Clinical trial of leptospires vaccine on its immunogenicity and safety / 예방의학회지

ABSTRACT

Since the reservior of leptospires organism is consisted of a broad spectrum of animals, the best method of prevention is vaccination. The clinical trial of leptospires vaccine conducted on human volunteer for its immunogenicity and safety. Summarized results are as follows 1. The Oral temperature among vaccinated group ranged from 36.7 +/- 0.34 degrees C, while in placebo injected group it ranged from 36.4 +/- 0.46 degrees C to 36.7 +/- 0.53 degrees C. There wan no association between vaccination and fever (p<0.05). 2. Mild local reactions revealed in vacciness were swelling (50-75%), Redness(75-90%), and induration(25-40%). Placebo injected group revealed only redness in 12.5% in the 1st injection and 37.5% in the second injection. The duration local reactions on injection site for both vaccinees and placebo groups disappeared within 48 hours. 3. Generalized Symptoms complained by the vaccinees were myalgia (25%), back pain(15%), headache(15%), pruritus(15%), and abdominal pain(10%), whereas placebo group complained of headache(25%), myalgia(12.5%), back pain(12.5%), pain in eyes(12.5%), abdominal pain(12.5%) prutitus(12.5%) and nausea(12.5%). 4. The serological test(MAT) of vaccinees showed geometric mean antibody titer as follows a. L. icterohemorrhagiae lai, 1 week after 1st vaccination 22.45, 1 week after 2nd vaccination 111.23, 3 week after 2nd vaccination 266.64, b. L. canicola canicola, 1 week after 1st vaccination 24.62, 1 week after 2nd vaccination 123.92, 3 week after 2nd vaccination 276.55, c. L. icterohemorrhagiae copenhageni, 1 week after 1st vaccination 28.28, 1 week after 2nd vaccination 128.55, 3 week after 2nd vaccinaton 247.88, Whereas all of the placebo injected group, showed below 1 20 titers. The sero-conversion rate of vaccinees were 100 percent.