The Immunogenicity and Safety Study of 47 Passaged Oka Strain Live Attenuated Varicella Vaccine in Healthy Children

Kang, Jin Han; Kim, Jong Hyun; Suh, Byung Kyu

Abstract

PURPOSE
We performed this study to find out short period humoral immunogenicity and safety of 47 passaged Oka strain live attenuated varicella vaccine(1,400PFU) in 12 months to 15 years aged healthy children.
METHODS
Ninety nine healthy chidren, who have no histories of varicella vaccination, recent chicken pox illness and contact, allergy to other vaccines and underlying severe diseases, were involved in this study from April 1997 to August 1997. 5ml blood were collected before vaccination and after vaccination from all vaccinees to measure varicella membrane antibody by FAMA, and varicella IgG antibody by EIA. And immediate reactions within 30 minutes after accination, local and systemic reactions within 3 days after vaccination and vaccine induced systemic illness during 6 weeks postvaccination period were observed in all vaccinees to identify side effects of study vaccine.
RESULTS
1) 49 seronegative and 50 seropositive vaccinees were identified in both prevaccination serologic tests. 2) Serologic responses after vaccination measured by the FAMA in seronegative group showed that the mean GMT level revealed 64.0, and seroconversion rate was 97.9%. And serologic responses after vaccination measured by the FAMA in seropositive group showed that the mean GMT level(242.2) was markedly elevated comparing with the mean GMT level(9.2) of prevaccination. 3) The results of EIA in seronegative group revealed that postvaccination mean GMT was 435.2(prevaccination GMT; 78.7), and 100% seroconversion rate. Also, the results of EIA in seropositve group showed that the mean GMT level(769.9) of postvaccination was almostly two fold hihger than the mean GMT level(419.7) of prevaccination. 4) Observed local reactions like injection sites redness, pain, hardness and itching sense were mild and disappeared within 3 days, also shorterm systemic reactions like irritability, lethargy, Poor appetites and rash were not remarkable. And there were no remarkable side effects due to vaccine during study period in all vaccinees.
CONCLUSION
We confirmed that 47 paasaged Oka strain live attenuated varicella vaccine has high shorterm humoral immunogenicity and safety However, we need more detail and longterm humoral and cell mediated immunogenicity studies of this vaccine including clinical field trials.