Immunogenicity and Safety of 2 Schedules of ALVAC-HIV vCP1452 in Chronically HIV-Infected Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-09-30

Brief Summary

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Prior pilot studies have shown that four monthly injections of ALVAC-HIV (vCP1433) are immunogenic in 60% HIV-infected patients with a boosting effect obtained after 1 or 2 injections followed by a plateau or a decrease of these responses prior to interrupting therapy. The goal of the present study is to look for an improved vaccination schedule in terms of strength and duration of the HIV-specific immunity induced by the HIV-recombinant canary pox vector ALVAC-HIV (vCP1452) by testing a strategy of immunization involving a first series of two versus three monthly injections followed by a boost three months later.

Detailed Description

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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.

Conditions

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HIV Infection

Keywords

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HIV-1 infection therapeutic vaccine Treatment Experienced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ALVAC-HIV 4 injections

Arm A: injection of ALVAC-HIV(vCP1452) for a total of 4 injections (W0, W4, W8, W20)

Group Type EXPERIMENTAL

one injection of vCP1452 at W0, W4, W8 and W20

Intervention Type BIOLOGICAL

ALVAC-HIV 3 injections

Arm B: injection of ALVAC-HIV(vCP1452) for a total of injections (W4, W8, W20)

Group Type EXPERIMENTAL

one injection of vCP1452 at W4, W8 and W20

Intervention Type BIOLOGICAL

Placebo - 4 injections

Arm C1: injection of placebo for a total of 4 injections (W0, W4, W8, W20)

Group Type PLACEBO_COMPARATOR

one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20

Intervention Type BIOLOGICAL

Placebo - 3 injections

Arm C2: injection of placebo for a total of 3 injections (W4, W8, W20)

Group Type PLACEBO_COMPARATOR

one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20

Intervention Type BIOLOGICAL

Interventions

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one injection of vCP1452 at W0, W4, W8 and W20

Intervention Type BIOLOGICAL

one injection of vCP1452 at W4, W8 and W20

Intervention Type BIOLOGICAL

one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Objectif Recherche Vaccins SIDA

Principal Investigators

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Christine Katlama, MD

Role: STUDY_CHAIR

Services des maladies infectieuses et tropicales, Hopital de la Pitié-Salpétrière, Université Pierre et Marie Curie, INSERM U720

Locations

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Northwestern University Medical School

Chicago, Illinois, United States

Site Status

Service des maladies infectieuses et tropicales, Hopital Pitié-Salpétrière, Pavillon Laveran

Paris, , France

Site Status

Klinikum der Johann Nolfgang Goethe Universitat Zentrum des Innerin Medizin

Frankfurt am Main, , Germany

Site Status

Fundacio Irsi Caixa Retrovirology Laboratory, Hospital Universitari Germans

Badalona, , Spain

Site Status

Servicios de Infecciosos, Hospital y clinic Provincial

Barcelona, , Spain

Site Status

Countries

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United States France Germany Spain

References

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Autran B, Debre P, Walker B, Katlama C. Therapeutic vaccines against HIV need international partnerships. Nat Rev Immunol. 2003 Jun;3(6):503-8. doi: 10.1038/nri1107.

Reference Type BACKGROUND

PMID: 12776210 (View on PubMed)

Autran B, Costagliola D, Murphy R, Katlama C. Evaluating therapeutic vaccines in patients infected with HIV. Expert Rev Vaccines. 2004 Aug;3(4 Suppl):S169-77. doi: 10.1586/14760584.3.4.s169.

Reference Type BACKGROUND

PMID: 15285715 (View on PubMed)

Autran B, Murphy RL, Costagliola D, Tubiana R, Clotet B, Gatell J, Staszewski S, Wincker N, Assoumou L, El-Habib R, Calvez V, Walker B, Katlama C; ORVACS Study Group. Greater viral rebound and reduced time to resume antiretroviral therapy after therapeutic immunization with the ALVAC-HIV vaccine (vCP1452). AIDS. 2008 Jul 11;22(11):1313-22. doi: 10.1097/QAD.0b013e3282fdce94.

Reference Type RESULT

PMID: 18580611 (View on PubMed)

Other Identifiers

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ORVACS 002

Identifier Type: -

Identifier Source: org_study_id

Immunogenicity and Safety of 2 Schedules of ALVAC-HIV vCP1452 in Chronically HIV-Infected Patients

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

ALVAC-HIV 4 injections

one injection of vCP1452 at W0, W4, W8 and W20

ALVAC-HIV 3 injections

one injection of vCP1452 at W4, W8 and W20

Placebo - 4 injections

one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20

Placebo - 3 injections

one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20

Interventions

one injection of vCP1452 at W0, W4, W8 and W20

one injection of vCP1452 at W4, W8 and W20

one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Objectif Recherche Vaccins SIDA

Responsible Party

Principal Investigators

Christine Katlama, MD

Locations

Northwestern University Medical School

Service des maladies infectieuses et tropicales, Hopital Pitié-Salpétrière, Pavillon Laveran

Klinikum der Johann Nolfgang Goethe Universitat Zentrum des Innerin Medizin

Fundacio Irsi Caixa Retrovirology Laboratory, Hospital Universitari Germans

Servicios de Infecciosos, Hospital y clinic Provincial

Countries

References

Autran B, Debre P, Walker B, Katlama C. Therapeutic vaccines against HIV need international partnerships. Nat Rev Immunol. 2003 Jun;3(6):503-8. doi: 10.1038/nri1107.

Autran B, Costagliola D, Murphy R, Katlama C. Evaluating therapeutic vaccines in patients infected with HIV. Expert Rev Vaccines. 2004 Aug;3(4 Suppl):S169-77. doi: 10.1586/14760584.3.4.s169.

Other Identifiers

ORVACS 002