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Evaluating the 2-dose Immunization Schedule of Human Papillomavirus (HPV)-16/18 in Adolescent Females

Primary Purpose

Human Papillomavirus, Cervical Intraepithelial Neoplasia, Persistent Infection

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

HPV-16/18 vaccine

About this trial

This is an interventional prevention trial for Human Papillomavirus

Eligibility Criteria

9 Years - 24 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Hezhou Center for Disease Prevention and Control
Zhongshan Center for Disease Prevention and Control

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

2-dose adolescent

3-dose adolescent

3-dose adult

Arm Description

300 adolescent girl will receive a two-dose schedule (0 day, 6 months) immunization of HPV-16/18 vaccine.

300 adolescent girl will receive a three-dose schedule (0 day, 2 months, 6 months) immunization of HPV-16/18 vaccine.

300 adult women will receive a three-dose schedule (0 day, 2 months, 6 months) immunization of HPV-16/18 vaccine.

Outcomes

Primary Outcome Measures

HPV-16 and HPV-18 antibody titers (GMT)

Compare the HPV-16 and HPV-18 specific antibody titers (GMT) between the 2-dose immunization schedule (0, 6 months) in adolescent females aged 9 to 14 years and the 3-dose immunization schedule (0, 2, 6 months) in young females aged 18 to 26 years.

Secondary Outcome Measures

HPV-16 and HPV-18 antibody titers (GMT) and the seroconversion rate

Compare the immunogenicity between the 2-dose (0, 6 months) and the 3-dose (0, 2, 6 months) immunization schedules in adolescent females aged 9-14 years, on the basis of: 1) antibody titers (GMT) and the seroconversion rate at one month after the final injection, 2) antibody titer persistence and 3) antibody titers at a steady status.

Local and systemic adverse events (AEs)

Evaluate all local and systemic adverse events (AEs) occurred within 7 days after each inoculation, at one month and 6 month after the whole immunization

Full Information

NCT ID

NCT02740777

First Posted

April 5, 2016

Last Updated

April 12, 2023

Sponsor

Shanghai Zerun Biotechnology Co.,Ltd

Collaborators

Guangxi Center for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT02740777

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zerun Biotechnology Co.,Ltd

Collaborators

Guangxi Center for Disease Control and Prevention

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Papillomavirus, Cervical Intraepithelial Neoplasia, Persistent Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

900 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2-dose adolescent

Arm Type

Experimental

Arm Description

300 adolescent girl will receive a two-dose schedule (0 day, 6 months) immunization of HPV-16/18 vaccine.

Arm Title

3-dose adolescent

Arm Type

Experimental

Arm Description

300 adolescent girl will receive a three-dose schedule (0 day, 2 months, 6 months) immunization of HPV-16/18 vaccine.

Arm Title

3-dose adult

Arm Type

Experimental

Arm Description

300 adult women will receive a three-dose schedule (0 day, 2 months, 6 months) immunization of HPV-16/18 vaccine.

Intervention Type

Biological

Intervention Name(s)

HPV-16/18 vaccine

Intervention Description

HPV 16 L1 virus like particles (VLP) 40μg; HPV 18 L1 VLP 20μg; Aluminium phosphate 225μg; NaCl 0.32M; Histidine buffer 10mM; Tween-80 0.01%.

Primary Outcome Measure Information:

Title

HPV-16 and HPV-18 antibody titers (GMT)

Description

Time Frame

one month after the final injection

Secondary Outcome Measure Information:

Title

HPV-16 and HPV-18 antibody titers (GMT) and the seroconversion rate

Description

Time Frame

30 months after the final injection

Title

Local and systemic adverse events (AEs)

Description

Evaluate all local and systemic adverse events (AEs) occurred within 7 days after each inoculation, at one month and 6 month after the whole immunization

Time Frame

6 months after the final injection

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhaojun Mo

Organizational Affiliation

Guangxi Center for Disease Prevention and Control(GXCDC)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hezhou Center for Disease Prevention and Control

City

Hezhou

State/Province

Guangxi

ZIP/Postal Code

542899

Country

China

Facility Name

Zhongshan Center for Disease Prevention and Control

City

Zhongshan

State/Province

Guangxi

ZIP/Postal Code

542699

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluating the 2-dose Immunization Schedule of Human Papillomavirus (HPV)-16/18 in Adolescent Females

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