Hepatitis B Vaccination in HIV-infected Adults

NCT ID: NCT02713620

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-01-31

Brief Summary

This is a follow up study from the published article entitled "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" by Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. that was published in PLoS One. 2013 Nov 12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013. ClinicalTrials.gov; NCT1289106. This study aimed to evaluate the efficacy of the HBV vaccination regimens using either four standard doses or four double doses compared with the current standard regimen of three doses in HIV-infected adults in northern Thailand. In addition, the investigators evaluated the efficacy of the HBV vaccination with the current standard regimen of three doses between healthy adults and HIV-infected patients.

Detailed Description

From February 4, 2011 to May 4, 2012, 132 HIV-infected adults with CD4+ cell counts >200 cells/mm3, undetectable plasma HIV-1 RNA, and negative for all HBV markers were randomly assigned to receive one of three recombinant vaccine (Hepavax-Gene® Berna, Korea) regimens: 20 μg IM at months 0, 1, and 6 (Standard doses group, n=44), 20 μg IM at months 0, 1, 2, 6 (four doses group, n=44), or 40 μg IM at months 0, 1, 2, and 6 (four double doses group, n=44). There was another group of healthy individuals received standard dose of 20 μg IM at months 0, 1, and 6 recruited during the same time and under the same protocol. In brief, at months 7 and 12, the percentages of responders (anti-HBs ≥10 mIU/mL) were 88.6% and 70.4% in the Standard doses group, 93.2% and 86.4% in the four doses group, (P=0.713 and 0.119), and 95.4% and 88.6% in the four double doses group, (P=0.434 and 0.062), respectively.

This current study aimed to evaluate the efficacy of the different HBV vaccination regimens at 36 months after vaccination. In addition to compare the group using four standard doses or four double doses with the current standard regimen of three doses in HIV-infected adults in northern Thailand, the investigators also compare the efficacy of the current standard regimen of 3 doses between HIV-infected and healthy individuals.

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy

the "Healthy group" receiving three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6

Group Type: PLACEBO_COMPARATOR

recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)

Intervention Type: BIOLOGICAL

Different HBV vaccine regimen in each group

HIV-Group1

the "Standard doses group" receiving three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6

Group Type: ACTIVE_COMPARATOR

recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)

Intervention Type: BIOLOGICAL

Different HBV vaccine regimen in each group

HIV-Group 2

the "Four doses group" receiving four intramuscular doses of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, 2, and 6

Group Type: ACTIVE_COMPARATOR

recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)

Intervention Type: BIOLOGICAL

Different HBV vaccine regimen in each group

HIV-Group 3

the "Four double doses group" receiving four intramuscular double doses (40 μg) of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, 2, and 6

Group Type: ACTIVE_COMPARATOR

recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)

Intervention Type: BIOLOGICAL

Different HBV vaccine regimen in each group

Interventions

recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)

Different HBV vaccine regimen in each group

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Healthy Group 1.1 ≥18 years old, 1.2 were negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), had no history of previous vaccine 1.3 were negative for antibody to hepatitis C virus (anti-HCV) 1.4 received three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6 during February 4, 2011 to May 4, 2012, the same time as the study under ClinicalTrials.gov; NCT1289106. were conducted.

1.4 and were willing to sign an informed consent

2. HIV Group 1 2.1 HIV-1 infection 2.2 ≥18 years old, 2.3 had a CD4+ cell count >200 cells/mm3, 2.4 undetectable plasma HIV-1 RNA, 2.5 were negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), had no history of previous vaccine, 2.6 were negative for antibody to hepatitis C virus (anti-HCV), 2.7 had no active opportunistic infections (at the time of screening), 2.8 were participated in ClinicalTrials.gov; NCT1289106.and receiving three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6 2.9 were willing to sign an informed consent

3. HIV-Group 2 3.1 HIV-1 infection 3.2 ≥18 years old, 3.3 had a CD4+ cell count >200 cells/mm3, 3.4 undetectable plasma HIV-1 RNA, 3.5 were negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), had no history of previous vaccine, 3.6 were negative for antibody to hepatitis C virus (anti-HCV), 3.7 had no active opportunistic infections (at the time of screening), 3.8 were participated in ClinicalTrials.gov; NCT1289106.and receiving four intramuscular doses of 20 μg of the same vaccine at months 0, 1, 2, and 6 3.9 were willing to sign an informed consent

4. HIV Group 3 4.1 HIV-1 infection 4.2 ≥18 years old, 4.3 had a CD4+ cell count >200 cells/mm3, 4.4 undetectable plasma HIV-1 RNA, 4.5 were negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), had no history of previous vaccine, 4.6 were negative for antibody to hepatitis C virus (anti-HCV), 4.7 had no active opportunistic infections (at the time of screening), 4.8 were participated in ClinicalTrials.gov; NCT1289106.and receiving four intramuscular double doses (40 μg) at months 0, 1, 2, and 6 4.9 were willing to sign an informed consent

Exclusion Criteria

For HIV group 1, 2, and 3

1. active malignancy receiving chemotherapy or radiation,

2. other immunocompromised conditions besides HIV (e.g., solid organ transplant),

3. received immunosuppressive (e.g., corticosteroid ≥ 0•5 mg/kg/day) or immunomodulating treatment in the last six months before screening visit, 4. had renal insufficiency (creatinine clearance <30 mL/min), 5. decompensated cirrhosis (Child-Pugh class C)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Romanee Chaiwarith

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Romanee Chaiwarith, MD

Role: PRINCIPAL_INVESTIGATOR

Chiang Mai Unviersity

Locations

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

Muang, Chiang Mai, Thailand

Countries

Thailand

References

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.

Reference Type: DERIVED

PMID: 31711528 (View on PubMed)

Other Identifiers

Research ID: 2986

Identifier Type: -

Identifier Source: org_study_id