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

NCT04965350 | Completed Phase 3

• 1 other identifier: 311-HPV-1005
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HPV Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (4)

2vHPV Consistency Lot 1

EXPERIMENTAL

Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)

2vHPV Consistency Lot 2

EXPERIMENTAL

Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)

2vHPV Consistency Lot 3

EXPERIMENTAL

Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)

2vHPV Pilot Scale Lot

ACTIVE COMPARATOR

Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)

Interventions

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris) BIOLOGICAL

sterile solution for intramuscular injection

2vHPV Consistency Lot 1; 2vHPV Consistency Lot 2; 2vHPV Consistency Lot 3; 2vHPV Pilot Scale Lot

Eligibility Criteria

• Age: 9 Years - 30 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zerun Biotechnology Co.,Ltd: lead
• Yuxi Zerun Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Mianyang Center for Disease Control and Prevention

Mianyang, Sichuan, China

Location

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Ting Huang

  Sichuan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 16, 2021
• Study Start: April 20, 2021
• Primary Completion: April 27, 2022
• Study Completion: May 16, 2022
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

CN (1)