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CompletedNCT03168412Updated Feb 21, 2019

A Study on the Recombinant Hepatitis E Vaccine (Escherichia Coli) (Accelerated Vaccination Schedule)

A Phase 4 interventional study of Recombinant Hepatitis E Vaccine (Escherichia Coli) and Recombinant Hepatitis E Vaccine (Escherichia Coli) in Hepatitis E, sponsored by Xiamen Innovax Biotech Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-21.

Sponsored by Xiamen Innovax Biotech Co., Ltd · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
125
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This phase IV clinical study was designed to evaluate the immunogenicity and safety of the recombinant Hepatitis E vaccine (Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults (over 18 years) with accelerated vaccination schedule. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-7-21 days schedule or a 0-1-6 month schedule.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Aged over 18 years old on the day of enrollment, including 18 years old;
  2. Axillary temperature is below than 37.0 ℃;
  3. Negative serological markers for hepatitis E and liver function are normal or no clinical significance;
  4. Judged as healthy and eligible for vaccination by the investigators through a selfreported medical history and some physical examinations;
  5. Able to understand this study information and willing to comply with all study requirements;
  6. Willing to participate in this study and sign informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy,breast-feeding or plan to be pregnant in 7 months;
  2. Administration of Hepatitis E Vaccine before the study;
  3. Participate in any other clinical trial during the study period;
  4. 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;
  5. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment;
  6. 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;
  7. 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;
  8. Had a fever (axillary temperature over 38°C) within 3 days or acute illness, or use systemic antibiotics or antiviral treatment within 5 days before vaccination;
  9. 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), liver and kidney disease and other chronic disease history;
  10. History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain. Allergic history to any component of this vaccine.
  11. Asthma that needed emergency treatment, hospitalization, oral or intravenous corticosteroid to keep stable in the past two years;
  12. Combining another severe internal medicine disease(such as cardiopathy,diabetes and hyperthyroidism)
  13. Anormal coagulation function or coagulopathy diagnosed by doctor;
  14. Epilepsy(not including alcohol epilepsy within 3 years prior to abstinence and simple epilepsy that do without curing within 3 years prior to the study )
  15. Anomal psychology or mind affecting the individual's ability to obey the study requirement;
  16. 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.
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
125 participants (actual)

Study arms

  • Experimental
    the Accelerated Vaccination Schedule Group

    Participants in this arm are aged over 18 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at 0,7,21 day.

    Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)

  • Active comparator
    the Standard Vaccination Schedule Group

    Participants in this arm are aged over 18 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at 0,1,6 month.

    Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)

Interventions

  • BiologicalRecombinant Hepatitis E Vaccine (Escherichia Coli)

    Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 7, 21 days.

    Also known as: Hecolin®

  • BiologicalRecombinant Hepatitis E Vaccine (Escherichia Coli)

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

    Also known as: Hecolin®

05

What researchers measure

Primary outcomes

  1. Anti-HEV antibody of Experimental Group

    Measure anti-HEV antibody in serum samples at 51st day to evaluate the immunogenicity of the Hepatitis E vaccine.

    Time frame: up to 2 months

Secondary outcomes

  1. Adverse reactions/events of Experimental Group and Control Group

    Measure solicited local adverse reactions/events within 7 days after each vaccination; Measure solicited systematic adverse reactions/events within 7 days after each vaccination; Measure unsolicited adverse reactions/events within 30 days after vaccination; Measure serious adverse events occurred throughout the study(up to 7 months).

    Time frame: up to 7 months

  2. Anti-HEV antibody of Experimental Group

    Measure anti-HEV antibody in serum samples at 21st day,28st day and month 7 to evaluate the immunogenicity of the Hepatitis E vaccine.

    Time frame: up to 7 months

  3. Anti-HEV antibody of Control Group

    Measure anti-HEV antibody in serum samples at month 1,2,7 to evaluate the immunogenicity of the Hepatitis E vaccine.

    Time frame: up to 7 months

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Study locations

1 site
  • Changshan Center for Disease Control and Prevention
    Quzhou, Zhejiang 324200, China
07

References and documents

Publications

  • Chen Z, Lin S, Duan J, Luo Y, Wang S, Gan Z, Yi H, Wu T, Huang S, Zhang Q, Lv H. Immunogenicity and safety of an accelerated hepatitis E vaccination schedule in healthy adults: a randomized, controlled, open-label, phase IV trial. Clin Microbiol Infect. 2019 Sep;25(9):1133-1139. doi: 10.1016/j.cmi.2019.01.015. Epub 2019 Jan 31. PubMed 30711651 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03168412
Lead sponsor
Xiamen Innovax Biotech Co., Ltd
Responsible party
Sponsor
First posted
May 30, 2017
Start date
May 25, 2017
Primary completion
Jul 15, 2018
Completion
Nov 28, 2018
Last update
Feb 21, 2019

Study contacts

Zhiping Chen
principal investigator · Zhejiang Provincial Center for Disease Control and Prevention

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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