Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children (PCV1103)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Papua New Guinea Institute of Medical Research
Sponsor:
Collaborator:
The University of Western Australia
Information provided by (Responsible Party):
Papua New Guinea Institute of Medical Research
ClinicalTrials.gov Identifier:
NCT01619462
First received: May 28, 2012
Last updated: March 20, 2014
Last verified: September 2012
  Purpose

The study aims to evaluate the safety and immunogenicity of the 10-valent and 13-valent pneumococcal conjugate vaccines when administered in an accelerated schedule in Papua New Guinean children, who experience early dense upper respiratory tract colonisation with a broad range of pneumococcal serotypes, and to compare antibody titres following a booster dose of polysaccharide vaccine at 9 months with those children who received no booster at the same age.


Condition Intervention Phase
Pneumonia
Meningitis
Bacteraemia
Sepsis
Otitis Media
Biological: Prevenar 13 and Synflorix
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines to Inform Policy Regarding Pneumococcal Vaccination of Papua New Guinean Children

Resource links provided by NLM:


Further study details as provided by Papua New Guinea Institute of Medical Research:

Primary Outcome Measures:
  • Proportion of children with serotype-specific IgG concentration >= 0.35ug/ml at 4 and 9 months of age for 90% of PCV vaccine serotypes and proportion of children with OPA >=1:8 titres at 4, 10 and 24 months [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    IgG concentration to vaccine serotypes are >= 0.35ug/ml post-dose 3 at 4 and 9 months. Serotype-specific IgG concentration >=0.35ug/ml is protective level against invasive pneumococcal diseases. Opsonophagocytic titre of >=1:8 examined at 4, 10 and 24 months will inform on functional antibodies induced by vaccination.


Secondary Outcome Measures:
  • Compare antibody concentrations to pneumococcal and Haemophilus influenzae protein antigens. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Measure antibody titres to surface proteins of pneumococci and Hi including Hi protein D, the carrier protein in PCV10 (Synflorix).

  • Determine carriage rates and bacterial load of pneumococci and H.influenzae [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Proportion of carriage before and after vaccination will be measured using conventional culture methods. Bacterial load will be measured using PCR to determine impact of vaccines

  • Determine rates of hospital admission for acute respiratory tract infections at 9 and 23 months [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]
    Admissions and morbidity for acute respiratory tract infections will be documented at 9 and 23 months.


Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Synflorix or PCV10
130 children will receive Synflorix at 1-2-3 months
Biological: Prevenar 13 and Synflorix
260 children will be randomized to receive either Prevenar 13 or Synflorix at 1-2-3 months. At 9 months 65 children in the Prevenar 13 arm and 65 children in the Synflorix arm will receive booster dose of Pneumovax and at 23 months all children will receive a micro dose of Pneumovax.Blood will be collected at 1, 4, 9, 10, 23 and 24 months to determine serotype-specific antibody responses. Nasopharyngeal swabs will also be collected to measure carriage of pneumococci and non-typeable Haemophilus influenzae.
Other Names:
  • Synflorix(R), PCV10
  • Prevenar 13(R), PCV13
Prevenar 13
130 children will receive Prevenar 13 at 1-2-3 months
Biological: Prevenar 13 and Synflorix
260 children will be randomized to receive either Prevenar 13 or Synflorix at 1-2-3 months. At 9 months 65 children in the Prevenar 13 arm and 65 children in the Synflorix arm will receive booster dose of Pneumovax and at 23 months all children will receive a micro dose of Pneumovax.Blood will be collected at 1, 4, 9, 10, 23 and 24 months to determine serotype-specific antibody responses. Nasopharyngeal swabs will also be collected to measure carriage of pneumococci and non-typeable Haemophilus influenzae.
Other Names:
  • Synflorix(R), PCV10
  • Prevenar 13(R), PCV13

Detailed Description:

The primary aim of the study is to determine whether PCV10 and PCV13 are safe and immunogenic in PNG infants for the serotypes in the respective vaccines. This study is important for the following reasons:

  1. There is a lack of data worldwide on immunogenicity in populations with very high early onset of dense URT carriage.
  2. The EPI immunisation schedule is very accelerated in PNG (ages 1,2 and 3 months).
  3. There are not data on functional antibody to PCVs in PNG.
  4. There are no data on NTHi Protein D antibody responses in PNG and worldwide in population with very high URT carriage rates from a young age, i.e. those most likely to benefit from a vaccine including NTHi protein carrier.
  5. It is important to investigate impact of vaccine on carriage density in view of our finding of limited impact of 7vPCV on URT carriage.
  6. There is no data on antibody responses following 10v or 13v PCV to booster with PPV as young as 9 months of age (which would be the most appropriate within the current PNG EPI schedule and in the many other third world countries).
  7. There is no data on antibody responses (including functional assays) to 23vPPV challenge at age 2 years after 23vPPV booster at age 9 months in children primed with PCV.
  8. The broad range of serotypes causing IPD in PNG necessitates continuing consideration of 23vPPV as a potential booster at age 9 months.
  9. Serotype-specific B cell memory is an important aspect that we can now test to address immunological safety of PPV in children primed with PCV.
  10. The Global Alliance for Vaccines and Immunisation (GAVI) and the World Health Organisation (WHO) have committed to the introduction of PCV for infants in GAVI-eligible countries (including PNG) using novel funding mechanism. In PNG, the introduction of a PCV is planned for 2013.
  Eligibility

Ages Eligible for Study:   up to 35 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Health infants between 28 - 35 days old

Exclusion Criteria:

  • Infants of women not intending to remain in the are for at least two years
  • Birth weigh < 2000 g (2kg)
  • Severe congenital abnormalities
  • Mother or child known to be HIV positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619462

Contacts
Contact: William Pomat, PhD +6755322800 ext 206 william.pomat@pngimr.org.pg

Locations
Papua New Guinea
Papua New Guinea Institute of Medical Research Recruiting
Goroka, Eastern Highlands Province, Papua New Guinea, 441
Contact: William Pomat, PhD    +6755322800 ext 206    william.pomat@pngimr.org.pg   
Contact: Vela Solomon, MBBS    +675322800 ext 241    vela.solomon@pngimr.org.pg   
Principal Investigator: William S Pomat, PhD         
Sponsors and Collaborators
Papua New Guinea Institute of Medical Research
The University of Western Australia
Investigators
Principal Investigator: William S Pomat, PhD Papua New Guinea Institute of Medical Research
Principal Investigator: Deborah Lehmann, MSc Telethon Institute for Child Health Research
Principal Investigator: Peter Richmond, MD The University of Western Australia
  More Information

No publications provided

Responsible Party: Papua New Guinea Institute of Medical Research
ClinicalTrials.gov Identifier: NCT01619462     History of Changes
Other Study ID Numbers: PCV1103
Study First Received: May 28, 2012
Last Updated: March 20, 2014
Health Authority: Australia: National Health and Medical Research Council
Papua New Guinea: Institute of Medical Research Institutional Review Board

Keywords provided by Papua New Guinea Institute of Medical Research:
pneumococcal
vaccine
papua new guinea

Additional relevant MeSH terms:
Bacteremia
Meningitis
Otitis
Otitis Media
Pneumonia
Sepsis
Bacterial Infections
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 28, 2014