Immunogenicity and Safety of Co-immunization With Cecolin and Hecolin

NCT05415345 | Unknown Phase 4

• 1 other identifier: PROPMHP001
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Human Papilloma Virus Infection Type 16; Human Papilloma Virus Infection Type 18; Hepatitis E Virus Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Local and systematic adverse events/reactions occurred within 7 days after each vaccination

  During the 7-day period following each vaccination

• Adverse events/reactions occurred within 30 days after each vaccination

  Within 30 days after any vaccination

• Serious adverse events occurred throughout the study

  Up to 7 months

Study Arms (3)

Group A

EXPERIMENTAL

Participants in this arm will be simultaneously administrated with HPV and HEV vaccine. The immunization schedule is 0,1,6 months.

Biological: Cecolin; Biological: Hecolin

Group B

ACTIVE COMPARATOR

Participants in this arm will be administrated with HPV vaccine. The immunization schedule is 0,1,6 months.

Biological: Cecolin

Group C

ACTIVE COMPARATOR

Participants in this arm will be administrated with HEV vaccine. The immunization schedule is 0,1,6 months.

Biological: Hecolin

Interventions

Cecolin BIOLOGICAL

Bivalent HPV Vaccine

Group A; Group B

Hecolin BIOLOGICAL

Hepatitis E vaccine

Group A; Group C

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiamen Innovax Biotech Co., Ltd: lead
• Zhejiang Provincial Center for Disease Control and Prevention: collaborator

Study Sites (1)

Zhejiang Provincial Center for Disease Control and Prevention

Hanzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

  PMID: 41276263 DERIVED

MeSH Terms

Conditions

Hepatitis E

Interventions

hecolin

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Zhenggang Jiang

  Zhejiang Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 13, 2022
• Study Start: October 25, 2021
• Primary Completion: November 30, 2022
• Study Completion: June 10, 2023
• Last Updated: June 13, 2022

Record last verified: 2022-05

Locations

CN (1)