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

NCT06197802 | Active Not Recruiting

• 1 other identifier: HPV-PRO-011-1
• Study Type: observational
• Target: 392
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancer; Condylomata Acuminata

Keywords

human papillomavirus vaccine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) group

Subjects would receive 3 doses of 270μg/0.5ml Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli)

Biological: Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)

Gardasil®9 group

Subjects would receive 3 doses of 270μg/0.5ml Gardasil®9

Biological: Gardasil®9

Interventions

Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli) BIOLOGICAL

Three doses administered intramuscularly at 0, 45 day and 6 month.

Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) group

Gardasil®9 BIOLOGICAL

Three doses administered intramuscularly at 0, 45 day and 6 month.

Gardasil®9 group

Eligibility Criteria

• Age: 20 Years - 28 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiamen University: lead
• Xiamen Innovax Biotech Co., Ltd: collaborator
• Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.: collaborator

Study Sites (1)

Jiangsu Provincial Centre for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

• Zhong GH, Bi ZF, Chu K, Zhang L, Chen L, Zhu KX, Quan JL, Nie C, Chen Q, Qiu LX, Xu JB, Li JX, Zhang ML, Liu S, Nie LL, Li K, Su YY, Huang SJ, Zhang QF, Huang WJ, Pan HX, Wu T, Zhang J, Xia NS. Immunogenicity comparison of an Escherichia coli-produced 9-valent human papillomavirus vaccine and Gardasil9 in Chinese women aged 18-26 years: three-year follow-up data from a randomised clinical trial. Lancet Reg Health West Pac. 2025 Aug 27;62:101671. doi: 10.1016/j.lanwpc.2025.101671. eCollection 2025 Sep.

  PMID: 40919385 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Condylomata Acuminata

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Zhang, master

  Xiamen University

  STUDY CHAIR

• Feng-cai Zhu, master

  Jiangsu Provincial Centre for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 9, 2024
• Study Start: December 30, 2023
• Primary Completion: April 5, 2024
• Study Completion: September 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)