The Durability of Protection and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female

Cervical Cancer Clinical Trial

Official title:

The Durability of Protection and Immuno-persistence Study of A Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Women Aged 18 to 45 Years

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045755
• Other study ID #: HPV-PRO-003-2
• Status: Recruiting
• Start date: April 13, 2021
• Est. completion date: January 2024

Study information

• Verified date: January 2023
• Source: Xiamen University
• Contact: Shaokai Zhang, Doctor
• Phone: +86-371-65587346
• Email: shaokaizhang[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to evaluate the durability of protection and immuno-persistence of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.

Description:

This is a follow-up study that is based on phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females aged 18-45 years (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006). The investigators will recruit people who have participated in phase III clinical study before and to evaluate the durability of protection and immuno-persistence of the bivalent HPV vaccine on 90m and 114m after dose 1.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1339
• Est. completion date: January 2024
• Est. primary completion date: August 10, 2023
• Gender: Female
• Age group: 26 Years to 54 Years

Eligibility

Inclusion Criteria:

1. Participants who participated in the Phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006) and received at least one dose;

2. Participants can fully understand the study content and sign an informed consent form;

3. Able to comply with the requests of the study;

Exclusion Criteria:

1. Participants used other HPV vaccine products (including both marketed and unmarketed vaccines) since participating in the Phase III clinical study.

2. According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Neoplasms
• Persistent Infection
• Vaginal Intraepithelial Neoplasia
• Vulvar Intraepithelial Neoplasia

Intervention

Biological:
• Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)
The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 µg of HPV-16 and 20 µg of HPV-18 L1 VLPs absorbed with 208 µg of aluminum adjuvant

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (3)

Lead Sponsor	Collaborator
Jun Zhang	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Xiamen Innovax Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1	To observe the number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1	expected 2-3 years
Primary	Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) on 90m and 114m after dose 1	To detect the HPV16 and HPV18 DNA on the gynecological specimens ( Cervical exfoliated cell specimens and biopsy specimens) collected from the subjects	expected 2-3 years
Secondary	Anti-HPV16 and anti-HPV18 type-specific IgG antibody level on 90m and 114m after dose 1	To detect the anti-HPV 16 and anti-HPV 18 seroconversion rates and geometric mean concentrations on 90m and 114m after dose 1	expected 2-3 years