Journal of the Formosan Medical Association
Volume 105, Issue 7 , Pages 542-549, 2006

Safety and Immunogenicity of Heptavalent Pneumococcal Conjugate Vaccine Booster in Taiwanese Toddlers

  • Chun-Yi Lu

      Affiliations

    • Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan
    • ,
  • Luan-Yin Chang

      Affiliations

    • Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan
    • ,
  • Fu-Yuan Huang

      Affiliations

    • Department of Pediatrics, Taipei Mackay Memorial Hospital, Taipei, Taiwan
    • ,
  • Chin-Yun Lee

      Affiliations

    • Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan
    • ,
  • Li-Min Huang

      Affiliations

    • Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan
    • Corresponding Author InformationCorrespondence to: Dr Li-Min Huang, Department of Pediatrics, National Taiwan University Hospital, 7, Chung-Shan South Road, Taipei 100, Taiwan

Department of Laboratory Medicine, Taipei, Taiwan

Received 12 August 2005; received in revised form 21 November 2005; accepted 6 December 2005.

Article Outline

Background/Purpose

Pneumococcal infection causes high morbidity and mortality in children. Prevention of pneumococcal diseases by effective vaccination is an urgent need. This study evaluated the safety and immunogenicity of heptavalent pneumococcal conjugate (7VPnC) vaccine (serotypes 4, 6B, 9V, 14, 18C, 19F, 23F) booster dose administered at 15-20 months of age in Taiwanese toddlers.

Methods

Fifty-eight healthy Taiwanese toddlers who were primed with three doses of the 7VPnC vaccine in infancy received a booster dose in an open-label, noncomparative trial. Routine oral polio vaccine and diphtheria toxoid, tetanus toxoid, and pertussis vaccine were administered concomitantly. Surveillance for safety was conducted after vaccination. Antibody concentration to each of the seven pneumococcal serotypes was measured before and 1 month after the booster dose.

Results

Mild to moderate local reactions were common (45-50%). Fever, fussiness, restlessness, and loss of appetite were the most frequent systemic reactions (31-50%). Before the booster dose of vaccine, 68% (for serotype 18C) to 100% (for serotype 14) of subjects had antibody concentrations ≥0.2μg/mL to different pneumococcal serotypes. After the booster dose, the geometric mean concentration of IgG increased significantly (p< 0.001) for all seven serotypes indicating the induction of immunologic memories. Ninety-eight percent of the toddlers had antibody concentration ≥ 0.2 μg/mL against all serotypes after the booster.

Conclusion

The 7VPnC vaccine containing the prevalent serotypes in Taiwan is safe and effective in boosting immunity against pneumococcal disease in Taiwanese children.

Key Words:  conjugate vaccines , immunology , serotyping , Streptococcus pneumoniae

No full text is available. To read the body of this article, please view the PDF online.

 

Back to Article Outline

References 

  1. Shao PL , Lu CY , Chang LY , et al.   Safety and immunogeni-city of heptavalent penumococcal conjugate vaccine in Taiwanese infants . J Formos Med Assoc . 2004;103:613–617
  2. Scheifele D , Halperin S , Pellertier L , et al.   Invasive pneu-mococcal infections in Canadian children, 1991–1998: implications for new vaccination strategies . Clin Infect Dis . 2000;31:58–64
  3. Kaplan SL , Mason EO , Barson WJ , et al.   Three-year multi-center surveillance of systemic pneumococcal infections in children . Pediatrics . 1998;102:538–545
  4. Recommendations of the Advisory Committee on Immunization Practices (ACIP)  . Preventing pneumococcal disease among infants and young children . MMWR . 2000;49(RR09):1–38
  5. Hsieh YC , Hsueh PR , Lu CY , et al.   Clinical manifestations and molecular epidemiology of necrotizing pneumonia and empyema caused by Streptococcus pneumoniae in children in Taiwan . Clin Infect Dis . 2004;38:830–835
  6. Black S , Shinefield H , Fireman B , et al.   Efficacy, safety, and immunogenicity of heptavalent pneumococcal conjugate vaccine in children . Pediatr Infect Dis J . 2000;19:187–195
  7. Eskola J , Kilpi T , Palmu A , et al.   Efficacy of a pneumococcal conjugate vaccine against acute otitis media . N Engl J Med. . 2001;344:403–409
  8. Shinefield HR , Black S , Ray P , et al.   Safety and immuno-genicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers . Pediatr Infect Dis J . 1999;18:757–763
  9. Rennels MB , Edwards KM , Keyserling HL , et al.   Safety and immunogenicity of heptavalent pneumococcal vaccine conjugated to CRM197 in United States infants . Pediatrics . 1998;101:604–611
  10. Jodar L , Butler J , Carlone G , et al.   Serological criteria for evaluation and licensure of new pneumococcal conjugate vaccine formulations for use in infants . Vaccine . 2003;21:3265–3272
  11. Quataert SA , Kirch CS , Wiedl LJ , et al.   Assignment of weight-based antibody units to a human antipneumococcal standard reference serum, lot 89-S . Clin Diagn Lab Immunol . 1995;2:590–597
  12. Tichmann-Schumann I , Soemantri P , Behre U , et al.   Immunogenicity and reactogenicity of four doses of diphtheria-tetanus-three-component acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b vaccine coadministered with 7-valent pneumococcal conjugate vaccine . Pediatr Infect Dis J . 2005;24:70–77
  13. Jokinen JT , Ahman H , Kilpi TM , et al.   Concentration of antipneumococcal antibodies as a serological correlate of protection: an application to acute otitis media . J Infect Dis . 2004;190:545–550
  14. Goldblatt D . Conjugate vaccines . Clin Exp Immunol . 2000;119:1–3
  15. Makela PH , Kayhty H , Leino T , et al.   Long-term persistence of immunity after immunization with Haemophilus influen-zae type b conjugate vaccine . Vaccine . 2003;22:287–292
  16. Black SB , Shinefield HR , Hansen J , et al.   Postlicensure evaluation of the effectiveness of seven valent pneumococcal conjugate vaccine . Pediatr Infect Dis J . 2001;20:1105–1107
  17. Stephens DS , Zughaier SM , Whitney CG , et al.   Incidence of macrolide resistance in Streptococcus pneumoniae after introduction of the pneumococcal conjugate vaccine: population-based assessment . Lancet . 2005;365:855–863
  18. Talbot TR , Poehling KA , Hartert TV , et al.   Reduction in high rates of antibiotic-nonsusceptible invasive pneumococcal disease in Tennessee after introduction of the pneumococ-cal conjugate vaccine . Clin Infect Dis . 2004;39:641–648
  19. Lipstich M . Bacterial vaccines and serotype replacement: lessons from Haemophilus influenzae and prospects for Streptococcus pneumoniae . Emerg Infect Dis . 1999;5:336–345
  20. Veenhoven R , Bogaert D , Uiterwaal C , et al.   Effect of conjugate pneumococcal vaccine followed by polysaccharide pneumococcal vaccine on recurrent acute otitis media: a randomized study . Lancet . 2003;361:2189–2195
  21. Porat N , Arguedas A , Spratt BG , et al.   Emergence of penicillin-nonsusceptible Streptococcus pneumoniae clones expressing serotypes not present in the antipneumococcal conjugate vaccine . J Infect Dis . 2004;190:2154–2161
  22. Hsueh PR , Teng LJ , Lee LN , et al.   Extremely high incidence of macrolide and trimethoprim-sulfamethoxazole resistance among clinical isolates of Streptococcus pneumoniae in Taiwan . J Clin Microbiol . 1999;37:897–901
  23. Siu LK , Chu ML , Ho M , et al.   Epidemiology of invasive pneumococcal infection in Taiwan: antibiotic resistance, serogroup distribution, and ribotypes analyses . Microb Drug Resist . 2002;8:201–208

PII: S0929-6646(09)60148-0

doi:10.1016/S0929-6646(09)60148-0

Journal of the Formosan Medical Association
Volume 105, Issue 7 , Pages 542-549, 2006

Article Tools