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

Primary Purpose

HPV Infection

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

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

About this trial

This is an interventional prevention trial for HPV Infection

Eligibility Criteria

9 Years - 30 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Mianyang Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

2vHPV Consistency Lot 1

2vHPV Consistency Lot 2

2vHPV Consistency Lot 3

2vHPV Pilot Scale Lot

Arm Description

Outcomes

Primary Outcome Measures

Geometric Mean Titers (GMTs) for HPV-16 and/or HPV-18 at one month post 3rd dose

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.

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (TEAE) during 30 days after each dose

Incidence of solicited adverse events (AEs) after vaccination

Incidence of unsolicited AEs after vaccination

Incidence of serious adverse events (SAEs)

Full Information

NCT ID

NCT04965350

First Posted

June 21, 2021

Last Updated

April 12, 2023

Sponsor

Shanghai Zerun Biotechnology Co.,Ltd

Collaborators

Yuxi Zerun Biotechnology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04965350

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

April 20, 2021 (Actual)

Primary Completion Date

April 27, 2022 (Actual)

Study Completion Date

May 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zerun Biotechnology Co.,Ltd

Collaborators

Yuxi Zerun Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HPV Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2vHPV Consistency Lot 1

Arm Type

Experimental

Arm Title

2vHPV Consistency Lot 2

Arm Type

Experimental

Arm Title

2vHPV Consistency Lot 3

Arm Type

Experimental

Arm Title

2vHPV Pilot Scale Lot

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

sterile solution for intramuscular injection

Primary Outcome Measure Information:

Title

Geometric Mean Titers (GMTs) for HPV-16 and/or HPV-18 at one month post 3rd dose

Time Frame

At Month 7

Title

Percentage of participants who seroconvert to HPV-16 and/or HPV-18 at one month post 3rd dose

Description

Time Frame

At Month 7

Secondary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events (TEAE) during 30 days after each dose

Time Frame

0~30 days after each vaccination

Title

Incidence of solicited adverse events (AEs) after vaccination

Time Frame

0~7 days after each vaccination

Title

Incidence of unsolicited AEs after vaccination

Time Frame

0~30 days after each vaccination

Title

Incidence of serious adverse events (SAEs)

Time Frame

Month 0 to Month 7

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ting Huang

Organizational Affiliation

Sichuan Center for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mianyang Center for Disease Control and Prevention

City

Mianyang

State/Province

Sichuan

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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