Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth

Phase 4 Completed 371 enrolled University of North Carolina, Chapel Hill National Institute of Mental Health (NIMH) · collab National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab National Institute on Drug Abuse (NIDA) · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

Hepatitis B is a contagious virus that can damage a person's liver. It can be prevented by vaccination, but for many HIV-positive people, the vaccines do not help them achieve adequate protection against this virus. In an attempt to improve response to vaccination and achieve protection from hepatitis B, this trial will compare the immune system response to 3 hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age.

Timeline

Start: 2004-01
Primary completion: 2008-01
Completion: 2009-06

Publications

Results Flynn PM, Cunningham CK, Rudy B, Wilson CM, Kapogiannis B, Worrell C, Bethel J, Monte D, Bojan K; Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Hepatitis B vaccination in HIV-infected youth: a randomized trial of three regimens. J Acquir Immune Defic Syndr. 2011 Apr;56(4):325-32. doi: 10.1097/QAI.0b013e318203e9f2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Engerix-B	Vaccine	20 ug	Intramuscular
Comparator	Engerix-B	Vaccine	40 ug	Intramuscular
Comparator	Twinrix	Vaccine	1 ml	Intramuscular

Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth

Summary

Timeline

Publications

Drugs

Indications