Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine

Sponsor

Shanghai Bovax Biotechnology Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05371353

Collaborator

(none)

600

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To access the immune persistence of Chinese women aged 9-45 years after receiving quadrivalent HPV vaccine with the immunization schedule of 0, 2 and 6 months.

Condition or Disease	Intervention/Treatment	Phase
HPV Infections Cervical Cancer Stage IIa Vaginal Cancer Genital Wart CIN1 CIN2 CIN3

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Evaluating the Immune Persistence of Recombination Quadrivalent HPV Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomized Clinical Trial

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

May 1, 2027

Anticipated Study Completion Date :

May 1, 2027

Outcome Measures

Primary Outcome Measures

Seroconversion rate (SCR) for Each of the HPV Types Contained in the Vaccine [Month 12]
The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18
SCR for Each of the HPV Types Contained in the Vaccine [Month 24]
The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18
SCR for Each of the HPV Types Contained in the Vaccine [Month 36]
The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18
SCR for Each of the HPV Types Contained in the Vaccine [Month 48]
The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18
SCR for Each of the HPV Types Contained in the Vaccine [Month 60]
The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18
Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine [Month 12]
The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7
GMTs for Each of the HPV Types Contained in the Vaccine [Month 24]
The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7
GMTs for Each of the HPV Types Contained in the Vaccine [Month 36]
The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7
GMTs for Each of the HPV Types Contained in the Vaccine [Month 48]
The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7
GMTs for Each of the HPV Types Contained in the Vaccine [Month 60]
The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subjects who participated in the phase III clinical trial of non inferior efficacy of HPV tetravalent vaccine of Yangchun Center for Disease Control and Prevention (protocol No.: 4-HPV-3001), completed three doses of HPV quadrivalent vaccine and provided blood sample at months 7; Or subjects who have participated in the bridging study of HPV quadrivalent vaccine of Mianyang Center for Disease Control and Prevention (scheme No.: 4-HPV-3002), completed the whole vaccine schedule at month 0，2，6, and provided blood sample at months 7;
The subjects aged 9 to 17 years old at Mianyang site and their legal guardian should provide legal indentification; the subjects aged over 18 years old should provide legal indentification;
The subject voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form;
Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements.

Exclusion Criteria:

Enrolling or plan to enroll in other clinical trials (drugs or vaccines) (except that the observational clinical study and the subjects at Mianyang site are still in the post exemption safety follow-up stage of the 4-HPV-3002 trial);
Suffering from thrombocytopenia or any coagulation dysfunction that can be a contraindication to blood collection (such as coagulation factor deficiency, coagulation diseases, platelet abnormalities, etc.);
According to the investigator's judgment, the subject has any condition may interfere with process of evaluation of immune persistence.