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Polly Clayden, HIV i-Base<\/strong><\/p>\n Preliminary results suggest that VRC01 – an investigational HIV neutralising monoclonal antibody – administered subcutaneously to neonates is safe and well tolerated. Its half-life would support monthly injections for those at risk of HIV through breastfeeding. These data from IMPAACT P1112 were presented at CROI 2017.<\/strong><\/p>\n IMPAACT P1112 is an ongoing, prospective, open label, dose escalating study of VRC01, given to infants at increased risk of HIV transmission as a single 20 or 40 mg\/kg subcutaneous dose within 72 hours of birth. Study sites are in US, Puerto Rico, and South Africa.<\/p>\n Increased risk of infant HIV infection is defined as one or more of the following maternal risk factors: no antiretrovirals (ARV) in pregnancy; began or restarted ARV in third trimester; detectable viral load; prolonged ruptured membranes; two class ARV resistance.<\/p>\n Eligible infants were 36 weeks of gestation or more weighing at least 2 kg at birth. All infants received ARV prophylaxis according to local standard of care. After VRC01 immunisation they received safety assessments for 4 hours followed by safety and pharmacokinetic (PK) measurements at 24 hours, days 3, 7, 14, 28, weeks 8, 16 and 24. Target VRC01 level is 50 mcg\/mL on day 28.<\/p>\n The study enrolled 27 infants: 52% male, 61% black, median age 2 days and birth weight 3105 grams. One infant in the 20 mg\/kg group was incorrectly enrolled and one in the 40 mg\/kg group was under dosed and excluded from the PK analysis.<\/p>\n VCR01 was well tolerated with no grade 3 and above systemic adverse events. Local injection site reactions were common, occurring in 6 and 11 infants in the 20 mg\/kg and 40 mg\/kg groups respectively. These resolved in four hours for 100% and 55% of infants in the respective dosing groups. The PK results are shown in Table 1.<\/p>\n These preliminary results showed persistent levels of VRC01 through day 28 of life. The 40 mg\/kg dose achieved the target level at day 28 compared with adults receiving 20 mg\/kg intravenously.<\/p>\n The investigators suggest that the half-life of VRC01 supports monthly injections for infants at ongoing risk of vertical transmission of HIV through breastfeeding.<\/p>\n Despite the massive success in preventing vertical transmission of HIV with ARVs, children still become infected for a number of reasons. <\/strong><\/p>\n A long acting monoclonal antibody might further prevent transmission during breastfeeding.<\/strong><\/p>\n Reference<\/p>\n\n
\n VRC01<\/th>\n Dose<\/th>\n Mean<\/th>\n SD<\/th>\n Median<\/th>\n Range<\/th>\n<\/tr>\n \n Cday28 (mcg\/mL)<\/td>\n 20 mg\/kg<\/td>\n 39.33<\/td>\n 14.94<\/td>\n 39.19<\/td>\n 16.71 to 76.56<\/td>\n<\/tr>\n \n 40 mg\/kg<\/td>\n 75.22<\/td>\n 21.38<\/td>\n 74.79<\/td>\n 47.61 to 122.59<\/td>\n<\/tr>\n \n Cmax (mcg\/mL)<\/td>\n 20 mg\/kg<\/td>\n 226.64<\/td>\n 30.78<\/td>\n 233.32<\/td>\n 153.63 to 260.64<\/td>\n<\/tr>\n \n 40 mg\/kg<\/td>\n 378.37<\/td>\n 79.20<\/td>\n 390.27<\/td>\n 247.44 to 536.60<\/td>\n<\/tr>\n \n Tmax (d)<\/td>\n 20 mg\/kg<\/td>\n 2.7<\/td>\n 2.2<\/td>\n 2<\/td>\n 1 to 7<\/td>\n<\/tr>\n \n 40 mg\/kg<\/td>\n 1.4<\/td>\n 0.8<\/td>\n 1<\/td>\n 1 to 3<\/td>\n<\/tr>\n \n Half-life (d)<\/td>\n 20 mg\/kg<\/td>\n 19.73<\/td>\n 4.99<\/td>\n 20.17<\/td>\n 13.11 to 28.60<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Comment<\/h3>\n