Immunogenicity and Safety of Co-immunization With Cecolin and Hecolin

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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Study on the Immunogenicity and Safety of Co-immunization With Recombinant Human Papillomavirus 16/18 Bivalent Vaccine and Hepatitis E Vaccine

Conditions
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Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Hepatitis E Virus Infection

Intervention / Treatment
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* Biological: Cecolin
* Biological: Hecolin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Participants in this arm will be simultaneously administrated with HPV and HEV vaccine. The immunization schedule is 0,1,6 months. | Biological: Cecolin<br>* Bivalent HPV Vaccine<br>Biological: Hecolin<br>* Hepatitis E vaccine<br>|
| Active Comparator: Group B<br>Participants in this arm will be administrated with HPV vaccine. The immunization schedule is 0,1,6 months. | Biological: Cecolin<br>* Bivalent HPV Vaccine<br>|
| Active Comparator: Group C<br>Participants in this arm will be administrated with HEV vaccine. The immunization schedule is 0,1,6 months. | Biological: Hecolin<br>* Hepatitis E vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the concentration of IgG antibodies to HPV-16 | Detect the level of IgG antibodies to HPV-16 at 7 month to determine whether group A is non-inferior to group B | At 7 months after first dose | 
| evaluate the concentration of IgG antibodies to HPV-18 | Detect the level of IgG antibodies to HPV-18 at 7 month to determine whether group A is non-inferior to group B | At 7 months after first dose | 
| evaluate the concentration of IgG antibodies to HEV | detect the level of IgG antibodies to HEV at 7 month to determine whether group A is non-inferior to group C | At 7 months after first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local and systematic adverse events/reactions occurred within 7 days after each vaccination | 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. | During the 7-day period following each vaccination | 
| Adverse events/reactions occurred within 30 days after each vaccination | To evaluate number of adverse events/reactions compared with non-simultane vaccination group. | Within 30 days after any vaccination | 
| Serious adverse events occurred throughout the study | Safety analysis. To evaluate number of SAEs compared with the non-simultane vaccination group | Up to 7 months |