Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate the Safety and Primary Immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years

To evaluate the safety and immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years.

Study Overview

• Status: Completed
• Conditions: Vulvar Cancer; Vaginal Cancer; CIN1; CIN2; VaIN1; VaIN2; VaIN3; Genital Wart; AIS; Invasive Carcinoma; Cervical Cancers; CIN 3; Vin III; Mild Dysplasia of Vulva; Moderate Dysplasia of Vulva
• Intervention / Treatment: Biological: 9-valent HPV Recombinant Vaccine; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hanzhou, China
    • Zhejiang Provincial Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy females between, and including, 9 and 45 years of age at the time of enrolment
• Be able to provide legal identification for the sake of recruitment
• Be able to understand and sign informed consent form prior to enrollment and for subjects aged 9-17 years, they and their legal guardian(s) are supposed to understand and sign informed consent form together
• Subjects who the investigator believes that they can and will comply with the protocol requirements
• Subject must be not pregnant at the enrollment and agree to use adequate contraceptive precautions within 7 months or don't have pregnancy plan

Exclusion Criteria:

• Fever or axillary temperature> 37.0℃ before vaccination
• Previous vaccination against HPV
• Planned administration/administration of investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding first dose of vaccine
• Planned to take part in other clinical research within 7 months after participating this study or have taken part in other clinical research within 3 months before participating this study
• Abnormal laboratory tests parameters(except the part the clinician diagnosed as non clinical significance)
• Administration of any whole blood, plasma or immunoglobulins products within 3 months preceding first vaccination
• Interval between administration of the study vaccination and any attenuated live vaccine less than 14 days, and other vaccines less than 10 days
• History of serious allergic disease requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock)
• History of to adverse event to vaccine, or allergic to some food or drug
• History of epilepsy, seizures or 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.
• Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy
• Subject to severe hepatorenal disease, cardiovascular disease, hypertension, diabetes, malignant tumor, all kinds of infectious diseases and acute illness, or during chronic disease acute attack period
• Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
• Breastfeeding, pregnancy (including pregnancy test positive), or planned to be pregnant within 7 months
• During acute disease (including infectious and non-infectious disease) and chronic diease period of onset
• Abnormal cervical cancer screening or subject to CIN or acuteness wet wart that relevant to HPV infection in the past two years
• Planned to move out of local before the end of the study or leave the local for a long time during the study period
• Other unsuitable factors for the study judged by investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule.
Experimental: 9-valent HPV Recombinant Vaccine	Biological: 9-valent HPV Recombinant Vaccine; Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Subjects Reporting Solicited Adverse Events	7 days after each vaccination
Number of Subjects Reporting Unsolicited Adverse Events	30 days after each vaccination
Number of Subjects Reporting Serious Adverse Events	30 days after third dose of vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58	30 days after third dose of vaccination

Collaborators and Investigators

• Sponsor: Shanghai Bovax Biotechnology Co., Ltd.
• Collaborators: Chongqing Bovax Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): August 20, 2019
• Study Completion (Actual): January 10, 2020

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 15, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; DNA Virus Infections; Skin Diseases, Infectious; Warts; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Vaginal Diseases; Vulvar Diseases; Vulvar Neoplasms; Vaginal Neoplasms; Condylomata Acuminata
• Other Study ID Numbers: 9-HPV-1001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No