NCT03627507

Brief 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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 29, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2019

Completed
Last Updated

February 11, 2022

Status Verified

May 1, 2018

Enrollment Period

10 months

First QC Date

May 30, 2018

Last Update Submit

February 10, 2022

Conditions

Hepatitis B Infection

Keywords

Hepatitis B, Seroconversion, Seroprotection, Vaccine

Outcome Measures

Primary Outcomes (1)

  • 1. The test vaccine will induce similar seroprotection rates at 7 months compared to comparator vaccine.

    The test vaccine will induce similar seroprotection rates to hepatitis B at 7 months ( study day 210) comparator vaccine.

    At 7 months(Study day 210)

Secondary Outcomes (1)

  • The Ratio of the GMTs of test and comparator vaccines in different time points.

    30 days after last vaccination

Study Arms (2)

Hepa B

EXPERIMENTAL

79 participant will be randomly assigned to the test group for receiving the locally produced 'Hepa-B' vaccine.

Biological: Hepa-B

Engerix B

ACTIVE COMPARATOR

79 participant will be randomly assigned to the comparator group for receiving 'Engerix-B' vaccine.

Biological: Engerix B

Interventions

Hepa-BBIOLOGICAL

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.

Hepa B
Engerix BBIOLOGICAL

.'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

Engerix B

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Considered healthy as per medical judgment of the investigator
  • Age: 20 to 45 years
  • Sex: Male, Female and Transgender
  • For married women, a negative urine pregnancy test (Rapid Diagnostic Test) during screening and prior to first, second and third dose of vaccination.Moreover, medical history will be taken thoroughly by study physician from the woman of childbearing age to completely exclude the probability of pregnancy.The women who are married and living with a partner must agree to use a reliable contraceptive method to prevent pregnancy until final follow-up following vaccination. However abstinence is also acceptable.

You may not qualify if:

  • Prior history of hepatitis B infection
  • Vaccination with any hepatitis B vaccine
  • Recent febrile illness (within 2 weeks)
  • Known or suspected hypersensitivity to any component of Hepatitis B vaccine (e.g., aluminium, yeast).
  • History of received hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product.
  • Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids) more than 14 days with in last 6 months. Does not include topical and inhaled steroids.
  • Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine.
  • Pregnant women, nursing mothers, and women planning to become pregnant within the study period.
  • HBsAg reactive, anti-HBs antibody (≥10mlU/ml), anti-HBc (total) reactive, and abnormal liver function test \[serum alanine aminotransferase (ALT) level\], serum creatinine and CBC (As mentioned in Appendix IV).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mirpur Field Office

Dhaka, Mirpur, 1216, Bangladesh

Location

Related Publications (8)

  • Mushahwar I. Viral Hepatitis: Molecular Biology, Diagnosis, Epidemiology, and Control. 1st ed. Amsterdam: Elsevier; 2004. Page 31, 79

    RESULT

  • Ghosh, D., Ghosh, C., Nath, M., Safwath, S., Saha, S., & Rowshon, A. (2018). Prevalence of anti-HBc total positivity in an impoverished Urban Community in Banglades. Bangladesh Medical Research Council Bulletin, 43(2), 63-70

    RESULT

  • Ahad M, Alim M. Current Challenges in Hepatitis B. TAJ: The Journal of Teachers Association RMC, Rajshahi. 2006; 19 (1):38-44

    RESULT

  • Mahtab MA, Chaudhury M, Uddin MH, Noor-E Alam SM, Rahim MA, Alam MA, Moben AL, Khondaker FA, Choudhury MF, Sarkar MJ, Poddar PK, Foez SA, Akbar SM. Cost Assessment of Hepatitis B Virus-related Hepatitis in Bangladesh. Euroasian J Hepatogastroenterol. 2016 Jul-Dec;6(2):163-166. doi: 10.5005/jp-journals-10018-1190. Epub 2016 Dec 1.

    PMID: 29201750RESULT

  • WHO. EPI Fact Sheet. 2016. http://www.searo.who.int/entity/immunization/data/bangladesh. pdf [Accessed 27 Nov. 2017].

    RESULT

  • WHO. Hepatitis B Fact Sheet. 2017. http://www.who.int/mediacentre/factsheets/fs204/en/ [Accessed 27 Nov. 2017]

    RESULT

  • Bzowej NH. Hepatitis B Therapy in Pregnancy. Curr Hepat Rep. 2010 Nov;9(4):197-204. doi: 10.1007/s11901-010-0059-x. Epub 2010 Sep 9.

    PMID: 20949113RESULT

  • Chowdhury F, Akter A, Rahman Bhuiyan T, Tauheed I, Ahmed T, Ahmmed F, Ahmed F, Karim M, Mainul Ahasan M, Rahman Mia M, Mohammad Ibna Masud M, Wahab Khan A, Masum Billah M, Nahar Z, Khan I, Rahad Hossain M, Ariful Islam AZM, Panday AS, Muktadir Rahman Ashik M, Qadri F. A non-inferiority trial comparing two recombinant vaccines (Hepa-B vs. Engerix-B) for hepatitis B among adults in Dhaka, Bangladesh. Vaccine. 2021 Oct 15;39(43):6385-6390. doi: 10.1016/j.vaccine.2021.09.031. Epub 2021 Sep 22.

    PMID: 34561142DERIVED

MeSH Terms

Conditions

Hepatitis BHIV Seropositivity

Interventions

Engerix-B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesHIV InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Firdausi Qadri, PhD

    International Centre for Diarrhoeal Disease Research, Bangladesh

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
. Since the test and comparator drugs used in this clinical study have different package of vial, a double blind design is not appropriate. Study investigators along with study staffs involved in safety evaluation and laboratory analysis will be blinded regarding the assigned treatment of the participant. The vaccine administration team will be unblinded to the treatment assignment list. The vaccine administrator team members will not be involved in the evaluation of vaccine safety and laboratory analysis.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Eligible participants will be assigned to receive the Hepa-B Vaccine and Engerix-B Vaccine, in a 1:1 ratio across the target population according to the randomization schedule. The study agents (Hepa B Vaccine or Engerix B Vaccine) will be labelled as per the randomization list.79 participant will receive locally produced Hepa-B Vaccine and 79 participant of comparator group will receive Engerix B Vaccine.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2018

First Posted

August 13, 2018

Study Start

July 29, 2018

Primary Completion

May 27, 2019

Study Completion

June 3, 2019

Last Updated

February 11, 2022

Record last verified: 2018-05

Locations

BA(1)