Subject: [pronut-hiv] Uganda: Country Begins Mother-to-Child Aids Vaccine Trials
Uganda: Country Begins Mother-to-Child Aids Vaccine Trials
The East African (Nairobi)
October 30, 2006
Dagi Kimani, Special Correspondent
Nairobi
Ugandan and American Aids researchers have begun the first ever
clinical trial of a vaccine to prevent mother-to-child transmission of
HIV through breast-feeding which, if successful, could prevent at least
25,000 infections in new-borns in East Africa alone.
In the first phase of the trials the researchers will be testing
whether the vaccine, formally known as ALVAC-HIV, is safe for use in
children, following which they will study whether it can stop the
transmission of the Aids virus to a suckling baby through breastmilk.
Preliminary results are expected in mid-2007.
According to the UNAids, breast-feeding by HIV-positive mothers
accounts for more than a third of all infections in new-borns,
translating to about 1,800 children each day around the world. In Uganda
alone, at least 8,000 of the country's 22,000 infections in children
each year occur as a result of breast-feeding.
The Ugandan study will initially involve 50 children born to
HIV-positive mothers, of whom 40 will randomly receive the test vaccine
and 10 will act as controls.
It will be conducted at the Mulago Hospital by researchers from
Makerere University and the John Hopkins University over a
two-and-a-half year period. Once enrolled, the subject infants will be
injected with the test vaccine, manufactured by Sanofi Pasteur, in four
separate doses over a period of three months.
Aids experts say that an effective vaccine to help prevent
mother-to-child transmission of HIV through breast-milk is the best
possible way to curb the problem, as healthy alternatives to
breast-feeding such as infant formulas are usually not available to most
mothers in poor countries. In most African setups, it is also not
practical to discourage breast-feeding for cultural reasons.
The ALVAC-HIV vaccine is one of at least five HIV vaccines under study
across the continent, all of which involve adults. Previous studies in
Uganda have shown it to be safe when administered to this group. The
largest trials involving the vaccine are being undertaken in Thailand,
where 16,000 volunteers are involved.
Elsewhere, Kenya's lakeside city of Kisumu has been selected to host a
study into a new microbicide to prevent the transmission of genital
herpes, an infection which afflicts more than 30 per cent of adults in
the region and which has been implicated in the transmission of HIV.
The microbicide, known as VivaGel (TM), will be tested concurrently in
Kisumu and at a site at the University of California, Los Angeles.
The trials will be funded by the US National Institute of Allergy and
Infectious Diseases, which is part of America's National Institutes of
Health.
At least 30 women aged between 18 and 24 years will be enrolled at each
site to help establish the safety of VivaGel TM when applied twice daily
for 14 days in healthy women.
Recruitment for study volunteers in Kisumu will start in the next two
weeks. Other studies on the microbicide are currently going on to
establish whether it can also protect against HIV infection.
VivaGel (TM) was developed by the American medical research company,
Starpharma Holdings Ltd. The company specialises in developing drugs
from new molecules known as dendrimers.
"This trial represents a key milestone in the development of VivaGel
(TM), supported by our clinical collaborators in the US and Kenya," Dr
Jackie Fairley, chief executive of Starpharma, said in a statement
announcing the Kisumu trials. "We consider prevention of genital herpes
to be a commercially important indication for VivaGel (TM)."
Genital herpes is among a slew of sexually transmitted diseases which
Aids experts say facilitate the transmission of HIV by creating sores
that act as doorways for the Aids virus during unprotected sex.
The disease is prevalent in both poor and rich countries, with between
15 and 25 per cent of adults in North America and Europe being infected
with the disease. In the United States alone, about 50 million people
are estimated to have the infection.
Together with HIV, the disease is responsible for the growing interest
among medical researchers in microbicides.
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