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PneumoniaPhase 2NCT00219401

Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea

A Phase 2 study testing Pneumococcal 7 valent conjugate vaccine (Prevenar®) in people with Pneumonia and Meningitis, run by Papua New Guinea Institute of Medical Research at 1 site in Papua New Guinea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The National Health Plan 2001-2010 calls for investigation of the feasibility of pneumococcal vaccines for Papau New Guinea. The Papua New Guinea (PNG) Institute of Medical Research, the Telethon Institute for Child Health Research and the Department of Paediatrics, University of Western Australia will collaborate to… Read more about this study

Who is it for?
Ages 1 minute to 3 daysHealthy volunteers can take part
Conditions the study is for
Pneumonia, Meningitis, Otitis Media
What is being tested?
Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
318 participants
Where
1 sitePapua New Guinea
Study dates
May 2005to 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 minute to 3 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • New born babies with birth weight >2000 g (2 kgs) and parents giving consent

Who cannot join

  • Acute neonatal infection;
  • Severe congenital abnormality;
  • Children of mothers known to be HIV positive will be excluded;
  • Serious asphyxia at birth;
  • Intended migration in the next 2 years;
  • Parents withdraw consent;

Trial locations and contacts

1 site in 1 country.

Papua New Guinea1 site

  • Papua New Guinea Institute of Medical Research

    Goroka, EHP, 441

Other trials in Papua New Guinea

About this study

The National Health Plan 2001-2010 calls for investigation of the feasibility of pneumococcal vaccines for Papau New Guinea. The Papua New Guinea (PNG) Institute of Medical Research, the Telethon Institute for Child Health Research and the Department of Paediatrics, University of Western Australia will collaborate to examine very closely the safety of neonatal vaccination, particularly with regard to impact on the development of immunity and response to other vaccines given to infants. This study will also provide a unique opportunity for training of PNG and Australian scientists in both countries.

Read the detailed description

In order to obtain the earliest possible protection against invasive pneumococcal disease, achieve optimal coverage and reduce burden of early carriage, neonatal pneumococcal conjugate vaccine (PCV) immunization needs to be considered. This study in the PNG highlands will enrol 312 infants at birth, who will be randomised to receive PCV either at 1-2-3 months (infant schedule according to PNG national EPI schedule) or 0-1-2 months of age (neonatal schedule) or receive only routine immunizations (controls). Blood samples will be taken at birth-2-3-4 months of age, pre- and post-pneumococcal polysaccharide booster (23vPPV) at 9-10 months of age (to assess immune memory) and at 18 months at study completion. Carriage will be assessed weekly for the first month of life and at regular intervals thereafter. There will be ongoing surveillance for respiratory and other diseases throughout the study. In addition to serotype-specific IgG, we will examine IgG avidity, IgG subclasses, mucosal IgA and T-cell cytokine responses to PCV and pneumococcal protein antigens. To ensure immunological safety, particularly for neonatal PCV, immune responses to concomitant vaccines and viral and environmental antigens will also be examined as well as overall T-cell maturation.

Being tested
Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Keywords
Pneumococcal vaccine, Antibody responses, Cellular immunology, Th1/Th2 immune responses, Paediatric, Neonatal, Infectious diseases, Papua New Guinea
Medical subject headings
Pneumonia, Meningitis, Otitis Media, Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pneumococcal 7 valent conjugate vaccine (Prevenar®)Biological

    Accelerated PCV vaccinaton.

Study groups in NCT00219401
Study groupRoleWhat they receive
Neonatal 7vPCVExperimentalReceive study vaccine (Prevnar) at birth, 1 and 2 months
Receives: Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Infant 7vPCVExperimentalReceive the study vaccine (Prevnar) at 1, 2 and 3 months
Receives: Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
ControlPlacebo comparatorDo not receive study vaccine (Prevnar)
Receives: Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunogenicity and Safety

    Serum PCV serotype-specific IgG antibody at 2, 4 and 9 mths. Mucosal PCV serotype-specific IgG antibody at 1, 3, 4 and 9 mths. PCV-induced T-cell memory (against vaccine protein carrier) at 3 and 9 mths. Local and systemic reactogenicity 48-96 hrs after vaccination. Monitoring of serious adverse events during 18 mth follow-up. T-cell development to bystander antigens at 3 and 9 mths.

    Measured: 5 yrs

Secondary outcomes (2)

  1. Immunogenicity

    Serum PCV and non-PCV serotype specific IgG antibody at 10 mths, after 23vPPV vaccination at 9 mths

    Measured: 5 years

  2. Pneumococcal-specific acquired immunity

    Assessment of cellular immune responses to pneumococcal protein antigens at 9 and 18 months of age.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionMay 2009
  4. Study completionMay 2010

Resources

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
318 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00219401
Sponsor's protocol ID
071613/Z/03/Z
Other IDs
303123 NHMRC Australia
Status last verified
Jul 2011
First submitted
15 Sep 2005
Last updated
12 Jul 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • van den Biggelaar AH, Richmond PC, Pomat WS, Phuanukoonnon S, Nadal-Sims MA, Devitt CJ, Siba PM, Lehmann D, Holt PG. Neonatal pneumococcal conjugate vaccine immunization primes T cells for preferential Th2 cytokine expression: a randomized controlled trial in Papua New Guinea. Vaccine. 2009 Feb 25;27(9):1340-7. doi: 10.1016/j.vaccine.2008.12.046. Epub 2009 Jan 14.

    PubMed 19150378

  • van den Biggelaar AH, Pomat W, Bosco A, Phuanukoonnon S, Devitt CJ, Nadal-Sims MA, Siba PM, Richmond PC, Lehmann D, Holt PG. Pneumococcal conjugate vaccination at birth in a high-risk setting: no evidence for neonatal T-cell tolerance. Vaccine. 2011 Jul 26;29(33):5414-20. doi: 10.1016/j.vaccine.2011.05.065. Epub 2011 Jun 7.

    PubMed 21645573

  • Francis JP, Richmond PC, Pomat WS, Michael A, Keno H, Phuanukoonnon S, Nelson JB, Whinnen M, Heinrich T, Smith WA, Prescott SL, Holt PG, Siba PM, Lehmann D, van den Biggelaar AH. Maternal antibodies to pneumolysin but not to pneumococcal surface protein A delay early pneumococcal carriage in high-risk Papua New Guinean infants. Clin Vaccine Immunol. 2009 Nov;16(11):1633-8. doi: 10.1128/CVI.00247-09. Epub 2009 Sep 23.

    PubMed 19776196

  • 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

  • Francis JP, Richmond PC, Michael A, Siba PM, Jacoby P, Hales BJ, Thomas WR, Lehmann D, Pomat WS, van den Biggelaar AHJ. A longitudinal study of natural antibody development to pneumococcal surface protein A families 1 and 2 in Papua New Guinean Highland children: a cohort study. Pneumonia (Nathan). 2016 Aug 15;8:12. doi: 10.1186/s41479-016-0014-x. eCollection 2016.

    PubMed 28702291

  • Aho C, Michael A, Yoannes M, Greenhill A, Jacoby P, Reeder J, Pomat W, Saleu G, Namuigi P, Phuanukoonnon S, Smith-Vaughan H, Leach AJ, Richmond P, Lehmann D; Neonatal Pneumococcal Conjugate Vaccine Trial Study Team. Limited impact of neonatal or early infant schedules of 7-valent pneumococcal conjugate vaccination on nasopharyngeal carriage of Streptococcus pneumoniae in Papua New Guinean children: A randomized controlled trial. Vaccine Rep. 2016 Dec;6:36-43. doi: 10.1016/j.vacrep.2016.08.002.

    PubMed 28580433

  • Pomat WS, van den Biggelaar AH, Phuanukoonnon S, Francis J, Jacoby P, Siba PM, Alpers MP, Reeder JC, Holt PG, Richmond PC, Lehmann D; Neonatal Pneumococcal Conjugate Vaccine Trial Study Team. Safety and immunogenicity of neonatal pneumococcal conjugate vaccination in Papua New Guinean children: a randomised controlled trial. PLoS One. 2013;8(2):e56698. doi: 10.1371/journal.pone.0056698. Epub 2013 Feb 22.

    PubMed 23451070

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pneumococcal 7 valent conjugate vaccine (Prevenar®) in people with Pneumonia and Meningitis, run by Papua New Guinea Institute of Medical Research 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 1 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 12 Jul 2011. 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. Some participants in this study may receive a placebo. 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?

Immunogenicity and Safety (time frame: 5 yrs). 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 NCT00219401, which also lists 7 linked publications.

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 12 Jul 2011.

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