Plateau Antibody Levels of a Recombinant (E.Coli) HPV Nonavalent Vaccine Versus Gardasil®9 in Young Women

Cervical Cancer Clinical Trial

Official title:

An Observational Study to Compare Plateau Antibody Levels of a Recombinant (E.Coli) Human Papillomavirus Nonavalent (Type 6/11/16/18/31/33/45/52/58) Vaccine Versus Gardasil®9 in Healthy Females 18-26 Years of Age

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06197802
• Other study ID #: HPV-PRO-011-1
• Status: Not yet recruiting
• Start date: January 10, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: Xiamen University
• Contact: Jun Zhang, master
• Phone: 86-592-2184110
• Email: zhangj[@]xmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is designed to compare plateau antibody levels of a novel recombinant human papillomavirus vaccine (types 6,11,16,18,31,33,45,52,58 )(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., with Gardasil®9 in females 18-26 Years of Age.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 392
• Est. completion date: December 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 28 Years

Eligibility

Inclusion Criteria:

• Subject who had previously participated in the Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck & Co., Inc.) in Healthy Females 18-26 Years of Age (Protocol No.: HPV-PRO-011, Identifiers: NCT04782895), and received at least one dose ;
• Subject is able to understand and comply with the requirements of the protocol(e.g. biological specimen collection, return for follow-up visits), and written informed consent must be obtained from the subject prior to enrollment;

Exclusion Criteria:

• Subject who had used other HPV vaccine products (including marketed and unmarketed vaccines) after participating in the Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck & Co., Inc.) in Healthy Females 18-26 Years of Age (Protocol No.: HPV-PRO-011, Identifiers: NCT04782895) ;
• Subject has abnormal coagulation function (such as coagulation factor deficiency, coagulopathy, platelet abnormalities) or coagulation disorders;
• Medical, psychological, social conditions, occupation or other factors, which considered by the investigator that may influence the conduct of the clinical study.

Related Conditions & MeSH terms

• Cervical Cancer
• Condylomata Acuminata
• Uterine Cervical Neoplasms

Intervention

Biological:
• Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)
Three doses administered intramuscularly at 0, 45 day and 6 month.
• Gardasil®9
Three doses administered intramuscularly at 0, 45 day and 6 month.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Xiamen University	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-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level	Anti-HPV 6,11,16,18,31,33,45,52 and 58 seropositive rates and geometric mean concentrations at months 30-36	30-36 months after the first dose