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

NCT02038842 | Completed Phase 1 Results DMC

• 2 other identifiers: ANRS VRI012012-002456-17
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Visit Week 30

Secondary Outcomes (2)

• To Assess the Tolerance of Each Prime-boost Combination

  Between week 0 and week 52

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

  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.

Study Arms (4)

MVA HIV-B and LIPO-5 vaccines

EXPERIMENTAL

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)

LIPO-5 and MVA HIV-B vaccines

EXPERIMENTAL

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)

GTU-MultiHIV B and LIPO-5 vaccines

EXPERIMENTAL

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

GTU-MultiHIV B and MVA HIV-B vaccines

EXPERIMENTAL

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

LIPO-5 BIOLOGICAL

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

GTU-MultiHIV B and LIPO-5 vaccines; LIPO-5 and MVA HIV-B vaccines; MVA HIV-B and LIPO-5 vaccines

MVA HIV-B (MVATG17401) BIOLOGICAL

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

GTU-MultiHIV B and MVA HIV-B vaccines; LIPO-5 and MVA HIV-B vaccines; MVA HIV-B and LIPO-5 vaccines

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

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

GTU-MultiHIV B and LIPO-5 vaccines; GTU-MultiHIV B and MVA HIV-B vaccines

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (1)

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

Créteil, 94010, France

Location

Related Publications (1)

• 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.

  PMID: 35613727 RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Pr. Jean-Daniel Lelièvre
• Organization: Service d'immunologie clinique - Hôpital Henri Mondor

jean-daniel.lelievre@hmn.aphp.fr

+33 1 49 81 24 55

Study Officials

• Jean-Daniel LELIEVRE Study Chair, Pr

  Hopital Henri Mondor

  PRINCIPAL INVESTIGATOR

• Laura RICHERT Methodologist, Dr

  Inserm Unit 897

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 17, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 14, 2026
• Results First Posted: October 14, 2025

Record last verified: 2025-09

Locations

FR (1)