Objective: To assess the immunogenicity and reactogenicity of a new formula
tion of live attenuated varicella Vaccine (Oka strain) in non-immune househ
old contacts of children with cancer or leukaemia.
Methodology: This was an open study with one group. Healthy varicella-susce
ptible adults and children living in the same household as children with ca
ncer or leukaemia were vaccinated with a new live attenuated varicella Vacc
ine (Oka strain) which is stable when stored at 2-8 degrees C (refrigerator
temperature) for at least 24 months (Varilrix). Children less than 13 year
s of age received one dose (0.5 mL containing at least 10(3.3) plaque formi
ng units) by subcutaneous injection and those aged over 13 years received t
wo doses 8 weeks apart. Adverse reactions following vaccination were record
ed daily by the vaccinees. Post-vaccination antibody estimation was determi
ned using indirect immunofluorescence 6 weeks after vaccination.
Results: Thirty-five seronegative subjects (28 children and 7 adults and ad
olescents) were vaccinated. All subjects tested (34) had seroconverted afte
r vaccination. Local injection site reactions were experienced by 15/35. Ot
her adverse reactions were uncommon (rash 2/35, fever (greater than or equa
l to 37.5 degrees C) 3/35). No cases of clinical varicella occurred amongst
the high-risk household contacts of the vaccine.
Conclusion: This is the first study of this formulation of varicella Vaccin
e in household contacts of children with cancer or leukaemia. The Vaccine w
as found to be safe and immunogenic, but further follow-up is needed to doc
ument duration of immunity.