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Non Inferiority Trial of Locally Manufactured 'Hepa-B' Vaccine in Bangladesh.

NCT03627507 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2022-02-11

No results posted yet for this study

Summary

Hepatitis B is a common and serious infectious disease of the liver, affecting millions of people throughout the world. Persistent Hepatitis B virus infections may cause development of chronic hepatic insufficiency, cirrhosis and hepatocellular carcinoma. Adding to that, Hepatitis B Virus carriers can transmit the disease for many years. It is transmitted through blood or other body fluids infected with the Hepatitis B virus. It is a major cause of morbidity and mortality in countries like Bangladesh. Immunization with Hepatitis B vaccine has been proved effective to prevent HBV infection. But the vaccines, which are recommended till now, are expensive. Locally manufactured Hepatitis B vaccine will be safe, cost effective and affordable for all.

The test vaccine will induce similar seroprotection rates to hepatitis B one month post-vaccination and at 7 months, one month after the third dose of vaccine compared to reference vaccine. This will be done by comparing the percentages of participants with ≥10 mIU/ml anti-HBs by vaccinated with either Hepa B or Engerix B vaccine. The non-inferiority margin will be 10%.

Conditions

  • Hepatitis B Infection

Interventions

BIOLOGICAL

Hepa-B

Incepta will manufacture a locally produced Hepatitis B vaccine named 'Hepa- B' which contain recombinant Hepatitis B surface antigen obtaine. This bulk is formulated to prepare finished dosage to manufacture large scale in fully GMP compliant plant. Incepta has conducted preclinical study at Bioneed, India. After successful completion of preclinical study, this non inferiority clinical trial with innovator product is needed for Licensure in Bangladesh.

BIOLOGICAL

Engerix B

.'Engerix B' is a recombinant DNA hepatitis B vaccine. It is sterile suspension of purified surface antigen of hepatitis B virus obtained by culturing genetically yeast cells (Saccharomyces cerevisiae cells), which carry the gene that codes for HBsAg

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Firdausi Qadri, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-29
Primary Completion
2019-05-27
Completion
2019-06-03

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03627507 on ClinicalTrials.gov