Lot Consistency Clinical Trial of Bivalent HPV Vaccine in 9 to 30 Years Old Healthy Females

A Phase III, Randomized, Double-blind Study to Assess the Consistency of the Immunogenicity of Three Consecutive Production Lots of Bivalent HPV Vaccine in Healthy Female Subjects Aged 9 - 30 Years and to Demonstrate Non-inferiority of the Candidate HPV Vaccine Manufactured at Commercial Scale Compared With a Pilot Scale

The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of bivalent HPV (Type 16,18) vaccine (Pichia pastoris) in healthy female subjects aged 9 - 30 years, and demonstrate the non-inferiority of the candidate HPV vaccine manufactured at commercial scale compared with a pilot scale.

Study Overview

• Status: Completed
• Conditions: HPV Infection
• Intervention / Treatment: Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)

• Study Type: Interventional
• Enrollment (Actual): 1100
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Mianyang, Sichuan, China
      • Mianyang Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 9-30 healthy female able to provide legal identification.
• Written informed consent had to be obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent had to be obtained from a parent or legal guardian of the subject and, in addition, the subject had to sign and personally date a written informed assent).
• Women of child-bearing age(WOCBA): Subject had to have a negative urine pregnancy test, no plan to be pregnant in 7 months, and agree to use adequate contraceptive precautions during study period.

Exclusion Criteria:

• Subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial.
• History of abnormal cervical screen test result (ASC-US or worse) or history of genital warts.
• History of severe allergic reaction that required medical intervention.
• History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.
• Pregnant or breastfeeding, or within 6 weeks after the end of pregnancy.
• Fever prior to vaccination (auxiliary temperature ≥37.3 °C).
• Hypertension (physical examination systolic blood pressure 140mmHg and or diastolic blood pressure 90mmHg.
• Received live attenuated vaccine within 15 days before vaccination or subunit or inactivated vaccine within 7 days.
• Received immunoglobulin and/or blood product 3 months prior to the first vaccination.
• Acute diseases or acute stage of the chronic diseases within 3 days preceding the vaccination.
• According to the judgment of the investigator, subject has or had any other symptoms, medical history and other factors that are not suitable for participating in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2vHPV Consistency Lot 1	Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris); sterile solution for intramuscular injection
Experimental: 2vHPV Consistency Lot 2	Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris); sterile solution for intramuscular injection
Experimental: 2vHPV Consistency Lot 3	Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris); sterile solution for intramuscular injection
Active Comparator: 2vHPV Pilot Scale Lot	Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris); sterile solution for intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers (GMTs) for HPV-16 and/or HPV-18 at one month post 3rd dose		At Month 7
Percentage of participants who seroconvert to HPV-16 and/or HPV-18 at one month post 3rd dose	Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:40 prior to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:40 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.	At Month 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Treatment-Emergent Adverse Events (TEAE) during 30 days after each dose	0~30 days after each vaccination
Incidence of solicited adverse events (AEs) after vaccination	0~7 days after each vaccination
Incidence of unsolicited AEs after vaccination	0~30 days after each vaccination
Incidence of serious adverse events (SAEs)	Month 0 to Month 7

Collaborators and Investigators

• Sponsor: Shanghai Zerun Biotechnology Co.,Ltd
• Collaborators: Yuxi Zerun Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Ting Huang, Sichuan Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): April 27, 2022
• Study Completion (Actual): May 16, 2022

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Tumor Virus Infections; Papillomavirus Infections
• Other Study ID Numbers: 311-HPV-1005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No