A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate the Safety and Immunogenicity of a 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Pichia Pastoris) in 9 to 45 Year Old Chinese Females
Overview
- Phase
- Phase 1
- Intervention
- HPV Vaccine
- Conditions
- HPV Infections
- Sponsor
- Shanghai Zerun Biotechnology Co.,Ltd
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Percentage of Subjects Reporting Solicited Local Symptoms
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Arms & Interventions
HPV vaccine
Subjects receive 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
Intervention: HPV Vaccine
Placebo
Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule.
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of Subjects Reporting Solicited Local Symptoms
Time Frame: During a 8-day period (Day 0-7) following each vaccination
Solicited local symptoms assessed including pain, redness, swelling, induration and itching.
Percentage of Subjects Reporting Solicited General Symptoms
Time Frame: During a 8-day period (Day 0-7) following each vaccination
Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction
Percentage of Subjects Reporting Unsolicited Adverse Events (AEs)
Time Frame: Within 31 days (Day 0-30) after any vaccination
An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study.
Percentage of Subjects Reporting Serious Adverse Events (SAE)
Time Frame: Throughout the study period (up to Month 12)
Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Secondary Outcomes
- Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58(30 days after the third dose (Month 7))
- Geometric Mean Titers (GMT) of HPV serotype-specific antibody(30 days after the third dose (Month 7))