Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls

Cervical Cancer Clinical Trial

Official title:

Immuno-persistence Study of A Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Female Subjects Aged 9 to 17 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03206255
• Other study ID #: HPV-PRO-006-2
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: August 15, 2018

Study information

• Verified date: January 2019
• Source: Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to evaluate the immuno-persistence (type specific IgG antibody) of the tested vaccine administered in girls aged 9-17 years ,comparing to young healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).

Description:

This is a follow-up study which is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) .We will recruit people who have participated in bridging study before and collect their serum samples to test the seroprevalence and geometric mean concentrations of anti-HPV16 and anti-HPV18 antibody on 18 and 30 months after dose 1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 940
• Est. completion date: August 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 28 Years

Eligibility

Inclusion Criteria:

1. Participants who participated in the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls (Unique Protocol ID:HPV-PRO-006-2, Identifiers: NCT02562508) and received at least one dose;

2. The legal guardian of participants under age 18 can provide identity certificate, or representative can provide authorization;

3. Participants under the age 18, able to sign or whose legal guardian agree to sign the written informed consent; or participants aged 18 and older agree to sign the written informed consent;

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

Exclusion Criteria:

1. Participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician after vaccination ;

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
• Uterine Cervical Neoplasms
• Vaginal Intraepithelial Neoplasia
• Vulvar Intraepithelial Neoplasia

Intervention

Procedure:
• 3 doses of HPV 16/18 bivalent vaccine
Participants have received 60µg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)
• 2 doses of HPV 16/18 bivalent vaccine
Participants have received 60µg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)

Locations

Country	Name	City	State
China	Jiangsu Provincial Centre for Disease Control and Prevention	Nanjing	Jiangsu

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	Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Months 18 and 30 (type specific IgG antibody)	To detect the anti-HPV 16 and anti-HPV 18 type specific IgG antibody level on 18 and 30 months after the dose 1	Month 18 and 30
Secondary	Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Months 18 and 30 (type specific neutralizing antibody)	To detect the anti-HPV 16 and anti-HPV 18 type specific neutralizing antibody level on 18 and 30 months after the dose 1	Month 18 and 30
Secondary	All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded		between 7 months and 30months after the dose1