Experimental HIV Vaccine for Infants

Fewer American babies are becoming infected with HIV from maternal-fetal transmission; yet, children in developing countries are still at high risk of becoming infected from their mothers.

Sufficient prenatal care and the necessity of breastfeeding as the primary source of food for a newborn increase a child's risk of infection. Currently, there are vaccines in trial cto fight the infection for these children.

An infant vaccine against HIV is looked at as the most effective method of stopping the HIV epidemic in areas where educational campaigns are not working. A new study examined the tolerability and potential toxicities of two new HIV vaccines for children.

The randomized, placebo-controlled, multicenter, phase I study was conducted to determine the safety of the two vaccines. Participant infants were born to HIV-1 infected mothers and were enrolled prior to 72 hours of age. Infants were excluded if they were born at less than 37 weeks, received any investigational medicines, had significant medical illness, had any laboratory abnormalities, were breastfed, were born to mothers with hepatitis B, or if the infants received any HIV-specific immunotherapy.

The two vaccines are a recombinant glycoprotein 120-MN/alumninum hydroxide (VaxGen) and a recombinant glycoprotein 120-SF2/MF59 (Chiron). They were given at varying doses and compared with administration of the adjuvant alone.

The VaxGen vaccine is produced in cultured Chinese hamster ovary cells and the adjuvant is aluminum hydroxide with thimerosal in Tris-buffered aluminum. The Chiron vaccine is also produced in genetically engineered Chinese hamster ovary cells and its adjuvant (MF59) is 0.5% polysorbate 80, 0.5% sorbitan trioleate, and 0.5% squalene in a citrate buffer.

The vaccines--or the placebo adjuvant--were given at birth, four weeks, eight weeks and 20 weeks with the evaluation of any problems occurring in regular intervals throughout the study period and during a two year follow-up period. Both vaccines were found to be safe and well tolerated. The most frequent hematologic abnormality was a low absolute neutrophil count, which occurred more frequently in the adjuvant groups in black infants.

The infants also tolerated the use of MF59 (Chiron adjuvant), which before this study had not been documented.

There was no word how long it will take before the virus is tested for efficiency or how long it will take to be release in the market.

Information from www.hivandhepatitis.com