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Infection and immunity · Nov 2004
Randomized Controlled Trial Clinical TrialEffect of dosage on immunogenicity of a Vi conjugate vaccine injected twice into 2- to 5-year-old Vietnamese children.
- Do Gia Canh, Feng-ying Kimi Lin, Vu Dinh Thiem, Dang Duc Trach, Nguyen Dinh Trong, Nguyen Duc Mao, Steven Hunt, Rachel Schneerson, John B Robbins, Chiayung Chu, Joseph Shiloach, Dolores A Bryla, Marie-Claude Bonnet, Dominique Schulz, and Shousun C Szu.
- Diarrhea Diseases Epidemiology and Field Research Section, National Institute of Hygiene and Epidemiology, Hanoi, Veitnam.
- Infect. Immun. 2004 Nov 1; 72 (11): 6586-8.
AbstractIn a double-blind, randomized, and placebo-controlled previous trial, the efficacy of Vi-rEPA for typhoid fever in 2- to 5-year-olds was 89.0% for 46 months. Vi-rEPA contained 25 microg of Vi and induced a greater-than-eightfold rise in immunoglobulin G (IgG) anti-Vi in all of the vaccinees tested. In this investigation, we conducted a dosage-immunogenicity study of 5, 12.5, and 25 microg of Vi-rEPA in this age group. Two doses of Vi-rEPA were injected 6 weeks apart. Blood samples were taken before and at 10 weeks (4 weeks after the second injection) and 1 year later. All postimmunization geometric mean (GM) levels were higher than the preimmune levels (P < 0.0001). At 10 weeks, the GM IgG anti-Vi level elicited by 25 microg (102 EU/ml) was higher than those elicited by 12.5 microg (74.7 EU/ml) and 5 microg (43 EU/ml) (P < 0.004): all of the children had > or = 3.52 EU/ml (estimated minimum protective level). One year later, the levels declined about sevenfold (13.3 and 11.3 versus 6.43 EU/ml, P < 0.0001) but remained significantly higher than the preimmune levels (P < 0.0001), and >96% of the children had a greater-than-eightfold rise. This study also confirmed the safety and consistent immunogenicity of the four lots of Vi-rEPA used in this and previous trials.
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