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Immunogenicity and Safety of 4 Prime-boost Combinations of HIV Vaccine Candidates in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT02038842•ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

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.

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

Eligibility

Age

21 - 50 years

Sex

ALL

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
+4 more 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
+16 more criteria

Locations (1)

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

Créteil, France

Key Dates

Start Date

March 1, 2014

Primary Completion Date

October 1, 2015

Completion Date

March 1, 2016

Last Updated

October 14, 2025

Enrollment

ACTUAL participants

Conditions

HIV Infection

Interventions

LIPO-5

BIOLOGICAL

MVA HIV-B (MVATG17401)

BIOLOGICAL

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

BIOLOGICAL

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

NCT04929028

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RECRUITING

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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