This study will evaluate the safety and immune response in healthy HIV-exposed and uninfected infants to the protein vaccine, CH505TF gp120, adjuvanted with GLA-SE.~This study will enroll 38 mother-infant pairs. To quantify the maternal HIV antibody response, mothers will also be enrolled in the study but will not receive study product. Infants will receive the CH505TF gp120 protein adjuvanted with GLA-SE at Weeks 0, 8, 16, 32, and 54. The first dose will be given within the first five days of life.~The study will be conducted in three parts (Parts A, B, and C), and to ensure safety, enrollment will proceed in stages.~Part A (Initial Safety) will enroll first. 5 infants in Part A will receive a low dose of protein with a low dose of adjuvant and 2 infants will receive placebo.~After safety review post first vaccination of infants in Part A, Part B will enroll. In Part B (Safety Ramp-Up), 2 infants will receive a higher dose of protein with a higher dose of adjuvant and 2 infants will receive placebo.~After safety review post first vaccination of infants in Part B, Part C will enroll. In Part C (Immunogenicity), 5 infants will receive low dose protein with higher dose of adjuvant, 16 infants will receive a higher dose of protein with higher dose of adjuvant, and 6 infants will receive placebo.~There are 14 scheduled clinic visits over 24.5 months. For infants, study visits may include physical examinations, medical history, vaccine injections, HIV testing, and blood, cord blood, and stool collection. For mothers, study visits may include medical history, physical examinations, questionnaires, risk reduction counseling, and blood, breastmilk, and stool collection.
This study will evaluate the safety and immune response in healthy HIV-exposed and uninfected infants to the protein vaccine, CH505TF gp120, adjuvanted with GLA-SE.