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A Phase II Trial to Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS in HIV- Negative Women

NCT07810062

CompletedPhase 2

Sponsor: Centre for Infectious Disease Research in Zambia

Conditions: To Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS Monoclonal Antibodies in HIV-negative Women

Interventions: Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LS

Countries: Zambia

A double blinded, Randomized, Placebo- controlled phase II trial to assess extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS in HIV- negative women

Eligibility overview

Sex: FEMALE

Age: 18 Years to 30 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 18 to 30 years of age Persons born Female (assigned female sex at birth) and identifying as female.Able and willing to complete the informed consent process
* Able to understand the information provided including the potential impact and/or risks linked to SC administration of the study product, willing to comply with protocol procedures, has access to the clinical research site and is available for follow-up for the study duration
* Based on clinical assessment, participant must be in good general health as per opinion of the Principal Investigator (PI) or designee
* Haemoglobin \> 10g/dl
* Creatinine ≤ 1.25 x ULN
* ALT \< 1.25 x ULN
* HIV negative
* Negative β-HCG (human chorionic gonadotropin) pregnancy test on day of enrolment
* If of reproductive potential, has evidence of effective contraceptive use and is willing to adhere to effective contraceptive use during the study period
* Sexually active in the last 3 months

Exclusion Criteria:

* Any significant acute or chronic medical condition, situation or circumstance 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
* If planning a pregnancy for the duration of the study, currently pregnant or breastfeeding
* 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.
* Receipt of any vaccines within 28 days prior to enrolment
* Administration of a monoclonal antibody or polyclonal immunoglobulin within 6 months prior to enrolment
* Investigational HIV-related products received within 6 months prior to enrolment
* Any history of anaphylaxis and related symptoms such as hives, respiratory difficulty, or angioedema
* Evidence of autoimmune disease or currently receiving immunosuppressive therapy
* Current participation in any other 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/designee

Locations (1)

Lusaka, Lusaka Province, Zambia