Safety and immunogenicity of heptavalent pneumococcal vaccine conjugated to CRM197 in United States infants.
Abstract | OBJECTIVE: To determine the safety and immunogenicity of heptavalent pneumococcal saccharide vaccine (serotypes 4, 6B, 9V, 14, 18C, 19F, 23F) individually conjugated to CRM197 ( PNCRM7), administered at 2, 4, 6, and 12 to 15 months of age. DESIGN: RESULTS: Significantly fewer children experienced local reactions at the PNCRM7 injection site than at the DTP/HbOC site. There was no increase in the incidence or severity of local reactions at the PNCRM7 site with increasing doses of vaccine. Mild to moderate postvaccination fever was common in both the PNCRM7 and control vaccine groups, however DTP/HbOC was administered concurrently. All 7 vaccine serotypes were immunogenic. The kinetics of the immune responses were serotype-specific. After three doses of PNCRM7, between 92% to 100% of children had >/=0.15 microg/mL of antibody, and 51% to 90% achieved a level of >/=1 microg/mL against specific serotypes. A booster dose of PNCRM7 resulted in a brisk anamnestic response to all 7 vaccine serotypes, demonstrating effective stimulation of T-cell memory by the primary series of vaccinations. CONCLUSION: Primary immunization followed by a booster dose of PNCRM7 seemed to be acceptably safe and resulted in significant rises in antibody to all 7 serotypes. Implications. Studies to assess vaccine efficacy of PNCRM7 for prevention of systemic disease, nasopharyngeal colonization, and acute otitis media are in progress. If PNCRM7 proves to be protective, there is the potential to prevent up to 85% of invasive pneumococcal disease occurring in US children.
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Authors | M B Rennels, K M Edwards, H L Keyserling, K S Reisinger, D A Hogerman, D V Madore, I Chang, P R Paradiso, F J Malinoski, A Kimura |
Journal | Pediatrics
(Pediatrics)
Vol. 101
Issue 4 Pt 1
Pg. 604-11
(Apr 1998)
ISSN: 0031-4005 [Print] United States |
PMID | 9521941
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Bacterial
- Bacterial Vaccines
- Heptavalent Pneumococcal Conjugate Vaccine
- Meningococcal Vaccines
- Pneumococcal Vaccines
- Vaccines, Conjugate
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Topics |
- Antibodies, Bacterial
(blood)
- Bacterial Typing Techniques
- Bacterial Vaccines
(administration & dosage, immunology)
- Double-Blind Method
- Female
- Heptavalent Pneumococcal Conjugate Vaccine
- Humans
- Immunization, Secondary
- Infant
- Male
- Meningococcal Vaccines
- Pneumococcal Infections
(immunology, prevention & control)
- Pneumococcal Vaccines
- Streptococcus pneumoniae
(classification, immunology)
- United States
- Vaccines, Conjugate
(administration & dosage, adverse effects, immunology)
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