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

Sponsor

Shanghai Zerun Biotechnology Co.,Ltd (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04965350

Collaborator

Yuxi Zerun Biotechnology Co., Ltd. (Other)

1,100

Enrollment

Location

Arms

8.4

Anticipated Duration (Months)

130.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HPV Infection	Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Apr 19, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 [At Month 7]
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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mianyang Center for Disease Control and Prevention	Mianyang	Sichuan	China

Sponsors and Collaborators

Shanghai Zerun Biotechnology Co.,Ltd
Yuxi Zerun Biotechnology Co., Ltd.

Investigators

Principal Investigator: Ting Huang, Sichuan Center for Disease Control and Prevention

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Zerun Biotechnology Co.,Ltd

ClinicalTrials.gov Identifier:

NCT04965350

Other Study ID Numbers:

311-HPV-1005

First Posted:

Jul 16, 2021

Last Update Posted:

Jul 16, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Papillomavirus Infections

Study Results

No Results Posted as of Jul 16, 2021