A Study of Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine

NCT ID: NCT03900572

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-09
• Study Completion Date: 2020-04-30

Brief Summary

A randomized, double-blind and placebo-controlled phase I study to evaluate the safety and immunogenicity of a 9-valent Human Papillomavirus (HPV) vaccine, administered intramuscularly according to a 0, 2, 6-month schedule in 9 to 45 years old healthy Chinese females.

Conditions

HPV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

HPV vaccine

Subjects receive 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.

Group Type: EXPERIMENTAL

HPV Vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intramuscular injection, 3 doses

Interventions

HPV Vaccine

Intramuscular injection, 3 doses

Intervention Type: BIOLOGICAL

Placebo

Intramuscular injection, 3 doses

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy females, 9 to 45 years old (inclusive).
• 9 to 17 years old participants: able to prove their identities and provide their legal guardians' identity information.
• Legal guardians of the 9 to 17 years old participants: able to understand (not illiterate) and agree to co-sign the informed consent forms with participants
• 18 to 45 years old participants: able to prove their legal identities.
• 18 to 45 years old participants: able to understand (not illiterate) the study and agree to sign the informed consent form.
• Child bearing age participants: agree not to become pregnant by using proper contraception means in the 7-month study period.

Exclusion Criteria

• History of cervical cancer or genital warts.
• History HPV vaccination or history of participation in HPV vaccine trial.
• History of severe allergy which needs medical intervention such as swelling of the mouth and throat, difficulty breathing, hypotension or shock.
• Skin abnormality at injection site including inflammation, sclerosis, redness, swelling, and extensive scars.
• History of allergy to vaccine or vaccine components including aluminum phosphate, histidine and Polysorbate 80, and severe adverse reactions in past vaccination.
• Medical history of epilepsy, convulsions, seizures , or family history of mental illness.
• Medical conditions including immunocompromised or diagnosed as congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases and received immunosuppressants in 6 months prior to first vaccination.
• History of asthma, thyroidectomy, angioneurotic edema, diabetes, and malignancy.
• Asplenia, functional asplenia, or any circumstances as a result of asplenia or splenectomy
• Diagnosis as coagulation abnormalities such as clotting factor deficiency, platelet abnormalities or having significant bruising, or coagulation disorder
• Being diagnosed with acute illnesses or acute onset of chronic illness during the last 3 days.
• Treatment with immunoglobulins or other blood-derived products within 3 months prior to Day 0 vaccination.
• Having received subunit or inactivated vaccine within 14 days prior to Day 0 vaccination or received attenuated vaccine within 28 days prior to Day 0 vaccination.
• Fever before vaccine administration with axillary temperature higher than 37.0°C.
• Currently breastfeeding, and being pregnant including pregnancy test positive.
• History of hypertension: Participants of 13 to 45 years of age have their respective systolic blood pressure greater than 150 mmHg and/or diastolic blood pressure greater than 100 mmHg; or participants of 9 to 12 years of age demonstrate their respective systolic blood pressure higher than 120 mmHg and/or diastolic blood pressure higher than 80 mmHg.
• Exhibits of abnormal lab test parameters.
• Any other factors which might affect any individual to be enrolled in the study according to the investigator's judgment.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Zerun Biotechnology Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xuecheng LIU, BS

Role: PRINCIPAL_INVESTIGATOR

Sichuan Provincial Center for Disease Prevention and Control

Locations

Sichuan Provincial Center for Disease Prevention and Control

Chengdu, Sichuan, China

Countries

China

Other Identifiers

312-HPV-2001

Identifier Type: -

Identifier Source: org_study_id