Status:
COMPLETED
Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
Lead Sponsor:
Xiamen University
Collaborating Sponsors:
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Conditions:
Condylomata Acuminata
Cervical Cancer
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This phase I clinical study was designed to evaluate the safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV vaccine), manufactured by Xiam...
Detailed Description
The study would have 2 stages. In the first stage, around 12 healthy adults aged 18-45 (male vs female,around 1:1)would receive 135μg/0.5ml of the HPV vaccine, the participants would be actively follo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03813940
Start Date
January 3 2019
End Date
April 1 2021
Last Update
April 8 2021
Active Locations (1)
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1
Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, China, 210009