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NeisVac C- a new vaccination schema in infants
Eva-Maria Poellabauer,
Baxter BioScience, Clinical Development and Medical Affairs Vaccines, Vienna,
Austria
Serogroup C meningococcal disease is an
important cause of invasive bacterial infections in children and young adults
and is associated with significant morbidity and mortality. Conjugate vaccines
have proven to be safe and effective in clinical practise and confer the
advantage of long-term polysaccharide-specific immunity for even the youngest at-risk
population.
The new meningococcal C conjugate vaccine, NeisVac-CÔ
(Baxter), containing de-O-acetylated serogroup C meningococcal polysaccharide
conjugated to tetanus toxoid carrier protein, offers an alternative to the
currently available purified polysaccharide vaccines. The vaccine has been
extensively evaluated in a total of six completed clinical studies in children/adolescents
of all ages and adults. Among the more than 2.700 volunteers who received the
vaccine in clinical studies to date, NeisVac-CÔ was found to be well tolerated
and highly immunogenic, eliciting both specific and boostable immune responses.
Among infants aged two to four months, serum bactericidal
antibody (SBA) titers of 32 were achieved in 99% of the vaccinees after two
doses (GMT: 773; 95% CI: 609-982): and in 100% after three doses (GMT: 1062; 95%
CI: 856-1319), with a booster dose in the second year of life inducing an
anamnestic response. One administration of vaccine in toddlers aged 12 to 17
months resulted in an SBA GMT of 564 (95% CI: 406-783) for NeisVac-CÔ, 123 (95%
CI: 78-195) for MCC-CRM197 (Wyeth) and 141 (95%CI: 90-222) for MCC-CRM197 (Chiron).
Also, a single dose of NeisVac-CÔ was demonstrated to induce immunologic memory
in these toddlers. One administration of NeisVac-CÔ resulted in SBA GMT's of 32
in >98% of preschoolers aged 3.5 to 6 years, 100% of school leavers aged 13
to 17 years and 100% of adults. Furthermore based on an interim analysis from an
infant study (n=600) in the UK, the two dose regimen is as immunogenic as the
three dose regimen in this age group.
Following licensure, NeisVac-CÔ demonstrated excellent
efficacy and tolerability within the scope of a large-scale UK-vaccination
program (1.8 million children and adolescents. Systemic events were very rare
(<0.01%), local reactions were consistent with established vaccination
experience.
As of April 2002, NeisVac-CÔ is licensed for vaccination in
infants from 2 months of age (3 dose regimen), and in children, adolescents and
adults (single dose regimen) in 16 European countries, as well as in Canada and
Argentina.
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