Varicella vaccine studies in healthy children and adults. Protection against varicella in family contacts by immediate inoculation with live varicella vaccine. Efficacy of postexposure immunization with live attenuated varicella vaccine in the household setting--a pilot study.
Immunization of normal children and adults with Oka strain live varicella vaccine from several manufacturers has been studied in our laboratory and elsewhere. This paper summarizes clinical trials designed to obtain information on minimum dose immunogenicity pre- and postexposure prophylaxis, immunization of various age groups, and booster immunizations for seropositive individuals. These studies documented a 94% to 100% seroconversion rate with 95% to 100% persistence of antibodies at 3 to 4 years. Protective efficacy was more than 90%, and the vaccine was successful in preventing varicella when a high dose was given postexposure. Clinical reactions were limited to temperature elevations and minor papulovesicular rashes that occurred in 5% to 10% of vaccinees. Herpes zoster has been absent in vaccinated healthy individuals. A live varicella vaccine (Oka strain) was given to susceptible household contacts of varicella to test the protective efficacy of the vaccination. Twenty-six contacts of 21 families were vaccinated, usually within three days after onset of the index cases. None of the vaccinated children developed clinical symptoms of varicella. Eighteen of 24 sera obtained before vaccination were found to be seronegative by complement fixation and neutralization tests. Seroconversion was observed in all of the 18. On the other hand, all of 19 unvaccinated contacts in the 15 families, who served as controls, showed typical manifestations of varicella from 10 to 33 days after onset of the index varicella cases. In three families, where only one sibling contact received vaccine and the other was an unvaccinated control, none of the vaccinated children showed any clinical symptoms while unvaccinated controls exhibited typical varicella symptoms 10 to 14 days after the onset of the index cases. These results indicate that varicella is prevented in household contacts by vaccination within three days following exposure. The aim of the present study was to examine the efficacy of postexposure vaccination with Varilrix in the household setting. A randomized, double-blind, placebo-controlled design was used. Twenty-two children received the varicella vaccine and 20, a placebo. The relative risk of developing varicella with a placebo compared with the vaccine was 1.1 (95% confidence interval 0.55-2.21). The risk of developing moderate to severe disease was eight times greater in the placebo group (RR=8), indicating an 80% protective effect against moderate/severe disease. The varicella vaccine Varilrix may not be effective in preventing varicella when administered after household exposure, although it is highly effective in ameliorating the disease in those who acquire it under these circumstances.
These small trials suggest varicella vaccine administered within three days to children following household contact with a varicella case reduces infection rates and severity of cases. No RCTs for adolescents or adults were identified. However safety was not adequately addressed.