British and Canadian researchers discovered a new type of
meningitis vaccine, which boosted the immunity of infants as young as six
months and could be a potential new weapon against the deadly disease.
The vaccine, produced by Swiss drugmaker Novartis AG was
well tolerated and generated high levels of immunogenicity in infants against
meningococcal serogroups A, C, W-135 and Y.
Meningistis caused by Neisseria meningitidis bacteria or
meningococcus is often deadly and frequently devastating. Between 1,400 and
2,800 people in the Unites States are struck by the disease each year. Up to 14
percent of these people die and up to one in five survivors suffer brain
damage, amputation and/or hearing loss.
The most exposed to this disease are infants younger than
one year, but disease incidence peaks again during the teen years.
Matthew Snape of Britain’s
University of Oxford
and colleagues studied the safety and effectiveness of the new vaccine, called MenACWY,
in 421 healthy infants in Britain
and Canada.
A previous vaccine currently licensed in the U.S. offered
poor protection for infants, Snape said.
"This vaccine offers the hope that the number of young
children experiencing this devastating illness can be dramatically
reduced," he added.
The new vaccine, also called Menveo was about 94 percent
effective when given in four doses, one at 2 months, 3 months, 4 months and 12
months, a dosing schedule that fits into standard vaccination programs in the
UK, Snape said. These infants developed antibodies to all four strains of meningitis.
Administered in three doses, one each at 2 months, 4 months
and 12 months, the standard vaccination program in the U.S., the
vaccine was 86 percent to 100 percent.
Unfortunately, the new vaccine does not protect against the
B serotype of meningococcal bacteria, which causes about a third of U.S. cases. There
is no vaccine, which can protect against meningococcus serotype B.
According to University
of Pittsburgh infectious
disease specialist Lee H. Harrison, MD, in an editorial accompanying Snape’s
study, the new vaccine represents a “major advance in the vaccine prevention of
meningococcal disease.”
The researchers noted that the study was too small to draw
firm conclusions on the safety of the vaccine. They also recommended further studies
to make sure the vaccine does not interact with pneumococcal glvcoconjugate
vaccine, which uses the same protein carrier.
The new vaccine will compete with Sanofi-Aventis SA’s
Menactra, a similar vaccine against meningitis, which has shown immune
responses in children aged 2-10. Menactra has been on the U.S. market since October when it was approved
by the U.S.
regulators.
GlaxoSmithKline PLC is also developing a vaccine against
four strains of meningitis that is currently in Phase II trials.
Novartis hopes to get regulatory approval in the European
Union and in the U.S.
this year for use in adolescents and in 2009 for use in infants. If approved,
peaks of Menveo are expected to hit $120 million a year, Karl Heinz Koch,
pharmaceutical analyst at private bank Vontobel in Zurich said.
The results of the study, funded by Novartis Vaccines and
Diagnostics, were published in the January 9/16 issue of the Journal of the
American Medical Association
