Clinical trial NCT03900572: A Study of Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HPV Infections
Keywords: Human Papilloma Virus
Papillomavirus vaccines
Cervical Cancer
Genital Warts
Lead sponsor: Shanghai Zerun Biotechnology Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2019-04-03
Enrollment: 90
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percentage of Subjects Reporting Solicited Local Symptoms
timeFrame: During a 8-day period (Day 0-7) following each vaccination
measure: Percentage of Subjects Reporting Solicited General Symptoms
timeFrame: During a 8-day period (Day 0-7) following each vaccination
measure: Percentage of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: Within 31 days (Day 0-30) after any vaccination
measure: Percentage of Subjects Reporting Serious Adverse Events (SAE)
timeFrame: Throughout the study period (up to Month 12)
Secondary outcomes:
measure: Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
timeFrame: 30 days after the third dose (Month 7)
measure: Geometric Mean Titers (GMT) of HPV serotype-specific antibody
timeFrame: 30 days after the third dose (Month 7)
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial Center for Disease Prevention and Control
state: Sichuan
Study officials:
affiliation: Sichuan Provincial Center for Disease Prevention and Control
name: Xuecheng LIU, BS
role: PRINCIPAL_INVESTIGATOR
References: