HIV/AIDS
Conditions
Interventions
Vaccine given intramuscularly
Sponsors
Centre for the AIDS Programme of Research in South Africa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ability and willingness to provide informed consent. • Age =18 years at time of consent • People with HIV (PWH) with confirmed HIV-1 infection as documented by medical records and enrolled in CAPRISA 002. • SHCS participants with known bnAb inducer- and non-neutralizing Ab inducer (nnAb inducer) status. (Note: Information on bnAb/nnAb status is available through CAPRISA 002-linked research prior to recruitment and has been obtained from analysis of CAPRISA 002 biobanked plasma samples from off-ART and/or on-ART timepoints. Based on this information participant will be classified into bnAb inducers and nnAb inducers.) • On suppressive ART with plasma HIV-1 RNA 250 cells/mm3 or CD4+ cell % = 15% at screening (- 90 days prior to IMP administration) • At screening: Absolute neutrophil count (ANC) = 750/mm3 • At screening: Platelets = 100,000/mm3 • At screening: Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) based on the institutional normal range • At screening: Haemoglobin (Hgb): o = 10.0 g/dL for volunteers who were assigned female sex at birth (AFAB) o = 11.0 g/dL for cisgender volunteers who were assigned male sex at birth (AMAB) and for transgender men who have been on hormone therapy for more than 6 consecutive months o = 11.0 g/dL for transgender women who have been on hormone therapy for more than 6 consecutive months o For transgender volunteers who have been on hormone therapy for less than 6 consecutive months, determine Hgb eligibility based on their sex assigned at birth. • Persons of pregnancy potential o Must have a negative beta human chorionic g
Exclusion criteria
Exclusion criteria: Presence of other, HIV-unrelated, immunosuppression considered as relevant by the site investigator (e.g. a daily steroid intake of =20mg for 3 months is considered clinically relevant) • Ongoing signs and symptoms of a febrile illness at the time of the vaccination (temperature > 37.5°, and e.g. flu-like or other symptoms of a febrile illness) • Reduced health status due to other illnesses, which would not allow to participate in this study. • Any clinically significant acute or chronic medical condition or other 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 • Participants currently taking immunosuppressive treatment (Note: in the case of oral steroids at a dose = 20mg prednisolone daily). • Volunteer who is pregnant or breast-feeding • Previous receipt of any anti-HIV monoclonal antibody or HIV vaccine. • Receipt of a non-HIV experimental vaccine(s) received within the last 6 months before IMP administration. Exceptions include vaccines that have subsequently undergone licensure or Emergency Use Authorization by SAHPRA • Receipt of any other vaccine within 28 days prior to IMP administration (D0) • Is currently participating in or has participated in a clinical study with an investigational compound or device from in the last 45 days prior to Day 0 and throughout the study treatment period. • History of serious reaction (e.g., hypersensitivity, anaphylaxis) to any vaccine or component of the IMP • Asplenia or functional asplenia • Site investigator concern for difficulty with venous access based on clinical history and physical examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of volunteers with Grade 2 or greater reactogenicity (i.e. solicited adverse events [AEs]) from Day 0 through Day 7 after IMP administration. •Proportion of volunteers with IMP-related unsolicited AEs, including safety laboratory (biochemical, haematological) parameters, from the day of IMP administration up to 28 days post IMP administration •Proportion of volunteers with Grade 2 or greater unsolicited AEs, including safety laboratory (biochemical, haematological) parameters, from the day of IMP administration up to 28 days post IMP administration •Proportion of volunteers with IMP-related serious adverse events (SAEs) throughout the study period •Proportion of volunteers in each group with potential immune-mediated diseases (pIMDs) from the day of IMP administration throughout the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome 1 includes: • Secondary outcome 1a: Response rate and magnitude of plasma antibody neutralization of autologous (HIV-1 BG505 wildtype and BG505.GT1.1) and other heterologous tier 1 and tier 2 HIV-1 strains as measured by the TZM-bl assay using the ART-Dex protocol before (1-2 pre-screening time points (optional), D=0) and after the immunization (weeks 1-24). Global comparison of pre- and post-immunization titres across all participants. • Secondary outcome 1b: Response rate and magnitude of plasma antibody neutralization of autologous (HIV-1 BG505 wildtype and BG505.GT1.1) and other heterologous tier 1 and tier 2 HIV-1 strains as measured by the TZM-bl assay using the ART-Dex protocol before (1-2 pre-screening time points (optional), D=0) and after the immunization (weeks 1-24). Comparison of pre- and post-immunization titres for bnAb inducers versus nnAb inducers. • Secondary outcome 1c: Response rate and magnitude of plasma IgG binding antibodies to BG505 SOSIP.664 gp140 and BG505 SOSIP.664. GT1.1 gp140 as measured by BAMA before (1-2 pre-screening time points (optional), D=0) and after the immunization (weeks 1-24). Global comparison of pre- and post-immunization titres across all participants. • Secondary outcome 1d: Response rate and magnitude of plasma IgG binding antibodies to BG505 SOSIP.664 gp140 and BG505 SOSIP.664. GT1.1 gp140 as measured by BAMA before (1-2 pre-screening time points (optional), D=0) and after the immunization (weeks 1-24). Comparison of pre- and post-immunization titres for bnAb inducers versus nnAb inducers The Secondary outcome 2 comprises the establishment of the study biobank of plasma and PBMC for Exploratory Objectives to be studied beyond completion of the clinical trial. Specimens will be stored at all collection time points: screening time point (optional), D=0, (weeks 1-24). | — |
Countries
South Africa
Contacts
Public ContactNirosha Gokul
Study coordinator
Outcome results
None listed