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Enrolling By Invitation
NCT07769983
RENEW-SHCS: Safety and Immunogenicity of a Recombinant HIV Env Protein Vaccine in ARV-treated Adults Living With HIV in the SHCS
Conditions: People Living With HIV, Antibody Response
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 30
Sponsor: University of Zurich
Location: Inselspital Bern Bern Canton of Bern
Summary
A vaccine trial in which people with HIV-1 participating in the Swiss HIV Cohort Study will receive a HIV-specific vaccine to stimulate antibodies against HIV while continuing their standard antiretroviral therapy
Eligibility 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 the SHCS.
* SHCS participants with known bnAb inducer- and non-neutralizing Ab inducer (nnAb inducer) status. (Note: Information on bnAb/nnAb status is available through SHCS-linked research prior to recruitment and has been obtained from analysis of SHCS 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 \ 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.
* 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 (EUA) by the FDA, World Health Organization (WHO) emergency use listing (EUL), Swissmedic licensure, European Medicines Agency (EMA) licensure.
* 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
Source: ClinicalTrials.gov (NCT07769983). StuddyBuddy aggregates publicly available trial information.