HIVNCT01135082
Pneumococcal Conjugate Vaccine (PCV) in HIV- Infected Children
A study testing valent pneumococcal conjugated vaccine in people with HIV, run by The HIV Netherlands Australia Thailand Research Collaboration at 2 sites in Thailand.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of 7 - valent pneumococcal conjugated vaccine in HIV - infected children, and assess the predictive factors for protective antibody responses after receiving the vaccine. Read more about this study
- Who is it for?
- Ages 2 months to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- valent pneumococcal conjugated vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesThailand
- Study dates
- Apr 2010to Jun 2011
- Phase
- Interventional
- 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 2 months to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- HIV - infected children
- HIV infected individuals
- Age between 2 months to 9 years
- Signed written informed consent
- HIV - exposed negative children
- Maternal HIV infection, documented prior to delivery.
- Age between 2 months to 9 years
- Signed written informed consent
Who cannot join
- Active opportunistic infection
- History of hypersensitivity to pneumococcal conjugate vaccine or diphtheria toxoid
- Using oral steroid or immunosuppressive drugs
- Received pneumococcal conjugate vaccine, or pnuemococal polysaccharide vaccine
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
HIV-NAT, The Thai Red Cross AIDS Research Center
Bangkok, 10330
Pediatric infectious diseases section, King Chulalongkorn Memorial hospital
Bangkok, 10330
About this study
Official title: The Immunogenicity and Safety of Pneumococcal Conjugate Vaccine in Human Immunodeficiency Virus - Infected Children
The purpose of this study is to evaluate the immunogenicity and safety of 7 - valent pneumococcal conjugated vaccine in HIV - infected children, and assess the predictive factors for protective antibody responses after receiving the vaccine.
Read the detailed description
- pneumoniae is an important cause of severe invasive bacterial disease in human immunodeficiency disease (HIV) infected children. The incidence of pneumococcal bacteremia cases requiring hospitalization among Thai children aged < 5 years had a range of 10.6-28.9 cases per 100,000 persons.[1]
Children infected with HIV have a markedly increased risk for pneumococcal infection compared with those who are not HIV-infected. HIV-infected children had rates of invasive pneumococcal disease (IPD) that were 2.8 and 12.6 times the rate among HIV-negative children aged <5 and <3 years, respectively. Incidence of IPD is 6.1 cases/100 patient-years among HIV-infected children through age 7 years [2]
Recent important strategy in prevention of invasive pneumococcal disease (IPD) is an implementation of pneumococcal conjugate vaccine (PCV), which can induce immunity starting from 2 months of age. In a small study of 5-valent PCV among children < 2 years of age, serotype-specific IgG antibodies (ELISA) response after 3 doses was found to be immunogenic among both groups.[3] The Pediatric AIDS Clinical Trials Group Study 292 show that the immunologic responses to 7- valent PCV were similar for all serotypes among asymptomatic and symptomatic HIV - infected children.[4] The study of quantitative and qualitative antibody responses to 9 - valent PCV in HIV-infected children in South Africa shows similar quantitative antibody responses but poorer qualitative antibody responses to the pneumococcal conjugate vaccine when compared to HIV-negative children.[5].
In Thailand, 7 - valent PCV (Prevnar® ) was available in 2003. It is recommended for young children and highly recommended for high risk children such as HIV-infected children, congenital heart disease or premature infants. However, one of the major obstacles for large scale implementation is cost issue. There is no previous study about immunogenicity, safety or efficacy of 7 - valent PCV in HIV -infected Thai children, the objective of this study is to assess the safety and immunogenicity of a 7 - valent PCV vaccine among HIV - infected compared with HIV - exposed children.
- Conditions
- HIV
- Being tested
- valent pneumococcal conjugated vaccine
- Keywords
- immunogenicity, safety, Pneumococcal conjugate vaccine, HIV infected children, objective of this study is to assess the safety and immunogenicity of a 7 - valent PCV vaccine among HIV - infected compared with HIV - exposed children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valent pneumococcal conjugated vaccineBiological
Dosage: 0.5 ml per dose Administration: intramuscular injection Location: left deltoid area x 1 injection Frequency: depend on first dose of vaccination. If 2-6 months of age, vaccination at month 0, 2, and 4. If 7-23 months of age, vaccination at month 0 and 2. If 2-9 years of age, vaccination at month 0. If patient is HIV positive, vacciation months 0 and 2 if age is 2-9 years.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Receive valent pneumococcal conjugated vaccine in HIV - infected children Receives: Biological: valent pneumococcal conjugated vaccine |
| 2 | Other | Receive valent pneumococcal conjugated vaccine in HIV negative children Receives: Biological: valent pneumococcal conjugated vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunogenicity
Proportion of children with PCV serotype - specific IgG antibody at 28 days after completion of primary series of vaccination.
Measured: 28 days
Secondary outcomes (2)
Safety
Number of adverse events after PCV administration
Measured: 28 days
compare serotype
Compare proportion of PCV serotype - specific IgG antibody in HIV - infected children by baseline clinical staging, CD4 and viral load.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Chitsanu Pancharoen, MD, Principal investigator, Pediatric infectious diseases unit, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135082
- Sponsor's protocol ID
- HIV-NAT 135
- Status last verified
- Sep 2014
- First submitted
- 1 Jun 2010
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Thanee C, Pancharoen C, Likitnukul S, Luangwedchakarn V, Umrod P, Phasomsap C, Apornpong T, Chuanchareon T, Butterworth O, Puthanakit T. The immunogenicity and safety of pneumococcal conjugate vaccine in human immunodeficiency virus-infected Thai children. Vaccine. 2011 Aug 11;29(35):5886-91. doi: 10.1016/j.vaccine.2011.06.072. Epub 2011 Jul 3.
PubMed 21729732
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immunogenicity and Safety of Pneumococcal Conjugate Vaccine in Human Immunodeficiency Virus - Infected Children
- ClinicalTrials.gov ID
- NCT01135082
- Acronym / sponsor ID
- HIV-NAT 135
- Conditions
- HIV
- Keywords
- immunogenicity, safety, Pneumococcal conjugate vaccine, HIV infected children, objective of this study is to assess the safety and immunogenicity of a 7 - valent PCV vaccine among HIV - infected compared with HIV - exposed children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 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.
The purpose of this study is to evaluate the immunogenicity and safety of 7 - valent pneumococcal conjugated vaccine in HIV - infected children, and assess the predictive factors for protective antibody responses after receiving the vaccine.
Detailed description
- pneumoniae is an important cause of severe invasive bacterial disease in human immunodeficiency disease (HIV) infected children. The incidence of pneumococcal bacteremia cases requiring hospitalization among Thai children aged < 5 years had a range of 10.6-28.9 cases per 100,000 persons.[1]
Children infected with HIV have a markedly increased risk for pneumococcal infection compared with those who are not HIV-infected. HIV-infected children had rates of invasive pneumococcal disease (IPD) that were 2.8 and 12.6 times the rate among HIV-negative children aged <5 and <3 years, respectively. Incidence of IPD is 6.1 cases/100 patient-years among HIV-infected children through age 7 years [2]
Recent important strategy in prevention of invasive pneumococcal disease (IPD) is an implementation of pneumococcal conjugate vaccine (PCV), which can induce immunity starting from 2 months of age. In a small study of 5-valent PCV among children < 2 years of age, serotype-specific IgG antibodies (ELISA) response after 3 doses was found to be immunogenic among both groups.[3] The Pediatric AIDS Clinical Trials Group Study 292 show that the immunologic responses to 7- valent PCV were similar for all serotypes among asymptomatic and symptomatic HIV - infected children.[4] The study of quantitative and qualitative antibody responses to 9 - valent PCV in HIV-infected children in South Africa shows similar quantitative antibody responses but poorer qualitative antibody responses to the pneumococcal conjugate vaccine when compared to HIV-negative children.[5].
In Thailand, 7 - valent PCV (Prevnar® ) was available in 2003. It is recommended for young children and highly recommended for high risk children such as HIV-infected children, congenital heart disease or premature infants. However, one of the major obstacles for large scale implementation is cost issue. There is no previous study about immunogenicity, safety or efficacy of 7 - valent PCV in HIV -infected Thai children, the objective of this study is to assess the safety and immunogenicity of a 7 - valent PCV vaccine among HIV - infected compared with HIV - exposed children.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Biological: valent pneumococcal conjugated vaccineReceive valent pneumococcal conjugated vaccine in HIV - infected children |
| 2 | Other | Biological: valent pneumococcal conjugated vaccineReceive valent pneumococcal conjugated vaccine in HIV negative children |
Who may qualify
- Ages
- 2 months to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- HIV - infected children
- HIV - exposed negative children
Key exclusion criteria (4 listed)
- Active opportunistic infection
- History of hypersensitivity to pneumococcal conjugate vaccine or diphtheria toxoid
- Using oral steroid or immunosuppressive drugs
- Received pneumococcal conjugate vaccine, or pnuemococal polysaccharide vaccine
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 |
|---|---|---|
| valent pneumococcal conjugated vaccineDosage: 0.5 ml per dose Administration: intramuscular injection Location: left deltoid area x 1 injection Frequency: depend on first dose of vaccination. If 2-6 months of age, vaccination at month 0, 2, and 4. If 7-23 months of age, vaccination at month 0 and 2. If 2-9 years of age, vaccination at month 0. If patient is HIV positive, vacciation months 0 and 2 if age is 2-9 years. | Biological | 1, 2 |
Primary outcome
immunogenicity
Time frame: 28 days
Proportion of children with PCV serotype - specific IgG antibody at 28 days after completion of primary series of vaccination.
2 secondary outcomes
Safety
Time frame: 28 days
compare serotype
Time frame: 28 days
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 4 Sep 2014.
- Results publication: PubMed 21729732Thanee C, Pancharoen C, Likitnukul S, Luangwedchakarn V, Umrod P, Phasomsap C, Apornpong T, Chuanchareon T, Butterworth O, Puthanakit T. The immunogenicity and safety of pneumococcal conjugate vaccine in human immunodeficiency virus-infected Thai children. Vaccine. 2011 Aug 11;29(35):5886-91. doi: 10.1016/j.vaccine.2011.06.072. Epub 2011 Jul 3.
- 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.
Chitsanu Pancharoen, MD principal investigator
Pediatric infectious diseases unit, Chulalongkorn University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing valent pneumococcal conjugated vaccine in people with HIV, 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 8 inclusion and 4 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 4 Sep 2014. 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.
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?
immunogenicity (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01135082, which also lists 1 linked publication.
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 4 Sep 2014.