Who is sponsoring NCT02713620?

NCT02713620 is sponsored by Chiang Mai University.

What drugs are being tested in NCT02713620?

Interventions in NCT02713620: recombinant HBV vaccine (Hepavax-Gene® Berna, Korea).

What condition does NCT02713620 study?

NCT02713620 studies Hepatitis B.

Is NCT02713620 still recruiting?

NCT02713620 is currently completed. Last updated 17 April 2017.

Last reviewed 2017-04-17 · How we verify

NCT02713620

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparison of Immunogenicity of Four Doses and Four Double Doses vs. Standard Doses of Hepatitis B Vaccination in HIV-infected Adults: a Result From Randomized Controlled Trial at 3 Years After Vaccination

Completed Phase 4 Last updated 17 April 2017

What this trial tests

Phase 4 trial testing recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) in Hepatitis B in 154 participants. Completed in 1 January 2016.

Timeline

1 January 2015

Primary endpoint
1 January 2016

1 January 2016

Quick facts

Lead sponsor	Chiang Mai University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	154
Start date	1 January 2015
Primary completion	1 January 2016
Estimated completion	1 January 2016
Sites	1 location across Thailand

Drugs / interventions tested

recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) — full drug profile →

Conditions studied

Hepatitis B — all drugs for Hepatitis B →

Sponsor

Chiang Mai University

Who can join

18 and older, any sex, with Hepatitis B. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Proportion of participants with protective immunity against HBV
Time frame: 36 months after vaccination
Comparison of proportion of participants who had protective immunity (anti-HBS titer \>=10 mIU/ml) against HBV between "healthy" v.s. "HIV group 1", "HIV group 2" v.s. "HIV group 1", "HIV group 3 v.s. "HIV group 1"

Sponsor's own description

This is a follow up study from the published article entitled "Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial" by Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. that was published in PLoS One. 2013 Nov 12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013. ClinicalTrials.gov; NCT1289106. This study aimed to evaluate the efficacy of the HBV vaccination regimens using either four standard doses or four double doses compared with the current standard regimen of three doses in HIV-infected adults in northern Thailand. In addition, the investigators evaluated the efficacy of the HBV vaccination with the current standard regimen of three doses between healthy adults and HIV-infected patients.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Platforms, advances, and technical challenges in virus-like particles-based vaccines.
Gupta R, Arora K, Roy SS, Joseph A, et al · · 2023 · cited 80× · PMID 36845125 · DOI 10.3389/fimmu.2023.1123805
Higher rate of long-term serologic response of four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: 4-year follow-up of a randomised controlled trial.
Chaiwarith R, Praparattanapan J, Kotarathititum W, Wipasa J, et al · · 2019 · cited 5× · PMID 31711528 · DOI 10.1186/s12981-019-0249-8

Verify or expand the search:

Other recruiting trials for Hepatitis B

Currently open trials in the same condition.

NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B · Phase 1 · recruiting
NCT07168356 — A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease · Phase 1 · recruiting
NCT06947356 — Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads · NA · recruiting
NCT06537414 — A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living Wit · Phase 2 · active not recruiting
NCT06623071 — Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384 · recruiting

Other Chiang Mai University trials

Trials by the same sponsor.

NCT07366775 — A Telenursing Program to Support Diabetes Self-Management · NA · active not recruiting
NCT07032610 — Long-term Immunogenicity of L-HAV Vaccine Among Healthy Thai Children and Adolescents · not yet recruiting
NCT06978621 — Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV · Phase 3 · recruiting
NCT06905041 — Preoperative Anemia Affected to Postoperative Outcomes in Liver Resection · not yet recruiting
NCT07476404 — Re-bleeding in Giant Meningioma and Intraoperative Hydroxyethyl Starch (HES) Fluid Therapy · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02713620 (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 Chiang Mai University
Last refreshed: 17 April 2017

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/NCT02713620.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing