None listed
Conditions
Interventions
Intervention1: Recombinant Hepatitis E antigen (HEV239 protein): Each dose to be administered intramuscularly over the deltoid.
3 doses of vaccination to be administered at 0, 1 & 6 month time points
Sponsors
Urihk Pharmaceutical Private Limited Subsidiary of Ureka Hong Kong Limited
Eligibility
Inclusion criteria
Inclusion criteria: The subjects must meet all of the following criteria: 1. Indian adults and adolescents of either gender, aged 16-65 years (both ends inclusive) who are seronegative for Anti-HEV 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 would be available during the entire study period of 7 months 4. Subjects who agree to comply with trial requirements and are willing to provide written informed consent and assent form wherever applicable (participant of >16 to
Exclusion criteria
Exclusion criteria: The Subjects must not meet any of the following criteria: 1. History of hypersensitivity to Investigational Products 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 child bearing potential not willing to practice acceptable method of contraception during study period 11. History or evidence of any chronic alcohol abuse / chronic tobacco or 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 immunogenicity of 3 doses of purified recombinant Hepatitis E Vaccine (E.coli) –Recombinant Hepatitis E Vaccine (E. Coli) compared to matching placebo in healthy Indian adults & adolescents assessed by Seroconversion rate from baseline to 1 month after third dose of IP administrationTimepoint: Seroconversion rate from baseline to 1 month after third dose of IP administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the immunogenicity of 3 doses of Recombinant Hepatitis E Vaccine (E. Coli) compared to matching placebo in healthy Indian adults & adolescents assessed by mean change in Geometric Mean Titre (GMT) of Anti-HEV antibodies from baseline to 1 month after third dose of IP administration.Timepoint: In Geometric Mean Titre (GMT) of Anti-HEV antibodies from baseline to 1 month after third dose of IP administration.;2. To evaluate the safety of 3 doses of Recombinant Hepatitis E Vaccine (E. Coli) compared to matching placebo in healthy Indian adults and adolescents assessed using solicited and unsolicited adverse events following immunization (AEFI).Timepoint: Safety of 3 doses of Recombinant Hepatitis E Vaccine ( E. Coli compared to matching placebo. | — |
Countries
India
Contacts
Public ContactMr Hitesh Thakur
Urihk Pharmaceutical Private Limited (Subsidiary of Ureka Hong Kong Limited)
Outcome results
None listed