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NCT03855176
Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients
Phase 4 trial testing Vaqta Injectable Product in Hepatitis A in 153 participants. Completed in 30 December 2022.
30 December 2022
Quick facts
| Lead sponsor | National Taiwan University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 153 |
| Start date | 12 September 2017 |
| Primary completion | 30 December 2022 |
| Estimated completion | 30 December 2022 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Vaqta Injectable Product — full drug profile →
Conditions studied
- Hepatitis A — all drugs for Hepatitis A →
- Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
- Vaccine Response Impaired — all drugs for Vaccine Response Impaired →
Sponsor
National Taiwan University Hospital
Who can join
Eligibility, any sex, with Hepatitis A or Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Chen GJ, Sun HY, Lin KY, Hsieh SM, et al · · 2023 · cited 7× · PMID 37036404 · DOI 10.1093/cid/ciad206
Verify or expand the search:
- PubMed search for NCT03855176
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hepatitis A
Currently open trials in the same condition.
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- NCT06058416 — Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old · Phase 4 · active not recruiting
Other National Taiwan University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03855176 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Taiwan University Hospital
- Last refreshed: 26 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03855176.
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