Cervarix (GlaxoSmithKline) in terms of safety and immunogenicity based on the GMT ratio. However, long-term comparative studies to evaluate the sustainability of GMT response and risk of cervical intraepithelial neoplasia grades 2-3 are needed.