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NCT03212911

HBV Vaccination in HIV-infected Adults

Status unknown Phase 4 Last updated 11 July 2017
What this trial tests

Phase 4 trial testing Hepatitis B vaccine in Hepatitis B Vaccination, HIV in 96 participants. Status unknown.

Timeline
1 July 2017
Primary endpoint
1 February 2018
1 July 2018

Quick facts

Lead sponsorChiang Mai University
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment96
Start date1 July 2017
Primary completion1 February 2018
Estimated completion1 July 2018
Sites1 location across Thailand

Drugs / interventions tested

Conditions studied

Sponsor

Chiang Mai University

Who can join

18 and older, any sex, with Hepatitis B Vaccination, HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The finding of isolated hepatitis B core antibody (isolated HBc) in absent of recent active hepatitis could cause by several scenarios, including false positive, remote infection without viremia, and occult infection with low viremia. Hepatitis B virus (HBV) vaccine booster could be a great prevention strategy for those who do not have HBV viremia. There is no standard consensus for management of this issue especially among HIV infected population. In addition, prior studies revealed that HIV-infected individuals had lower immunologic response to HBV vaccine than general population. This study intends to compare the immune response and safety of 4- versus 3-standard dose of hepatitis B virus vaccination in HIV-infected adults who has isolated HBc. The immunologic response will be evaluated after the participants receive vaccination.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Immunogenicity and safety of 4 vs. 3 standard doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody.
    Laksananun N, Praparattanapan J, Kotarathititum W, Supparatpinyo K, et al · · 2019 · cited 8× · PMID 31053142 · DOI 10.1186/s12981-019-0225-3

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Other trials of Hepatitis B vaccine

Trials testing the same drug.

Other Chiang Mai University trials

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