Brief Title
Evaluating the 2-dose Immunization Schedule of Human Papillomavirus (HPV)-16/18 in Adolescent Females
Official Title
Immunogenicity Study of a 2-dose Immunization Schedule of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Adolescent Females Aged 9 to 14 Years
Brief Summary
To evaluate the immune non-inferiority, as measured by antibody responses, of a 2-dose
immunization schedule (0, 6 months) of recombinant human papillomavirus virus-like particle
vaccine (type 16 and 18 L1 proteins, yeast) (hereinafter referred as HPV-2 vaccine) in
adolescent females aged 9 to 14 years in comparison to 3-dose immunization schedule (0, 2, 6
months) in young females aged 18 to 26 years.
Detailed Description
The study plans to enroll 600 adolescent females aged 9 to 14 years and 300 adult females
aged 18 to 26 years. The adolescents will be divided into two cohorts, 300 each, receiving
either a 2-dose (0, 6 months) immunization schedule or a 3-dose (0, 2, 6 months) immunization
schedule. The adult female group will receive a 3-dose (0, 2, 6 months) immunization
schedule.
Each subject shall be administrated with the studied vaccine according to either 2-dose or
3-dose schedule as above. Immediate reactions occurred during 30 minutes after each
inoculation, all the local and systematic reactions occurred from 0 to 7 days after each
inoculation will be recorded. All the adverse events (AEs) occurred from the first dose of
administration to 1 month after the final dose of administration, as well as all the serious
adverse events (SAEs) occurred from the first dose of administration to 6 months after the
final dose of administration will be collected. Blood samples will be collected at day 0
(prior to immunization) , month 6 (prior to the last injection) , month 7, month 12, month
24, and month 36. All the blood samples will be tested HPV 16- and HPV 18-specific antibody
titers.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
HPV-16 and HPV-18 antibody titers (GMT)
Secondary Outcome
HPV-16 and HPV-18 antibody titers (GMT) and the seroconversion rate
Condition
Human Papillomavirus
Intervention
HPV-16/18 vaccine
Study Arms / Comparison Groups
2-dose adolescent
Description: 300 adolescent girl will receive a two-dose schedule (0 day, 6 months) immunization of HPV-16/18 vaccine.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
900
Start Date
February 2016
Completion Date
May 2019
Primary Completion Date
November 2016
Eligibility Criteria
Inclusion Criteria:
Adult group:
- 18-26 healthy female
- enable to provide an legal identification
- have the ability to understand and sign the Informed Consent Form
- aren't pregnant and do not have pregnancy plan within the 7 months after the first
injection
- used effective contraceptive method from the last menstruation, and agreed to avoid
sexual activity without effective contraceptive method within the 15 days after
injection
Adolescent group:
- 9-14 healthy female
- enable to provide an legal identification
- guardians have the ability to understand the Informed Consent Form, and both
participant and guardian agreed to sign the Form (in case of unable to sign, the
participant can use fingerprint as signature)
Exclusion Criteria:
- History of HPV infection
- Previous administration of any HPV vaccine
- History of severe allergic reaction requiring medical intervention (such as oral and
throat swelling, difficulty breathing, hypotension or shock)
- History of allergic to vaccine, or to any ingredient of vaccine.
- 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.
- History of asthma, thyroidectomy, angioneurotic edema, diabetes or malignant
- Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy
- Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency,
coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
- Acute disease or chronic disease acute exacerbation 7 days prior to vaccination
- Administration of immunoglobulins and/or any blood products within 3 months, or
administration of any live attenuated vaccine within 28 days, or administration of any
subunit or inactivated vaccines within 14 days.
- Fever or axillary temperature> 37.0 °C before vaccination
- During menstrual period, breastfeeding, pregnancy(pregnancy test positive), or planned
pregnant within 7 month
- History of hypertension, physical examination systolic blood pressure> 150mmHg and/or
diastolic blood pressure> 100mmHg
- Abnormal laboratory tests parameters
- Any clinical significant disease or findings during study screening that, in the
opinion of the Investigator may interfere with the study
Gender
Female
Ages
9 Years - 24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Zhaojun Mo, +86 771-2518780, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02740777
Organization ID
311-HPV-1004
Responsible Party
Sponsor
Study Sponsor
Shanghai Zerun Biotechnology Co.,Ltd
Collaborators
Guangxi Center for Disease Control and Prevention
Study Sponsor
Zhaojun Mo, Principal Investigator, Guangxi Center for Disease Prevention and Control(GXCDC)
Verification Date
March 2017