Phase IV Multicentre Study on the Safety and Immunogenicity of Recombinant Hepatitis E Vaccine (E. coli) in Healthy Adults

A Prospective, Multicentre, Single Arm, Phase-IV Study to evaluate the Safety and Immunogenicity of Recombinant Hepatitis E Vaccine (E. Coli) in Healthy Adults - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/12/099590

Enrollment

1000

Registered

2025-12-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Recombinant Hepatitis E Vaccine (E. Coli): Each dose of 0.5 ml to be administered from prefilled syringe. Each dose would contain 30 g of purified recombinant Hepatitis E antigen (HEV23

Eligibility

Inclusion criteria

Inclusion criteria: 1. Indian adults of either gender aged 18-65 years (both ends inclusive) who are seronegative for anti-HEV IgG antibody (as per the cut off values specified in kit brochure). 2. Subjects who are apparently healthy or having a clinically stable medical condition/disorder that would not interfere with evaluation of study vaccine. 3. Subjects who are willing to be available during the entire study period. 4. Subjects who agree to comply with trial requirements and are willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity to study vaccine or their constituents, kanamycin or any other aminoglycoside. 2. History of administration of any other vaccine or immunoglobulin in past 1 month or planned immunization of any other vaccine in next 7 months. 3. Clinical or laboratory evidence of ongoing viral hepatitis. 4. History or evidence of uncontrolled epilepsy or any progressive neurological disorder in the subject or family. 5. History or evidence of thrombocytopenia, blood coagulation abnormality or concomitant administration of any anticoagulant drugs. 6. History or evidence of any congenital or acquired immunodeficiency viz. HIV infection and/or concomitant administration of immunosuppressive drugs. 7. History or evidence of acute infections, acute flare of chronic infections or fever at the time of administration of vaccine. 8. History or evidence of any significant cardiovascular, hepatic, renal, neurological or neoplastic disorder which preludes participation of subject into the trial as per investigator discretion. 9. Subject who is pregnant as confirmed by positive UPT, or lactating female. 10. Female of childbearing potential not willing to practice acceptable method of contraception during study period. 11. History or evidence of any chronic alcohol abuse / drug abuse. 12. Subject who has participated in any other clinical study in past 3 months. 13. Subject judged ineligible for the vaccination by the investigator for any other reason.

Design outcomes

Primary

Measure	Time frame
1.To evaluate the safety of 3 doses of Recombinant Hepatitis E Vaccine (E. Coli) in healthy Indian adults of either gender aged 18-65 years assessed using solicited and unsolicited adverse events following immunization. 2. To evaluate the immunogenicity of 3 doses of Recombinant Hepatitis E Vaccine (E. Coli) in healthy Indian adults of either gender aged 18-65 years assessed by seroconversion rate from baseline to 30 days after third dose of vaccine administration.Timepoint: SafetY 1. Incidence, severity, and relationship of local and systemic solicited AEs reported up to 7 days following each of the three vaccine doses. 2. Incidence, severity and relationship of unsolicited AEs from the first dose administration till the end of study visit. 3. Incidence of SAE from the first dose administration till the end of study visit. Immunogenicity 1. Proportion of subjects achieving seroconversion against Hepatitis E at one month after three dose vaccination. 2. Geometric mean concentrations (GMCs) for anti-Hepatitis E antibodies at one month after three dose vaccination.	—

Measure

Time frame

1.To evaluate the safety of 3 doses of Recombinant Hepatitis E Vaccine (E. Coli) in healthy Indian adults of either gender aged 18-65 years assessed using solicited and unsolicited adverse events following immunization. 2. To evaluate the immunogenicity of 3 doses of Recombinant Hepatitis E Vaccine (E. Coli) in healthy Indian adults of either gender aged 18-65 years assessed by seroconversion rate from baseline to 30 days after third dose of vaccine administration.Timepoint: SafetY 1. Incidence, severity, and relationship of local and systemic solicited AEs reported up to 7 days following each of the three vaccine doses. 2. Incidence, severity and relationship of unsolicited AEs from the first dose administration till the end of study visit. 3. Incidence of SAE from the first dose administration till the end of study visit. Immunogenicity 1. Proportion of subjects achieving seroconversion against Hepatitis E at one month after three dose vaccination. 2. Geometric mean concentrations (GMCs) for anti-Hepatitis E antibodies at one month after three dose vaccination.

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Secondary

Measure	Time frame
1. To demonstrate safety and seroconversion with age and gender stratification (18 to 35 years, 36 to 50 years, and 51 to 65 years).Timepoint: 1. Incidence, severity, and relationship of local and systemic solicited AEs reported up to 7 days following each of the three vaccine doses in male and female subjects aged 18 to 35 years, 36 to 50 years, and 51 to 65 years. 2. Incidence, severity and relationship of unsolicited AEs from the first dose administration till the end of study visit in male and female subjects aged 18 to 35 years, 36 to 50 years, and 51 to 65 years. 3. Incidence of SAE from the first dose administration till the end of study visit in male and female subjects aged 18 to 35 years, 36 to 50 years, and 51 to 65 years. 4. Proportion of male and female subjects achieving seroconversion against Hepatitis E at one month after three dose vaccination aged 18 to 35 years, 36 to 50 years, and 51 to 65 years. 5. Geometric mean concentrations (GMCs) for anti-Hepatitis E antibodies at one month after three dose vaccination in male and female subjects aged 18 to 35 years, 36 to 50 years, and 51 to 65 years.	—

Measure

Time frame

1. To demonstrate safety and seroconversion with age and gender stratification (18 to 35 years, 36 to 50 years, and 51 to 65 years).Timepoint: 1. Incidence, severity, and relationship of local and systemic solicited AEs reported up to 7 days following each of the three vaccine doses in male and female subjects aged 18 to 35 years, 36 to 50 years, and 51 to 65 years. 2. Incidence, severity and relationship of unsolicited AEs from the first dose administration till the end of study visit in male and female subjects aged 18 to 35 years, 36 to 50 years, and 51 to 65 years. 3. Incidence of SAE from the first dose administration till the end of study visit in male and female subjects aged 18 to 35 years, 36 to 50 years, and 51 to 65 years. 4. Proportion of male and female subjects achieving seroconversion against Hepatitis E at one month after three dose vaccination aged 18 to 35 years, 36 to 50 years, and 51 to 65 years. 5. Geometric mean concentrations (GMCs) for anti-Hepatitis E antibodies at one month after three dose vaccination in male and female subjects aged 18 to 35 years, 36 to 50 years, and 51 to 65 years.

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Countries

India

Contacts

Public ContactDr Nidhi Singh

Urihk Pharmaceutical Private Limited (Subsidiary of Ureka Hong Kong)

arjun@urihkpharma.com9324461446

Outcome results