NCT00219362

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2004

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

1.6 years

First QC Date

September 16, 2005

Last Update Submit

November 24, 2009

Conditions

HIV Infection

Keywords

HIV-1 infectiontherapeutic vaccineTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of the frequency of HIV-specific PBMC (CD4/CD8) at W24 (4 weeks after the last immunization)

Secondary Outcomes (9)

  • - 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

  • +4 more secondary outcomes

Study Arms (4)

ALVAC-HIV 4 injections

EXPERIMENTAL

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

ALVAC-HIV 3 injections

EXPERIMENTAL

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 - 4 injections

PLACEBO COMPARATOR

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 - 3 injections

PLACEBO COMPARATOR

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

Interventions

one injection of vCP1452 at W0, W4, W8 and W20BIOLOGICAL
ALVAC-HIV 4 injections
one injection of vCP1452 at W4, W8 and W20BIOLOGICAL
ALVAC-HIV 3 injections
one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20BIOLOGICAL
Placebo - 3 injectionsPlacebo - 4 injections

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Antiretroviral therapy started with CD4 cell count \> 400/mm3
  • Patients treated at time of primary HIV infection
  • Patient with past AIDS defining event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Northwestern University Medical School

Chicago, Illinois, 60611, United States

Location

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

Paris, 75013, France

Location

Klinikum der Johann Nolfgang Goethe Universitat Zentrum des Innerin Medizin

Frankfurt am Main, 60590, Germany

Location

Fundacio Irsi Caixa Retrovirology Laboratory, Hospital Universitari Germans

Badalona, 08916, Spain

Location

Servicios de Infecciosos, Hospital y clinic Provincial

Barcelona, 08036, Spain

Location

Related Publications (3)

  • 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.

    PMID: 12776210BACKGROUND

  • 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.

    PMID: 15285715BACKGROUND

  • 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.

    PMID: 18580611RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

N-(8-aminohexyl)-5-iodonaphthalene-1-sulfonamide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Christine Katlama, MD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

April 1, 2004

Primary Completion

November 1, 2005

Study Completion

September 1, 2006

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

FR(1)US(1)ES(2)DE(1)