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Hepatitis B en Haitian Immigrants in Chile: Molecular Characterization and Determination of Vaccine Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04326803
Recruitment Status : Not yet recruiting
First Posted : March 30, 2020
Last Update Posted : March 31, 2020
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Brief Summary:
International migration to Chile has sharply increased since 2010. Particularly, Haitian migration now totals approximately 200.000 people. Preliminary results show a high prevalence of hepatitis B infection in this population. Approximately 35% of adult Haitian migrants in Chile have been exposed to hepatitis B infection. In this study the investigators aim to study the clinical and molecular characteristics of this infection and also to assess the serological response to an accelerated schedule of hepatitis B vaccination (0, 1 and 2 months).

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Hepatitis B recombinant vaccine Phase 4

Detailed Description:
Migration from Haiti to Chile has increased exponentially in the last years. More than 200.000 people from this island are currently living in Chile. Preliminary results of the investigators group show that HIV infection and hepatitis B virus (HBV) infection are 2.9% and 2.4% (14 and 16 times higher than the reported prevalence in Chile), respectively, and overall HBV infection (anti-HBc antibody) is 34%. The molecular characterization of the HBV variants infecting people from Haiti has not been carried out. The current evidence suggests that HBV traveled from Africa together with the slave trade 200 to 300 years ago, with genotypes infecting Haitians resembling that of their origins, but with some striking differences, such as the presence of a recently described subtype (A5), which is now uncommon in Africa. HBV genotypes and subgenotypes may influence the emergence of specific mutations in the surface antigen region of the virus which in turn could lead to escape mutants which can infect properly vaccinated people. There is no information regarding the genotypes and escape mutants in Haitian immigrants to Chile. The most effective way to control and prevent is vaccination, but the response to vaccination varies widely in different ethnic groups, with genetic factors being relevant. Mutations in the interferon lambda 3 gene (IFNL3), previously known as interleukin 28B (IL28B) are clearly associated with lower response to interferon treatment and spontaneous clearance in hepatitis C, and clinical evolution of various viral infections. Less favorable IFNL3 mutations are especially prevalent in African descendants. The hypothesis of the project is that Haitian immigrants in Chile have a high prevalence of HBV infection with viral genotypes/mutations different from the native Chilean genotypes, which may result in a particular clinical presentation. The investigators also conjecture that the response to HBV vaccination may also differ in Haitian immigrants due to genetic variations in the IFNL3 gene. The HBV infection prevalence in this population will be estimated and the researchers will try to explain if mutations in IFNL3 increase the rate of spontaneous clearance of the infection (comparing carriers to patients who cleared the infection). They will also determine the presence of HBV DNA in all enrolled subjects to study the occurrence of occult hepatitis B (OBI), which is the presence of DNA in the absence of HBsAg. HBV DNA will be amplified and sequenced in the pre-S1, pre-S2 and S region (surface antigens) to study the presence of escape mutants. Finally, the investigators will conduct a study of vaccination of Haitian immigrants to assess the effectiveness of the vaccine in this population and determine which factors may influence vaccine response, including mutations in the IFNL3 gene. The information regarding the prevalence, epidemiology, presence of escape mutants, genetic factors influencing HBV infection and the response to the vaccine in Haitian immigrants, are critical for a better understanding of this infection and for the development of public health policies based on scientific evidence and not in political or other reasons that usually perpetuate stigma and inequalities in health care for marginalized groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A single group of subject will be offered to enroll in a study to assess the serological response to an accelerated schedule (0, 1 and 6 months) of recombinant hepatitis B vaccine
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hepatitis B Virus (HBV) Infection in Haitian Immigrants in Chile: Determination of HBV Genotypes, Viral Escape Mutants and Host Factors Influencing Response to Vaccination
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 30, 2023

Arm Intervention/treatment
Experimental: Vaccine group
Administration of 3 doses hepatitis B vaccine (recombinant hepatitis B vaccine, injectable suspension for intramuscular use) at month 0, 1 and 2.
Biological: Hepatitis B recombinant vaccine
Administration of 20 mcg of hepatitis B recombinant vaccine im at month 0, 1 and 2
Other Name: Engerix-B vaccine

Primary Outcome Measures :
  1. Response rate [ Time Frame: 4-8 weeks after the third dose of the vaccine ]
    Developing antibodies against HBsAg (anti-HBs) > 10 mIU/mL

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Adults (> 18 yo) born in Haiti.
  • Living in Chile (and planning to stay in Santiago for the next 4 months).

Exclusion Criteria:

  • Not signing the informed consent.
  • Pregnancy.
  • HIV or HCV infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04326803

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Contact: Ruth Núñez, RN 56223543820

Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
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Principal Investigator: Alejandro Soza, MD Pontificia Universidad Catolica de Chile
Additional Information:
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Responsible Party: Pontificia Universidad Catolica de Chile Identifier: NCT04326803    
Other Study ID Numbers: 180814005
1191389 ( Other Grant/Funding Number: FONDECYT (Chile) )
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Available on request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pontificia Universidad Catolica de Chile:
hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs