CompletedNCT02038842VRI01Updated Apr 14, 2026Results posted

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

A Phase 1/2 interventional study of LIPO-5 and MVA HIV-B (MVATG17401) in HIV Infection, sponsored by ANRS, Emerging Infectious Diseases. Completed at 1 site in France. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by ANRS, Emerging Infectious Diseases · Phase 1/2, Interventional, and Prevention

Phase: Phase 1/2
Study type: Interventional
Enrollment: 92
Allocation: Randomized
Ages: 21 Years to 50 Years
Sex: All

Study 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. 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 studied

HIV Infection

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In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 92 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

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Lead sponsor

ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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 ;
- 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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 92 participants (actual)

Study arms

Experimental
MVA HIV-B and LIPO-5 vaccines
MVA 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
Biological: LIPO-5 · Biological: MVA HIV-B (MVATG17401)
Experimental
LIPO-5 and MVA HIV-B vaccines
LIPO-5 primes 1mL intramuscular at Week 0 and Week 8 and MVA HIV-B 0,5mL intramuscular boosts at Week 20 and Week 28
Biological: LIPO-5 · Biological: MVA HIV-B (MVATG17401)
Experimental
GTU-MultiHIV B and LIPO-5 vaccines
GTU-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
Biological: LIPO-5 · Biological: GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
Experimental
GTU-MultiHIV B and MVA HIV-B vaccines
GTU-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
Biological: MVA HIV-B (MVATG17401) · Biological: GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots

Interventions

BiologicalLIPO-5
LIPO-5: 1mL IntraMuscular, 2 shots;
Also known as: ANRS LIPO-5 vaccine candidate, ANRS MVA HIV-B (MVATG17401) vaccine candidate, FIT Biotech GTU-MultiHIV B vaccine candidate
BiologicalMVA HIV-B (MVATG17401)
MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots;
BiologicalGTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots

What researchers measure

Primary outcomes

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
Time frame: Visit Week 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.
Time frame: Visit Week 30

Secondary outcomes

To Assess the Tolerance of Each Prime-boost Combination
Count of participants with at least one clinical/biological AE/SAE related to vaccine immunisation.
Time frame: Between week 0 and week 52
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.
Time frame: 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.

Results

Posted Oct 14, 2025

Participant flow

Healthy volunteers will be recruited through the ARNS network of volunteers, through advertising via media and through a dedicated website, and given a telephone number to contact. From March 2014 to March 2015, 129 participants were screened in four sites in France.

Participant flow — Overall Study
Milestone	MVA HIV-B/LIPO-5	LIPO-5/MVA HIV-B	GTU-MultiHIV B/LIPO-5	GTU-MultiHIV B/MVA HIV-B
Started	23	23	23	23
Completed	21	21	18	19
Not completed	2	2	5	4
Withdrew: Withdrawal by subject	2	2	0	0
Withdrew: Participant decision	0	0	2	1
Withdrew: Adverse event	0	0	3	1
Withdrew: Other (professional impossibility, etc.)	0	0	0	2

Outcome measures

PrimaryEvaluation 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

Time frame:: Visit Week 2
Reported as:: Count of participants · Participants

Evaluation of the Safety of MVA HIV-B at Week 2 in Arm 1
Participants	MVA HIV-B/LIPO-5
Evaluation of the Safety of MVA HIV-B at Week 2 in Arm 1	22

PrimaryTo 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.

Time frame:: Visit Week 30
Reported as:: Count of participants · Participants

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
Participants	MVA HIV-B/LIPO-5	LIPO-5/MVA HIV-B	GTU-MultiHIV B/LIPO-5	GTU-MultiHIV B/MVA HIV-B
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	7	9	0	14

Statistical analysis

MVA HIV-B/LIPO-5 vs LIPO-5/MVA HIV-B vs GTU-MultiHIV B/LIPO-5 vs GTU-MultiHIV B/MVA HIV-B · Binomial · p = =0.02 (One-sided test for the observed proportion being superior to the theoretical decision threshold of 50%.)

SecondaryTo Assess the Tolerance of Each Prime-boost Combination

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

Time frame:: Between week 0 and week 52
Reported as:: Count of participants · Participants

To Assess the Tolerance of Each Prime-boost Combination
Participants	MVA HIV-B/LIPO-5	LIPO-5/MVA HIV-B	GTU-MultiHIV B/LIPO-5	GTU-MultiHIV B/MVA HIV-B
Clinical AE related to vaccine immunisation	22	21	21	23
Clinical SAE related to vaccine immunisation	0	0	2	0
Biological AE related to vaccine immunisation	1	0	0	1
Biological SAE related to vaccine immunisation	1	0	0	1

SecondaryTo 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.

Time frame:: 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.
Reported as:: Count of participants · Participants

To Assess for Each Prime-boost Combination the Type of Vaccine-induced T Cell Response
Participants	MVA HIV-B/LIPO-5	LIPO-5/MVA HIV-B	GTU-MultiHIV B/LIPO-5	GTU-MultiHIV B/MVA HIV-B
Week 2	5	1	1	1
Week 6	—	—	0	1
Week 10	13	1	—	—
Week 14	—	—	0	0
Week 22	9	8	1	12

Adverse events

Collected over Each 92 participants were followed up for 52 weeks, unless they did not complete the study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
MVA HIV-B/LIPO-5	0/23 (0%)	3/23 (13%)	22/23 (95.7%)
LIPO-5/MVA HIV-B	0/23 (0%)	5/23 (21.7%)	23/23 (100%)
GTU-MultiHIV B/LIPO-5	0/23 (0%)	7/23 (30.4%)	22/23 (95.7%)
GTU-MultiHIV B/MVA HIV-B	0/23 (0%)	3/23 (13%)	23/23 (100%)

Most frequent serious events

Showing 10 of 22

Most frequent serious events
Event	MVA HIV-B/LIPO-5	LIPO-5/MVA HIV-B	GTU-MultiHIV B/LIPO-5	GTU-MultiHIV B/MVA HIV-B
Blood creatine phosphokinase increasedInvestigations	2/23	1/23	0/23	1/23
Blood urine presentInvestigations	0/23	2/23	0/23	0/23
AnaemiaBlood and lymphatic system disorders	0/23	1/23	1/23	0/23
Gilbert's syndromeCongenital, familial and genetic disorders	0/23	1/23	0/23	0/23
AstheniaGeneral disorders and administration site conditions	0/23	0/23	1/23	0/23
VitiligoImmune system disorders	0/23	0/23	1/23	0/23
EpididymitisInfections and infestations	0/23	0/23	1/23	0/23
Toxicity to various agentsInjury, poisoning and procedural complications	0/23	0/23	0/23	1/23
Haemoglobin decreasedInvestigations	1/23	0/23	1/23	0/23
Lipase increasedInvestigations	1/23	0/23	1/23	1/23

Most frequent other events

Showing 10 of 153

Most frequent other events
Event	MVA HIV-B/LIPO-5	LIPO-5/MVA HIV-B	GTU-MultiHIV B/LIPO-5	GTU-MultiHIV B/MVA HIV-B
INJECTION SITE PAINGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	21/23	19/23	17/23	20/23
MYALGIAMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	5/23	3/23	4/23	11/23
HEADACHENERVOUS SYSTEM DISORDERS	8/23	7/23	6/23	11/23
INJECTION SITE INDURATIONGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	5/23	3/23	7/23	10/23
ASTHENIAGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	6/23	6/23	9/23	8/23
FATIGUEGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	7/23	4/23	2/23	9/23
INJECTION SITE HYPERSENSITIVITYGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	7/23	6/23	6/23	9/23
INJECTION SITE ERYTHEMAGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	7/23	5/23	7/23	6/23
NASOPHARYNGITISINFECTIONS AND INFESTATIONS	2/23	7/23	6/23	4/23
INFLUENZA LIKE ILLNESSGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	0/23	4/23	1/23	4/23

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	MVA HIV-B/LIPO-5	LIPO-5/MVA HIV-B	GTU-MultiHIV B/LIPO-5	GTU-MultiHIV B/MVA HIV-B	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	23	23	23	23	92
>=65 years	0	0	0	0	0

Age, Continuous
Age, Continuous(years)	MVA HIV-B/LIPO-5	LIPO-5/MVA HIV-B	GTU-MultiHIV B/LIPO-5	GTU-MultiHIV B/MVA HIV-B	Total
Median	26 (24 to 36)	24 (22 to 33)	29 (25 to 38)	26 (24 to 36)	27 (24 to 33.5)

Sex: Female, Male
Sex: Female, Male(Participants)	MVA HIV-B/LIPO-5	LIPO-5/MVA HIV-B	GTU-MultiHIV B/LIPO-5	GTU-MultiHIV B/MVA HIV-B	Total
Female	8	11	9	14	42
Male	15	12	14	9	50

Region of Enrollment
Region of Enrollment(participants)	MVA HIV-B/LIPO-5	LIPO-5/MVA HIV-B	GTU-MultiHIV B/LIPO-5	GTU-MultiHIV B/MVA HIV-B	Total
France	23	23	23	23	92

Study locations

1 site

Service d'Immunologie Clinique 51, avenue du Marechal de Lattre de Tassigny
Créteil, 94010, France

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02038842
Lead sponsor: ANRS, Emerging Infectious Diseases
Responsible party: Sponsor
First posted: Jan 17, 2014
Start date: Mar 2014
Primary completion: Oct 2015
Completion: Mar 2016
Results posted: Oct 14, 2025
Last update: Apr 14, 2026

Study contacts

Jean-Daniel LELIEVRE Study Chair, Pr

principal investigator · Hopital Henri Mondor

Laura RICHERT Methodologist, Dr

principal investigator · Inserm Unit 897

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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