Clinical trial NCT01414504: Pneumococcal Conjugate Vaccine Followup
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Immune Tolerance
Keywords: pneumococcal,
pneumococcal polysaccharide vaccine,
challenge dose,
hyporesponsiveness,
Papua New Guinea
Lead sponsor: Papua New Guinea Institute of Medical Research
Sponsor class: OTHER_GOV
Collaborators: name: The University of Western Australia
First posted: 2011-08-11
Enrollment: 280
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Known HIV infection or other immunosuppressive condition or treatment.
* Prior receipt of 2 doses of pneumococcal polysaccharide vaccine

Primary outcomes:
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.
timeFrame: 2yrs
Secondary outcomes:
measure: Measure the number of circulating serotype-specific memory B-cells pre- & post- booster immunisation
timeFrame: 2yrs
measure: Measure nasopharyngeal pneumococcal serotype-specific carriage rates pre- and post- 23vPPV challenge dose
timeFrame: 2yrs
Other outcomes:
Locations:
city: Goroka
country: Papua New Guinea
facility: PNG Institute of Medical Research
state: Eastern Highlands
Study officials:
affiliation: School of Paediatrics and Child Health, University of Western Australia
name: Peter C Richmond, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Telethon Institute for Child Health Research
name: Deborah Lehmann, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Papua New Guinea Institute of Medical Research
name: William S Pomat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.