Can a vaccine boost HIV immunity in people already on treatment?

NCT ID NCT07769983

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This phase 1 trial is testing whether an experimental HIV vaccine can safely stimulate the immune system to produce antibodies against HIV in people who are already living with the virus and taking antiretroviral therapy. The study involves 30 adults from the Swiss HIV Cohort Study, some of whom have previously shown the ability to produce broadly neutralizing antibodies. The goal is to see if the vaccine can boost or newly trigger these antibody responses, which might one day help the body control HIV without daily medication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental HIV-1 envelope protein vaccine (BG505 SOSIP.GT1.1 gp140) with adjuvant
What this could lead to
If successful, this could help people living with HIV generate stronger antibody responses, potentially reducing reliance on daily antiretroviral therapy or improving immune control of the virus.
What could go wrong
This is an early-phase trial with only 30 participants, so results may not apply broadly. The vaccine may not produce the desired antibody response, and side effects such as injection-site reactions or immune-related events are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \<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 * 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. 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. * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Inselspital Bern

    Bern, Canton of Bern, 3010, Switzerland

  • University Hospital Zurich

    Zurich, Canton of Zurich, 8091, Switzerland

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