HIV/AIDS
Conditions
Interventions
ePGT121v1LS VRC07523LS
None
Sponsors
South African Medical Research Council
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part A: Eligibility criteria Inclusion criteria • 18-45 years of age • Able and willing to provide a signed informed consent form to participate in the study. • HIV-uninfected based on a negative rapid (point of care) test on screening • Negative pregnancy test on day of enrolment. • If of reproductive potential, has evidence of uninterrupted reliable contraceptive use in the previous 21 days, and is willing to adhere to effective contraceptive use for the duration of the study. Effective contraception is defined as one of the following methods: Condoms (internal and external) with or without a spermicide, Diaphragm or cervical cap with spermicide, Intrauterine device (IUD), Hormonal contraception, Tubal ligation, Be Sexually Abstinent. If not of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy or bilateral oophorectomy. • Agrees not to participate in other research studies involving drugs, medical devices, or vaginal products for the duration of the study. • Based on clinical assessment (medical history, physical examination, screening laboratory tests) must be in good general health as per opinion of the Principal Investigator (PI) or designee, and able to adhere to study follow-up visits. Screening laboratory parameters • Haemoglobin > 10 g/dL • White blood cell (WBC) count = 2,500 to 12,000 cells/mm3 • WBC differential either within institutional normal range or site clinicians' approval • Platelets = 125,000 to 550,000 cells/mm3 • Alanine aminotransferase (ALT) < 1.25 times the institutional upper limit of normal (ULN) (ie, < 1.25 times the reference range upper limit) and creatinine < 1.1 times the institutional ULN (ie, < 1.1 times the reference range upper limit) • C-reactive protein < 10 mg/dL • Negative HIV-1 test rapid test result on screening; • Negative Hepatitis B surface antigen (HBsAg) • Negative anti-Hepatitis C virus antibodies (anti-HCV) or negative HCV polymerase chain Part B: Eligibility criteria 4.4.1 Inclusion criteria 4.4.1.1 Mother • Greater than or equal to 18 years of age • Documented HIV-1 infection • Breastfeeding at the time of consenting or willing to initiate breastfeeding in the immediate postpartum period. • Able and willing to provide a signed informed consent form to participate in the study for herself and her infant. 4.4.1.2 Newborn • Infant with a birth weight greater than or equal to 2.0 kg and lower than or equal to 4.5 kg • Gestational age greater or equal to 34 weeks, assessed using New Ballard Score
Exclusion criteria
Exclusion criteria: Part A: Eligibility criteria Exclusion criteria • Weight 100kg • Current or planned pregnancy during the study period, including any infertility treatment during the study period. • Breastfeeding or planned breastfeeding during the study period • Current or planned participation in any other research studies that would interfere with the objectives of this study e.g. planned or current participation in an HIV bNAb, vaccine or antiretroviral study, as decided by the PI/designee. • History of severe adverse (including allergic) reaction associated with a bNAb or any product contained within / component of the bNAb. • History of venous or arterial thrombosis or thrombocytopaenia • Receipt of blood product, HIV-vaccine, HIV or any other bNAb, within 120 days of planned study product administration. • 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. This includes any short or long-term infectious disease, uncontrolled chronic disease, psychiatric condition, skin disease or skin / joint conditions that flare up with autoimmune activation, history or family history of psoriasis. • Past or current autoimmune disease, (except for mild, stable and uncomplicated autoimmune disease that does not require immunosuppressive medication and that, in the judgment of the investigator, is likely not subject to exacerbation and likely not to complicate solicited and unsolicited AE assessments). • History of innate or acquired immunodeficiency • Clinically significant medical conditions or abnormal laboratory results or past medical history with clinically significant implications for current health. • Reported current Tuberculosis before the full treatment period has passed. • History of asthma, diabetes mellitus type 1 or type 2, elevated blood pressure (= 150 mm Hg at History of asthma, diabetes mellitus type 1 or type 2, elevated blood pressure (= 150 mm Hg at enrollment or diastolic blood pressure = 100 mm Hg at enrolment). • Bleeding disorder diagnosed by a clinician (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions). • History of malignancy or under investigation for a malignancy. • History of seizures or seizure disorder or on treatment for seizures. • Presence of asplenia. • Any contraindication to receipt of injections or infusions or blood draws, including inability to establish venous access for IV arm. • Evidence of residual inflammation for which signs or symptoms could be confused with reactions to the study product. Part B: Exclusion criteria Mother • Prior participation in any HIV-1 vaccine trial • Concurrent receipt of any other active or passive HIV immunotherapy or investigational product (IP) • Documented or suspected serious medical illness with fetal compromise or immediate life- threatening condition (other than HIV-infection as judged by the examining clinician) • Unable or not willing to breastfeed • Active tuberculosis • Plan to relocate in 1 year • Mother does not have her own cell phone • Mother not able to provide two alternate contact phone numbers Newborn • HIV-infected on birth PCR • Receipt of or anticipated need for blood product, immunoglobulin or immunosuppressive therapy. This includes infants who require hepatitis B immunoglobulins (HB
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adults Safety – reactogenicity, and adverse events that are possibly, probably or definitely related to study product ;Infants Safety – reactogenicity, and adverse events that are possibly, probably or definitely related to study product | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety – reactogenicity, and adverse events that are possibly, probably or definitely related to study product;Concentration, Cmax, half-life of bNAbs in adult and infant participants throughout the follow-up peri | — |
Countries
South Africa
Contacts
Public ContactTrisha Ramraj
Senior Scientist
Outcome results
None listed