Clinical trial NCT01289106: Modified Dose and Schedule of Recombinant Hepatitis B Vaccination in HIV-infected Adult Subjects
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV Infection
Keywords: Hepatitis B vaccine
HIV infection
Modified HBV vaccine dose
Modified HBV vaccine schedule
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2011-02-03
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Seroconversion rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at day 210
timeFrame: Day 210
Secondary outcomes:
measure: Seroprotective rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at 1 year
timeFrame: 1 year
measure: Number of subjects with adverse events after vaccination
timeFrame: 180 days
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
state: Chiang Mai
Study officials:
affiliation: Faculty of Medicine, Chiang Mai University
name: Kanokporn Chaiklang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chaiwarith R, Praparattanapan J, Kotarathititum W, Wipasa J, Chaiklang K, Supparatpinyo K. Higher rate of long-term serologic response of four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: 4-year follow-up of a randomised controlled trial. AIDS Res Ther. 2019 Nov 11;16(1):33. doi: 10.1186/s12981-019-0249-8.
citation: Chawansuntati K, Chaiklang K, Chaiwarith R, Praparattanapan J, Supparatpinyo K, Wipasa J. Hepatitis B Vaccination Induced TNF-alpha- and IL-2-Producing T Cell Responses in HIV- Healthy Individuals Higher than in HIV+ Individuals Who Received the Same Vaccination Regimen. J Immunol Res. 2018 Feb 27;2018:8350862. doi: 10.1155/2018/8350862. eCollection 2018.
citation: 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.