HIV InfectionsPhase 4NCT01138215
The Immunogenicity of Varicella-zoster Virus Vaccine in HIV-infected Children
A Phase 4 study testing VZV vaccination in people with HIV Infections and Varicella-zoster Virus, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
Trial summary
To study about the immunogenicity, safety and efficacy of varicella-zoster virus vaccine in HIV-infected children. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- HIV Infections, Varicella-zoster Virus
- What is being tested?
- VZV vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2009to Aug 2009
- Phase
- Phase 4
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- HIV-infected children.
- Aged between 1 to 15 years.
- CD4 T lymphocyte percentage ≥ 15% or ≥ 200 cell/ml within 6 months at time of enrollment.
- Written informed consent was obtained from each child's parent or guardian before enrollment.
- HIV-infected children who age more than 7 years old sign assent.
Who cannot join
- History of clinical varicella or zoster.
- History of exposure to VZV within 1 month before study entry.
- Received varicella vaccine.
- Received immunoglobulin or blood product within 3 months before study entry.
- Using oral steroid or immunosuppressive drugs within 3 months before study entry.
- History of hypersensitivity to vaccine component (Neomycin).
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Pediatrics, Chulalongkorn University
Bangkok, 10330
About this study
To study about the immunogenicity, safety and efficacy of varicella-zoster virus vaccine in HIV-infected children.
Read the detailed description
VZV causes two clinical diseases, primary infection results in varicella (chickenpox) after which virus latent in dorsal root ganglion. Reactivation of VZV results in herpes zoster (shingles) about years or decades. Immunocompetent children, varicella generally mild self limiting illness. In HIV infected children, VZV is often more severe illness with progressive varicella characterized by continuing eruption of lesions and high fever persist into second weeks, as well as encephalitis, hepatitis and pneumonia can developed. Zoster in immunocompromised patient become disseminated with lesions appearing outsides primary dermatomes and with visceral complications and can cause recurrences of herpes zoster. VZV illness in patients with immunodeficiency disorders require admission to hospital and the use of antiviral drugs. Sometimes, antiviral drug fails in immunocompromised children. Passive immunization with varicella zoster-immunoglobulin (VZIG), administered within three days of exposure, is effective in preventing disease or in reducing severity of illness in susceptible immunocompromised persons. About half of the cases of varicella in immunocompromised children occur without a recognised exposure to VZV. Both severe and fatal varicella has been documented despite appropriate immunoprophylaxis withVZIG. Furthermore, VZIG is expensive and short supply. These limitations make passive immunization a less than optimum strategy for preventing chickenpox. Permanent protection provided by administering the vaccine to high-risk persons would be preferable.
Sartori AM., University of Sao Paolo in Sep 2004 found that after give two doses of the varicella vaccine in 41 susceptible HIV-infected childrens in CDC class N1 or A1. Seroconversion occurred in 53% and 60% of vaccines after one and two doses, respectively. No significant fall in CD4 T lymphocytes or increase in HIV viral load at eight weeks after vaccination.
Saro H. Armenian, University of Southern California in Nov 2005 administrated single dose of live varicella vaccine to 10 HIV infected children. After vaccination, positive VZV-LPA response was detected in 50% of patients at week 2 and 100% at week 4, remained positive in 90% at week 52. VZV IgG was detected in 11% at week 2, 67% at week 8, only 33% at week 52.
Myron J. Levin, University of Colorado in June 2006-2008 study about the safety and immunogenicity of vaccine in varicella-zoster virus (VZV) naive, HIV-infected children with moderate symptoms and/or more pronounced past or current decreases in CD4+ T cell counts. Recipients (97 children) were stratified into 3 groups : group I - CDC category 1 and immunologic category 1 (least affected group of HIV-infected children), group II - CDC category A, B, or N and immunologic category 2 (CD4% = 15-24), group III : CDC category C and/or immunologic category 3, but at least 3 months prior to vaccination, had achieved clinical category A or N and equivalent of immunologic category 1 (CD4% = 25). After 2 doses of vaccines , 79% of children developed VZV-specific antibody and/or CMI 2 months after vaccine and 83% were responders 1 year after vaccination. Bekker V., Emma Children's Hospital, Netherland in Nov 2006 administered 2 doses of varicella vaccine to 15 VZV-seronegative HIV-1 infected children (total lymphocyte counts > 700 lymphocytes/microl) and 6 HIV-negative VZV-seronegative. Only 60% of the HIV-1 infected children had VZV-specific Ab after two immunizations, where as 100% of the siblings seroconverted.
Thai HIV infected children usually start antiretroviral late due to limited access to care with more severe suppressed of immune status than children in developed countries. Moreover, VZV vaccine is not in the country guideline and still expensive. We would like to provide VZV prevention for this group of children and to evaluate the VZV antibody response in Thai HIV children after VZV vaccination.
- Conditions
- HIV Infections, Varicella-zoster Virus
- Being tested
- VZV vaccination
- Keywords
- varicella-zoster virus vaccine, varicella-zoster virus antibody, immunogenicity, safety and efficacy, HIV-infected children, Assess protective VZV Antibody, Adverse events from VZV vaccine
- Medical subject headings
- HIV Infections, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VZV vaccinationBiological
Dose : 0.5 ml Route : subcutaneous injection (SC)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Receive 1 course of VZV vaccine : 2 doses of vaccines with 3 months apart. Receives: Biological: VZV vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children with protective VZV Antibody in HIV infected children after 2 doses of VZV vaccine.
Measured: 1 month after vaccine completion
Secondary outcomes (2)
Adverse events from VZV vaccine.
Measured: 1 month after completion of vaccine
Compare proportion of children who developed VZV antibody by baseline characteristics e.g. immune status, age, gender.
Measured: 1 month after completion of vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startJun 2009
- Primary completionAug 2009
- Study completionAug 2009
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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Chulalongkorn University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138215
- Sponsor's protocol ID
- HIV-NAT 111
- Status last verified
- Jul 2020
- First submitted
- 4 Jun 2010
- 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
- The Immunogenicity of Varicella-zoster Virus Vaccine in HIV-infected Children
- ClinicalTrials.gov ID
- NCT01138215
- Acronym / sponsor ID
- HIV-NAT 111
- Conditions
- HIV Infections, Varicella-zoster Virus
- Keywords
- varicella-zoster virus vaccine, varicella-zoster virus antibody, immunogenicity, safety and efficacy, HIV-infected children, Assess protective VZV Antibody, Adverse events from VZV vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Chulalongkorn University
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 7 Jun 2010 (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.
To study about the immunogenicity, safety and efficacy of varicella-zoster virus vaccine in HIV-infected children.
Detailed description
VZV causes two clinical diseases, primary infection results in varicella (chickenpox) after which virus latent in dorsal root ganglion. Reactivation of VZV results in herpes zoster (shingles) about years or decades. Immunocompetent children, varicella generally mild self limiting illness. In HIV infected children, VZV is often more severe illness with progressive varicella characterized by continuing eruption of lesions and high fever persist into second weeks, as well as encephalitis, hepatitis and pneumonia can developed. Zoster in immunocompromised patient become disseminated with lesions appearing outsides primary dermatomes and with visceral complications and can cause recurrences of herpes zoster. VZV illness in patients with immunodeficiency disorders require admission to hospital and the use of antiviral drugs. Sometimes, antiviral drug fails in immunocompromised children. Passive immunization with varicella zoster-immunoglobulin (VZIG), administered within three days of exposure, is effective in preventing disease or in reducing severity of illness in susceptible immunocompromised persons. About half of the cases of varicella in immunocompromised children occur without a recognised exposure to VZV. Both severe and fatal varicella has been documented despite appropriate immunoprophylaxis withVZIG. Furthermore, VZIG is expensive and short supply. These limitations make passive immunization a less than optimum strategy for preventing chickenpox. Permanent protection provided by administering the vaccine to high-risk persons would be preferable.
Sartori AM., University of Sao Paolo in Sep 2004 found that after give two doses of the varicella vaccine in 41 susceptible HIV-infected childrens in CDC class N1 or A1. Seroconversion occurred in 53% and 60% of vaccines after one and two doses, respectively. No significant fall in CD4 T lymphocytes or increase in HIV viral load at eight weeks after vaccination.
Saro H. Armenian, University of Southern California in Nov 2005 administrated single dose of live varicella vaccine to 10 HIV infected children. After vaccination, positive VZV-LPA response was detected in 50% of patients at week 2 and 100% at week 4, remained positive in 90% at week 52. VZV IgG was detected in 11% at week 2, 67% at week 8, only 33% at week 52.
Myron J. Levin, University of Colorado in June 2006-2008 study about the safety and immunogenicity of vaccine in varicella-zoster virus (VZV) naive, HIV-infected children with moderate symptoms and/or more pronounced past or current decreases in CD4+ T cell counts. Recipients (97 children) were stratified into 3 groups : group I - CDC category 1 and immunologic category 1 (least affected group of HIV-infected children), group II - CDC category A, B, or N and immunologic category 2 (CD4% = 15-24), group III : CDC category C and/or immunologic category 3, but at least 3 months prior to vaccination, had achieved clinical category A or N and equivalent of immunologic category 1 (CD4% = 25). After 2 doses of vaccines , 79% of children developed VZV-specific antibody and/or CMI 2 months after vaccine and 83% were responders 1 year after vaccination. Bekker V., Emma Children's Hospital, Netherland in Nov 2006 administered 2 doses of varicella vaccine to 15 VZV-seronegative HIV-1 infected children (total lymphocyte counts > 700 lymphocytes/microl) and 6 HIV-negative VZV-seronegative. Only 60% of the HIV-1 infected children had VZV-specific Ab after two immunizations, where as 100% of the siblings seroconverted.
Thai HIV infected children usually start antiretroviral late due to limited access to care with more severe suppressed of immune status than children in developed countries. Moreover, VZV vaccine is not in the country guideline and still expensive. We would like to provide VZV prevention for this group of children and to evaluate the VZV antibody response in Thai HIV children after VZV vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: VZV vaccinationReceive 1 course of VZV vaccine : 2 doses of vaccines with 3 months apart. |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- HIV-infected children.
- Aged between 1 to 15 years.
- CD4 T lymphocyte percentage ≥ 15% or ≥ 200 cell/ml within 6 months at time of enrollment.
- Written informed consent was obtained from each child's parent or guardian before enrollment.
- HIV-infected children who age more than 7 years old sign assent.
Key exclusion criteria (6 listed)
- History of clinical varicella or zoster.
- History of exposure to VZV within 1 month before study entry.
- Received varicella vaccine.
- Received immunoglobulin or blood product within 3 months before study entry.
- Using oral steroid or immunosuppressive drugs within 3 months before study entry.
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 |
|---|---|---|
| VZV vaccinationDose : 0.5 ml Route : subcutaneous injection (SC) | Biological | 1 |
Primary outcome
Proportion of children with protective VZV Antibody in HIV infected children after 2 doses of VZV vaccine.
Time frame: 1 month after vaccine completion
2 secondary outcomes
Adverse events from VZV vaccine.
Time frame: 1 month after completion of vaccine
Compare proportion of children who developed VZV antibody by baseline characteristics e.g. immune status, age, gender.
Time frame: 1 month after completion of vaccine
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VZV vaccination in people with HIV Infections and Varicella-zoster Virus, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site 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 6 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 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 VZV Antibody in HIV infected children after 2 doses of VZV vaccine. (time frame: 1 month after vaccine completion). 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.