HPV Infections Clinical Trial
Official title:
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
Verified date | April 2023 |
Source | Shanghai Zerun Biotechnology Co.,Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | April 30, 2020 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 9 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Sichuan Provincial Center for Disease Prevention and Control | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zerun Biotechnology Co.,Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed including pain, redness, swelling, induration and itching. | During a 8-day period (Day 0-7) following each vaccination | |
Primary | Percentage of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction | During a 8-day period (Day 0-7) following each vaccination | |
Primary | Percentage of Subjects Reporting Unsolicited Adverse Events (AEs) | An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. | Within 31 days (Day 0-30) after any vaccination | |
Primary | Percentage of Subjects Reporting Serious Adverse Events (SAE) | 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. | Throughout the study period (up to Month 12) | |
Secondary | Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Seroconversion is defined as a participant who was anti-HPV seronegative at Day 0 (before vaccination) and became seropositive 30days after the third dose (Month 7). | 30 days after the third dose (Month 7) | |
Secondary | Geometric Mean Titers (GMT) of HPV serotype-specific antibody | HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 specific antibodies GMT | 30 days after the third dose (Month 7) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00956553 -
Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls
|
Phase 4 | |
Completed |
NCT05372016 -
Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
|
Phase 3 | |
Recruiting |
NCT05027776 -
Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years
|
Phase 3 | |
Suspended |
NCT00733122 -
Tolerability and Immunogenicity of Gardasil in Females Between 16 and 23 Years of Age in India (V501-034)
|
Phase 3 | |
Recruiting |
NCT04895020 -
Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years
|
Phase 3 | |
Recruiting |
NCT05371353 -
Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine
|
||
Completed |
NCT00635830 -
An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)
|
Phase 1 | |
Not yet recruiting |
NCT01021904 -
Primary and Secondary Prevention of Human Papillomavirus (HPV) Disease in China
|
Phase 4 | |
Completed |
NCT00378560 -
V501 Efficacy Study in Women Aged 18 to 26 (V501-027)
|
Phase 2 | |
Completed |
NCT00682812 -
Significance of the High-risk Hpv Viral Load
|
N/A | |
Completed |
NCT01086709 -
Crossover Vaccination of Women Previously Randomized Into Protocol 04-C-N191
|
||
Completed |
NCT00711815 -
A Study to Identify Markers in Blood and Tissue of HPV Clearance
|
N/A | |
Completed |
NCT00834106 -
Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)
|
Phase 3 | |
Completed |
NCT03085381 -
A Phase I Study of Quadrivalent HPV Recombinant Vaccine
|
Phase 1 | |
Completed |
NCT00847340 -
Human Papillomavirus (HPV) Genotypes in Genital Warts in Colombian Population
|
N/A | |
Completed |
NCT00411749 -
V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)
|
Phase 2 | |
Completed |
NCT00943722 -
A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)
|
Phase 3 |