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HIV InfectionPhase 1/2VRI01NCT02038842

Immunogenicity and Safety of 4 Prime-boost Combinations of HIV Vaccine Candidates in Healthy Volunteers

A Phase 1/2 study testing LIPO-5, MVA HIV-B (MVATG17401) and GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots in people with HIV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The development of a safe and effective HIV-1 vaccine strategy would probably be the best solution for the ultimate control of the worldwide AIDS pandemic. Heterologous prime-boost immunisations are today considered promising HIV prophylactic vaccine strategies. Read more about this study

Who is it for?
Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infection
What is being tested?
LIPO-5, MVA HIV-B (MVATG17401) and GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteFrance
Study dates
Mar 2014to Mar 2016
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Written and signed informed consent
  • Subject at low risk to contract HIV i.e.
  • no history of injecting drug use in the previous ten years;
  • no gonorrhea or syphilis in the last six months;
  • no high risk partner (e.g. injecting drug user, HIV positive partner) either currently or within the past six months ;
  • no unprotected anal intercourse in the last six months, outside a relationship with a regular partner known/presumed to be HIV negative ;
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  • no unprotected vaginal intercourse in the last six months outside a relationship with a regular known/presumed HIV negative partner
  • Available for follow-up for the duration of the study (56 weeks from screening)
  • Willing to undergo a HIV test
  • Willing to undergo a genital infection screen
  • If heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; contraceptive implant/patch; IntraUterine Contraceptive Device (IUCD); consistent record with condoms if using these; physiological or anatomical sterility in self or partner) from 14 days prior to the first vaccination until 4 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination
  • If heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination
  • Subject registered in French Health ministry computerised file and authorised to participate in a clinical trial
  • Subject covered by Health Insurance

Who cannot join

  • Clinically relevant abnormality on history or examination including history of:
  • uncontrolled infection;
  • autoimmune disease;
  • immunodeficiency or use of immunosuppressive drugs within 3 months prior to screening;
  • cancer;
  • chronic diseases requiring long-term treatment whose interruption during the trial has no impact on the health status in the short or long-term
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  • Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days prior to W0
  • Planned receipt of other vaccines than those planned by the protocol and those recommended in France (excluding live attenuated vaccines) during the trial follow-up (reference : Weekly Epidemiological Newsletter 14-15 dated on April 10th, 2012 (Bulletin Epidémiologique hebdomadaire 14-15 / 10 avril 2012))
  • Receipt of blood products or immunoglobin within 4 months prior to screening
  • History of severe local or general reaction to vaccination defined as
  • local: extensive, indurated redness and swelling involving most of the antero-lateral thigh or the major circumference of the arm, not resolving within 72 hours
  • general: fever ≥ 39.5°C within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
  • Positive for ANA antibodies at a titer considered clinically significant: titer ≥ local cut-off associated with positive anti-native DNA and extractable nuclear antigen antibodies
  • HIV-1 or HIV-2 positive or indeterminate at screening
  • Woman expecting to conceive during the study period
  • Pregnant or breastfeeding woman
  • Symptoms, physical signs or laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, which could interfere with the interpretation of the trial results or compromise the health of the volunteers
  • Clinically significant grade 1 routine laboratory parameters
  • Grade 2 or above routine laboratory parameters
  • Known hypersensitivity to aminoglycosides and eggs (as used in the vaccine production processes)
  • Known hypersensitivity to one of the trial vaccine components, the metabolites or formulation excipients
  • Anticipated non-compliance with the protocol
  • Participation in another clinical trial with an on-going exclusion period at screening
  • Participation in a HIV preventive vaccine clinical trial (unless participant were randomized in placebo arm)
  • Subject under legal guardianship or incapacitation
  • Subject who is an active blood donor and unwilling to interrupt blood donations during the his/her participation in the trial

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service d'Immunologie Clinique 51, avenue du Marechal de Lattre de Tassigny

    Créteil, 94010

Other trials in France

About this study

Official title: Phase I/II Open-label Randomized Multicenter Trial to Assess Immunogenicity and Safety of 4 Prime-boost Combinations of HIV Vaccine Candidates (MVA HIV-B/LIPO-5; LIPO-5/MVA HIV-B; GTU®-MultiHIV B/LIPO-5; GTU®-MultiHIV B/MVA HIV-B) in Healthy Volunteers at Low Risk of HIV Infection

The development of a safe and effective HIV-1 vaccine strategy would probably be the best solution for the ultimate control of the worldwide AIDS pandemic. Heterologous prime-boost immunisations are today considered promising HIV prophylactic vaccine strategies. It is thus relevant to pursue the development of different candidate vaccines in prime-boost vaccine strategies to identify the most promising prime-boost combinations and to integrate scientific inquiry into trial protocols from the beginning to maximize learning opportunities.

Read the detailed description

Phase I/II, multicenter, national, open-label, randomized trial HIV including 4 prophylactic prime-boost HIV vaccines strategies:

Volunteers are randomly allocated in a 1:1:1:1 ratio at trial entry to 4 parallel arms with the following prime-boost strategies:

Arm 1. MVA HIV-B primes at Week 0 and Week 8 + LIPO-5 boosts at Week 20 and Week 28 Arm 2. LIPO-5 primes at Week 0 and Week 8 + MVA HIV-B boosts at Week 20 and Week 28 Arm 3. GTU-MultiHIV B primes at Week 0, Week 4 and Week 12 + LIPO-5 boosts at Week 20 and Week 28 Arm 4. GTU-MultiHIV B primes at Week 0, Week 4 and Week 12 + MVA HIV-B boosts at Week 20 and Week 28

Conditions
HIV Infection
Being tested
LIPO-5, MVA HIV-B (MVATG17401), GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
Medical subject headings
HIV Infections

What participants receive

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

  • LIPO-5Biological

    Also called ANRS LIPO-5 vaccine candidate, ANRS MVA HIV-B (MVATG17401) vaccine candidate, FIT Biotech GTU-MultiHIV B vaccine candidate

    LIPO-5: 1mL IntraMuscular, 2 shots;

  • MVA HIV-B (MVATG17401)Biological

    MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots;

  • GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shotsBiological

    GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots

Study groups in NCT02038842
Study groupRoleWhat they receive
MVA HIV-B and LIPO-5 vaccinesExperimentalMVA HIV-B primes 0,5 milliliter (mL) Intramuscular at Week 0 and Week 8 LIPO-5 1mL Intramuscular boosts at Week 20 and Week 28
Receives: Biological: LIPO-5; Biological: MVA HIV-B (MVATG17401)
LIPO-5 and MVA HIV-B vaccinesExperimentalLIPO-5 primes 1mL intramuscular at Week 0 and Week 8 and MVA HIV-B 0,5mL intramuscular boosts at Week 20 and Week 28
Receives: Biological: LIPO-5; Biological: MVA HIV-B (MVATG17401)
GTU-MultiHIV B and LIPO-5 vaccinesExperimentalGTU-MultiHIV B 0,5mL intramuscular via Biojector 2000 and 0,5mL intradermic primes at Week 0, Week 4 and Week 12 and LIPO-5 1mL intramuscular boosts at Week 20 and Week 28
Receives: Biological: LIPO-5; Biological: GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
GTU-MultiHIV B and MVA HIV-B vaccinesExperimentalGTU-MultiHIV B 0,5mL intramuscular via Biojector 2000 and 0,5mL intradermic primes at Week 0, Week 4 and Week 12 and MVA HIV-B 0,5mL intramuscular boosts at Week 20 and Week 28
Receives: Biological: MVA HIV-B (MVATG17401); Biological: GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots

What is being measured

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

  1. Evaluation of the Safety of MVA HIV-B at Week 2 in Arm 1

    Count of participants without any grade 3 or 4 adverse events (clinical or biological) related to MVA-vaccine immunisation, reported from Week 0 to Week 2 in arm 1

    Measured: Visit Week 2

  2. To Discard Vaccine Strategies With an Insufficient Level of Immunogenicity, Defined by HIV-specific IFN-γ-ELISPOT Responses, Among 4 HIV Prophylactic Prime-boost Combinations in Healthy Volunteers at Low Risk of HIV Infection

    Count of participants with a HIV-specific Interferon-gamma Enzyme Linked Immunosorbent SPOT (IFN-γ ELISPOT) response in each of the 4 arms, defined by a positive response to at least one of the stimulating HIV peptide pools (15-mer pools covering Env, Gag, Pol, and Nef) measured in stimulated Peripheral Blood Mononuclear Cell (PBMC) by a standard IFN-γ ELISPOT assay at Week 30, i.e. 2 weeks after the last vaccine immunisation.

    Measured: Visit Week 30

Secondary outcomes (2)

  1. To Assess the Tolerance of Each Prime-boost Combination

    Count of participants with at least one clinical/biological AE/SAE related to vaccine immunisation.

    Measured: Between week 0 and week 52

  2. To Assess for Each Prime-boost Combination the Type of Vaccine-induced T Cell Response

    In all participants having received at least 1 dose of vaccine, the count of participants with HIV-specific ELISPOT response to at least one of stimulating HIV peptide pools.

    Measured: At W2, W10 and W22 for reporting groups : MVA HIV-B/LIPO-5 and LIPO-5/MVA HIV-B. And at W2, W6, W14 and W22 for reporting groups : GTU-MultiHIV B/LIPO-T and GTU-MultiHIV B/MVA HIV-B.

Timeline

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

  1. First posted17 Jan 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionOct 2015
  4. Study completionMar 2016

Resources

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02038842
Sponsor's protocol ID
ANRS VRI01
Other IDs
2012-002456-17
Acronym
VRI01
Status last verified
Sep 2025
First submitted
2 Jan 2014
Last updated
14 Apr 2026
Data monitoring committee
Yes

Publications

  • Richert L, Lelievre JD, Lacabaratz C, Hardel L, Hocini H, Wiedemann A, Lucht F, Poizot-Martin I, Bauduin C, Diallo A, Rieux V, Rouch E, Surenaud M, Lefebvre C, Foucat E, Tisserand P, Guillaumat L, Durand M, Hejblum B, Launay O, Thiebaut R, Levy Y; ANRS VRI01 Study Group. T Cell Immunogenicity, Gene Expression Profile, and Safety of Four Heterologous Prime-Boost Combinations of HIV Vaccine Candidates in Healthy Volunteers: Results of the Randomized Multi-Arm Phase I/II ANRS VRI01 Trial. J Immunol. 2022 Jun 15;208(12):2663-2674. doi: 10.4049/jimmunol.2101076. Epub 2022 May 25.

    PubMed 35613727

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LIPO-5, MVA HIV-B (MVATG17401) and GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots in people with HIV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.

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 14 inclusion and 26 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: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Evaluation of the Safety of MVA HIV-B at Week 2 in Arm 1 (time frame: Visit Week 2). The study lists 2 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 NCT02038842, which also lists 1 linked publication.

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 14 Apr 2026.

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