- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05415345
Immunogenicity and Safety of Co-immunization With Cecolin and Hecolin
June 8, 2022 updated by: Xiamen Innovax Biotech Co., Ltd
Study on the Immunogenicity and Safety of Co-immunization With Recombinant Human Papillomavirus 16/18 Bivalent Vaccine and Hepatitis E Vaccine
The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with recombinant human papillomavirus bivalent (Types 16,18) vaccine (Escherichia coli) and Hepatitis E vaccine (Escherichia coli)
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Cecolin is the first Chinese domestic human papillomavirus (HPV) vaccine.
Cecolin is designed to protect against HPV types 16 and 18, the most common virus types that lead to cervical cancer.
Hecolin is the first prophylactic vaccine against hepatitis E virus (HEV).
The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with Cecolin and Hecolin.
Study Type
Interventional
Enrollment (Anticipated)
480
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Zhejiang
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Hanzhou, Zhejiang, China, 310000
- Zhejiang Provincial Center for Disease Control and Prevention
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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
18 years to 25 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female, aged between 18 and 25 years (including 18 and 25 years) on the day of enrollment
- Judged as healthy and eligible for vaccination by the investigators through a self- reported medical history and some physical examinations
- Willing to participate in this study and sign informed consent form
- Able to understand this study information and willing to comply with all study requirements
- Axillary temperature ≤37.0 °C
- Negative urine pregnancy test
Exclusion Criteria:
- Women who are pregnant or breastfeeding or who plan to get pregnant within the next seven 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 during the study period
- Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study
- 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
- Plan to participate in another clinical study at the same time during the study
- Previous vaccination against HPV or HEV
- Immunodeficiency (such as HIV positive), 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, which has been unstable for the past two years and requires urgent treatment, hospitalization, oral or intravenous corticosteroid
- Complicated with serious medical diseases, such as hypertension, heart disease, diabetes, hyperthyroidism, etc
- Medical diagnosis of abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulation disorders
- Epilepsy, excluding febrile epilepsy under 2 years of age, alcoholic epilepsy 3 years before abstinence or simple epilepsy that did not require treatment for the past 3 years
- Past or present mental illness due to a psychological condition that does not comply with the requirements of the study; mental illness that has not been well controlled in the past two years; mental illness requiring medication; and suicidal tendency in the past five years
- 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
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: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group A
Participants in this arm will be simultaneously administrated with HPV and HEV vaccine.
The immunization schedule is 0,1,6 months.
|
Bivalent HPV Vaccine
Hepatitis E vaccine
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ACTIVE_COMPARATOR: Group B
Participants in this arm will be administrated with HPV vaccine.
The immunization schedule is 0,1,6 months.
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Bivalent HPV Vaccine
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ACTIVE_COMPARATOR: Group C
Participants in this arm will be administrated with HEV vaccine.
The immunization schedule is 0,1,6 months.
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Hepatitis E vaccine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluate the concentration of IgG antibodies to HPV-16
Time Frame: At 7 months after first dose
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Detect the level of IgG antibodies to HPV-16 at 7 month to determine whether group A is non-inferior to group B
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At 7 months after first dose
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evaluate the concentration of IgG antibodies to HPV-18
Time Frame: At 7 months after first dose
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Detect the level of IgG antibodies to HPV-18 at 7 month to determine whether group A is non-inferior to group B
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At 7 months after first dose
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evaluate the concentration of IgG antibodies to HEV
Time Frame: At 7 months after first dose
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detect the level of IgG antibodies to HEV at 7 month to determine whether group A is non-inferior to group C
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At 7 months after first dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local and systematic adverse events/reactions occurred within 7 days after each vaccination
Time Frame: During the 7-day period following each vaccination
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Adverse reactions associated with vaccine will be observed in subjects after vaccination.
To evaluate number of adverse events/reactions compared with non-simultane vaccination group.
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During the 7-day period following each vaccination
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Adverse events/reactions occurred within 30 days after each vaccination
Time Frame: Within 30 days after any vaccination
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To evaluate number of adverse events/reactions compared with non-simultane vaccination group.
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Within 30 days after any vaccination
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Serious adverse events occurred throughout the study
Time Frame: Up to 7 months
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Safety analysis.
To evaluate number of SAEs compared with the non-simultane vaccination group
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Up to 7 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zhenggang Jiang, Zhejiang Provincial Center for Disease Control and Prevention
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)
October 25, 2021
Primary Completion (ANTICIPATED)
November 30, 2022
Study Completion (ANTICIPATED)
June 10, 2023
Study Registration Dates
First Submitted
May 27, 2022
First Submitted That Met QC Criteria
June 8, 2022
First Posted (ACTUAL)
June 13, 2022
Study Record Updates
Last Update Posted (ACTUAL)
June 13, 2022
Last Update Submitted That Met QC Criteria
June 8, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Liver Diseases
- Hepatitis, Viral, Human
- DNA Virus Infections
- Tumor Virus Infections
- Neoplasms, Squamous Cell
- Infections
- Communicable Diseases
- Hepatitis
- Virus Diseases
- Papillomavirus Infections
- Papilloma
- Hepatitis E
Other Study ID Numbers
- PROPMHP001
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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