Modified Dose and Schedule of Recombinant Hepatitis B Vaccination in HIV-infected Adult Subjects

HIV Infection Clinical Trial

Official title:

Open-Label, Randomized Controlled Trial Comparing Three Strategies of Hepatitis B Vaccination in HIV-1-Infected Patients With CD4 Cell Counts Above 200 permm3 and Suppressed Viral Load

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01289106
• Other study ID #: MED-10-10-21A-13
• Status: Recruiting
• Phase: Phase 3
• First received: February 1, 2011
• Last updated: February 2, 2011
• Start date: January 2011
• Est. completion date: April 2012

Study information

• Verified date: January 2011
• Source: Chiang Mai University
• Contact: Kanokporn Chaiklang, MD
• Phone: +66 89 8539864
• Email: kanokpornk[@]rihes.org
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purposes of this study include 1) to compare the seroconversion rate of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months), and 2) to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients.

Description:

HIV and HBV share similar risk factors and routes of transmission. HIV/HBV coinfection is associated with greater chance of chronic HBV carrier state, higher level of HBV replication and increasing its potential for transmission. Currently, there are no concrete data to determine the best HBV vaccination schedule in HIV-infected patients. Standard HBV vaccination (20 μg at 0, 1 and 6 months) gives seroconversion rate of 33-63% in HIV-infected individuals compared with >90% in healthy individuals. This study aims to compare the efficacy of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months) and to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients with CD4 level above 200 permm3 and suppressed viral load.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: April 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Positive for anti-HIV antibody

• At least 18 years of age

• CD4 > 200 cell/mm3

• On antiretroviral therapy

• Viral load < 50 copies/ml

• Negative for any HBV serological marker (HBsAg, Anti-HBs, Anti-HBc)

• No history of previous hepatitis B vaccination

• Anti-HCV negative

• No active opportunistic infection at the time of screening

• Willing to sign informed consent

• Able to follow up

Exclusion Criteria:

• Pregnancy or breast feeding

• History of hypersensitivity to any component of vaccine

• Diagnosis of malignancy and receiving chemotherapy or radiation

• Other immunocompromised conditions not related to HIV infection (solid-organ transplantation, chemotherapy in the last 6 months)

• On Immunosuppressive treatment, immunomodulating treatment or corticosteroid (equal or above 0.5 mg per kg per day of prednisolone)

• Renal failure (creatinine clearance < 30 mL/min)

• Decompensated cirrhosis (child-pugh C)

• Not able to follow up

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis B
• HIV Infection
• HIV Infections

Intervention

Biological:
• Hepavax-Gene
20 µg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months
• Hepavax-Gene
20 µg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
• Hepavax-Gene
40 µg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months

Locations

Country	Name	City	State
Thailand	Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University	Muang	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at day 210	To compare the seroconversion rate at day 210 of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months); To compare the seroconversion rate at day 210 of an intensive double-dose regimen (40 µg at 0,1,2 and 6 months) to a standard-dose regimen (20 µg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients	Day 210	No
Secondary	Seroprotective rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at 1 year	To determine the seroprotective rate at 1 year of each of the vaccination regimens.	1 year	No
Secondary	Number of subjects with adverse events after vaccination	Adverse events include pain at injected site, swelling at injected site, redness at injected site, fever, headache, fatique and anaphylaxis	180 days	Yes