Pneumonia Clinical Trial
Official title:
Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea
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.
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; |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Papua New Guinea | Papua New Guinea Institute of Medical Research | Goroka | EHP |
Lead Sponsor | Collaborator |
---|---|
Papua New Guinea Institute of Medical Research | The University of Western Australia |
Papua New Guinea,
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
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 |
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