HIV InfectionsPhase 2NCT00886964
Hepatitis B Vaccination (HBV) in HIV Infected Children
A Phase 2 study testing Intradermal HBV 1 course and Intramuscular HBV I course in people with HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 2 sites in Thailand.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Intradermal HBV 1 course and Intramuscular HBV I course
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesThailand
- Study dates
- Apr 2009to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Active AIDS
- Active opportunistic infection
- Platelet < 50,000/ mm3 at screening visit
- History of hypersensitivity to HBV vaccine
- Using oral steroid or immunosuppressive drugs
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
HIV-NAT
Bangkok, 10330
Pediatric infectious diseases section, King Chulalongkorn Memorial hospital
Bangkok, 10330
About this study
Official title: 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
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Intradermal HBV 1 course, Intramuscular HBV I course
- Keywords
- HBV vaccine, HIV children, immune recovery, HBV antibody, Intradermal, Intramuscular, antibody response after HBV vaccine, treatment experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal HBV 1 courseBiological
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
Intramuscular HBV I courseBiological
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | HBV ID Receives: Biological: Intradermal HBV 1 course |
| 2 | Active comparator | HBV IM Receives: Biological: Intramuscular HBV I course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children with protective antiHBs at 8 weeks after first dose of HBV ID is superior to HBV IM
Measured: 8 weeks
Secondary outcomes (3)
Proportion of children with positive antiHBs at 4 weeks after second and third dose of HBV
Measured: 4 weeks
Number of adverse events in HBV ID group and HBV IM group
Measured: 7 months
Proportion of protective antiHBs in HIV children after protocol defining immune recovery
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- ART AIDS Charity Fund
- Responsible party
- Sponsor
- Investigators
- Torsak Bunupuradah, MD, Principal investigator, The HIV Netherlands Australia Thailand Research Collaboration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886964
- Sponsor's protocol ID
- HIV-NAT 107
- Status last verified
- Jul 2020
- First submitted
- 22 Apr 2009
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Intradermal Compare to Intramuscular Hepatitis B Vaccination in HIV Children
- ClinicalTrials.gov ID
- NCT00886964
- Acronym / sponsor ID
- HIV-NAT 107
- Conditions
- HIV Infections
- Keywords
- HBV vaccine, HIV children, immune recovery, HBV antibody, Intradermal, Intramuscular, antibody response after HBV vaccine, treatment experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- ART AIDS Charity Fund
- Study start
- Apr 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: Intradermal HBV 1 courseHBV ID |
| 2 | Active comparator | Biological: Intramuscular HBV I courseHBV IM |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Active AIDS
- Active opportunistic infection
- Platelet < 50,000/ mm3 at screening visit
- History of hypersensitivity to HBV vaccine
- Using oral steroid or immunosuppressive drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradermal HBV 1 courseDosage: 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 | Biological | 1 |
| Intramuscular HBV I courseDosage: 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 | Biological | 2 |
Primary outcome
Proportion of children with protective antiHBs at 8 weeks after first dose of HBV ID is superior to HBV IM
Time frame: 8 weeks
3 secondary outcomes
Proportion of children with positive antiHBs at 4 weeks after second and third dose of HBV
Time frame: 4 weeks
Number of adverse events in HBV ID group and HBV IM group
Time frame: 7 months
Proportion of protective antiHBs in HIV children after protocol defining immune recovery
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torsak Bunupuradah, MD principal investigator
The HIV Netherlands Australia Thailand Research Collaboration
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intradermal HBV 1 course and Intramuscular HBV I course in people with HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children with protective antiHBs at 8 weeks after first dose of HBV ID is superior to HBV IM (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.