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

Purpose

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.

Condition	Intervention	Phase
HIV Infection	Biological: Hepavax-Gene	Phase 3


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

Resource links provided by NLM:

MedlinePlus related topics: Genes and Gene Therapy HIV/AIDS Hepatitis Hepatitis A Hepatitis B

U.S. FDA Resources

Further study details as provided by Chiang Mai University:

Primary Outcome Measures:

Seroconversion rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at day 210 [ Time Frame: Day 210 ] [ Designated as safety issue: No ]
1. 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)
2. 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

Secondary Outcome Measures:

Seroprotective rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To determine the seroprotective rate at 1 year of each of the vaccination regimens.
Number of subjects with adverse events after vaccination [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
Adverse events include pain at injected site, swelling at injected site, redness at injected site, fever, headache, fatique and anaphylaxis


Estimated Enrollment:	132
Study Start Date:	January 2011
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm A 20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months	Biological: Hepavax-Gene 20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months Other Name: Berna
Experimental: Arm B 20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months	Biological: Hepavax-Gene 20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months Other Name: Berna
Experimental: Arm C 40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months	Biological: Hepavax-Gene 40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months Other Name: Berna

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289106

Contacts


Contact: Kanokporn Chaiklang, MD	+66 89 8539864	kanokpornk@rihes.org

Locations


Thailand
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University	Recruiting
Muang, Chiang Mai, Thailand, 50200
Contact: Kanokporn Chaiklang, MD +66 89 8539864 kanokpornk@rihes.org
Principal Investigator: Kanokporn Chaiklang, MD

Sponsors and Collaborators

Chiang Mai University

Investigators


Principal Investigator:	Kanokporn Chaiklang, MD	Faculty of Medicine, Chiang Mai University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial. PLoS One. 2013 Nov 12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013.


Responsible Party:	Kanokporn Chaiklang, Faculty of Medicine, Chiang Mai University
ClinicalTrials.gov Identifier:	NCT01289106 History of Changes
Other Study ID Numbers:	MED-10-10-21A-13
Study First Received:	February 1, 2011
Last Updated:	February 2, 2011
Health Authority:	Thailand: Ethical Committee

Keywords provided by Chiang Mai University:


Hepatitis B vaccine HIV infection Modified HBV vaccine dose Modified HBV vaccine schedule

Additional relevant MeSH terms:


Hepatitis HIV Infections Hepatitis B Liver Diseases Digestive System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections	Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Hepadnaviridae Infections DNA Virus Infections Hepatitis, Viral, Human

ClinicalTrials.gov processed this record on September 29, 2016