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

Primary Purpose

HIV Infection

Status

Unknown status

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

Hepavax-Gene

About this trial

This is an interventional prevention trial for HIV Infection focused on measuring Hepatitis B vaccine, HIV infection, Modified HBV vaccine dose, Modified HBV vaccine schedule

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months

20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months

40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT01289106

First Posted

February 1, 2011

Last Updated

February 2, 2011

Sponsor

Chiang Mai University

1. Study Identification

Unique Protocol Identification Number

NCT01289106

Brief Title

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

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

October 2011 (Anticipated)

Study Completion Date

April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Chiang Mai University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infection

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Active Comparator

Arm Description

20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months

Arm Title

Arm B

Arm Type

Experimental

Arm Description

20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months

Arm Title

Arm C

Arm Type

Experimental

Arm Description

40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months

Intervention Type

Biological

Intervention Name(s)

Hepavax-Gene

Other Intervention Name(s)

Berna

Intervention Description

20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months

Intervention Type

Biological

Intervention Name(s)

Hepavax-Gene

Other Intervention Name(s)

Berna

Intervention Description

20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months

Intervention Type

Biological

Intervention Name(s)

Hepavax-Gene

Other Intervention Name(s)

Berna

Intervention Description

40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months

Primary Outcome Measure Information:

Title

Seroconversion rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at day 210

Description

Time Frame

Day 210

Secondary Outcome Measure Information:

Title

Seroprotective rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at 1 year

Description

To determine the seroprotective rate at 1 year of each of the vaccination regimens.

Time Frame

1 year

Title

Number of subjects with adverse events after vaccination

Description

Adverse events include pain at injected site, swelling at injected site, redness at injected site, fever, headache, fatique and anaphylaxis

Time Frame

180 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kanokporn Chaiklang, MD

Phone

+66 89 8539864

kanokpornk@rihes.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kanokporn Chaiklang, MD

Organizational Affiliation

Faculty of Medicine, Chiang Mai University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University

City

Muang

State/Province

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kanokporn Chaiklang, MD

Phone

+66 89 8539864

kanokpornk@rihes.org

First Name & Middle Initial & Last Name & Degree

Kanokporn Chaiklang, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

31711528

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.

Results Reference

derived

PubMed Identifier

29682590

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.

Results Reference

derived

PubMed Identifier

24265819

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.

Results Reference

derived

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

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