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

NCT ID: NCT04326803

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2023-12-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Hepatitis B

Keywords

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hepatitis B migration HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vaccine group

Administration of 3 doses hepatitis B vaccine (recombinant hepatitis B vaccine, injectable suspension for intramuscular use) at month 0, 1 and 2.

Group Type EXPERIMENTAL

Hepatitis B recombinant vaccine

Intervention Type BIOLOGICAL

Administration of 20 mcg of hepatitis B recombinant vaccine im at month 0, 1 and 2

Interventions

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Hepatitis B recombinant vaccine

Administration of 20 mcg of hepatitis B recombinant vaccine im at month 0, 1 and 2

Intervention Type BIOLOGICAL

Other Intervention Names

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Engerix-B vaccine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alejandro Soza, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Central Contacts

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Ruth Núñez, RN

Role: CONTACT

Phone: 56223543820

Email: [email protected]

References

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Zampino R, Boemio A, Sagnelli C, Alessio L, Adinolfi LE, Sagnelli E, Coppola N. Hepatitis B virus burden in developing countries. World J Gastroenterol. 2015 Nov 14;21(42):11941-53. doi: 10.3748/wjg.v21.i42.11941.

Reference Type BACKGROUND
PMID: 26576083 (View on PubMed)

Locarnini S, Hatzakis A, Chen DS, Lok A. Strategies to control hepatitis B: Public policy, epidemiology, vaccine and drugs. J Hepatol. 2015 Apr;62(1 Suppl):S76-86. doi: 10.1016/j.jhep.2015.01.018.

Reference Type BACKGROUND
PMID: 25920093 (View on PubMed)

Related Links

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http://hepatitis.cl

Site in Spanish with information about viral hepatitis and liver diseases.

Other Identifiers

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1191389

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

180814005

Identifier Type: -

Identifier Source: org_study_id