Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients

NCT03855176 | Completed Phase 4

• 1 other identifier: 201608071MINB
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

Though HAV is mainly transmitted through the fecal-oral route, infection by sexual intercourse and blood transfusion is also possible. Injection drug users (IDUs) and men who have sex with men (MSM) have a higher risk of acquiring HAV due to their behaviors. Reemerging threat of hepatitis A among MSM in Taiwan has been reported recently. Based on the guidelines for the diagnosis and treatment of HIV/AIDS and the Advisory Committee on Immunization Practices (ACIP), Taiwan, vaccination of individuals against HAV with any of the following indications is recommended: HIV patients, adults with chronic hepatic disease, hemophilia, liver transplantation, occupational exposure, MSM, persons who use injection or noninjection illicit drugs, or persons traveling to or working in countries that have endemicity of HAV. In HIV-infected patients, the immunogenicity to HAV vaccination is sub-optimal in HIV-infected patients and the seroconversion rate is estimated 68-90% after administration of 2 or 3 doses of HAV vaccine. Furthermore, the antibody titers of HIV-infected patients following HAV vaccination are significantly lower compared to those of HIV-uninfected persons. The sub-optimal response among HIV-infected subjects remains an unresolved problem. In this study, the investigators aim to determine the to conduct a randomized clinical trial to compare the immunogenicity of 2 different doses of HAV vaccination (1 dose versus 2 doses) in HIV-infected patients who failed to achieve serologic response in the primary vaccination. This proposal will provide the solid evidence to elucidate the role of booster HAV vaccination in HIV-infected patients without response to primary HAV vaccination.

Conditions

Hepatitis A; Human Immunodeficiency Virus; Vaccine Response Impaired

Outcome Measures

Primary Outcomes (1)

• Serological responses at week 48

  Serological responses to HAV vaccination at week 48 after boosting vaccination

  Week 48

Other Outcomes (1)

• Vaccine reaction

  Vaccine reaction within 28 days after HAV vaccination

Study Arms (2)

1-dose group

ACTIVE COMPARATOR

Provide 1 booster dose of HAV vaccine (Vaqta Injectable Product) to those who failed to response after primary HAV vaccination.

Drug: Vaqta Injectable Product

2-dose group

EXPERIMENTAL

Provide 2 booster doses of HAV vaccine (Vaqta Injectable Product) to those who failed to response after primary HAV vaccination.

Drug: Vaqta Injectable Product

Interventions

Vaqta Injectable Product DRUG

Inactive vaccine against hepatitis A virus

1-dose group; 2-dose group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-positive individuals aged 20 year or more, and
• Those who had completed at least a primary series of HAV vaccination (i.e. two doses of HAVRIX 1440, 6-12 months apart; or two doses of Vaqta 50U, 6-18 months apart), and
• Those who failed to achieve serological response at least 4 weeks after the last dose of primary HAV vaccination.

You may not qualify if:

• Patients who have acute illness or acute hepatitis A related symptoms (fever, malaise, nausea, vomiting, abdominal discomfort, and jaundice) within 30 days.
• Patients who have positive anti-HAV IgM within 30 days.
• Patients who were taking immunosuppressant or steroid.
• Patients who were allergic to HAV vaccine.
• Incompetent or unconsented patients.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Chen GJ, Sun HY, Lin KY, Hsieh SM, Chuang YC, Liu WD, Huang YS, Pan SC, Wu UI, Cheng A, Huang YC, Wu CH, Su YC, Liu WC, Chang SY, Hung CC. A Randomized Clinical Trial of 1-Dose vs Accelerated 2-Dose Schedule for Hepatitis A Virus (HAV) Revaccination Among People With Human Immunodeficiency Virus Who Were Nonresponders or Had Seroreversion After Primary HAV Vaccination. Clin Infect Dis. 2023 Aug 22;77(4):529-536. doi: 10.1093/cid/ciad206.

  PMID: 37036404 DERIVED

MeSH Terms

Conditions

Hepatitis A; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Chien-Ching Hung

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: February 26, 2019
• Study Start: September 12, 2017
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)