NHP PILOT STUDY OF A NOVEL PROTEIN ADJUVANT FOR VACCINES AGAINST HUMAN PATHOGENS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. An animal request was submitted to the TRAC committee on 1/15/10 for six adult female Rhesus macaques. The animals will be assigned to one of four groups as defined in the table below. All animals will be immunized subcutaneously with 50 ug purified rRBD (receptor binding domain) immunogen plus a control or test adjuvant (also listed in the table below). PBS will serve as a negative control (i.e. no adjuvant). CpG-C ISS-ODN is a commonly used adjuvant and will be used to compare the immunogenicity and safety of the test adjuvant (rOv-ASP-1). We anticipate, based on preliminary results seen in mice, that the test adjuvant, rOv-ASP-1, will provide immune responses that are equal to or superior to the CpG. Immunizations will be given on Days 0, 28, 56, 168 and 336. Blood samples will be collected prior to and one week after each immunization to measure antibody and cytokine responses. Physical exams, CBC and chemistries (including liver panels) will be performed to monitor the health of the animals and to detect any adverse reactions to the immunizations. Group Designation # of animals assigned to group Immunization given Group 1 1 50 ug rRBD + PBS (no adjuvant) Group 2 2 50 ug rRBD + 50 ug rOv-ASP-1 Group 3 2 50 ug rRBD + 100 ug rOv-ASP-1 Group 4 1 50 ug rRBD + 250 ug CpG-C ISS-ODN