Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) Versus Gardasil®9 in Healthy Females 18-26 Years of Age
A 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
1 other identifier
interventional
488
1 country
1
Brief Summary
This study is designed to compare the immunogenicity 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 4, 2021
CompletedStudy Start
First participant enrolled
March 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2022
CompletedJune 15, 2023
June 1, 2023
1.2 years
February 25, 2021
June 14, 2023
Conditions
Keywords
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 seroconversion rates and geometric mean concentrations at months 7
7 months after the first dose
Secondary Outcomes (4)
safety1:Local and systematic adverse events/reactions occurred within 7 days after each vaccination.
During the 7-day period following each vaccination
safety2:Adverse events/reactions occurred within 30 days after each vaccination.
Within 30 days (Day 0-30) after any vaccination
safety3:Severe adverse events occurred throughout the study. To evaluate number of SAEs compared with the control vaccine.
Up to 8 month
safety4:Pregnancy and pregnancy outcome. To evaluate number of births and terminations compared with the control vaccine.
Up to 8 month
Other Outcomes (1)
Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific IgG antibody level
7 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
EXPERIMENTALSubjects would receive 3 doses of 270μg/0.5ml Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli) .
Gardasil®9 group
ACTIVE COMPARATORSubjects would receive 3 doses of 270μg/0.5ml Gardasil®9 .
Interventions
Three doses administered intramuscularly at 0, 45 day and 6 month.
Three doses administered intramuscularly at 0, 45 day and 6 month.
Eligibility Criteria
You may qualify if:
- Subject is female, between and including 18-26 years of age at the first vaccination;
- Subject is able to understand and comply with the requirements of the protocol(e.g. biological specimen collection, completion of the diary cards, return for follow-up visits), and written informed consent must be obtained from the subject prior to enrollment;
- Subject who agrees to practice effective contraception within 8 months after the first vaccination or has undergone tubal ligation,subtotal hysterectomy for benign lesion, ovarian benign tumor resection;
- No previous history of sexually transmitted diseases (including syphilis, gonorrhea, chancroid, venereal lymphogranuloma, groin granuloma, etc.);
- No previous history of abnormal cervical screening results or cervical intraepithelial neoplasia (CIN);
You may not qualify if:
- Axillary temperature \> 37.0℃;
- Subject who has a positive urine pregnancy test, or is pregnant or breastfeeding;
- Subject has used of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine or plans to use during the study period , or has participated in another clinical research in the past two years, or plans to participate in another research during the study period;
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs or systemic corticosteroids (Except intranasal steroid, the use of low dose topical, ophthalmic and inhaled steroid preparations will be permitted.) within 6 months prior to vaccination.
- Administration of immunoglobulin and/or blood products within 3 months prior to vaccination or planned to use them within 7 months after the first dose.
- Administration of inactivated vaccine within 14 days prior to vaccination or live vaccine within 21 days;
- Fever (Axillary temperature ≥38.0℃) 3 days prior to vaccination or system administration of antibiotics or antiviral agents within 5 days prior to vaccination;
- Subject has received other HPV vaccines or participated in clinical research related to HPV or cervical cancer previously;
- Subject has immunodeficiency disease, primary disease of important viscera, cancer and autoimmune disease (including systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy due to any condition, and other immunological diseases that investigators believe may influence the immune response).
- History of severe allergy (e.g., anaphylaxis, generalized urticaria, dyspnea, angioedema, and other significant reaction) to any previous vaccination, or be allergic to any of the components of the study vaccines.
- Asthma, which has been unstable for the past two years and requires emergency treatment, hospitalization, oral or intravenous corticosteroids;
- Subject has Serious medical disorders;
- Self-report coagulation disorders or abnormal coagulation function;
- Epilepsy, excluding febrile epilepsy under 2 years of age, alcoholic epilepsy 3 years prior to abstinence or simple epilepsy that does not require treatment in the past 3 years;
- Medical, psychological, social conditions, occupation or other factors, which considered by the investigator that may influence the conduct of the clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiamen Universitylead
- Xiamen Innovax Biotech Co., Ltdcollaborator
- Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.collaborator
Study Sites (1)
Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, 210009, China
Related Publications (1)
Zhu FC, Zhong GH, Huang WJ, Chu K, Zhang L, Bi ZF, Zhu KX, Chen Q, Zheng TQ, Zhang ML, Liu S, Xu JB, Pan HX, Sun G, Zheng FZ, Zhang QF, Yi XM, Zhuang SJ, Huang SJ, Pan HR, Su YY, Wu T, Zhang J, Xia NS. Head-to-head immunogenicity comparison of an Escherichia coli-produced 9-valent human papillomavirus vaccine and Gardasil 9 in women aged 18-26 years in China: a randomised blinded clinical trial. Lancet Infect Dis. 2023 Nov;23(11):1313-1322. doi: 10.1016/S1473-3099(23)00275-X. Epub 2023 Jul 17.
PMID: 37475116DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jun Zhang, master
Xiamen University
- PRINCIPAL INVESTIGATOR
Feng-cai Zhu, master
Jiangsu Provincial Centre for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
February 25, 2021
First Posted
March 4, 2021
Study Start
March 14, 2021
Primary Completion
May 30, 2022
Study Completion
July 25, 2022
Last Updated
June 15, 2023
Record last verified: 2023-06