The purpose of this study is to evaluate the safety and immunogenicity of 426c.Mod.Core-C4b vaccine adjuvanted with 3M-052-AF + Alum in infants with perinatal HIV exposure who are without HIV at birth
Mother's age is at least 18 years and is willing and able to provide written informed consent for their and their infant's participation in this study
Mother is in the second or third trimester of singleton pregnancy, as determined by a clinical exam or sonography and reported menstrual history
Mother agrees to donate umbilical cord blood
Mother has a planned Caesarian delivery at Chris Hani Baragwanath Academic Hospital (Soweto) and plans to remain in the area after delivery and through study duration
Any World Health Organization (WHO) grade IV illness within 1 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; and 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 (Ig), or immunomodulating therapy within 45 days prior to, and the day of delivery
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Treatment groupsSee each treatment group below.
HIV Vaccine Trials Network
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Fred Hutchinson Cancer Center
Collaborator
Access to Advanced Health Institute
Collaborator