HIV InfectionPhase 2MANON 02NCT00219362
Immunogenicity and Safety of 2 Schedules of ALVAC-HIV vCP1452 in Chronically HIV-Infected Patients
A Phase 2 study testing one injection of vCP1452 at W0, W4, W8 and W20 and one injection of vCP1452 at W4, W8 and W20 in people with HIV Infection, run by Objectif Recherche Vaccins SIDA at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- one injection of vCP1452 at W0, W4, W8 and W20 and one injection of vCP1452 at W4, W8 and W20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Apr 2004to Sep 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Antiretroviral therapy started with CD4 cell count > 400/mm3
- Patients treated at time of primary HIV infection
- Patient with past AIDS defining event
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Spain2 sites
Fundacio Irsi Caixa Retrovirology Laboratory, Hospital Universitari Germans
Badalona, 08916
Servicios de Infecciosos, Hospital y clinic Provincial
Barcelona, 08036
United States1 site
Northwestern University Medical School
Chicago, Illinois, 60611
France1 site
Service des maladies infectieuses et tropicales, Hopital Pitié-Salpétrière, Pavillon Laveran
Paris, 75013
Germany1 site
Klinikum der Johann Nolfgang Goethe Universitat Zentrum des Innerin Medizin
Frankfurt am Main, 60590
About this study
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
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.
Read the detailed description
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
- HIV Infection
- Being tested
- 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
- Keywords
- HIV-1 infection, therapeutic vaccine, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one injection of vCP1452 at W0, W4, W8 and W20Biological
one injection of vCP1452 at W4, W8 and W20Biological
one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20Biological
| Study group | Role | What they receive |
|---|---|---|
| ALVAC-HIV 4 injections | Experimental | Arm A: injection of ALVAC-HIV(vCP1452) for a total of 4 injections (W0, W4, W8, W20) Receives: 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) Receives: 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) Receives: 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) Receives: Biological: one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionNov 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Objectif Recherche Vaccins SIDA
- Sponsor type
- University, hospital or other
- Investigators
- Christine Katlama, MD, Study chair, Services des maladies infectieuses et tropicales, Hopital de la Pitié-Salpétrière, Université Pierre et Marie Curie, INSERM U720
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219362
- Sponsor's protocol ID
- ORVACS 002
- Acronym
- MANON 02
- Status last verified
- Nov 2009
- First submitted
- 16 Sep 2005
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12776210Autran 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.
PubMed 15285715Autran 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.
PubMed 18580611
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00219362
- Acronym / sponsor ID
- MANON 02 / ORVACS 002
- Conditions
- HIV Infection
- Keywords
- HIV-1 infection, therapeutic vaccine, Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Objectif Recherche Vaccins SIDAUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALVAC-HIV 4 injections | Experimental | Biological: one injection of vCP1452 at W0, W4, W8 and W20Arm A: injection of ALVAC-HIV(vCP1452) for a total of 4 injections (W0, W4, W8, W20) |
| ALVAC-HIV 3 injections | Experimental | Biological: one injection of vCP1452 at W4, W8 and W20Arm B: injection of ALVAC-HIV(vCP1452) for a total of injections (W4, W8, W20) |
| Placebo - 4 injections | Placebo comparator | Biological: one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20Arm C1: injection of placebo for a total of 4 injections (W0, W4, W8, W20) |
| Placebo - 3 injections | Placebo comparator | Biological: one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20Arm C2: injection of placebo for a total of 3 injections (W4, W8, W20) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Antiretroviral therapy started with CD4 cell count > 400/mm3
- Patients treated at time of primary HIV infection
- Patient with past AIDS defining event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| one injection of vCP1452 at W0, W4, W8 and W20 | Biological | ALVAC-HIV 4 injections |
| one injection of vCP1452 at W4, W8 and W20 | Biological | ALVAC-HIV 3 injections |
| one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20 | Biological | Placebo - 3 injections, Placebo - 4 injections |
Primary outcome
Change from baseline of the frequency of HIV-specific PBMC (CD4/CD8) at W24 (4 weeks after the last immunization)
9 secondary outcomes
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2009.
- Background: PubMed 12776210Autran 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.
- Background: PubMed 15285715Autran 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.
- Results publication: PubMed 18580611Autran 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Katlama, MD study chair
Services des maladies infectieuses et tropicales, Hopital de la Pitié-Salpétrière, Université Pierre et Marie Curie, INSERM U720
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing one injection of vCP1452 at W0, W4, W8 and W20 and one injection of vCP1452 at W4, W8 and W20 in people with HIV Infection, run by Objectif Recherche Vaccins SIDA at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, United States, France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of the frequency of HIV-specific PBMC (CD4/CD8) at W24 (4 weeks after the last immunization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00219362, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2009.