Age 18–45 years. Born female. Able and willing to complete the informed consent process. Able to understand the information provided about the study, willing to comply with protocol procedures and available to attend the study site for the duration of the study. Based on clinical assessment, participants must be in good general health as per opinion of the Principal Investigator (PI) or designee. Haemoglobin >10 g/dL. Neutrophil count within institutional normal range. Platelets within institutional normal range. Creatinine <1.1 times upper limit of normal. Alanine aminotransferase <1.25 times upper limit of normal. HIV negative as per FDA-approved method of detection (for groups with HIV-negative participants only). Negative pregnancy test. If of reproductive potential, there is evidence of effective contraceptive use and willingness to adhere to effective contraceptive use during the study period. Willing to have blood samples collected, stored and used for research purposes. Willing to adhere to reduced risk sexual behaviour during study participation.
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Any clinically significant acute or chronic medical condition that in the opinion of the PI/designee makes the participant unsuitable for participation in the study or jeopardises the safety or rights of the participant. Any history of anaphylaxis and related symptoms such as hives, respiratory difficulty or angioedema. Evidence of autoimmune disease or currently receiving immunosuppressive therapy. If planning a pregnancy for the duration of the study, currently pregnant or breastfeeding. Exceeding 95 kg in body weight (due to limitations related to SC antibody administration). A history of alcohol or substance use judged by the PI to potentially interfere with participant study compliance. Prior participation in an investigational HIV vaccine trial, except if proof of allocation to the placebo arm is available. Administration of a monoclonal antibody or polyclonal immunoglobulin within 28 days prior to enrolment. Involvement in other concurrent research studies that would interfere with the objectives of this study.
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Confirmed HIV-1 infection prior to enrolment. An HIV viral load of >1000 copies/mL at screening. A CD4 count of ≥450 cells/µL at screening. ART naive, and willing to defer treatment (after appropriate counselling) for up to a maximum of 8 weeks after product administration. No major comorbidities or AIDS-defining illness.
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