People Living With HIVPhase 1RENEW-SHCSNCT07769983

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

A Phase 1 study testing The Patients will all receive a vaccination with a recombinant HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 vaccine, adjuvanted,. in people with People Living With HIV and Antibody Response, run by University of Zurich at 2 sites in Switzerland.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: People Living With HIV, Antibody Response
What is being tested?: The Patients will all receive a vaccination with a recombinant HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 vaccine, adjuvanted,.
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 2 sitesSwitzerland
Study dates: 25 Feb 2025to Mar 2028
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

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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
Must have a negative beta human chorionic gonadotropin (β-HCG) pregnancy test (urine or serum) on day 0 before IMP administration.
All participants born female who are engaging in sexual activity that could lead to pregnancy must commit to use of an effective method of contraception from 21 days before IMP administration to week 24 of the study.
Effective contraception includes condoms (male or female) with or without spermicide, diaphragm or cervical cap with spermicide, intrauterine device, hormonal contraception, including contraceptive implant or injectable, oral contraception, successful vasectomy in the male partner.
Participants born female do not have to use birth control if they are not engaging in sexual activity that could lead to pregnancy or are not of reproductive potential such as having undergone hysterectomy, bilateral oophorectomy, or tubal ligation, postmenopausal (amenorrhea for at least 1 year), surgically sterile.

Who cannot join

• 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.

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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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland2 sites

Inselspital Bern
Bern, Canton of Bern, 3010
University Hospital Zurich
Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

Official title: RENEW-SHCS: A Phase 1 Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Env Protein BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted, in ARV-treated Adults Living With HIV Enrolled in the SHCS and to Restimulate and Newly Prime Antibody Responses.

Read the detailed description

Vaccination of people with HIV (PWH) on suppressive antiretroviral therapy (ART) represents a novel approach for evaluating candidate broadly neutralizing antibody (bnAb) immunogens for preventive and therapeutic HIV vaccines. RENEW-SHCS is a phase I, open-label, non-randomized vaccination trial evaluating a single dose of the recombinant germline-targeting envelope trimer BG505 SOSIP.v4.1-GT1.1 (GT1.1), adjuvanted with 3M052-AF and Aluminum hydroxide (alum), in PWH on suppressive ART enrolled from the Swiss HIV Cohort Study. Participants were previously classified as bnAb or non-neutralizing antibody (nnAb) inducers, with a target enrollment of 15 per group, and are monitored for safety and immunogenicity for 24 weeks while continuing standard ART

Conditions: People Living With HIV, Antibody Response
Being tested: The Patients will all receive a vaccination with a recombinant HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 vaccine, adjuvanted,.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT07769983
Study group	Role	What they receive
Single vaccination with recombinant BG505 SOSIP.GT1.1 gp140 vaccine	Experimental	Not described Receives: Biological: The Patients will all receive a vaccination with a recombinant HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 vaccine, adjuvanted,.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
Measured: 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
Measured: 28 days
Safety - IMP related SAEs
Proportion of volunteers with IP-related serious adverse events (SAEs) throughout the study period
Measured: 168 days
Safety - pIMDs
Proportion of volunteers with potential immune-mediated diseases (pIMDs) from the day of IMP administration throughout the study period
Measured: 168 days

Secondary outcomes (2)

Immunogenicity - Frequency of Ab responses
Frequency IgG Env binding and neutralizing antibody boosting after vaccination with BG505 SOSIP.GT1.1 gp140 vaccine in PWH on ART, with and without bnAb activity compared to pre-immunization baseline.
Measured: From enrollment to the end of study observation at Day 168
Immunogenicity - Magnitude Ab responses
Magnitude of IgG Env binding and neutralizing antibody boosting after vaccination with BG505 SOSIP.GT1.1 gp140 vaccine in PWH on ART, with and without bnAb activity compared to pre-immunization baseline.
Measured: 168 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Feb 2025Mar 2028

First posted18 Aug 2026
Study start25 Feb 2025
Primary completionJan 2028 (estimated)
Study completionMar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for People Living With HIVStudies of the same condition, open and under way.
More trials run by University of ZurichThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07769983
Sponsor's protocol ID: SNCTP000006192 BASEC2024-01623
Acronym: RENEW-SHCS
Status last verified: Aug 2026
First submitted: 13 Jan 2025
Last updated: 11 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 30202088
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.
PubMed 37883985

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RENEW-SHCS: A Phase 1 Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Env Protein BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted, in ARV-treated Adults Living With HIV Enrolled in the SHCS and to Restimulate and Newly Prime Antibody Responses.
ClinicalTrials.gov ID: NCT07769983
Acronym / sponsor ID: RENEW-SHCS / SNCTP000006192 BASEC2024-01623
Conditions: People Living With HIV, Antibody Response
Phase: Phase 1
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 30 participants (estimated)
Lead sponsor: University of ZurichUniversity, hospital or other
Study start: 25 Feb 2025 (actual)
Primary completion: Jan 2028 (estimated)
Study completion: Mar 2028 (estimated)
First posted: 18 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 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.

Arm	Type	Receives
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,.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

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.]

Key exclusion criteria (11 listed)

• 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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The Patients will all receive a 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.	Biological	Single vaccination with recombinant BG505 SOSIP.GT1.1 gp140 vaccine

Primary outcome

Safety - reactogenicity
Time frame: 7 days
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).
Safety - IP related unsolicited adverse events
Time frame: 28 days
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
Safety - Grade 2 or greater unsolicited AEs
Time frame: 28 days
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
Safety - IMP related SAEs
Time frame: 168 days
Proportion of volunteers with IP-related serious adverse events (SAEs) throughout the study period
Safety - pIMDs
Time frame: 168 days
Proportion of volunteers with potential immune-mediated diseases (pIMDs) from the day of IMP administration throughout the study period

2 secondary outcomes

Immunogenicity - Frequency of Ab responses
Time frame: From enrollment to the end of study observation at Day 168
Immunogenicity - Magnitude Ab responses
Time frame: 168 days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Background: PubMed 30202088Kouyos 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.
Background: PubMed 37883985Trkola 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Huldrych Günthard, Prof. Dr. med. study director

University of Zurich, Universitiy Hospital Zurich

Alexandra Trkola, Prof. Dr. study chair

University of Zurich

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety - reactogenicity (time frame: 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07769983, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.