Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea

Pneumonia Clinical Trial

Official title:

Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219401
• Other study ID #: 071613/Z/03/Z
• Secondary ID: 303123 NHMRC Aus
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2005
• Last updated: July 10, 2011
• Start date: May 2005
• Est. completion date: May 2010

Study information

• Verified date: July 2011
• Source: Papua New Guinea Institute of Medical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: May 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis
• Otitis Media
• Pneumonia

Intervention

Biological:
• Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Accelerated PCV vaccinaton.

Locations

Country	Name	City	State
Papua New Guinea	Papua New Guinea Institute of Medical Research	Goroka	EHP

Sponsors (2)

Lead Sponsor	Collaborator
Papua New Guinea Institute of Medical Research	The University of Western Australia

Country where clinical trial is conducted

Papua New Guinea, 

References & Publications (3)

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 — View Citation

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 2 — View Citation

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 tria — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 yrs	Yes
Secondary	Immunogenicity	Serum PCV and non-PCV serotype specific IgG antibody at 10 mths, after 23vPPV vaccination at 9 mths	5 years	Yes
Secondary	Pneumococcal-specific acquired immunity	Assessment of cellular immune responses to pneumococcal protein antigens at 9 and 18 months of age.	5 years	No