THE end to malaria infection is in
sight as the first malaria vaccine
candidate to reach phase-3 of
clinical testing, and found to
partially protect children against the
disease up to four years after
vaccination, is set to be available by
October this year, scientists have
reported.
Giving the hint about this
development yesterday, Brian
Greenwood, corresponding author
and Professor of Clinical Tropical
Medicine at London School of
Hygiene & Tropical Medicine in the
UK, explained that results of the
tests suggested that the vaccine
candidate known as RTS, S/AS01
could prevent a substantial number
of cases of clinical malaria, especially
in areas of high transmission.
Greenwood noted that the European
Medicines Agency, EMA, will “assess
the quality, safety, and efficacy of
the vaccine based on these final
data. There is currently no licensed
vaccine against malaria anywhere in
the world.”
If the EMA gives a favourable
opinion, the World Health
Organisation could recommend the
use of RTS,S/AS01 as early as
October this year. If licensed, RTS,S/
AS01 would be the first licensed
human vaccine against a parasitic
disease,” Greenwood added.
The findings, published in the
journal, The Lancet , revealed that
vaccine efficacy against clinical and
severe malaria was better in children
than in young infants, but waned
over time in both groups.
However, protection was prolonged
by a booster dose, increasing the
average number of cases prevented
in both children and young infants.
Further, Greenwood argued that
despite the falling efficacy over time,
there is still a clear benefit from
RTS,S/AS01.
“An average of 1,363 cases of clinical
malaria were prevented over four
years of follow-up for every 1,000
children vaccinated, and 1,774 cases
in those who also received a booster
shot. Over three years of follow-up,
an average 558 cases were averted
for every 1,000 infants vaccinated,
and 983 cases in those also given a
booster dose.
“Given that there were an estimated
198 million malaria cases in 2013,
this level of efficacy potentially
translates into millions of cases of
malaria in children being
prevented,” he said.
The RTS,S/AS01 vaccine was
developed for use in sub-Saharan
Africa where malaria still kills around
1,300 children every day. The
phase-3 randomised trial enrolled
15,459 young infants (aged six to 12
weeks at first vaccination) and
children (five to 17 months at first
vaccination) from 11 sites across
seven sub-Saharan African countries
(Burkina Faso, Gabon, Ghana, Kenya,
Malawi, Mozambique and United
Republic of Tanzania) with varying
levels of malaria transmission.
In 2014, initial phase-3 results at 18
months showed vaccine efficacy of
about 46 per cent against clinical
malaria in children and around 27
per cent among young infants.
In this study, members of the RTS, S/
AS01 Clinical Trials Partnership
followed up the infants and children
for a further 20 to 30 months,
respectively, and assessed the
impact of a fourth booster dose.
Participants were each vaccinated
three times with RTS,S/AS01 with or
without a booster dose 18 months
later, or given four doses of a
comparator vaccine (control group).
www.vanguardngr.com/2015/04/malaria-end-in-sight-as-who-sets-to-approve-1st-human-vaccine/

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