Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection (ANRS 12100 HEPADAK-2)
Terminated
GlaxoSmithKline
Phase 3
2005-08-01
Chronic hepatitis B infection is a major public health issue in Senegal. The study will
compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine
(12 intra-muscular injections over a 6-month period) to a treatment with Lamivudine alone on
the control of viral replication in patients with a replicative hepatitis B virus (HBV)
infection and an increase in hepatic enzymes.
Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection (ANRS 12100 HEPADAK-2)
Terminated
French National Agency for Research on AIDS and Viral Hepatitis
Phase 3
2005-08-01
Chronic hepatitis B infection is a major public health issue in Senegal. The study will
compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine
(12 intra-muscular injections over a 6-month period) to a treatment with Lamivudine alone on
the control of viral replication in patients with a replicative hepatitis B virus (HBV)
infection and an increase in hepatic enzymes.
National Institute of Allergy and Infectious Diseases (NIAID)
Phase 2
2005-12-01
The purpose of this study is to evaluate the safety of administering a combination vaccine
(DTaP-HepB-IPV; Pediarix™) to infants at birth, 2 and 6 months compared to the administration
of a HepB vaccine at birth and the same combination vaccine at 2, 4, and 6 months of age.
Additionally, researchers will assess the body's antibody response (proteins produced by the
body's immune system that help fight infections) following each vaccine dose. The study will
enroll 5 healthy newborns, ages 0-5 days. Participants will be involved in study related
procedures for up to 288 days, including blood sample collection and 5 study visits.
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