This is the first phase of a medical trial in which a new HIV vaccine is tested on people who are already HIV-positive and receiving antiretroviral therapy. This vaccine contains a special HIV protein called BG505 SOSIP.GT1.1 gp140. The study is being conducted in Switzerland and includes individuals who are already participating in the Swiss HIV Cohort Study.
Summary description of the study
The aim of the study is to verify the safety of the vaccine and to find out if it can stimulate the immune system to produce antibodies against HIV. In particular, the researchers want to find out if the vaccine can stimulate the immune system to enhance existing antibody responses against HIV and to produce new antibodies. This applies to both individuals who already have a strong antibody response against HIV and those who do not yet have antibodies against HIV.
(BASEC)
Intervention under investigation
Safety of the vaccine and observation of the immune response.
(BASEC)
Disease under investigation
HIV
(BASEC)
- Age ≥18 years at the time of consent - People with HIV, with confirmed HIV-1 infection - Participants of the SHCS, whose blood has been previously tested for antibodies (bnAb inducers or nnAb inducers) (BASEC)
Exclusion criteria
- Presence of another non-HIV related immunosuppression - Pregnant or breastfeeding women - Administration of an experimental vaccine that is not HIV within the last 6 months prior to the administration of the investigational drug (BASEC)
Trial sites
Bern, Zurich
(BASEC)
Sponsor
Prof. Dr. med. Huldrych Günthard
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Huldrych Günthard
+41 44 255 34 50
huldrych.guenthard@clutterusz.chUniversity Hospital Zurich
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
29.11.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
RENEW-SHCS: A Phase 1 open-label clinical trial to evaluate the safety and immunogenicity of recombinant HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 vaccine, adjuvanted, in antiretroviral-treated adults living with HIV enrolled in the Swiss HIV Cohort (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
not available
Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available