Hepatitis B Vaccination (HBV) in HIV Infected Children

Immunogenicity and Safety of Intradermal Compare to Intramuscular Hepatitis B Vaccination in HIV Children

The purpose of this study is :

• To evaluate prevalence of protective hepatitis B antibody comparing intradermal (ID) and intramuscular (IM) route in antiHbsAb negative HIV infected children treated with highly active antiretroviral therapy (HAART)
• To revaccinate the HBV vaccine in the children who didn't have protective HBV Ab

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Biological: Intradermal HBV 1 course; Biological: Intramuscular HBV I course

Detailed Description

Hepatitis B virus (HBV) and HIV share the same route of transmission and can have co-infection. The prevalence of this co-infection was 8.7% in Thai adult[1, 2] and 12.1% in African HIV vertically transmitted children[3]. Occurrence of HBV has effects to treatment due to having the same medication, lamivudine, tenofovir, emtricitabine or entecavir, to anti HIV medication. HBV can cause chronic liver disease, cirrhosis and hepatocellular carcinoma.

In Thailand, the routine HBV vaccination program was started since 1992. Few reports in severe immune compromise HIV children has been shown to lose their expected preventive measles and hepatitis B antibody from history of scheduled vaccination even after the immune recovery by HAART[4, 5]. Limited data in of prevalence of protective hepatitis B antibody response after immune recovery in Thai HIV infected children treated with highly active antiretroviral therapy. In addition, HBV revaccination in this group of children should be considered[6].

The response of HBV revaccination intramuscularly (IM) at 0, 2 and 6 months in 63 HIV children shown response rates 17.4, 82.5, and 92.1% at 2, 6 and 7 months respectively[6]. Protective anti-HBs were shown in the majority of non-responders to IM HBV vaccine health care workers [21/23 (91.3%)] by two doses of intradermal route (ID)[7].

We hypothesize to see the faster and higher response of antiHBs after first dose of ID compare to IM in anti HBsAb negative HIV infected children. No randomized control trial compare antibody response between IM and ID route in HIV children after immune recovery. The benefit from this trial would be decreased the vaccine cost for resourced limited country.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • HIV-NAT
  • Bangkok, Thailand, 10330
    • Pediatric infectious diseases section, King Chulalongkorn Memorial hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HIV infected individuals
• Age 1-18 years
• Current CD4 within 6 months ≥ 15% or ≥ 200 cells/ml in children age ≥ 6 years
• Signed written informed consent
• Negative HBs Ag, antiHBs, and antiHBc at screening visit

Exclusion Criteria:

• Active AIDS
• Active opportunistic infection
• Platelet < 50,000/ mm3 at screening visit
• History of hypersensitivity to HBV vaccine
• Using oral steroid or immunosuppressive drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; HBV ID	Biological: Intradermal HBV 1 course; Dosage: 2 microgram (mcg), 0.1 ml per dose Location: left deltoid area x 1 injection Common reactions: local pain, low grade fever, small hyperpigmented induration (granulomatous reaction) which may last up to 6-12 months
Active Comparator: 2; HBV IM	Biological: Intramuscular HBV I course; Dosage: 2 microgram (mcg), 0.1 ml per dose Location: left deltoid area x 1 injection Common reactions: local pain, low grade fever, small hyperpigmented induration (granulomatous reaction) which may last up to 6-12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of children with protective antiHBs at 8 weeks after first dose of HBV ID is superior to HBV IM	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of children with positive antiHBs at 4 weeks after second and third dose of HBV	4 weeks
Number of adverse events in HBV ID group and HBV IM group	7 months
Proportion of protective antiHBs in HIV children after protocol defining immune recovery	7 months

Collaborators and Investigators

• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: ART AIDS Charity Fund
• Investigators: Principal Investigator: Torsak Bunupuradah, MD, The HIV Netherlands Australia Thailand Research Collaboration

Publications and helpful links

Helpful Links

• HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: April 22, 2009
• First Submitted That Met QC Criteria: April 22, 2009
• First Posted (Estimate): April 23, 2009

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: treatment experienced; HIV children; Intradermal; Intramuscular; HBV vaccine; immune recovery; HBV antibody; antibody response after HBV vaccine
• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis; Hepatitis B
• Other Study ID Numbers: HIV-NAT 107