RENEW-SHCS: Safety and Immunogenicity of a Recombinant HIV Env Protein Vaccine in ARV-treated Adults Living With HIV in the SHCS

NCT07769983 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: SNCTP000006192 BASEC2024-01623
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

People Living With HIV; Antibody Response

Outcome Measures

Primary Outcomes (5)

• Safety - reactogenicity

  Proportion of volunteers with Grade 2 or greater reactogenicity (i.e., solicited adverse events) from Day 0 through Day 7 after administration of investigational medical product (IMP).

  7 days

• Safety - IP related unsolicited adverse events

  Proportion of volunteers with IP-related unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, from the day of IMP administration up to 28 days post administration

  28 days

• Safety - Grade 2 or greater unsolicited AEs

  Proportion of volunteers with Grade 2 or greater unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, from the day of each IP administration up to 28 days post each IP administration

  28 days

• Safety - IMP related SAEs

  Proportion of volunteers with IP-related serious adverse events (SAEs) throughout the study period

  168 days

• Safety - pIMDs

  Proportion of volunteers with potential immune-mediated diseases (pIMDs) from the day of IMP administration throughout the study period

  168 days

Secondary Outcomes (2)

• Immunogenicity - Frequency of Ab responses

  From enrollment to the end of study observation at Day 168

• Immunogenicity - Magnitude Ab responses

  168 days

Study Arms (1)

Single vaccination with recombinant BG505 SOSIP.GT1.1 gp140 vaccine

EXPERIMENTAL

Biological: The Patients will all receive a vaccination with a recombinant HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 vaccine, adjuvanted,.

Interventions

The Patients will all receive a vaccination with a recombinant HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 vaccine, adjuvanted,. BIOLOGICAL

The vaccination with the HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 will be administered on Day 0 in selected PLWH with and without prior broadly neutralizing HIV-1 antibody activity.

Single vaccination with recombinant BG505 SOSIP.GT1.1 gp140 vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<50 copies/ml for at least 1 year prior to screening. \[Note: Intermittent blips (HIV-1 RNA between 50-200 copies) documented in prior years on ART are allowed but viral load at screening must be \<50 copies. No switch to a novel ART regimen allowed 1 month before IMP administration. Switching from TDF to TAF and vice versa is not considered as switch to a novel regimen.\]
• CD4+ cell count \> 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):
• ≥ 10.0 g/dL for volunteers who were assigned female sex at birth (AFAB)
• ≥ 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
• ≥ 11.0 g/dL for transgender women who have been on hormone therapy for more than 6 consecutive months
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (2)

Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

• Kouyos RD, Rusert P, Kadelka C, Huber M, Marzel A, Ebner H, Schanz M, Liechti T, Friedrich N, Braun DL, Scherrer AU, Weber J, Uhr T, Baumann NS, Leemann C, Kuster H, Chave JP, Cavassini M, Bernasconi E, Hoffmann M, Calmy A, Battegay M, Rauch A, Yerly S, Aubert V, Klimkait T, Boni J, Metzner KJ, Gunthard HF, Trkola A; Swiss HIV Cohort Study. Tracing HIV-1 strains that imprint broadly neutralizing antibody responses. Nature. 2018 Sep;561(7723):406-410. doi: 10.1038/s41586-018-0517-0. Epub 2018 Sep 10.

  PMID: 30202088 BACKGROUND

• Trkola A, Moore PL. Vaccinating people living with HIV: a fast track to preventive and therapeutic HIV vaccines. Lancet Infect Dis. 2024 Apr;24(4):e252-e255. doi: 10.1016/S1473-3099(23)00481-4. Epub 2023 Oct 23.

  PMID: 37883985 BACKGROUND

Study Officials

• Huldrych Günthard, Prof. Dr. med.

  University of Zurich, Universitiy Hospital Zurich

  STUDY DIRECTOR

• Alexandra Trkola, Prof. Dr.

  University of Zurich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive a single vaccination with a recombinant HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 vaccine, adjuvanted. The vaccination with the HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 will be administered on Day 0 in selected PLWH with and without prior broadly neutralizing HIV-1 antibody activity.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: August 18, 2026
• Study Start: February 25, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 11, 2026

Record last verified: 2026-08

Locations

CH (2)