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

NCT02740777 | Completed Phase 2 DMC

• 1 other identifier: 311-HPV-1004
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 2

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.

Conditions

Human Papillomavirus; Cervical Intraepithelial Neoplasia; Persistent Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  one month after the final injection

Secondary Outcomes (2)

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

  30 months after the final injection

• Local and systemic adverse events (AEs)

  6 months after the final injection

Study Arms (3)

2-dose adolescent

EXPERIMENTAL

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

Biological: HPV-16/18 vaccine

3-dose adolescent

EXPERIMENTAL

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

Biological: HPV-16/18 vaccine

3-dose adult

EXPERIMENTAL

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

Biological: HPV-16/18 vaccine

Interventions

HPV-16/18 vaccine BIOLOGICAL

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%.

2-dose adolescent; 3-dose adolescent; 3-dose adult

Eligibility Criteria

• Age: 9 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adult group:
• 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:
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zerun Biotechnology Co.,Ltd: lead
• Guangxi Center for Disease Control and Prevention: collaborator

Study Sites (2)

Hezhou Center for Disease Prevention and Control

Hezhou, Guangxi, 542899, China

Location

Zhongshan Center for Disease Prevention and Control

Zhongshan, Guangxi, 542699, China

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; 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; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhaojun Mo

  Guangxi Center for Disease Prevention and Control(GXCDC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 15, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: July 1, 2019
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)