A baby born HIV negative can become infected with the virus through breastfeeding. But in most resource-limited settings, where water safety is an issue, where there is stigma over not breastfeeding and use of breastmilk substitutes is not affordable or sustainable, most HIV-infected women choose to breastfeed.
Paediatrician and HIV investigator Dr. Mary Glenn Fowler says in populations where breastfeeding up to two years is the norm, transmission through breastfeeding accounts for over a third of all infant HIV infections.
Breastfeeding, therefore, has been an area of serious study on how to keep babies free of the virus while leaving them with access to the benefits of breastmilk.
Such a study is beginning at Mulago Hospital, Kampala. Fowler, who is also the onsite Johns Hopkins University investigator, says the main purpose of the first small study of 50 infants born to HIV-infected mothers is to evaluate the safety and immunogenicity of the candidate vaccine known as ALVAC-HIV in infants born to HIV-infected women in Uganda.
The HIV Vaccine Safety Study will be the first step in trying to find ways to reduce the risk of HIV transmission from mothers to babies during the breastfeeding period. Recruitment of mothers who would like their babies to participate will begin soon.
In addition to looking at safety, the study will also see if the baby is able to make immune responses to the vaccine. If the trial is successful, the study will move to a bigger trial to determine if the study vaccine could protect the baby from becoming HIV infected during breastfeeding.
The phase I safety trial of the ALVAC vaccine in Uganda is being undertaken by Makerere University in collaboration with Johns Hopkins University, Baltimore-USA (MUJHU research collaboration). It is funded by the National Institutes of Health in the US.
HIV infected, but healthy women with high CD4 counts (above 500 cells/ml) who are attending the antenatal clinics at Mulago Hospital and volunteer to enroll their babies in the study will be screened to see if they and their newborns are eligible.
Healthy newborns to consenting eligible women will be enrolled into the safety trial over a three to six-month period and the babies will be followed up for 24 months.
Fowler says the ALVAC candidate vaccine has already been studied extensively for safety among several thousand adult volunteers in the US and Thailand and has an excellent overall safety profile. The vaccine contains no live virus, so there is no chance to get HIV from the injections. The ALVAC vaccine has also been given to 27 infants born to HIV-infected women in the US, where it was shown to be safe.
â€œWe feel very good about the safety of the ALVAC vaccine and are encouraged to go ahead and do a similar small safety study of the ALVAC vaccine here,â€ says Fowler.
HIV: Making breastmilk safe