Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea

Papua New Guinea Institute of Medical Research

Status and phase: Completed; Phase 2

Conditions: Meningitis; Otitis Media; Pneumonia

Treatments: Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)

Study type: Interventional

Funder types: Other

Identifiers

NCT00219401

071613/Z/03/Z

303123 NHMRC Australia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 318 patients

Sex: All

Ages: 1 minute to 3 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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318 participants in 3 patient groups, including a placebo group

Neonatal 7vPCV

Experimental group

Description:

Receive study vaccine (Prevnar) at birth, 1 and 2 months

Treatment:

Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)

Infant 7vPCV

Experimental group

Description:

Receive the study vaccine (Prevnar) at 1, 2 and 3 months

Treatment:

Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)

Control

Placebo Comparator group

Description:

Do not receive study vaccine (Prevnar)

Treatment:

Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)