A Long-term Prospective Study of Varicella Vaccine in Healthy Children

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Abstract
Background. Studies in Japan and the United States have shown that varicella vaccine is both safe and efficacious. In 1984, we undertook a 10-year prospective study using a research lot of Oka/Merck varicella vaccine to assess antibody persistence and breakthrough chickenpox rates. In 1987, we began a similar prospective study with lots made in production facilities that ended after 6 years because many children were given a second dose. The purpose of this study is to report humoral antibody persistence and breakthrough chickenpox rates after 6 to 10 years of prospective follow-up. Methods. One hundred forty-three seronegative children received a research lot (950 plaque-forming units/dose) with 97.9% seroconversion by an assay for fluorescent antibody to membrane antigen (FAMA). One hundred thirty-eight children received production lots (1145 to 3265 plaque-forming units/dose) with 93.5% seroconversion. Yearly chickenpox exposure surveys were completed by phone, and children were seen by a study nurse whenever chickenpox was suspected. A subset in each group had serum collected every 2 years and tested for FAMA antibody. Results. In the research group there have been 25 cases of chickenpox in 137 seroconverters in a period of more than 10 years (yearly rate of 1.7%). In the production lot group there have been 22 cases of chickenpox in 129 seroconverters in a 6-year period (yearly rate of 2.8%). In the research group the median titer rose from 1:16 to 1:64 between 1 and 10 years. In the production group, the median titer did not change between 1, 2, and 4 years. Median antibody titers were compared between the research and production groups at 1, 2, and 4 years and did not differ. The rate of development of modified chickenpox has not increased with time since vaccination, and neither has the case severity. Children with FAMA titers ≤8 at 6-weeks' postvaccination were four times more likely to develop chickenpox than those with titers ≥64. Conclusions. 1) Modified chickenpox has occurred in approximately 2% to 3% of vaccinees per year, regardless of the vaccine lot given. 2) FAMA titers have risen between 1 and 10 years in research lot recipients and remained the same in production lot recipients. 3) The likelihood of modified chickenpox developing is inversely related to the 6-week postvaccination FAMA titer.