A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls

NCT02562508 | Completed Phase 3

• 1 other identifier: HPV-PRO-006
• Study Type: interventional
• Target: 979
• Locations: 1 country
• Sites: 1

Brief Summary

This is a bridging trial of the recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD.The primary objective of this study is to evaluate the immunogenicity (type specific IgG antibody) and safety of the tested vaccine administered in girls aged 9-17 years is non-inferior to young healthy adults of 18-26 years according to the standard 3-dose schedule (0,1,6 months). Meanwhile, this study tries to compare the difference of safety and immunogenicity among different schedules (0-6m vs 0-1-6m).

Conditions

Cervical Intraepithelial Neoplasia; Cervical Cancer; Vaginal Intraepithelial Neoplasia; Vulvar Intraepithelial Neoplasia; Persistent Infection

Keywords

Human Papilloma Virus 16; Human Papilloma Virus 18; vaccine; adolescent girl; bridging trial; non-inferiority

Outcome Measures

Primary Outcomes (1)

• Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 (type specific IgG antibody)

  To detect the anti-HPV 16 and anti-HPV 18 type specific IgG antibody level on day 0 (before the 1st dose) ,six month after the dose 1 (before the 3rd dose) and one month after dose 3

  Month 7

Secondary Outcomes (1)

• Number of Participants with Adverse Events

  Month 7

Other Outcomes (1)

• Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody)

  Month 7

Study Arms (3)

9-17y (0,1,6m)

EXPERIMENTAL

Participants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine

Procedure: 3 doses of HPV 16/18 bivalent vaccine

9-14y (0,6m)

EXPERIMENTAL

Participants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 2 doses of HPV 16/18 bivalent vaccine

Procedure: 2 doses of HPV 16/18 bivalent vaccine

18-26y (0,1,6m)

EXPERIMENTAL

Participants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine

Procedure: 3 doses of HPV 16/18 bivalent vaccine

Interventions

3 doses of HPV 16/18 bivalent vaccine PROCEDURE

Participants would receive 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)

18-26y (0,1,6m); 9-17y (0,1,6m)

2 doses of HPV 16/18 bivalent vaccine PROCEDURE

Participants would receive 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)

9-14y (0,6m)

Eligibility Criteria

• Age: 9 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Females aged between 9 and 26 years when they receive the first vaccination (9≤age\<27);
• Participants aged 9-17 years whose legal guardian can provide identity certificate, or representative can provide authorization;
• Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations;
• Participants aged 9-17 years, able to sign or whose legal guardian agree to sign the written informed consent; or participants aged 18-26 years and agree to sign the written informed consent;
• Able to comply with the requests of the study;
• Axillary temperature not higher than 37.0°C;
• Nonpregnancy verified by a urine pregnancy test;

You may not qualify if:

• Pregnant or lactating woman and any woman who are willing or intend to become pregnant in next 7 months;
• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first vaccination, or plan to use during the study period;
• Participants who received an immunosuppressive agent or other immunomodulator agent for a long term (for 14 days or more) within 6 months of the first vaccination, or systematic corticosteroid (however, a topical corticosteroid is allowed, such as ointment, eye drops, inhalant, or nasal spray);
• Participants who received immunoglobulin and/or blood product 3 months prior to the first vaccination, or planned to receive during the study period;
• Use of any inactivated vaccine 14 days preceding dosing of study vaccine or attenuated vaccine 21 days before the enrollment;
• Participants had fever (auxiliary temperature ≥38.0 °C) within 3 days prior to vaccination, or any acute disease requiring systematic antibiotics or antiviral therapy within the past 5 days;
• Concurrently participating another clinical trial;
• Participants who have received HPV vaccines;
• Participants with immunodeficiency disease (such as HIV positive), primary disease in vital organs, cancer (or precancerous lesion), or chronic history of immunological disease requiring treatment (including systemic lupus erythematosus), rheumatoid arthritis, asplenia or splenectomy due to any conditions, and other immunological diseases that may impact immune response as considered by investigator), etc.;
• Participants with a history of allergy, including severe adverse reactions due to the past vaccination, such as hypersensitivity, urticaria, dyspnea, angioneurotic edema, or abdominal pain;
• Participants with asthma, which is unstable in the past 2 years, requiring emergency treatment, hospitalization, or oral or intravenous corticosteroid;
• Participants with concurrent severe medical disorders, such as hypertension, heart disease, diabetes mellitus, or hyperthyroidism, etc.;
• Participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician;
• Participants with epilepsy, excluding febrile epilepsy in patients under 2 years old, alcoholic epilepsy 3 years prior to alcohol abstinence, or pure epilepsy requiring no treatment within the past 3 years;
• Participants who are not compliant to the study's requirements due to psychological conditions, or those with prior or existing mental disease or bipolar psychosis which are not well controlled within the past 2 years and require taking drugs, or those with suicidal tendency within the past 5 years;

Sponsors & Collaborators

• Jun Zhang: lead
• Xiamen Innovax Biotech Co., Ltd: collaborator
• Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.: collaborator

Study Sites (1)

Jiangsu Provincial Centre for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms; Persistent Infection

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ting Wu, Ph. D.

  Xiamen University

  STUDY CHAIR

• Yuemei Hu, Bachelor

  Jiangsu Provincial Centre for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 29, 2015
• Study Start: December 5, 2015
• Primary Completion: August 12, 2016
• Study Completion: August 12, 2016
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

CN (1)