NCT05668572

A Phase III Trial Evaluates the Efficacy, Immunogenicity and Safety Profile of HPV Vaccine

A Multi-centre, Blinded, Randomized and Gardasil-controlled Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety Profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12,000 (actual)
• Sponsor: Beijing Health Guard Biotechnology, Inc · Industry
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is to demonstrate that the administration of the investigational vaccine can reduce the Combined Incidence of HPV types 6/11/16/18/31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), high-grade Anal Intraepithelial Neoplasia (AIN 2/3), vulvar cancer, vaginal cancer or anal cancer.

Detailed description

This is a multi-center, blinded, randomized and Gardasil-controlled (quadrivalent HPV vaccine GARDASIL®) Phase III clinical study. The study will recruit a total of approximately 12,000 healthy Chinese women ages 20-45 years with permanent residence, who will be randomized at a 1: 1 ratio to receive the investigational vaccine or the positive control (quadrivalent HPV vaccine GARDASIL®), respectively. Healthy women ages 20-45 eligible for the study will be stratified at a 2: 2: 1 ratio into three age subgroups (i.e. 20-26 years of age, 27-35 years of age and 36-45 years of age), and each subgroup will be randomized at a 1: 1 ratio to receive the investigational vaccine or the positive control (quadrivalent HPV vaccine GARDASIL®), respectively. A total of 1,000 subjects will be allocated to an Immunogenicity Cohort, who will also be randomized at a 1: 1 ratio to receive the investigational vaccine or the positive control. The Immunogenicity Cohort is set up to evaluate the immune responses induced by the investigational vaccine and their persistence. For the Sample allocation plan, twelve thousand (12,000) subjects from the chosen clinical trial sites are stratified at a 2: 2: 1 ratio into 3 age subgroups, i.e. 4,800 in the subgroup of ages 20-26 years, 4,800 in the subgroup of ages 27-35 years, and 2,400 in the subgroup 36-45 years of age. Immunogenicity evaluation will be conducted at a clinical trial site in 1,000 subjects, selected randomly in the order of enrollment. The Primary study objectives also involve: -To demonstrate that administration of the investigational vaccine reduces the Combined Incidence of HPV types 6/11/16/18/31/33/45/52/58-related persistent infections, and cervical, vulvar, vaginal and anal lesions detected in samples from three or more consecutive visits (+/-1 month visit window) 12 months or longer apart. The Secondary study objectives involve: * To evaluate the safety profile of the investigational vaccine in healthy women ages 20-45; * To demonstrate that geometric mean titers of antibody responses specific to HPV types 6/11/16/18 induced by the investigational vaccine are non-inferior to those generated by GARDASIL; * To demonstrate that the investigational vaccine produces antibody responses specific to HPV types 31/33/45/52/58; * To evaluate the levels and persistence of antibody responses against HPV types 6/11/16/18/31/33/45/52/58 generated by the investigational vaccine; * To demonstrate that the investigational vaccine reduces the Combined Incidence of HPV types 6/11/16/18/31/33/45/52/58-related persistent infections detected in samples from 2 or more consecutive visits 6 months (+/-1 month visit window) or longer apart. The Exploratory study objectives involve: * To evaluate the impact of a 3-dose regimen of the investigational vaccine on the incidence of HPV types 6/11/16/18/31/33/45/52/58-related cytological abnormalities (ASC-US, positive for high-risk HPV types, or worse) as determined by the Thinprep cytologic test (TCT test) among subjects, who are naïve (seronegative) to the relevant HPV type(s) (HPV 6/11/16/18/31/33/45/52/58) at baseline and remain negative to the relevant HPV type(s) as determined by HPV-DNA test and without abnormal cervical biopsy result through Month 7; * To evaluate the incidence of non-vaccine HPV type-related Cervical Intraepithelial Neoplasia (CIN), Adenocarcinoma in Situ (AIS) and Cervical Carcinoma as determined by histopathologic examination post 3 doses of the investigational vaccine; * To evaluate the incidence of non-vaccine HPV type-related persistent infections for no less than 6 months, and cervical, vulvar, vaginal and anal diseases as determined by histopathologic examination post 3 doses of the investigational vaccine; * To evaluate the incidence of non-vaccine HPV type-related cytological abnormalities (ASC-US, positive for high-risk HPV types, or worse) as determined by the TCT test post 3 doses of the investigational vaccine.

Conditions

• Human Papillomavirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli)	0.5-mL suspension for injection, each 0.5-mL prefilled syringe dose contains L1 proteins of HPV types 6/11/16/18/31/33/45/52/58 in the amounts of 30mcg, 40mcg, 60mcg, 40mcg, 20mcg, 20mcg, 20mcg, 20mcg and 20mcg, respectively, totaling 270mcg of antigens. A 3-dose regimen administered at months 0, 2 and 6.
BIOLOGICAL	Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)（GARDASIL®）	0.5-mL suspension for injection, each 0.5-mL single-dose syringe contains approximately 20 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 40 mcg of HPV Type 16 L1 protein, 20 mcg of HPV Type 18 L1 protein, totaling 120 mcg of antigens

Timeline

• Start date: 2020-12-05
• Primary completion: 2022-07-21
• Completion: 2023-02-23
• First posted: 2022-12-30
• Last updated: 2023-01-04

Locations

3 sites across 1 country: China