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

NCT04326803 | Unknown Phase 4

• 2 other identifiers: 1808140051191389
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hepatitis B

Keywords

hepatitis B; migration; HIV

Outcome Measures

Primary Outcomes (1)

• Response rate

  Developing antibodies against HBsAg (anti-HBs) \> 10 mIU/mL

  4-8 weeks after the third dose of the vaccine

Study Arms (1)

Vaccine group

EXPERIMENTAL

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

Interventions

Hepatitis B recombinant vaccine BIOLOGICAL

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

Also known as: Engerix-B vaccine

Vaccine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Related Publications (2)

• 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.

  PMID: 26576083 BACKGROUND

• 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.

  PMID: 25920093 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Hepatitis B

Interventions

COMVAX

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Alejandro Soza, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Núñez, RN

CONTACT

56223543820; r.nunezpuentes@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: June 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2023
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share