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38 | FACILITATING RESEARCH
Clinical approach
Hybrid vigour
A clinical trial facility in Kenya has hosted
groundbreaking work on a malaria vaccine.
Accurate information helped to
ensure a mature debate about
mixed-species embryos.
1
One of the factors holding back
medical research in Africa is a dearth
of centres and staff able to carry out
clinical trials. A facility established at
the KEMRI–Wellcome Trust Research
Programme at Kilifi, Kenya, has not
only hosted a highly successful
clinical trial of the world’s leading
malaria vaccine but is also providing
a base to test locally important
interventions and develop a skilled
local workforce.
Malaria kills around a million people a
year, most of them young children in
sub-Saharan Africa. Progress towards
an effective vaccine has been painfully
slow, but there are encouraging signs
that some have a significant (albeit not
complete) protective effect.
Of these, the RTS,S vaccine developed
by GlaxoSmithKline is the most
promising, typically achieving protection
rates of about 30 per cent. Even more
positively, a phase II trial, organised by
the Malaria Vaccine Initiative and run in
Kilifi and a second site in Tanzania,
upped this figure to 53 per cent, thanks
to a new immune-boosting adjuvant.
These exciting findings have justified a
much larger phase III trial involving
15 000 children across several sites in
Africa, including Kilifi and the Trustfunded
facilities in Malawi.
The Kilifi facility occupies a building
funded by the Trust and the Malaria
Clinical Trials Alliance, and complements
the main laboratory and administrative
block funded by the Trust. Kilifi now has
all the facilities needed to run major
international trials, and has trained local
staff to design and run their own studies
to equally high standards. Moreover, by
concentrating the physical infrastructure
and specialist support staff, the facility
can offer a high-quality environment for
all kinds of intervention – vaccine, drug
trials or other clinical studies.
Thus, as well as globally important trials,
the facility also hosts studies addressing
local public health questions. For
example, Jay Berkley has begun a
Trust-funded trial of prophylactic
antibiotic use in malnourished children.
After being discharged from hospital,
such children often die when they return
home. Dr Berkley is testing whether a
year’s use of antibiotics after discharge
can protect vulnerable children during
this critical period.
Bejon P et al. Efficacy of RTS,S/AS01E: clinical malaria
in 5 to 17 month old children. N Engl J Med
2008;359:2512–32.
Abdulla S et al. Safety and immunogenicity of RTS,
S/AS02D malaria vaccine in infants. N Engl J Med
2008;359:2533–44.
The Malaria Vaccine Initiative is funded by the
Bill and Melinda Gates Foundation and operated
by the not-for-profit organisation PATH.
In 2007, the Government introduced
draft legislation to update the 1990
Human Fertilisation and Embryology
Act. Perhaps the most contentious
change was a provision to allow the
creation of human–animal hybrid
embryos – seen by scientists as vital
in embryonic stem cell research but
of ethical concern to some groups. To
encourage informed discussion about
a potentially highly emotive subject,
the Wellcome Trust organised a range
of briefings and other activities to
communicate the scientific, medical
and ethical context of the new Act.
The UK has a well-established regulatory
framework for research on human
embryos, rooted in the 1990 Human
Fertilisation and Embryology Act. The
new legislation was designed to take
account of the rapid pace of change
since 1990, including the use of human–
animal hybrid embryos, a potential
source of human embryonic stem cells.
Although of great medical potential,
research on such cells is held back by a
lack of human material. To overcome this
difficulty, human DNA can be inserted
into non-human eggs and early-stage
embryos grown to the point at which
embryonic stem cells can be isolated.
To promote a reasoned debate, the Trust
developed briefing material on the key
issues for members of the House of
Images
1 Staff at the Clinical Trial Facility in Kilifi.
2 An early human embryo.