A Phase I Study of Quadrivalent HPV Recombinant Vaccine

NCT03085381 | Completed Phase 1

• 1 other identifier: 4-HPV-1001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and primary immunogenicity of the quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (hansenula polymorpha) in Chinese female subjects aged 9-45 years.

Conditions

HPV Infections

Outcome Measures

Primary Outcomes (1)

• Systemic and local adverse events during the period of first dose vaccination to 30 days after last dose of vaccination

  30 days after last dose of vaccination

Study Arms (2)

HPV vaccine

EXPERIMENTAL

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

Biological: HPV vaccine

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

HPV vaccine BIOLOGICAL

HPV vaccine

Placebo BIOLOGICAL

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, or planned administration/administration of a vaccine not foreseen by the study protocol within 30 days preceding first dose of vaccine; Planned to take part in other clinical research within 7 months after participating this study
• Abnormal laboratory tests parameters
• 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
• During menstrual period or acute disease period of onset
• Breastfeeding, pregnancy (including pregnancy test positive), or planned to be pregnant within 7 months
• Abnormal cervical cancer screening or subject to CIN or acuteness wet wart that relevant to HPV infection in the past two years

Sponsors & Collaborators

• Shanghai Bovax Biotechnology Co., Ltd.: lead

Study Sites (1)

Liu Zhou Centre for Disease Control and Prevention

Liuchow, Guangxi, China

Location

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Papillomavirus Vaccines

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Zhaojun Mo, Master

  Guangxi Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

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: March 19, 2017
• First Posted: March 21, 2017
• Study Start: December 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: August 1, 2018
• Last Updated: September 14, 2018

Record last verified: 2018-09

Locations

CN (1)