- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03813940
Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
An Open-Label, Single-Center Phase I Clinical Trial to Estimate Safety of the Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type) (E.Coli) in Healthy Adults Aged 18 to 45 Years
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Jiangsu
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Nanjing, Jiangsu, China, 210009
- Jiangsu Provincial Centre for Disease Control and Prevention
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Health people aged between 18 and 45 years.
- Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
- Able to comply with the requests of the study.
- Written informed consent obtained from the participants.
- Axillary temperature not higher than 37.0°C
- Men, or non-pregnant women verified by a urine pregnancy test.
Exclusion criteria:
- Pregnant or breastfeeding or plan to be pregnant within 7 months.
- Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.
- Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.
- Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine or plan to use within 7 months.
- Administration of any attenuated live vaccines within 21 days preceding the first dose of the study vaccine or any subunit or inactivated vaccines within 14 days before vaccination.
- Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
- Having the plan to participate another clinical trial during the study period.
- Received another HPV vaccine.
- Immunodeficiency , primary disease of important organs, malignant tumor, or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
- History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy, urticaria, dyspnea, angioneurotic edema or abdominal pain.
- Asthma that required emergent treatment, hospitalization, oral or intravenous corticosteroid for unstable condition within the past 2 years.
- Having serious disease of internal medicine, such as hypertension(systolic blood pressure > 140mmHg or diastolic blood pressure >90mmHg), cardiac disease, diabetes, hyperthyroidism et al.
- Diagnosed coagulant function abnormality or blood coagulation disorder. 14) The results of blood routine test and blood biochemical test were abnormal. The grade was 2 or above.
15) Epilepsy, except fever epilepsy at under 2 years of age, alcohol-induced epilepsy in 3 years before abstinence, or idiopathic epilepsy requiring no treatment in the past 3 years.
16) Past or current two-stage affective psychosis, not well controlled in the past 2 years or requiring drugs, or hve a tendency to commit suicide in the past 5 years.
17) Other medical, psychological, social or occupational factors that, according to the investigators' judgment, might affect the individual's ability to obey the protocol or sign the informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HPV Vaccine,270μg/1.0ml
Participants in this arm would receive 270μg/1.0ml HPV vaccines.
|
HPV vaccine (270μg/1.0ml)
administered intramuscularly according to a 0, 1, 6 month vaccination schedule
|
Experimental: HPV Vaccine,135μg/0.5ml
Participants in this arm would receive 135μg/0.5ml HPV vaccines
|
HPV vaccine (135μg/0.5ml)
administered intramuscularly according to a 0, 1, 6 month vaccination schedule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Solicited local adverse reactions
Time Frame: During the 7-day (Day 0-6) period following each vaccination
|
Solicited local adverse reactions occurred within 7 days after each vaccination;
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During the 7-day (Day 0-6) period following each vaccination
|
Solicited systematic adverse reactions
Time Frame: During the 7-day (Day 0-6) period following each vaccination
|
Solicited systematic adverse reactions occurred within 7 days after each vaccination;
|
During the 7-day (Day 0-6) period following each vaccination
|
Unsolicited adverse events
Time Frame: Within 30 days (Day 0-29) after any vaccination
|
Unsolicited adverse reactions occurred within 30 days after each vaccination;
|
Within 30 days (Day 0-29) after any vaccination
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Serious adverse events
Time Frame: throughout the study period, an average of 7 months
|
Serious adverse events occurred throughout the study;
|
throughout the study period, an average of 7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinically Relevant Abnormalities in Blood Biochemistry
Time Frame: Before and the second day after the first and third vaccination
|
Biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase basophils, total bilirubin, direct bilirubin, indirect bilirubin, creatinine, urea nitrogen. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below". |
Before and the second day after the first and third vaccination
|
Clinically Relevant Abnormalities in Hematological Parameters
Time Frame: Before and the second day after the first and third vaccination
|
Hematological Parameters assessed in blood samples include platelets, red blood cell, hemoglobin and white blood cells. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below". |
Before and the second day after the first and third vaccination
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody)
Time Frame: month 7
|
To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level on day 0 (before the 1st dose) and one month after dose 3
|
month 7
|
Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 (type specific IgG antibody)
Time Frame: month 7
|
To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific IgG antibody level on day 0 (before the 1st dose) and one month after dose 3
|
month 7
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yue-Mei Hu, Bachelor, Jiangsu Provincial Centre 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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HPV-PRO-007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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