Evaluating Safety and Immune Response to the HIV-1 CH505 Transmitted/Founder gp120 Adjuvanted With GLA-SE in Healthy, HIV-exposed Uninfected Infants

Infant Inclusion Criteria:

• Born via Caesarean section to an HIV-1-infected woman who meets all maternal inclusion/exclusion criteria listed below.
• Estimated gestational age at birth is at least 37 weeks.
• Weight at birth is at least 2.5 kg.
• Has initiated antiretroviral prophylaxis consistent with current site-specific standard of care.
• Hemoglobin >14.0 g/dL.
• White Blood Cell Count ≥ 7000 cells/mm3
• Platelets > 100,000 cells/mm3
• Alanine aminotransferase (ALT) 350 cells/microliter during her pregnancy.
• Mother has a documented SARS-CoV-2 negative PCR test within 2 days before delivery to 5 days after delivery
• Mother has access to the participating HVTN CRS and willingness to be followed for the planned duration of the study.
• Assessment of understanding: Mother demonstrates understanding of this study; completes a questionnaire prior to delivery with verbal demonstration of understanding of all questionnaire items answered incorrectly.
• Mother agrees not to enroll either herself or her infant in another research study for the duration of the trial without prior approval of the HVTN 135 PSRT.
• Mother has confirmed HIV-1 infection documented by medical records at any time during or prior to screening, and confirmed by the HVTN CRS by serology.
• Mother has been on cART for at least sixteen weeks prior to delivery and intends to continue with cART for the duration of breastfeeding.\
• Mother has a viral load of less than 400 copies/mL between two weeks before and 5 days after delivery.

Mother Exclusion Criteria:

• Any WHO Grade IV illness within one year prior to study enrollment as determined by the history and physical examination and review of the medical record (if available). These include HIV wasting syndrome, PJP Pneumonia, Cerebral Toxoplasmosis, extrapulmonary Cryptococcosis, Progressive Multifocal Leukoencephalopathy, any disseminated endemic mycosis (histoplasmosis), candidiasis of the esophagus, trachea, bronchi or lung, disseminated atypical mycobacteria, non-typhoid Salmonella septicemia, extrapulmonary tuberculosis, lymphoma, Kaposi's sarcoma.
• Prior participation in any HIV-1 vaccine or anti-HIV antibody-mediated prevention trial.
• Receipt of any investigational agent during this pregnancy.
• Receipt of blood products, immunoglobulin, or immunomodulating therapy within 45 days prior to delivery of the placenta.
• Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent.
• Any condition that places the newborn at higher risk of early-onset sepsis, such as concern for active maternal infection at delivery as determined by local site investigators (eg, fever).
• Detectable Hepatitis B surface antigen.