|
 |
 Home > Available Issues |
|
|
 Original Articles |
| An Open Randomized Comparative Clinical Trial of Two 23 Valent Pneumococcal Vaccines in Healthy Adults |
| Sohn Young Mo, Shin so Yung |
| Department of Pediatric, Yonsei University, College of Medicine, Medicial Research Division, Yuhan Cynamid.Inc |
Vol.27 Num.2 (p167~174)
|
|
|
Background : 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.
Methods : 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) consitituted with thirty three males and two females had the mean age of 24.4 years and group B(Pnu-Imune 23) consitituted 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.
Results : 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).
Conclusion : 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).
|
|
|
Keywords : Pneumococal vaccine |
|
|
|
|
|
|
|
|
