A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)

NCT02417597 | Completed Phase 4

• 1 other identifier: PRO-HE-006
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This phase IV clinical study was designed to evaluate the safety and immunogenicity of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 65 years of age at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-1-6 month schedule.

Conditions

Hepatitis E

Keywords

hepatitis E

Outcome Measures

Primary Outcomes (1)

• Adverse reactions/events

  Measure solicited local adverse reactions within 7 days after each vaccination; Measure solicited systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure serious adverse events occurred throughout the study

  up to 10 months

Secondary Outcomes (1)

• Anti-HEV antibody

  7 months

Study Arms (3)

Experimental Group

EXPERIMENTAL

Participants in this arm are aged over 65 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.

Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)

Immunogenicity Control Group

ACTIVE COMPARATOR

Participants in this arm are aged beteen 18-65 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.

Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)

Safety Control Group

NO INTERVENTION

Participants in this arm are aged over 65 years.

Interventions

Recombinant Hepatitis E Vaccine (Escherichia Coli) BIOLOGICAL

Participants would intramuscularly receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) at 0, 1, 6 month.

Also known as: Hecolin®

Experimental Group; Immunogenicity Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy people aged over 18 years old on the day of enrollment
• Axillary temperature is below than 37.0 ℃
• Blood pressure is not higher than 160/100 mmHg (with or without any medicine)
• Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
• Able to understand this study information and willing to comply with all study requirements.
• Willing to participate in this study and sign informed consent form.

You may not qualify if:

• Participated in any other clinical trial during the study period.
• 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.
• Immunodeficiency (such as HIV carriers), 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.
• Pregnant or breastfeeding
• Allergic history to any component of this vaccine.
• 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.

Sponsors & Collaborators

• Xiamen Innovax Biotech Co., Ltd: lead
• Xiamen University: collaborator
• Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.: collaborator

Study Sites (1)

Kaihua Center for Disease Control and Prevention

Quzhou, Zhejiang, China

Location

Related Publications (1)

• Yu XY, Chen ZP, Wang SY, Pan HR, Wang ZF, Zhang QF, Shen LZ, Zheng XP, Yan CF, Lu M, Chen B, Zheng Y, Zhang J, Lv HK, Huang SJ. Safety and immunogenicity of hepatitis E vaccine in elderly people older than 65 years. Vaccine. 2019 Jul 26;37(32):4581-4586. doi: 10.1016/j.vaccine.2019.04.006. Epub 2019 Jun 28.

  PMID: 31262585 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

• Zhiping Chen

  Zhejiang Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 11, 2015
• First Posted: April 15, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 18, 2016

Record last verified: 2015-10

Locations

CN (1)