EHVA T01/ANRS VRI05 - A Phase I/II randomised therapeutic HIV vaccine trial in individuals who started antiretrovirals during primary or chronic infection

EHVA T01(European HIV Vaccine Alliance Therapeutic Trial 01)/ANRS VRI05: A Phase I/II randomised therapeutic HIV vaccine trial in individuals who started antiretrovirals during primary or chronic infection - EHVA T01(European HIV Vaccine Alliance Therapeutic Trial01)/ANRS VRI05

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003081-27-GB

Enrollment

192

Registered

2017-09-25

Start date

2018-02-19

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus (HIV) infection MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: GTU-MultiHIV B clade Pharmaceutical Form: Solution for injection Other descriptive name: MULTIHIV ANTIGEN Concentration unit: mg/ml millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. HIV-1-infected 2. Aged 18 – 65 years old on the day of screening 3. Weight >50kg 4. Written informed consent 5. Nadir CD4 count > 300 cells/mm3 6. CD4 count at screening > 600 cells/mm3 7. Viral load ,=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating 2.HIV-2 infection (either isolated or associated with HIV-1) 3.VL >200 copies/ml on 2 occasions in the 12 months prior to screening 4.Previous interruptions in cART 5.Previous virological failures defined by loss of virological suppression with the presence of resistant mutations 6.Haemoglobin (Hb= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours 27.Grade 2 or worse routine laboratory parameters. Hyperbilirubinaemia to be considered an exclusion criterion only when confirmed to be conjugated bilirubinaemia

Design outcomes

Primary

Measure	Time frame
Main Objective: We are testing therapeutic HIV vaccines with or without an antibody in people who are HIV positive on treatment. Therapeutic means that it might benefit people who are HIV positive. We want to find out if the active products help the immune system to control the virus (stop it multiplying). We are testing a combination of two vaccines. They are called GTU-MultiHIV B-clade DNA and MVA HIV-B. One vaccine aims to generate a response from your immune system and the second vaccine aims to boost these responses. This is called a “prime-boost regimen”. We are also testing a monoclonal antibody called vedolizumab which is given by an infusion. Monoclonal means that it is made by identical cells, all of them are clones of a cell of the immune system. Vedolizumab might reinforce the action of the immune system against HIV. It might reduce HIV replication and make the immune system control the HIV infection even when antiretroviral treatment is stopped. ; Secondary Objective: We want to find out which immune responses are most closely associated with controlling viral load. We also plan to undertake a comprehensive analysis of the relationships between a range of biomarkers (including immune responses) and virological control, independent of vaccination/mAb. ; Primary end point(s): Efficacy Time from treatment interruption (scheduled for 24 weeks after enrolment) to the earliest time of reaching ? Confirmation of HIV RNA = 10,000 copies/ml on a separate sample ? Resuming antiretroviral therapy for any reason over a period of 24 weeks Safety ? A clinical decision to discontinue the regimen for an adverse event that is considered related to product. ; Timepoint(s) of evaluation of this end point: The time	—

Measure

Time frame

Main Objective: We are testing therapeutic HIV vaccines with or without an antibody in people who are HIV positive on treatment. Therapeutic means that it might benefit people who are HIV positive. We want to find out if the active products help the immune system to control the virus (stop it multiplying). We are testing a combination of two vaccines. They are called GTU-MultiHIV B-clade DNA and MVA HIV-B. One vaccine aims to generate a response from your immune system and the second vaccine aims to boost these responses. This is called a “prime-boost regimen”. We are also testing a monoclonal antibody called vedolizumab which is given by an infusion. Monoclonal means that it is made by identical cells, all of them are clones of a cell of the immune system. Vedolizumab might reinforce the action of the immune system against HIV. It might reduce HIV replication and make the immune system control the HIV infection even when antiretroviral treatment is stopped. ; Secondary Objective: We want to find out which immune responses are most closely associated with controlling viral load. We also plan to undertake a comprehensive analysis of the relationships between a range of biomarkers (including immune responses) and virological control, independent of vaccination/mAb. ; Primary end point(s): Efficacy Time from treatment interruption (scheduled for 24 weeks after enrolment) to the earliest time of reaching ? Confirmation of HIV RNA = 10,000 copies/ml on a separate sample ? Resuming antiretroviral therapy for any reason over a period of 24 weeks Safety ? A clinical decision to discontinue the regimen for an adverse event that is considered related to product. ; Timepoint(s) of evaluation of this end point: The time

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Secondary

Measure	Time frame
Secondary end point(s): Secondary virological efficacy outcome measures: - Level of HIV total DNA - Cell Associated (CA) HIV RNA Quantification Secondary safety outcome measures: - Grade 3 and worse solicited clinical and laboratory adverse events - Any adverse event leading to interruption in the vaccine or vedolizumab schedule - Any event that results in resuming treatment during the ATI - Serious Adverse Events - Other clinical and laboratory adverse events - Time to VL suppression after restarting ART Secondary Immunological Outcomes: - Response rate, magnitude and polyfunctionality of vaccine induced CD4 and CD8 T-cell responses. ; Timepoint(s) of evaluation of this end point: Secondary virological outcomes will be assessed in all patients at week 24 and before cART is resumed and at Baseline if relevant. Depending on the results, secondary virological outcomes may be assessed at other time points. Adverse events will be assessed at all weeks (except weeks -6, 12+1day, 25, 27, 29, 30, 33 and 35). Secondary immunological outcomes will be assessed 2 weeks after the final immunisation at week 14. Depending on the results, secondary immunological outcomes may be assessed at other time points.	—

Measure

Time frame

Secondary end point(s): Secondary virological efficacy outcome measures: - Level of HIV total DNA - Cell Associated (CA) HIV RNA Quantification Secondary safety outcome measures: - Grade 3 and worse solicited clinical and laboratory adverse events - Any adverse event leading to interruption in the vaccine or vedolizumab schedule - Any event that results in resuming treatment during the ATI - Serious Adverse Events - Other clinical and laboratory adverse events - Time to VL suppression after restarting ART Secondary Immunological Outcomes: - Response rate, magnitude and polyfunctionality of vaccine induced CD4 and CD8 T-cell responses. ; Timepoint(s) of evaluation of this end point: Secondary virological outcomes will be assessed in all patients at week 24 and before cART is resumed and at Baseline if relevant. Depending on the results, secondary virological outcomes may be assessed at other time points. Adverse events will be assessed at all weeks (except weeks -6, 12+1day, 25, 27, 29, 30, 33 and 35). Secondary immunological outcomes will be assessed 2 weeks after the final immunisation at week 14. Depending on the results, secondary immunological outcomes may be assessed at other time points.

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Countries

France, Spain, Switzerland, United Kingdom

Contacts

Public ContactEHVA

MRC CTU at UCL

mrcctu.ehvat01tmt@ucl.ac.uk02076704783

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026