- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02740790
Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 Vaccine in Healthy Females
Immunogenicity and Safety of Recombinant Human Papillomavirus Bivalent(Type 16 and 18) Vaccine (Yeast) in Healthy Females
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a multi-centre, randomized, blinded, placebo controlled study. The study vaccine is recombinant human papillomavirus bivalent (types 16 and 18) vaccine (Yeast), the placebo is aluminium phosphate diluent.
After informed and received the consent of participants/guardians, 1200 healthy females aged 9-45 will be enrolled into three age groups: 9-17, 8-26, 27-45. With the proportion of 1:1, vaccine group and placebo group will receive injection of 0.5ml of vaccine or placebo diluent.
Participants will be injected of vaccine or placebo on a three-dose schedule (0, 2, 6 months). After each inoculation, the immediate reaction will be observed for 30 minutes, and the local and systemic reaction will be systematically observed for 7 days. After the first inoculation, adverse event will be collected until one month after the final inoculation, while serious adverse event will be collected until 6 months after the final inoculation. For every participants, blood samples will be collected before the first inoculation (month 0), one month after the final inoculation (month 7), 6 months after the final inoculation (month 12) to detect the neutralizing antibody of HPV type 16 and 18, and proceed safety and immunogenicity analysis. For participants in 9-14 age group who received the vaccine, neutralizing antibody will also be detected in month 24, 36 and 48 to examine the immune persistency. Meanwhile, some participants will be chosen to study the deviation of gene expression after the vaccination and the association of that with the neutralizing antibody level.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Guangxi
-
Nanning, Guangxi, China
- GuangXi Center for Diseases Control and Prevention
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy female between, and including, 9 and 45 years of age at the time of the first vaccination
- Provide legal identification for for the sake of recruitment
- Be able to understand and sign informed consent prior to enrollment (For subjects below the legal age of consent, informed consent must be signed by parent(s)/legal guardian(s) in addition).
- Subject must be not pregnant at the enrollment and agree to using adequate contraceptive precautions within 7 months.
Exclusion Criteria:
- History of cervical cancer
- Previous administration of any HPV vaccine
- History of severe allergic reaction requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock)
- History of allergic to vaccine, or to any ingredient of vaccine.
- History of epilepsy, seizures or convulsions, or family history of mental illness
- Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose.
- History of asthma, thyroidectomy, angioneurotic edema, diabetes or malignant
- Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy
- Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
- Acute disease or chronic disease acute exacerbation 7 days prior to vaccination
- Administration of immunoglobulins and/or any blood products within 3 months, or administration of any live attenuated vaccine within 28 days, or administration of any subunit or inactivated vaccines within 14 days.
- Fever or axillary temperature> 37.0 °C before vaccination
- During menstrual period, breastfeeding, pregnancy(pregnancy test positive), or planned pregnant within 7 month
- History of hypertension, physical examination systolic blood pressure> 150mmHg and/or diastolic blood pressure> 100mmHg
- Abnormal laboratory tests parameters
- Any clinical significant disease or findings during study screening that, in the opinion of the Investigator may interfere with the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HPV vaccine 1
300 women between 9-17 yeas of age, receiving 0,2,6 month-schedule experimental HPV vaccines
|
Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
|
Placebo Comparator: Placebo 1
300 women between 9-17 yeas of age, receiving 0,2,6 month-schedule Placebo.
|
Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
|
Experimental: HPV vaccine 2
120 women between 18-26 yeas of age, receiving 0,2,6 month-schedule experimental HPV vaccines
|
Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
|
Experimental: HPV vaccine 3
180 women between 27-45 yeas of age, receiving 0,2,6 month-schedule experimental HPV vaccines
|
Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
|
Placebo Comparator: Placebo 2
120 women between 18-26 yeas of age, receiving 0,2,6 month-schedule Placebo.
|
Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
|
Placebo Comparator: Placebo 3
180 women between 27-45 yeas of age, receiving 0,2,6 month-schedule Placebo.
|
Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The neutralizing antibody responses of HPV 16/18 after vaccination by measuring Geometric Mean Titer (GMT).
Time Frame: 1 month after vaccination
|
1 month after vaccination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions
Time Frame: 7 days after each vaccine dose
|
7 days after each vaccine dose
|
Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions
Time Frame: 6 months after finish vaccinations
|
6 months after finish vaccinations
|
The durability of neutralizing antibody responses of HPV 16/18 after vaccination.
Time Frame: 48 months after finish vaccinations
|
48 months after finish vaccinations
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rong-cheng Li, MD, Guangxi Centers for Disease Control and Prevention
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 311-HPV-1002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Human Papillomavirus
-
Kaiser PermanenteNational Cancer Institute (NCI)Recruiting
-
Queen Mary University of LondonCompleted
-
Lake Cumberland District Health DepartmentMerck Sharp & Dohme LLCCompletedHuman PapillomavirusUnited States
-
The University of Hong KongQueen Mary Hospital, Hong KongUnknown
-
Global Alliance to Immunize Against AIDS Vaccine...Merck Sharp & Dohme LLCUnknownHuman PapillomavirusMali
-
H. Lee Moffitt Cancer Center and Research InstituteMerck Sharp & Dohme LLCCompleted
-
Laval UniversityCompletedHuman PapillomavirusCanada
-
University Hospital, ToulouseCompleted
-
University of North Carolina, Chapel HillHarvard Medical School (HMS and HSDM); Pfizer; North Carolina Department of Health...CompletedHuman PapillomavirusUnited States
-
The AlfredMerck Sharp & Dohme LLCCompletedHuman Papillomavirus Infection | Human PapillomavirusAustralia
Clinical Trials on HPV vaccine
-
University of PretoriaUniversity of StellenboschActive, not recruiting
-
Sun Yat-sen UniversityRecruitingPremature Ovarian Failure | Menstrual DisorderChina
-
Xiamen UniversityXiamen Innovax Biotech Co., Ltd; Beijing Wantai Biological Pharmacy Enterprise...CompletedCervical Cancer | Cervical Intraepithelial NeoplasiaChina
-
Simon DobsonMinistry of Health, British ColumbiaCompletedCervical Cancer | Genital WartsCanada
-
Jun ZhangXiamen Innovax Biotech Co., Ltd; Beijing Wantai Biological Pharmacy Enterprise...Completed
-
H. Lee Moffitt Cancer Center and Research InstituteFlorida Department of Health; Health Choice NetworkRecruitingHuman Papilloma Virus (HPV) VaccineUnited States
-
Jun ZhangXiamen Innovax Biotech Co., Ltd; Beijing Wantai Biological Pharmacy Enterprise...Active, not recruiting
-
Laval UniversityCompletedHuman PapillomavirusCanada
-
Xiamen Innovax Biotech Co., LtdCompleted
-
University of WashingtonActive, not recruiting