Background:
@EN Recently two 23-valent pneumococcal vaccines have been introduced in Korea. There are no comparative clinical trials of immunogenicity between these vaccines and very few data about immunogenicity obtained from Korean was available.
@ES Methods
@EN We compared the safety and immunogenicity between two 23-valent pneumococcal vaccines in Korean adults in an open randomized comparative clinical trial. Seventy healthy young medical students were injected with one of the two 23-valent
Pneumococcal
vaccines(Pneumo-23 vs Pnu-Imune 23). Group A(Pneumo-23) constituted with thirty three males and two females had the mean age of 24.4 years and group B(Pnu-Imune 23) constituted with thirty two males and three females had mean age of 24.2 years.
Antibody
concentrations polysaccharides(3,6B,14,18C,19F,23F) were determined by an enzyme-linked immunosorbent assay.
@ES Results:
@EN We could not find any significant differences in the incidence of side reactions including local pain or tenderness(25 in Group A, 27 in Group B), lump or hardness(2 in Group A, 4 in Group B) and redness(5 in Group A, 6 in Group B) or the
systemic
reactions including muscle pain(15 in Group A, Group B;P>0.1) and headache(8 in Group A, 2 in Group B;P>0.08) between the two vaccines. Ratio of fold increase(FI) of geometric mean antibody concentration before and after vaccination against each
six
capsular polysaccharide was evaluated. FI of IgG concentrations against polysaccharide serotypes 14, (10.7 in Group A, 12.8 in Group B) 19F(2.1 in Group A, 2.4 in Group B), 23F(8.9 in Group A, 6.4 in Group B), 6B(4.0 in Group A. 3.5 in Group B)
and
3(2.4 in Group A, 2.8 in Group B) were not significantly different. The FI of serotype 18C IgG was significantly different showing 7.4 in Group A and 4.2 in Group B(P<0.05)
@ES Conclusion:
@EN We concluded that two 23 valent pneumococcal vaccines were safe and immunogenic in Korean young adults and thee was no significant difference of the immunogenicity and safety between the two vaccines(Pneumo 23 vs Pnu-Imune 23).
|