HIV InfectionPhase 3EP46 NOVAANCT01426243

The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient.

A Phase 3 study testing Yellow fever vaccination (STAMARIL) in people with HIV Infection and Yellow Fever, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Main objective : To develop the tools for evaluation of humoral and cell-mediated immunity after Yellow Fever Vaccine (YFV) and compare virological and immune responses in HIV-positive and HIV-negative individuals who had not been given YFV before. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infection, Yellow Fever
What is being tested?: Yellow fever vaccination (STAMARIL)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 1 siteFrance
Study dates: Jul 2011to Dec 2017
Phase: Phase 3
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 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Adults under HAART for at least one year (and stable on treatment for at least 3 months prior to enrolment)
> 350 CD4/mm3 (with half of them a nadir < 200 CD4/mm3) and a viral load < 50 copies/mL for at least 6 months.
Patients were HCV negative or non-replicative and treated for at least 2 years with normal ALT and negative HBs antigen.
HIV and HCV negatives

Who cannot join

Previous vaccination against yellow fever or yellow fever Fluorescence anti-IgG positive.
Administration of immunoglobulins < 3 months or any vaccine <1 month.
Pregnancy ongoing or planned during the study.
Coinfection with HCV virus untreated.
HBs Ag positive.
Hypersensitivity reaction to eggs / chicken protein; hereditary fructose intolerance.

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Immunosuppression, whether congenital, idiopathic or as a result of corticosteroids systemically (at doses ≥ 20mg/d of prednisone), or due to radiation or antineoplastic older than 6 months.
History of thymic dysfunction (including thymoma and thymectomy).
For HIV + subjects: ART Celsentri or by other anti-CCR5.
Group 2: HIV negative subjects
Previous vaccination against yellow fever or yellow fever Fluorescence anti-IgG positive.
Administration of immunoglobulins < 3 months or any vaccine <1 month.
Other vaccinations should be deferred beyond M3.
Pregnancy ongoing or planned during the study.
Coinfection with HCV virus untreated.
HBs Ag positive.
Hypersensitivity reaction to eggs / chicken protein; hereditary fructose intolerance.
Immunosuppression, whether congenital, idiopathic or as a result of corticosteroids systemically (at doses ≥ 20mg/d of prednisone), or due to radiation or antineoplastic older than 6 months.
History of thymic dysfunction (including thymoma and thymectomy).
For HIV + subjects: ART Celsentri or by other anti-CCR5, coinfection with HCV virus untreated

Trial locations and contacts

1 site in 1 country.

France1 site

Voir Liste Des Centres
Paris

Other trials in France

About this study

Official title: The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient

Main objective :

To develop the tools for evaluation of humoral and cell-mediated immunity after Yellow Fever Vaccine (YFV) and compare virological and immune responses in HIV-positive and HIV-negative individuals who had not been given YFV before.

Secondary objectives :

To develop and assess ELISPOT technology for yellow fever and to measure the response within 7, 14, 28, 90 and 365 days of administration of YFV in 30 HIV negative subjects and 40 HIV positive subjects (CD4 > 350/mm3 under Highly Active Antiretroviral Therapy (HAART) for at least one year, with a viral load < 50 copies/mL since at least 6 months) in terms of : (1) seroconversion by fluorescence, (2) cytotoxic response in ELISPOT, (3) neutralizing antibody levels in Plaque reduction neutralization test (PRNT:reference method) and a new pseudotype based method, (4) post-vaccination viremia and (5) diversity of viral quasi-species.
To assess the impact of YFV on the T-lymphocyte response against HIV by ELISPOT and viral load.

Read the detailed description

Method :

Clinical Trial Phase III, Multicentre protocol at Saint-Louis hospital, Bichat hospital and Cochin-Pasteur hospital, with CERVI, INSERM U 941 and SC10 collaboration.

Trial treatment : Yellow fever vaccination (STAMARIL)

Criterion :

Immuno-virologic: At J-7, J7, J28, M3 and M12 will be determined the levels of antibodies by fluorescence, at J0, J7, J28, M3 and M12 titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis and nucleotide sequences on phylogenetic strains of viremia. Titles and Amariles kinetics of viremia, neutralizing antibodies and ELISPOT will be considered as surrogate markers of response in terms of groups.

Clinical and biological tolerance: At all follows up will be measured the incidence of CDC classification events (for HIV+) and general and local reactions of degree ≥ 2 in the setting of the injection of STAMARIL®.

Schedule :

Date of first enrolment : third quarter 2011. Inclusion period : 18 months. For each subject, participation in this trial will be for 12 months.

Conditions: HIV Infection, Yellow Fever
Being tested: Yellow fever vaccination (STAMARIL)
Medical subject headings: HIV Infections, Yellow Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Yellow fever vaccination (STAMARIL)Biological
Yellow fever vaccination (STAMARIL)
Yellow fever vaccination (STAMARIL)Biological
Yellow fever vaccination (STAMARIL)

Study groups in NCT01426243
Study group	Role	What they receive
Voluntary HIV positive subjects	Active comparator	40 HIV positive adults under HAART for at least one year (and stable on treatment for at least 3 months prior to enrolment), > 350 CD4/mm3 (with half of them a nadir < 200 CD4/mm3) and a viral load < 50 copies/mL for at least 6 months. Patients were HCV negative or non-replicative and treated for at least 2 years with normal ALT and negative HBs antigen. Receives: Biological: Yellow fever vaccination (STAMARIL)
HIV negative subjects	Other	Voluntary HIV negative subjects matched according to age (18-40 years and 40-55 years) and with HIV positive subjects, vaccinated at J0 and followed over one year Receives: Biological: Yellow fever vaccination (STAMARIL)

What is being measured

The primary outcome is the main question the study is designed to answer.

Immuno-virologic criterion
- At Day-7 will be determined the levels of antibodies by fluorescence.
Measured: DAY-7
Immuno-virologic criterion
At Day 0 will be determined titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis and nucleotide sequences on phylogenetic strains of viremia
Measured: Day 0
Immuno-virologic criterion
At Day 28 will be determined titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis (if it's positive at day7) and nucleotide sequences on phylogenetic strains of viremia
Measured: Day 28
Immuno-virologic criterion
At Month 3 will be determined fluorescence, PRNT and ELISPOT.
Measured: Month 3
Immuno-virologic criterion
At Month 12 will be determined fluorescence, PRNT and ELISPOT.
Measured: Month 12
Immuno-virologic criterion
At Day 7 will be determined titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis and nucleotide sequences on phylogenetic strains of viremia
Measured: Day 7

Secondary outcomes (7)

Clinical and biological tolerance
At Day -7 will be determined the levels of antibodies by fluorescence
Measured: day -7
clinical and biological tolerance
At Day 0: incidence of HIV+ event and general+local reactions of d°>2 after vaccination
Measured: day 0
clinical and biological tolerance
At Day7: incidence of HIV+ event and general+local reactions of d°>2 after vaccination
Measured: day 7
clinical and biological tolerance
At Day14:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
Measured: day 14
clinical and biological tolerance
At Day 28:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
Measured: day 28
clinical and biological tolerance
At Month3:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
Measured: month 3
clinical and biological tolerance
At Month 12:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
Measured: month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Dec 2017

First posted31 Aug 2011 (estimated)
Study startJul 2011
Primary completionFeb 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01426243
Sponsor's protocol ID: 2009-014921-17
Other IDs: 2009
Acronym: EP46 NOVAA
Status last verified: Feb 2018
First submitted: 10 Feb 2011
Last updated: 18 Jan 2019
Results posted: No
Data monitoring committee: No

Publications

Colin de Verdiere N, Durier C, Samri A, Meiffredy V, Launay O, Matheron S, Mercier-Delarue S, Even S, Aboulker JP, Molina JM, Autran B, Simon F; ANRS EP46 NOVAA Group. Immunogenicity and safety of yellow fever vaccine in HIV-1-infected patients. AIDS. 2018 Oct 23;32(16):2291-2299. doi: 10.1097/QAD.0000000000001963.
PubMed 30096071

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient
ClinicalTrials.gov ID: NCT01426243
Acronym / sponsor ID: EP46 NOVAA / 2009-014921-17
Conditions: HIV Infection, Yellow Fever
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: French National Agency for Research on AIDS and Viral HepatitisOther government
Study start: Jul 2011
Primary completion: Feb 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 31 Aug 2011 (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.

Main objective :

Secondary objectives :

To develop and assess ELISPOT technology for yellow fever and to measure the response within 7, 14, 28, 90 and 365 days of administration of YFV in 30 HIV negative subjects and 40 HIV positive subjects (CD4 > 350/mm3 under Highly Active Antiretroviral Therapy (HAART) for at least one year, with a viral load < 50 copies/mL since at least 6 months) in terms of : (1) seroconversion by fluorescence, (2) cytotoxic response in ELISPOT, (3) neutralizing antibody levels in Plaque reduction neutralization test (PRNT:reference method) and a new pseudotype based method, (4) post-vaccination viremia and (5) diversity of viral quasi-species.
To assess the impact of YFV on the T-lymphocyte response against HIV by ELISPOT and viral load.

Detailed description

Method :

Clinical Trial Phase III, Multicentre protocol at Saint-Louis hospital, Bichat hospital and Cochin-Pasteur hospital, with CERVI, INSERM U 941 and SC10 collaboration.

Trial treatment : Yellow fever vaccination (STAMARIL)

Criterion :

Schedule :

Date of first enrolment : third quarter 2011. Inclusion period : 18 months. For each subject, participation in this trial will be for 12 months.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Voluntary HIV positive subjects	Active comparator	Biological: Yellow fever vaccination (STAMARIL)40 HIV positive adults under HAART for at least one year (and stable on treatment for at least 3 months prior to enrolment), > 350 CD4/mm3 (with half of them a nadir < 200 CD4/mm3) and a viral load < 50 copies/mL for at least 6 months. Patients were HCV negative or non-replicative and treated for at least 2 years with normal ALT and negative HBs antigen.
HIV negative subjects	Other	Biological: Yellow fever vaccination (STAMARIL)Voluntary HIV negative subjects matched according to age (18-40 years and 40-55 years) and with HIV positive subjects, vaccinated at J0 and followed over one year

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Adults under HAART for at least one year (and stable on treatment for at least 3 months prior to enrolment)
> 350 CD4/mm3 (with half of them a nadir < 200 CD4/mm3) and a viral load < 50 copies/mL for at least 6 months.
Patients were HCV negative or non-replicative and treated for at least 2 years with normal ALT and negative HBs antigen.
HIV and HCV negatives

Key exclusion criteria (20 listed)

Previous vaccination against yellow fever or yellow fever Fluorescence anti-IgG positive.
Administration of immunoglobulins < 3 months or any vaccine <1 month.
Pregnancy ongoing or planned during the study.
Coinfection with HCV virus untreated.
HBs Ag positive.

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
Yellow fever vaccination (STAMARIL)Yellow fever vaccination (STAMARIL)	Biological	HIV negative subjects, Voluntary HIV positive subjects
Yellow fever vaccination (STAMARIL)Yellow fever vaccination (STAMARIL)	Biological	HIV negative subjects

Primary outcome

Immuno-virologic criterion
Time frame: DAY-7
- At Day-7 will be determined the levels of antibodies by fluorescence.
Immuno-virologic criterion
Time frame: Day 0
At Day 0 will be determined titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis and nucleotide sequences on phylogenetic strains of viremia
Immuno-virologic criterion
Time frame: Day 28
At Day 28 will be determined titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis (if it's positive at day7) and nucleotide sequences on phylogenetic strains of viremia
Immuno-virologic criterion
Time frame: Month 3
At Month 3 will be determined fluorescence, PRNT and ELISPOT.
Immuno-virologic criterion
Time frame: Month 12
At Month 12 will be determined fluorescence, PRNT and ELISPOT.
Immuno-virologic criterion
Time frame: Day 7
At Day 7 will be determined titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis and nucleotide sequences on phylogenetic strains of viremia

7 secondary outcomes

Clinical and biological tolerance
Time frame: day -7
clinical and biological tolerance
Time frame: day 0
clinical and biological tolerance
Time frame: day 7
clinical and biological tolerance
Time frame: day 14
clinical and biological tolerance
Time frame: day 28
clinical and biological tolerance
Time frame: month 3
clinical and biological tolerance
Time frame: month 12

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 18 Jan 2019.
Derived from this study: PubMed 30096071Colin de Verdiere N, Durier C, Samri A, Meiffredy V, Launay O, Matheron S, Mercier-Delarue S, Even S, Aboulker JP, Molina JM, Autran B, Simon F; ANRS EP46 NOVAA Group. Immunogenicity and safety of yellow fever vaccine in HIV-1-infected patients. AIDS. 2018 Oct 23;32(16):2291-2299. doi: 10.1097/QAD.0000000000001963.
Related InfoLink provided by the sponsor.

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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.

Nathalie COLIN de VERDIERE principal investigator

Maladies Infectieuses St Louis Paris

Sophie MATHERON principal investigator

Maladies Infectieuses et Tropicales Bichat Paris

Odile LAUNAY principal investigator

CIC Cochin Paris

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Yellow fever vaccination (STAMARIL) in people with HIV Infection and Yellow Fever, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.

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 4 inclusion and 20 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 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Immuno-virologic criterion (time frame: DAY-7). The study lists 6 primary outcomes in all. 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 NCT01426243, which also lists 1 linked publication.

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 18 Jan 2019.