Immunogenicity and Safety of 2 Schedules of ALVAC-HIV vCP1452 in Chronically HIV-Infected Patients (MANON 02)
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ClinicalTrials.gov Identifier: NCT00219362 |
Recruitment Status
:
Completed
First Posted
: September 22, 2005
Last Update Posted
: November 25, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Biological: one injection of vCP1452 at W0, W4, W8 and W20 Biological: one injection of vCP1452 at W4, W8 and W20 Biological: one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20 | Phase 2 |
Manon 02 is a phase II, multicentre, randomized, placebo-controlled study with 3 arms comprising 2 steps:
Step I : Immunization phase from W0 to W24, on HAART
The immunization will be administered by intramuscular injection :
Arm A: one injection of vCP1452 at W0, W4, W8 and W20 + HAART, for a total of 4 injections Arm B: one injection of vCP1452 at W4, W8 and W20 + HAART, for a total of 3 injections Arm C: one injection of placebo at W0, W4, W8 and W20 + HAART, for a total of 4 injections or at W4, W8 and W20 + HAART, for a total of 3 injections
Step II: Post immunization phase from W24 to W48, off HAART
Discontinuation of antiretroviral therapy (ARV) from W24 to W48 :
The ARV treatment interruption will be proposed at W24, 4 weeks after the last immunization, to patient who had completed their immunization phase and have CD4 cell counts > 350 cells/mm3 and HIV plasma RNA < 400 cp/ml.
In order to be able to evaluate the capacity of the immune response to reduce the viral replication, a period of 16 weeks of interruption is recommended from W24 to W40.
Resumption of antiretroviral therapy :
From W24 to W40 : During this 16 weeks period, in case of a decline of CD4 cell counts below 250 cells/mm3 or of a loss of CD4 greater than 50% of the baseline value, HAART will be restarted.
From W40 to W48 : HAART should be reintroduced if HIV-1 RNA levels > 50 000 cp/ml on 2 consecutive measurements at two weeks interval even if the CD4 counts are above 250 cells/mm3.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Randomized, Placebo-controlled Study to Evaluate the Immunogenicity and the Safety of 2 Schedules of an Homologous Prime-boost With the ALVAC-HIV vCP1452 in Chronically HIV-Infected Patients |
Study Start Date : | April 2004 |
Actual Primary Completion Date : | November 2005 |
Actual Study Completion Date : | September 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: ALVAC-HIV 4 injections
Arm A: injection of ALVAC-HIV(vCP1452) for a total of 4 injections (W0, W4, W8, W20)
|
Biological: one injection of vCP1452 at W0, W4, W8 and W20 |
Experimental: ALVAC-HIV 3 injections
Arm B: injection of ALVAC-HIV(vCP1452) for a total of injections (W4, W8, W20)
|
Biological: one injection of vCP1452 at W4, W8 and W20 |
Placebo Comparator: Placebo - 4 injections
Arm C1: injection of placebo for a total of 4 injections (W0, W4, W8, W20)
|
Biological: one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20 |
Placebo Comparator: Placebo - 3 injections
Arm C2: injection of placebo for a total of 3 injections (W4, W8, W20)
|
Biological: one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20 |
- Change from baseline of the frequency of HIV-specific PBMC (CD4/CD8) at W24 (4 weeks after the last immunization)
- - Percentage of responders as defined by an increase of at least 0.7 log10 from baseline of the frequencies of HIV-specific PBMC and/or CD4 and/or CD8 T cells four weeks after the last immunization(W24) as measured by ELISpot IFNγ
- - Change from baseline of the frequency of HIV-specific PBMC and/or CD4 and/or CD8 T cells at week 4, 6, 8, 12, 20 and 24 in the study arms as measured by ELISpot IFNγ
- - Evaluation of the magnitude of CD4 and CD8 T cell response at W4, W6, W8, W12, W20, W24 in the study arms
- - Evaluation of the immune responses, HIV-specific PBMC and/or CD4 and/or CD8 T cells at W48
- - Percentage of patients who generate a primary immune response against the artificial pol/nef sequences present in the vaccine but not in the HIV strain
- - Evaluation of the immune responses directed to vCP1452 in the study arms at all study point during the immunization phase
- - Percentage of patients who do not reach the restart therapy criteria from W24 to W48
- - Percentage of patients who remain off therapy at W48
- - Evaluation of the safety and tolerability of the vCP1452

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Documented HIV infection
- under potent antiretroviral therapy for more than 6 months
- with entry CD4+ counts > 350 cells/mm3 for at least 1 year
- plasma HIV RNA < 400 cp/ml for at least the last 6 months
- Contraception needed for women
Exclusion Criteria:
- Antiretroviral therapy started with CD4 cell count > 400/mm3
- Patients treated at time of primary HIV infection
- Patient with past AIDS defining event

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219362
United States, Illinois | |
Northwestern University Medical School | |
Chicago, Illinois, United States, 60611 | |
France | |
Service des maladies infectieuses et tropicales, Hopital Pitié-Salpétrière, Pavillon Laveran | |
Paris, France, 75013 | |
Germany | |
Klinikum der Johann Nolfgang Goethe Universitat Zentrum des Innerin Medizin | |
Frankfurt Am Main, Germany, 60590 | |
Spain | |
Fundacio Irsi Caixa Retrovirology Laboratory, Hospital Universitari Germans | |
Badalona, Spain, 08916 | |
Servicios de Infecciosos, Hospital y clinic Provincial | |
Barcelona, Spain, 08036 |
Study Chair: | Christine Katlama, MD | Services des maladies infectieuses et tropicales, Hopital de la Pitié-Salpétrière, Université Pierre et Marie Curie, INSERM U720 |
Publications of Results:
Other Publications:
Responsible Party: | Pr Christine KATLAMA, Objectif Recherche Vaccins SIDA |
ClinicalTrials.gov Identifier: | NCT00219362 History of Changes |
Other Study ID Numbers: |
ORVACS 002 |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | November 25, 2009 |
Last Verified: | November 2009 |
Keywords provided by Objectif Recherche Vaccins SIDA:
HIV-1 infection therapeutic vaccine Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |