Efficiency of the Hepatitis B Sci-B-Vac Vaccine in HIV Positive Patients

NCT01437475 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-10-06

No results posted yet for this study

Summary

HBV vaccination is of paramount importance among HIV positive persons due to an increased risk of infection and disease progression. The most widely used ENGERIX B vaccine reaches a lower rate of vaccination (20-70%) among HIV positive vaccinees (compared to over 90% in the normal population). Sci-B-Vac is novel vaccine containing 3 antigens and is therefore more immunogenic (as opposed to one in ENGERIX B). Its use has been associated with higher and more rapid vaccination rates. Therefore, it has a theoretical advantage in HIV positive individuals.

Conditions

Interventions

BIOLOGICAL

Sci-B-Vac

10 microgram/ml hepatitis B surface antigen, 1 ml given intramuscularly

Sponsors & Collaborators

  • SciGen, Israel

    collaborator INDUSTRY
  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Dan Turner, MD · Tel-Aviv Sourasky Medical Center

  • Danny Alon, MD · Tel-Aviv Sourasky Medical Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-03-31
Completion
2013-11-30

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01437475 on ClinicalTrials.gov