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

Jun Zhang

Status: Enrolling

Conditions: Vaginal Intraepithelial Neoplasia; Vulvar Intraepithelial Neoplasia; Persistent Infection; Cervical Intraepithelial Neoplasia; Cervical Cancer

Treatments: Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05045755

HPV-PRO-003-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,339 estimated patients

Sex: Female

Ages: 26 to 54 years old

Volunteers: No Healthy Volunteers

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;

Trial design

1,339 participants in 2 patient groups

Vaccine group

Description:

Participants in this arm have received 3 doses of HPV 16/18 bivalent vaccine that contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant.

Treatment:

Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

Control group

Description:

Participants in this arm have received 3 doses of HEV vaccine that contains 30μg HEV virus-like particle antigen adsorbed in alum-adjuvant.