- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03900572
A Study of Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine
April 12, 2023 updated by: Shanghai Zerun Biotechnology Co.,Ltd
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xuecheng LIU, BS
- Phone Number: +8618981958206
- Email: 534210793@qq.com
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Sichuan Provincial Center for Disease Prevention and Control
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 43 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HPV vaccine
Subjects receive 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
|
Intramuscular injection, 3 doses
|
Placebo Comparator: Placebo
Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule.
|
Intramuscular injection, 3 doses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During a 8-day period (Day 0-7) following each vaccination
|
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
|
During a 8-day period (Day 0-7) following each vaccination
|
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.
|
Within 31 days (Day 0-30) after any vaccination
|
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.
|
Throughout the study period (up to Month 12)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Time Frame: 30 days after the third dose (Month 7)
|
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)
|
Geometric Mean Titers (GMT) of HPV serotype-specific antibody
Time Frame: 30 days after the third dose (Month 7)
|
HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 specific antibodies GMT
|
30 days after the third dose (Month 7)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xuecheng LIU, BS, Sichuan Provincial Center for Disease Prevention and Control
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2019
Primary Completion (Actual)
April 30, 2020
Study Completion (Actual)
April 30, 2020
Study Registration Dates
First Submitted
March 28, 2019
First Submitted That Met QC Criteria
April 2, 2019
First Posted (Actual)
April 3, 2019
Study Record Updates
Last Update Posted (Estimate)
April 13, 2023
Last Update Submitted That Met QC Criteria
April 12, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 312-HPV-2001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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