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

NCT03676101 | Completed Phase 1

• 1 other identifier: 9-HPV-1001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancers; Vulvar Cancer; Vaginal Cancer; CIN1; CIN2; CIN 3; AIS; Invasive Carcinoma; Mild Dysplasia of Vulva; Moderate Dysplasia of Vulva; Vin III; VaIN1; VaIN2; VaIN3; Genital Wart

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58

  30 days after third dose of vaccination

Study Arms (2)

9-valent HPV Recombinant Vaccine

EXPERIMENTAL

Biological: 9-valent HPV Recombinant Vaccine

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

9-valent HPV Recombinant Vaccine BIOLOGICAL

Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.

9-valent HPV Recombinant Vaccine

Placebo BIOLOGICAL

Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule.

Placebo

Eligibility Criteria

• Age: 9 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Bovax Biotechnology Co., Ltd.: lead
• Chongqing Bovax Biopharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Zhejiang Provincial Center for Disease Control and Prevention

Hanzhou, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal 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; Vulvar Diseases; Vaginal 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 Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 18, 2018
• Study Start: October 10, 2018
• Primary Completion: August 20, 2019
• Study Completion: January 10, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

CN (1)