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Comparing 2 methods of HBV vaccination in HIV positive patients

Comparing efficacy of two strategies of HBV vaccination in HIV infected patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013122415878N2
Enrollment
150
Registered
2014-01-12
Start date
2012-12-05
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus. Asymptomatic human immunodeficiency virus [HIV] infection status- Viral vaccines

Interventions

Intervention 1: Double dose of HB vaccine (40 µg) in 4 times (0,1,2,6 months) intramuscularly. Intervention 2: low dose of HBV vaccine intradermaly (4 µg) in 4 times 0,1,2,6 months. Intervention 3: Ro
Prevention
Double dose of HB vaccine (40 µg) in 4 times (0,1,2,6 months) intramuscularly
low dose of HBV vaccine intradermaly (4 µg) in 4 times 0,1,2,6 months
Routine HBV vaccination (20 µg) in 3 times 0,1,6 months, intramuscularly

Sponsors

Pasteur Institute of Iran
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: HIV positive adults referring to Iranian research center for HIV/AIDS with negative hepatitis B markers (HBsAg, anti-HBc, anti-HBs), no history of HBV vaccination, CD4 count more than 200 cells/mm3 and negative pregnancy test. Exclusion criteria: Patients with immunosuppression (not related to HIV) like organ recipients, chemotherapy, using systemic steroids, hemopathy, cancer, opportunistic infection, splenectomy, renal failure, cases receiving other vaccines 1 month before study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
HBV vaccination. Timepoint: 1 and 4 months after the last dose of HBV vaccine. Method of measurement: checking of anti-HBs titre.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Amitis Ramezani

Pasteur Institute of Iran

amitisramezani@hotmail.com;iiccom@iiccom.org;aramezani@pasteur.ac.ir+98 21 6696 8852

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026