A Phase III, Randomized, Blinded, Positive-controlled Study to Compare the Immunogenicity of Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris) in Healthy Female Subjects Aged 16-26 Years.

Shanghai Zerun Biotechnology Co.,Ltd1 site in 1 country1,200 target enrollmentSeptember 1, 2022

ConditionsCervical Cancer Genital Wart CIN VIN Papillomavirus Infections

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Cervical Cancer
Sponsor: Shanghai Zerun Biotechnology Co.,Ltd
Enrollment: 1200
Locations: 1
Primary Endpoint: Geometric Mean Titers (GMT) of HPV neutralizing antibodies
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the immunogenicity and safety of Zerun 9-valent HPV recombinant vaccine in healthy female 16-26 years of age by comparing with GARDASIL®9.

Registry

clinicaltrials.gov

Start Date

September 1, 2022

End Date

December 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Shanghai Zerun Biotechnology Co.,Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy female 16-26 years of age
•16-17 years old subjects and their guardians able to provide legal identification; 18-26 years old subjects able to provide their legal identification;
•Able to understand (not illiterate) and sign the informed consent;
•Able to make a decision to participate in the clinical trial and the subject agrees to participate in the clinical trial;
•Women of child-bearing age (WOCBA): subjects must have a negative urine pregnancy test result, have used effective contraceptive measures within 2 weeks before enrollment, have no pregnancy plans, and agree to use adequate contraceptive precautions from enrollment to the 7th month (one month after full immunization).

Exclusion Criteria

•Abnormal cervical cancer screen test results (ASC-US or worse), history of HPV infection, history of abnormal cervical biopsy results, or history of genital warts;
•Subjects with severe congenital malformations or that cause serious organ damage, developmental disorders, genetic defects, or severe malnutrition;
•Subjects have received a marketed HPV vaccine or participated in an HPV vaccine clinical trial, or participated in clinical trials of other vaccines within the past 6 months;
•Fever prior to vaccination (axillary body temperature ≥37.3℃);
•History of severe allergic reaction that required medical intervention (such as swelling of the mouth and throat, dyspnea, hypotension or shock, etc.);
•History of allergic to vaccine, or to any ingredient of vaccine (Aluminum phosphate adjuvant, sodium chloride, histidine, polysorbate 80),or history of severe adverse reaction
•History of epilepsy, psychosis, major depression requiring medication, seizures, convulsions, or family history of mental illness
•Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose
•History of asthma, thyroidectomy, angioedema, severe liver, kidney, or cardiovascular disease, diabetes mellitus that can not be controlled by stable doses of insulin, or malignancy;
•Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy;

Outcomes

Primary Outcomes

Geometric Mean Titers (GMT) of HPV neutralizing antibodies

Time Frame: 30 days postdose 3 (Month 7)

HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 neutralizing antibodies GMT

Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

Time Frame: 30 days postdose 3 (Month 7)

Seroconversion is defined as a participant in PPS who was anti-HPV seronegative at Day 0 (before vaccination) and became seropositive 30days after the third dose (Month 7).

Secondary Outcomes

Percentage of subjects reporting solicited general symptoms(0-7 days after each dose)
Percentage of subjects reporting unsolicited adverse events (AEs)(0-30 days after each dose)
Percentage of subjects reporting solicited local symptoms(0-7 days after each dose)
Percentage of subjects reporting serious adverse events (SAEs)(Month 0 to Month 12)