HIV/AIDS
Conditions
Sponsors
Centre for the AIDS Programme of Research in South Africa
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • 18 to 40 years of age • Female sex at birth • Able and willing to complete the informed consent process • Has understood the information provided, including the potential impact and/or risks linked to SC administration of the study product, and is willing to comply with protocol procedures, has accessibility to the clinical research site and is available for follow-up for the study duration • Based on clinical assessment must be in good general health as per opinion of the Principal Investigator (PI) or designee • Assessed by site staff to be at low risk for HIV • If of reproductive potential, has evidence of effective contraceptive use in the previous 21 days, and agrees to continued use during the study period • Willing to have blood and genital samples collected, stored, and used for research purposes
Exclusion criteria
Exclusion criteria: • clinically significant acute or chronic medical condition that in the opinion of PI or designee makes the participant unsuitable for participation in the study, or jeopardizes the safety or rights of the volunteer • If planning a pregnancy for the duration of the study, currently pregnant or breastfeeding • Exceeding the weight of 90 kilograms • 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 mAb or polyclonal immunoglobulin within 28 days prior to enrolment • Any history of anaphylaxis and related symptoms such as hives, respiratory difficulty and angioedema • Evidence of autoimmune disease, or receiving immunosuppressive therapy • Participants in this study may not take part in other concurrent research studies that would interfere with the objectives of this study. The determination of whether participation in another study would be exclusionary for a given participant will be made by the PI or designee.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with mild, moderate and severe reactogenicity events within the first 3 days after SC administration. ? Proportion of participants with mild, moderate and severe adverse events up to 24 weeks after the last SC administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximal concentration, time of maximal concentration, area under the concentration vs time curve and terminal half-life of VRC07-523LS and PGT121 mAbs. ? Proportion of participants who report that the SC injections are acceptable. ? Changes in humoral immune function (neutralizing and non-neutralizing antibody function) in the systemic and genital tract compartments before and after SC mAb administration. ? Changes in the concentration of serum anti- mAbs before and after SC mAb administration. | — |
Countries
South Africa
Contacts
Public ContactSharana Mahomed
Project Director
Outcome results
None listed