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

Vaginal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05371353
• Other study ID #: 4-HPV-3003
• Status: Recruiting
• Start date: May 14, 2022
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: Shanghai Bovax Biotechnology Co., Ltd.
• Contact: Jikai Zhang
• Phone: 020-89020236
• Email: 56061237[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer Stage IIa
• CIN1
• CIN2
• CIN3
• Condylomata Acuminata
• Genital Wart
• HPV Infections
• Papillomavirus Infections
• Uterine Cervical Neoplasms
• Vaginal Cancer
• Vaginal Neoplasms

Locations

Country	Name	City	State
China	Center for Disease Control and Prevention	Mianyang	Sichuan
China	Yangchun Center For Disease Prevention And Control	Yangchun	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Bovax Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate (SCR) for Each of the HPV Types Contained in the Vaccine	The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18	Month 12
Primary	SCR for Each of the HPV Types Contained in the Vaccine	The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18	Month 24
Primary	SCR for Each of the HPV Types Contained in the Vaccine	The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18	Month 36
Primary	SCR for Each of the HPV Types Contained in the Vaccine	The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18	Month 48
Primary	SCR for Each of the HPV Types Contained in the Vaccine	The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18	Month 60
Primary	Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine	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	Month 12
Primary	GMTs for Each of the HPV Types Contained in the Vaccine	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	Month 24
Primary	GMTs for Each of the HPV Types Contained in the Vaccine	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	Month 36
Primary	GMTs for Each of the HPV Types Contained in the Vaccine	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	Month 48
Primary	GMTs for Each of the HPV Types Contained in the Vaccine	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	Month 60