Immune TolerancePhase 2PCVFUNCT01414504
Pneumococcal Conjugate Vaccine Followup
A Phase 2 study testing Prevenar + PPV, Infant PCV (Prevenar) + PPV at 9 months and No Prevenar + PPV at 9 months in people with Immune Tolerance, run by William Pomat at 1 site in Papua New Guinea.
Trial summary
Recently, controversy has emerged regarding the role of the 23vPPV in infants due to potential immunological hypo-responsiveness (i.e. a poorer immune response to repeat vaccination). Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Tolerance
- What is being tested?
- Prevenar + PPV, Infant PCV (Prevenar) + PPV at 9 months and No Prevenar + PPV at 9 months
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- Dec 2009to Sep 2012
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- PNG Infants aged 3 to 5 yrs of age who participated in previous PNG Neonatal PCV study and received PPV between 9 and 12 months of age, or age- and sex-matched controls who live in the same villages or urban area
- Informed parental/guardian consent
Who cannot join
- Known HIV infection or other immunosuppressive condition or treatment.
- Prior receipt of 2 doses of pneumococcal polysaccharide vaccine
Trial locations and contacts
1 site in 1 country.
Papua New Guinea1 site
PNG Institute of Medical Research
Goroka, Eastern Highlands Province, 441
About this study
Official title: Pneumococcal Conjugate Vaccine Followup: Investigation of Serotype-specific Antibody Persistence and B Cell Memory at Age 3-5 Years Following 23valent Pneumococcal Polysaccharide Vaccine at Age 9 Months in PNG Children Previously Primed With 7valent Pneumococcal Conjugate Vaccine
Recently, controversy has emerged regarding the role of the 23vPPV in infants due to potential immunological hypo-responsiveness (i.e. a poorer immune response to repeat vaccination). Although previous experience of 23vPPV in children in PNG has demonstrated protective efficacy against acute lower respiratory tract infection, the investigators feel it is a matter of urgency to determine if 23vPPV administration provides elevated antibody concentrations at 3 to 5 years of age, and to ensure the immunological safety of the 23vPPV in infants.
Following consent and eligibility assessment, a baseline blood sample and nose swab will be taken, a 0.1ml dose of 23vPPV will be administered and a follow up blood sample and nose swab will be collected 28 days later. The investigators will also collect data on incidence of ALRI in all study participants by medical record review.
- Conditions
- Immune Tolerance
- Being tested
- Prevenar + PPV, Infant PCV (Prevenar) + PPV at 9 months, No Prevenar + PPV at 9 months, Control
- Keywords
- pneumococcal,, pneumococcal polysaccharide vaccine,, challenge dose,, hyporesponsiveness,, Papua New Guinea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevenar + PPVBiological
0.5mL dose of Prevenar at 0-1-2 months, 0.5mL Pneumovax at 9 months and 0.1mL Pneumovax at 3-5 yrs
Infant PCV (Prevenar) + PPV at 9 monthsBiological
Also called Prevenar, Pneumovax23
0.5mL Prevenar at 1-2-3 months,0.5mL Pneumovax (PPV) at 9 months, 0.1mL Pneumovax at 3-5 yrs
No Prevenar + PPV at 9 monthsBiological
no Prevenar, 0.5mL Pneumovax at 9 months, 0.1mL Pneumovax at 3-5 yrs
ControlBiological
control, 0.1mL Pneumovax at 3-5yrs
| Study group | Role | What they receive |
|---|---|---|
| Neonatal PCV + PPV 9 months | Active comparator | Group 1: Children receiving 7VPCV at 0-1-2 months of age and PPV at 9 months of age Receives: Biological: Prevenar + PPV |
| Infant PCV + PPV at 9 months | Active comparator | Group 2: Children receiving 7VPCV at 1-2-3 months of age and PPV at 9 months of age Receives: Biological: Infant PCV (Prevenar) + PPV at 9 months |
| No PCV + PPV at 9 months | Active comparator | Group 3: Children who only received PPV at 9 months of age Receives: Biological: No Prevenar + PPV at 9 months |
| Control | Active comparator | Group 4: Children who have not received any previous pneumococcal vaccine Receives: Biological: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure serotype-specific antibody persistence in children aged 3-5 years after vaccination with 23vPPV at 9 months of age and compared to unvaccinated controls.
Children who were previously vaccinated with Pneumovax (23vPPV) at 9 months will be followed up at age 3-5 years of age. They will be given a challenge dose of Pneumovax (0.1mL) and followed up 1 months later. Age matched controls identified from each villages will also be recruited and given a challenge dose of Pneumovax. Serotype-specific antibodies will be measure pre- and post-challenge dose to determine anitbody levels.
Measured: 2yrs
Secondary outcomes (2)
Measure the number of circulating serotype-specific memory B-cells pre- & post- booster immunisation
Measured: 2yrs
Measure nasopharyngeal pneumococcal serotype-specific carriage rates pre- and post- 23vPPV challenge dose
Measured: 2yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startDec 2009
- Primary completionSep 2011
- Study completionSep 2012
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 Immune ToleranceStudies 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Pomat
- Sponsor type
- Other government
- Collaborators
- The University of Western Australia
- Responsible party
- Sponsor-investigator, William Pomat, Papua New Guinea Institute of Medical Research
- Investigators
- Peter C Richmond, MD, Principal investigator, School of Paediatrics and Child Health, University of Western AustraliaDeborah Lehmann, MSc, Principal investigator, Telethon Institute for Child Health ResearchWilliam S Pomat, PhD, Principal investigator, Papua New Guinea Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414504
- Sponsor's protocol ID
- PCVFU927
- Acronym
- PCVFU
- Status last verified
- Sep 2012
- First submitted
- 2 Aug 2011
- Last updated
- 17 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
van den Biggelaar AHJ, Richmond PC, Fuery A, Anderson D, Opa C, Saleu G, Lai M, Francis JP, Alpers MP, Pomat WS, Lehmann D. Pneumococcal responses are similar in Papua New Guinean children aged 3-5 years vaccinated in infancy with pneumococcal polysaccharide vaccine with or without prior pneumococcal conjugate vaccine, or without pneumococcal vaccination. PLoS One. 2017 Oct 13;12(10):e0185877. doi: 10.1371/journal.pone.0185877. eCollection 2017.
PubMed 29028802
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumococcal Conjugate Vaccine Followup: Investigation of Serotype-specific Antibody Persistence and B Cell Memory at Age 3-5 Years Following 23valent Pneumococcal Polysaccharide Vaccine at Age 9 Months in PNG Children Previously Primed With 7valent Pneumococcal Conjugate Vaccine
- ClinicalTrials.gov ID
- NCT01414504
- Acronym / sponsor ID
- PCVFU / PCVFU927
- Conditions
- Immune Tolerance
- Keywords
- pneumococcal,, pneumococcal polysaccharide vaccine,, challenge dose,, hyporesponsiveness,, Papua New Guinea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- William PomatOther government
- Collaborators
- The University of Western Australia
- Study start
- Dec 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Aug 2011 (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.
Recently, controversy has emerged regarding the role of the 23vPPV in infants due to potential immunological hypo-responsiveness (i.e. a poorer immune response to repeat vaccination). Although previous experience of 23vPPV in children in PNG has demonstrated protective efficacy against acute lower respiratory tract infection, the investigators feel it is a matter of urgency to determine if 23vPPV administration provides elevated antibody concentrations at 3 to 5 years of age, and to ensure the immunological safety of the 23vPPV in infants.
Following consent and eligibility assessment, a baseline blood sample and nose swab will be taken, a 0.1ml dose of 23vPPV will be administered and a follow up blood sample and nose swab will be collected 28 days later. The investigators will also collect data on incidence of ALRI in all study participants by medical record review.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neonatal PCV + PPV 9 months | Active comparator | Biological: Prevenar + PPVGroup 1: Children receiving 7VPCV at 0-1-2 months of age and PPV at 9 months of age |
| Infant PCV + PPV at 9 months | Active comparator | Biological: Infant PCV (Prevenar) + PPV at 9 monthsGroup 2: Children receiving 7VPCV at 1-2-3 months of age and PPV at 9 months of age |
| No PCV + PPV at 9 months | Active comparator | Biological: No Prevenar + PPV at 9 monthsGroup 3: Children who only received PPV at 9 months of age |
| Control | Active comparator | Biological: ControlGroup 4: Children who have not received any previous pneumococcal vaccine |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- PNG Infants aged 3 to 5 yrs of age who participated in previous PNG Neonatal PCV study and received PPV between 9 and 12 months of age, or age- and sex-matched controls who live in the same villages or urban area
- Informed parental/guardian consent
Key exclusion criteria (2 listed)
- Known HIV infection or other immunosuppressive condition or treatment.
- Prior receipt of 2 doses of pneumococcal 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 |
|---|---|---|
| Prevenar + PPV0.5mL dose of Prevenar at 0-1-2 months, 0.5mL Pneumovax at 9 months and 0.1mL Pneumovax at 3-5 yrs | Biological | Neonatal PCV + PPV 9 months |
| Infant PCV (Prevenar) + PPV at 9 monthsAlso: Prevenar, Pneumovax230.5mL Prevenar at 1-2-3 months,0.5mL Pneumovax (PPV) at 9 months, 0.1mL Pneumovax at 3-5 yrs | Biological | Infant PCV + PPV at 9 months |
| No Prevenar + PPV at 9 monthsno Prevenar, 0.5mL Pneumovax at 9 months, 0.1mL Pneumovax at 3-5 yrs | Biological | No PCV + PPV at 9 months |
| Controlcontrol, 0.1mL Pneumovax at 3-5yrs | Biological | Control |
Primary outcome
Measure serotype-specific antibody persistence in children aged 3-5 years after vaccination with 23vPPV at 9 months of age and compared to unvaccinated controls.
Time frame: 2yrs
Children who were previously vaccinated with Pneumovax (23vPPV) at 9 months will be followed up at age 3-5 years of age. They will be given a challenge dose of Pneumovax (0.1mL) and followed up 1 months later. Age matched controls identified from each villages will also be recruited and given a challenge dose of Pneumovax. Serotype-specific antibodies will be measure pre- and post-challenge dose to determine anitbody levels.
2 secondary outcomes
Measure the number of circulating serotype-specific memory B-cells pre- & post- booster immunisation
Time frame: 2yrs
Measure nasopharyngeal pneumococcal serotype-specific carriage rates pre- and post- 23vPPV challenge dose
Time frame: 2yrs
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 Sep 2012.
- Derived from this study: PubMed 29028802van den Biggelaar AHJ, Richmond PC, Fuery A, Anderson D, Opa C, Saleu G, Lai M, Francis JP, Alpers MP, Pomat WS, Lehmann D. Pneumococcal responses are similar in Papua New Guinean children aged 3-5 years vaccinated in infancy with pneumococcal polysaccharide vaccine with or without prior pneumococcal conjugate vaccine, or without pneumococcal vaccination. PLoS One. 2017 Oct 13;12(10):e0185877. doi: 10.1371/journal.pone.0185877. eCollection 2017.
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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.
Peter C Richmond, MD principal investigator
School of Paediatrics and Child Health, University of Western Australia
Deborah Lehmann, MSc principal investigator
Telethon Institute for Child Health Research
William S Pomat, PhD principal investigator
Papua New Guinea Institute of Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prevenar + PPV, Infant PCV (Prevenar) + PPV at 9 months and No Prevenar + PPV at 9 months in people with Immune Tolerance, run by William Pomat at 1 site in Papua New Guinea.
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 2 inclusion and 2 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 Sep 2012. 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 Papua New Guinea. 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?
Measure serotype-specific antibody persistence in children aged 3-5 years after vaccination with 23vPPV at 9 months of age and compared to unvaccinated controls. (time frame: 2yrs). 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 NCT01414504, 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 17 Sep 2012.