Uganda launches HIV vaccine trials for babies

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clinical trialsUganda has screened and vaccinated at least a quarter of the 50 babies needed for vaccine trial focused on prevention of HIV transmission from mother to child during breastfeeding.

The first baby in the vaccine trials was enrolled in October and by last week 14 of them had received either the vaccine or placebo saline solution (for control) while 16 have been screened to participate. 

The study is in its phase I, randomised double blind — where the researchers will not know which babies receive the vaccine or the placebo solution, while 40 babies will randomly receive the vaccine and 10 the placebo.

In this first phase of the trial, the researchers are testing whether the vaccine, formally known as Alvac-HIV, is safe for use in children, following which they will study whether it can stop mother-to-child transmission of the Aids-causing virus during breastfeeding.

Last week, Prof Francis Mmiro, the lead investigator, said the baby vaccine trial has been successful so far, adding that he hoped the vaccine will be added to the many given to babies at birth and thereafter like polio, tetanus, hepatitis B and measles.

Preliminary results are expected by mid 2007 in the-two -and a half-year study.

The Alvac-HIV vaccine is being given to children less than or equal to three days of age, who weigh at least 2kg, have normal blood levels and are born to HIV positive mothers. 

The babies enrolled are also not participating in other trials, have not received blood transfusions, do not have serious illnesses, and can be monitored for 24 months. Their families should, therefore, be living around Mulago referral hospital in Kampala.

The study primarily aims at evaluating the safety and immunogenicity of the vaccine in infants born to HIV-infected women.

If successful, the vaccine could prevent at least 25,000 infections in newborns in East Africa alone. The trial is being carried out by the Uganda in collaboration with US Aids researchers.

Many children, especially in the developing world, are infected by their HIV positive mothers who cannot afford to buy milk based formulas and are forced to breastfeed them.

In Uganda, at least 8,000 babies were infected last year. At least 22,000 infections are registered in children each year.

So far, 535 women have been referred to Makerere University John Hopkins Collaboration at Mulago Hospital.

via The East African / Nation Media