- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04326803
Hepatitis B en Haitian Immigrants in Chile: Molecular Characterization and Determination of Vaccine Response
March 27, 2020 updated by: Pontificia Universidad Catolica de Chile
Hepatitis B Virus (HBV) Infection in Haitian Immigrants in Chile: Determination of HBV Genotypes, Viral Escape Mutants and Host Factors Influencing Response to Vaccination
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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ruth Núñez, RN
- Phone Number: 56223543820
- Email: r.nunezpuentes@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
Administration of 20 mcg of hepatitis B recombinant vaccine im at month 0, 1 and 2
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: 4-8 weeks after the third dose of the vaccine
|
Developing antibodies against HBsAg (anti-HBs) > 10 mIU/mL
|
4-8 weeks after the third dose of the vaccine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2020
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
December 30, 2023
Study Registration Dates
First Submitted
March 26, 2020
First Submitted That Met QC Criteria
March 26, 2020
First Posted (Actual)
March 30, 2020
Study Record Updates
Last Update Posted (Actual)
March 31, 2020
Last Update Submitted That Met QC Criteria
March 27, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- 180814005
- 1191389 (Other Grant/Funding Number: FONDECYT (Chile))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Available on request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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