A Clinical Trial to Evaluate a Recombinant Hepatitis E Vaccine in Healthy Adults

NCT02603055 | Completed Phase 1

• 1 other identifier: JSVCT025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to 15%. The investigational hepatitis E vaccine is a recombinant aluminium-adjuvant hepatitis E vaccine. This is a single center, randomized, blinding, parallel-controlled phase Ib clinical trial. This study will determine the safety and immunogenicity of the investigational recombinant hepatitis E vaccine in healthy adults between 16 and 65 years.

Conditions

Hepatitis E

Keywords

Safety; immunogenicity; Hepatitis E

Outcome Measures

Primary Outcomes (2)

• Occurrence of adverse reactions after vaccination

  Occurrence of adverse reactions within 7 days after each vaccination with the Recombinant Hepatitis E vaccine.

  within 7 days after each vaccination

• The geometric mean concentration of antibody against Hepatitis E responses to the Hepatitis E vaccine

  Antibody against Hepatitis E responses to the Hepatitis E vaccine at 7 months after the first vaccination

  7 months after the first vaccination

Secondary Outcomes (3)

• Occurrence of adverse events after each vaccination

  within 28 days after each vaccination

• Occurrence of serious adverse events after the vaccination.

  within 12 months after the first vaccination

• The positive rates of antibody against Hepatitis E responses to the Hepatitis E vaccine.

  7 months after the first vaccination

Study Arms (2)

30μg/0.5ml Hepatitis E vaccine

EXPERIMENTAL

three doses, 30μg/0.5ml per dose

Biological: 30μg/0.5ml Hepatitis E vaccine

30μg/0.5ml Recombinant Hepatitis E vaccine

ACTIVE COMPARATOR

30μg/0.5ml Hepatitis E vaccine developed by Xiamen innovax biotech Co., Ltd. three doses, 30μg/0.5ml per dose

Biological: 30μg/0.5ml Recombinant Hepatitis E vaccine

Interventions

30μg/0.5ml Hepatitis E vaccine BIOLOGICAL

three doses, 30μg/0.5ml per dose

30μg/0.5ml Hepatitis E vaccine

30μg/0.5ml Recombinant Hepatitis E vaccine BIOLOGICAL

30μg/0.5ml Hepatitis E vaccine developed by Xiamen innovax biotech Co.,Ltd.,three doses, 30μg/0.5ml per dose

30μg/0.5ml Recombinant Hepatitis E vaccine

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 16 and 65 years with normal intelligence.
• Negative in antibody against hepatitis E test.
• No plan to go out for a long time within 9 months.
• Able to understand the content of informed consent and willing to sign the informed consent
• General good health as established by medical history and physical examination.
• Able and willing to complete all the secluded study process during the whole study follow-up period.
• No history of hepatitis B, hepatitis C and hepatitis E(Patients diagnosed as hepatitis B, hepatitis C and hepatitis E by town or above)
• Axillary temperature ≤37.0°C on the day of enrollment

You may not qualify if:

• Woman who is pregnant, breast-feeding or planning to be pregnant during the study period
• Allergic history of any vaccination or drugs, or allergic to any ingredient of the Hepatitis E vaccine
• History of serious adverse reactions after vaccination, such as allergies, urticaria, breathing difficulties, angioneurotic oedema or abdominal pain
• Autoimmune disease or immunodeficiency
• Asthma that was unstable and need emergency treatment, hospitalization, oral or intravenous corticosteroid within two years
• Type I or II diabetes, not including gestational diabetes
• History of thyroidectomy, or need treatment for thyroid disease in the past 12 months
• History of serious angioneurotic edema in the past 3 years, or need treatment for it in the past 2 years
• Severe hypertension, with the blood pressure still more than 150/100 mmHg after drug maintenance treatment
• Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulation disorders diagnosed by the doctor.
• Patients who are active or not have a definite cure of malignant tumors, or who may recur in the study period.
• Epilepsy, not including alcohol epilepsy in the first 3 years abstinence or simple epilepsy without the need of treatment in the past 3 years
• Asplenia or functional asplenia, or asplenia and splenectomy under any circumstances
• Guillain Barre Syndrome
• Prior administration of immunodepressant, cytotoxic or corticosteroids (not including corticosteroid therapy for allergic rhinitis and acute non concurrent dermatitis )treatment in last 6 months

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Changchun Institute of Biological Products Co., Ltd.: collaborator

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Hepatitis E

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 11, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

CN (1)