NCT04588077 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

A two-dose hepatitis B vaccine for adults (Heplisav-B)
Med Lett Drugs Ther. 2018 Jan 29;60(1539):17-18. No abstract available.
Amjad W, Alukal J, Zhang T, Maheshwari A, Thuluvath PJ
Two-Dose Hepatitis B Vaccine (Heplisav-B) Results in Better Seroconversion Than Three-Dose Vaccine (Engerix-B) in Chronic Liver Disease. Dig Dis Sci. 2021 Jun;66(6):2101-2106. doi: 10.1007/s10620-020
Jackson S, Lentino J, Kopp J, Murray L, Ellison W, Rhee M, Shockey G, Akella L, Erby K, Heyward WL, Janssen RS; HBV-23 Study Group
Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant
Roni DA, Pathapati RM, Kumar AS, Nihal L, Sridhar K, Tumkur Rajashekar S
Safety and efficacy of hepatitis B vaccination in cirrhosis of liver. Adv Virol. 2013;2013:196704. doi: 10.1155/2013/196704. Epub 2013 Jun 6.
Shetty A, Jun Yum J, Saab S
The Gastroenterologist's Guide to Preventive Management of Compensated Cirrhosis. Gastroenterol Hepatol (N Y). 2019 Aug;15(8):423-430.
Yanny B, Konyn P, Najarian LM, Mitry A, Saab S
Management Approaches to Hepatitis B Virus Vaccination Nonresponse. Gastroenterol Hepatol (N Y). 2019 Feb;15(2):93-99.

Comparison the Seroconversion Rate Between Two-dose and Three-dose Regimens of Heplisav B Among Patients With Cirrhosis, a Randomized-control Prospective Study.

Details for clinical trial NCT04588077

Clinical trial NCT04588077 - References