Immunogenicity of the Hepatitis B Vaccine

NCT04540653 | Unknown Phase 4

• 1 other identifier: PI02102-2017
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

More than five decades have passed since the identification of the etiologic agent of hepatitis B and yet this infection is a challenge for public health worldwide. The development and availability of the first hepatitis B vaccines, still in the 1980s, was a milestone for the prevention of the hepatitis B virus, and currently known as the gold standard strategy for the elimination of this infectious disease. In several countries, the introduction of the immunobiological occurred gradually, by age groups and risk groups, and in general, started with newborns and children. This universal immunization strategy has contributed to reducing the incidence and changing the epidemiological profile of HBV worldwide. At the beginning of the 21st century, it was already possible to shift the epidemiological curve of the infection to parasitize with 50 years or more. On the other hand, despite vaccination against hepatitis B being the most assertive tool for the prevention of HBV, the low performance of the vaccine in older groups remains a challenge for public health and the object of this study. To our knowledge, there are no data showing the efficacy of doses of enhanced hepatitis B vaccines for older adults, and the purpose of this study is to investigate and compare the immunogenicity of the hepatitis B vaccine in adult adults aged 50 years and over, using conventional doses (20μg) versus (vs) booster doses.

Conditions

Vaccine Response Impaired; Hepatitis B; Aging

Keywords

Vaccine Response Impaired; Hepatitis B; Aging

Outcome Measures

Primary Outcomes (1)

• More than 90% of the appropriate intervention sample of associated anti-HBs (≥10mUI / mL) after three doses of hepatitis B vaccine

  Success of the proposed procedure, defined by the development of isolated anti-HBs titers (≥10mUI / mL) after three reinforced doses (40μg) of the hepatitis B vaccine, within 30 to 60 days after the end of the vaccination schedule.

  Success of the proposed procedure, defined by the development of isolated anti-HBs titers (≥10mUI / mL) after three reinforced doses (40μg) of the hepatitis B vaccine, in 30 to 60 days after the end of the vaccination schedule.

Secondary Outcomes (2)

• About 20-30% of the appropriate intervention sample of associated anti-HBs (≥10mUI / mL) after first dose of hepatitis B vaccine

  Success of the proposed procedure, defined by the development of isolated anti-HBs titers (≥10mUI / mL) after one reinforced dose (40μg) of the hepatitis B vaccine, within 30 to 60 days after the end of the vaccination schedule.

• About 75-80% of the appropriate intervention sample of associated anti-HBs (≥10mUI / mL) after second dose of hepatitis B vaccine

  Success of the proposed procedure, defined by the development of isolated anti-HBs titers (≥10mUI / mL) after two reinforced doses (40μg) of the hepatitis B vaccine, within 30 to 60 days after the end of the vaccination schedule.

Study Arms (2)

Standard vaccination schedule

OTHER

To evaluate the immunogenicity of the monovalent hepatitis B vaccine, expressed in Hansenula polymorpha, aged ≥50 years old, using a standard vaccination schedule (three doses of 20 μg, in months 0, 1, 6).

Biological: Standard vaccination schedule

Reinforced vaccination schedule

EXPERIMENTAL

To evaluate the immunogenicity of the monovalent hepatitis B vaccine, expressed in Hansenula polymorpha, in individuals aged ≥50 years, using a reinforced vaccination schedule (three doses of 40 μg, in months 0, 1, 6).

Biological: Reinforced vaccination schedule

Interventions

Standard vaccination schedule BIOLOGICAL

Administer a standard vaccination schedule (three doses of 20 μg of the hepatitis B vaccine, in months 0, 1, 6) at an age of ≥50 years and evaluate a production kinetics after each dose administered in the period of about 30 to 60 days.

Standard vaccination schedule

Reinforced vaccination schedule BIOLOGICAL

Administer an enhanced vaccination schedule (three doses of 40 μg of the hepatitis B vaccine, in months 0, 1, 6) in individuals aged ≥50 years and assess the kinetics of antibody production after each dose administered in the period of approximately 30 to 60 days.

Reinforced vaccination schedule

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• person is 50 years of age or older.

You may not qualify if:

• people with chronic renal failure, cancer and HIV / AIDS, using corticosteroids;
• people with a history of hepatitis B vaccination (vaccination record of hepatitis B vaccine doses or previous report of hepatitis B vaccination);
• people who are positive for anti-HBs and / or total anti-HBc serological markers.

Sponsors & Collaborators

• Universidade Federal de Goias: lead

Study Sites (1)

Karlla Antonieta Amorim Caetano

Goiânia, Goiás, 74605-080, Brazil

Location

Related Publications (17)

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Related Links

• WHO; World Health Organization. Global Hepatitis Report 2017. Geneva: WHO; 2017.
• United Nations; Department of Economic and Social Affairs, Population Division (2019). World Population Ageing 2019. New York: United Nations; 2019.
• Bergamaschi FPR. Epidemiologia da infecção pelo vírus da hepatite b em assentamento rural em Mato Grosso do Sul, Brasil Central \[Tese\]. Goiânia-GO: Universidade Federal de Goiás; 2013. 95p

MeSH Terms

Conditions

Hepatitis B

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

• Karlla Caetano, PhD

  Universidade Federal de Goiás

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The intervention group (Reinforced Intervention Scheme - EIR) indicates 3 doses of 40 μg (2 mL) of hepatitis B vaccine, in months 0, 1 and 6, while the comparison group (Conventional Comparison Scheme - ECC) completes 3 doses of 20 μg (1 mL) of the vaccine, in months 0, 1 and 6. To evaluate the kinetics of the hepatitis B vaccine, after each dose administered, about 30 to 60 days, 5 mL of blood was again collected from the participants for quantitative detection of anti-HBs, using the Microparticle Chemiluminescent Immunoassay (CMIA) method, according to the manufacturer's instructions.

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: July 29, 2017
• Primary Completion: July 3, 2020
• Study Completion: March 31, 2022
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)