Safety and immunogenicity of three doses of an eleven-valent diphtheria toxoid and tetanus protein--conjugated pneumococcal vaccine in Filipino infants.
BACKGROUND
An 11-valent pneumococcal conjugate vaccine could provide significantly larger reduction in pneumococcal disease burden than the currently available 7-valent vaccine formulation in many countries.


METHODS
In total, 50 infants were enrolled to this open, uncontrolled study, which evaluated the safety and immunogenicity of an aluminium adjuvanted 11-valent mixed-carrier diphtheria toxoid or tetanus protein-conjugated vaccine (11-PncTD) when administered in three doses at 6, 10 and 14 weeks of age simultaneously with DTwP//PRP-T and OPV vaccines in Filipino infants.


RESULTS
The rates of local reactions between the two injection sites, those associated with the 11-PncTD vaccine and those with the DTwP//PRP-T were almost of equal frequency for all three vaccine doses except for induration, which was significantly more common in the DTP//PRP-T injection site. Fever was present in 39%, 22% and 21% of infants following each of the three doses. Antibody responses were determined by an enzyme immunoassay method before the first vaccination and after the three doses. The vaccine elicited a significant anti-pneumococcal polysaccharide antibody response against all serotypes included in the vaccine, except for type 14, for which the pre-vaccination geometric mean antibody concentration (GMC) was high (1.61 microg/ml). The GMCs one month after the vaccination series ranged from 1.1 micrograms/ml for type 6B to 23.4 microg/ml for type 4.


CONCLUSIONS
The 11-PncTD vaccine is safe, well-tolerated and immunogenic. The effectiveness of the non-adjuvanted formulation of the vaccine in preventing pneumonia is currently being evaluated in the Philippines.
Capeding
Maria Z Rosario
MZ
Research Institute for Tropical Medicine, Metro Manila, Philippines. ritmari@info.com.ph
Puumalainen
Taneli
T
Gepanayao
Connie P
CP
Käyhty
Helena
H
Lucero
Marilla G
MG
Nohynek
Hanna
H
D022422:Diphtheria-Tetanus Vaccine / Q000008:administration & dosage* / Q000276:immunology; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010679:Philippines; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000276:immunology; D011018:Pneumonia, Pneumococcal / Q000276:immunology* / Q000517:prevention & control; D017778:Vaccines, Combined / Q000008:administration & dosage* / Q000276:immunology; D018074:Vaccines, Conjugate / Q000008:administration & dosage* / Q000276:immunology
D022422:Diphtheria-Tetanus Vaccine; D022242:Pneumococcal Vaccines; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate