Received 5 October 2001; received in revised form 13 March 2002; accepted 29
August 2002
Abstract
In countries where routine varicella vaccination is implemented, it is
usually given at the same age as that recommended for measles-mumps-rubella
(MMR) vaccination. A combined multivalent measles-mumps-rubella-varicella (MMRV)
vaccine would offer the convenience of a single injection and facilitate
implementation of varicella vaccination into routine childhood immunisation
schedules. We evaluated the immunogenicity and reactogenicity of a tetravalent
MMRV candidate vaccine compared to an extemporaneous mix of a
measles-mumps-rubella vaccine and varicella vaccine (MMR/V), and to a
measles-mumps-rubella (MMR) vaccine alone. A multicentre study was conducted in
which a total of 240 healthy children aged 12 months (80 per group) were
randomised to receive MMRV, MMR/V, or MMR alone. Active surveillance for adverse
events was undertaken for 43 days post-vaccination. Blood samples were taken
prior to vaccination and at 60 days post-vaccination. There were no significant
differences between groups in rates of pain, redness, or swelling at the site of
vaccination. There was no significant difference in the rate of any fever (axillary
temperature 37.5°C) and
grade 3 fever (axillary temperature >39.0°C) between the groups receiving MMRV
and MMR during the 43-day follow-up period. Although, a significant increase was
found for fever of any cause with onset between days 0 and 14 for MMRV compared
to the MMR group, there was no significant difference in grade 3 fever rates
during the same period. With respect to immunogenicity, MMRV and MMR/V
demonstrated similar seroconversion rates to each component compared to MMR
alone, with at least 91.9% of subjects in all groups seroconverting to each
vaccine component 60 days after vaccination. Decreased GMTs for varicella
antibody at day 60 indicated that there may have been inhibition of this
response compared to MMR/V. This tetravalent MMRV candidate vaccine showed
promising results, although further examination of the possible increase in
minor fever and decreased varicella immunogenicity should be assessed in future
studies.
*Corresponding author. Present address:
Department of Public Health, The University of Melbourne, Vic., 3010, Australia.
Tel.: +61-3-8344-9351; fax: +61-3-8347-6929.
ALL INFORMATION, DATA, AND
MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH
YOUR HEALTH CARE PROVIDER.
37.5°C) and
grade 3 fever (axillary temperature >39.0°C) between the groups receiving MMRV
and MMR during the 43-day follow-up period. Although, a significant increase was
found for fever of any cause with onset between days 0 and 14 for MMRV compared
to the MMR group, there was no significant difference in grade 3 fever rates
during the same period. With respect to immunogenicity, MMRV and MMR/V
demonstrated similar seroconversion rates to each component compared to MMR
alone, with at least 91.9% of subjects in all groups seroconverting to each
vaccine component 60 days after vaccination. Decreased GMTs for varicella
antibody at day 60 indicated that there may have been inhibition of this
response compared to MMR/V. This tetravalent MMRV candidate vaccine showed
promising results, although further examination of the possible increase in
minor fever and decreased varicella immunogenicity should be assessed in future
studies.