Reactogenicity and immunogenicity of a varicella vaccine in healthy seronegative and seropositive subjects.

ABSTRACT

The epidemiology of varicella appears to be changing an unexplained upward age shift in varicella prevalence and a subsequent dramatic rise in morbidity and mortality among adolescents and adults have highlighted the importance of effective varicella mass vaccination programs. This age shift is being seen in temperate regions but is particularly marked in tropical and sub-tropical regions. To assess the need for serological pre-screening in mass vaccination programs, we performed an open study to compare the reactogenicity and immunogenicity of a varicella vaccine in initially seronegative and seropositive subjects to see whether there was an increase in reactogenicity among initially seropositive subjects. Two hundred and forty-six seronegative and seropositive male and female subjects, aged 9 months to 60 years, received a single dose of a live attenuated varicella virus (Oka-strain) vaccine, Varilrix (GlaxoSmithKline Biologicals, Rixensart, Belgium). Subjects were categorized according to antibody status and age group; serum antibodies were measured before and after vaccination (day 42). The study showed that there was no difference in reactogenicity in initially seropositive vaccinees compared with initially seronegative subjects. The varicella vaccine was found to be safe and well tolerated in all age groups. Ninety-eight percent of initially seropositive and 94.8% of initially seronegative subjects reported no clinical signs or symptoms during the 42-day follow-up period. The vaccine was immunogenic in both groups. The seroconversion rate after 6 weeks in initially seronegative subjects was 94.3%. In 53.0% of initially seropositive subjects of all age classes, a 4-fold rise in antibody titer was observed.