Immunogenicity and safety of Vi capsular polysaccharide typhoid vaccine in healthy persons in Korea.
The purpose of this study was to evaluate the immunogenicity and safety of Salmonella Typhi Vi capsular polysaccharide vaccine (Vi vaccine) in Korea. The immunogenicity of a single dose of Vi vaccine was evaluated in 157 subjects (75 children and 82 adults) before and at 1, 6, and 12 months after vaccination. Immunogenicity was measured with a passive hemagglutination assay (PHA), quantified as geometric mean titers (GMTs) and seroconversion rates. The safety of the vaccine was investigated by determining adverse reactions occurring within 4 h, 3 days, and 1 month after injection. The seroconversion rate for children and adults 1 month after vaccination was 96.92% and 89.02%, respectively. In the case of children, the GMTs of Vi antibodies before vaccination were 5.87 +/- 1.34 and 142.59 +/- 2.39 at one month after vaccination. For adults, the GMTs before and one month after vaccination were 5.58 +/- 1.28 and 58.56 +/- 3.67, respectively. Vi antibodies persisted for as long as 6 and 12 months after vaccination. All adverse reactions in adults and children were minor and did not require treatment. The Vi CPS vaccine was safe and immunogenic in adults and children older than 5 years.
Central Research Institute, Boryung Pharm. Co. Ltd., Ansan 425-120, Korea.
Sang-Min
SM
Lim
Hahn-Sun
HS
Jung
Min Ja
MJ
Kim
Dae-Won
DW
Park
Woo-Joo
WJ
Kim
Hee-Jin
HJ
Cheong
Seung-Chul
SC
Park
Kwang-Chul
KC
Lee
Young-Kyoo
YK
Shin
Hyun Kwang
HK
Tan
Sang-Lin
SL
Kim
Jang Wook
JW
Sohn
D000293:Adolescent; D000328:Adult; D000368:Aged; D000907:Antibodies, Bacterial / Q000097:blood; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007114:Immunization; D008297:Male; D008875:Middle Aged; D011135:Polysaccharides, Bacterial / Q000009:adverse effects / Q000276:immunology*; D011358:Product Surveillance, Postmarketing; D014436:Typhoid-Paratyphoid Vaccines / Q000009:adverse effects / Q000276:immunology*
D000907:Antibodies, Bacterial; D011135:Polysaccharides, Bacterial; D014436:Typhoid-Paratyphoid Vaccines; C057664:Vi polysaccharide vaccine, typhoid