CHILD-INNOVAC

NASAL VACCINATION AGAINST RESPIRATORY INFECTIONS IN YOUNG CHILDREN

 Coordinatore INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) 

 Organization address address: 101 Rue de Tolbiac
city: PARIS
postcode: 75654

contact info
Titolo: Mr.
Nome: Samir
Cognome: Ould Ali
Email: send email
Telefono: +33 3 20299375
Fax: +33 3 20490138

 Nazionalità Coordinatore France [FR]
 Totale costo 7˙367˙737 €
 EC contributo 5˙000˙000 €
 Programma FP7-HEALTH
Specific Programme "Cooperation": Health
 Code Call FP7-HEALTH-2007-A
 Funding Scheme CP-FP
 Anno di inizio 2008
 Periodo (anno-mese-giorno) 2008-03-01   -   2012-02-29

 Partecipanti

# participant  country  role  EC contrib. [€] 
1    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)

 Organization address address: 101 Rue de Tolbiac
city: PARIS
postcode: 75654

contact info
Titolo: Mr.
Nome: Samir
Cognome: Ould Ali
Email: send email
Telefono: +33 3 20299375
Fax: +33 3 20490138

FR (PARIS) coordinator 0.00
2    "MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT"

 Organization address address: PARNASSUSPLEIN 5
city: DEN HAAG
postcode: 2500 EJ

contact info
Titolo: Mr.
Nome: Erik P.J.
Cognome: Popping
Email: send email
Telefono: +31 30274250
Fax: +31 302744439

NL (DEN HAAG) participant 0.00
3    IMPERIAL COLLEGE OF SCIENCE, TECHNOLOGY AND MEDICINE

 Organization address address: SOUTH KENSINGTON CAMPUS EXHIBITION ROAD
city: LONDON
postcode: SW7 2AZ

contact info
Titolo: Mr.
Nome: Mike
Cognome: Robinson
Email: send email
Telefono: +44 20 7594 3866
Fax: +44 20 7594 3868

UK (LONDON) participant 0.00
4    INNOGENETICS NV

 Organization address address: TECHNOLOGIEPARK 6
city: ZWIJNAARDE
postcode: 9052

contact info
Titolo: Dr.
Nome: Annie
Cognome: Van Broekhoven
Email: send email
Telefono: +32 9 3291201
Fax: +32 9 3291904

BE (ZWIJNAARDE) participant 0.00
5    INSERM - TRANSFERT SA

 Organization address address: Rue Watt 7
city: PARIS
postcode: 75013

contact info
Titolo: Mr.
Nome: Louis
Cognome: Jammayrac
Email: send email
Telefono: +33 1 55030101
Fax: +33 1 55030160

FR (PARIS) participant 0.00
6    ISTITUTO SUPERIORE DI SANITA

 Organization address address: Viale Regina Elena 299
city: ROMA
postcode: 161

contact info
Titolo: Dr.
Nome: Rosa Maria
Cognome: Martoccia
Email: send email
Telefono: +39 6 49902688
Fax: +39 6 49903007

IT (ROMA) participant 0.00
7    NATIONAL UNIVERSITY OF IRELAND MAYNOOTH

 Organization address address: CO KILDARE
city: MAYNOOTH

contact info
Titolo: Mr.
Nome: Mike
Cognome: O’malley
Email: send email
Telefono: +353 1 708 3797
Fax: +353 1 628 9177

IE (MAYNOOTH) participant 0.00
8    RIJKSINSTITUUT VOOR VOLKSGEZONDHEIDEN MILIEU*NATIONAL INSTITUTEFOR PUBLIC HEALTH AND THE ENVIRONMENTEN

 Organization address address: Antonie Van Leeuwenhoeklaan 9
city: BILTHOVEN
postcode: 3721 MA

contact info
Titolo: Ms.
Nome: Marjon
Cognome: Straver
Email: send email
Telefono: +31 302747547
Fax: +31 302744486

NL (BILTHOVEN) participant 0.00
9    SMITTSKYDDSINSTITUTET

 Organization address address: Nobels vaeg 18
city: SOLNA
postcode: 17182

contact info
Titolo: Mr.
Nome: Bengt-åke
Cognome: Andersson
Email: send email
Telefono: +46 84572300
Fax: +46 8303668

SE (SOLNA) participant 0.00
10    UNIVERSITE LIBRE DE BRUXELLES

 Organization address address: Avenue Franklin Roosevelt 50
city: BRUXELLES
postcode: 1050

contact info
Titolo: Prof.
Nome: Françoise
Cognome: Mascart
Email: send email
Telefono: +32 2 5553467
Fax: +32 2 5554499

BE (BRUXELLES) participant 0.00

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

cough    pathogens    bpze    safety    trials    protection    responses    child    evaluation    countries    immune    vaccination    whooping    infections    natural    infection    bordetella    rsv    mice    tested    birth    attenuated    multivalent    il    human    lasting    mouse    strain    yet    months    syncytial    vaccines    manufacturing    million    annually    infants    clinical    cells    doses    nasal    pre    stability    innovac    trial    respiratory    models    live    gmp    protective    virus    vaccine    immunity    pertussis    memory   

 Obiettivo del progetto (Objective)

'Respiratory infections are the most frequent cause of childhood morbidity and mortality worldwide. For many respiratory pathogens no vaccine is available, for others classical immunisations remain insufficiently effective. This project concerns the development of novel, nasal vaccines against two major respiratory pathogens, B. pertussis and Respiratory Syncytial Virus (RSV). No vaccine is yet available against RSV, and, although efficacious vaccines against pertussis are widely used, roughly 40 million cases and 200,000-400,000 pertussis-linked deaths are recorded annually, mostly in infants (<6 months) not yet sufficiently protected by the current vaccines. This proposal will yield proof of principle and provide prototypes of multivalent nasal vaccines based on attenuated B. pertussis. The concept is based on the fact that early in life, infants can mount strong anti-B. pertussis T cell responses upon natural infection in contrast to vaccination. Live attenuated B. pertussis BPZE1 has already been constructed and shown to be much more protective in infant mice after a single nasal dose than two doses of current pertussis vaccines. Immunity induced by BPZE1 will be studied in detail, and its genetic and biological stability and safety in various mouse models will be characterised. GMP lots of BPZE1 will be produced and tested for safety in a phase 1 trial in adults as a prerequisite to future trials in the target population. In parallel, human immune responses, in particular memory responses to infection and vaccination will be analysed, which will serve as a basis for immunogenic evaluations of BPZE1. Finally, we will develop BPZE1 as a vector for the presentation of heterologous RSV antigens to the respiratory mucosa. This will be tested in mouse models. A successful outcome of this project should lead to further clinical trials with BPZE1 and to the development of multivalent nasal vaccines able to protect against several respiratory pathogens simultaneously.'

Introduzione (Teaser)

Aiming to provide immunity against two serious respiratory pathogens, an EU-funded study performed a pre-clinical and clinical evaluation of an attenuated Bordetella pertussis vaccine. Results demonstrate that the nasal vaccines are safe to administer, and provides a rapid and long-lasting immune response against whooping cough.

Descrizione progetto (Article)

Respiratory infections such as Pertussis or whooping cough affect 40 million people annually and can be prevented by vaccination. Current vaccination strategies require at least three doses to be given one or two months apart to confer protection. However, vaccination usually starts two months after birth rendering infants below the age of six months highly susceptible to infection.

Despite the immaturity of the immune system at birth, previous studies showed that early vaccination with the whooping cough agent Bordetella pertussis generates a strong immune response. The EU-funded CHILD-INNOVAC project developed an attenuated B. pertussis strain called BPZE1 to be delivered as a nasal live vaccine. This would mimic the natural infection without causing disease.

Pre-clinical testing in various animal models ensured the safety and stability of this vaccine, making it viable for clinical development. Among the most exciting results of the project was the protective effect of BPZE1 in mice against non-related respiratory viruses, such as respiratory syncytial virus (RSV). This intriguing protection was found to correlate with an increase in regulatory T cells, and also with IL-10 and IL-17 production.

Following harmonisation of the study protocols for immunological evaluation, 400 children were enrolled in three countries. In order to evaluate the duration, strength and diversity of the elicited immune responses following vaccination or infection, partners developed assays for the detection of B. pertussis-specific memory T cells and antibody-secreting B cells.

Methods for manufacturing a nasal vaccine for human use were developed and the vaccine was administered to healthy adult male volunteers. Trial objectives included the assessment of safety, tolerability and immune responses of the vaccine as well as the colonisation properties of the modified B. pertussis strain.

By demonstrating the safety of the BPZE1 vaccine, the CHILD-INNOVAC consortium facilitated its good manufacturing practice (GMP) production, toxicology studies and the first-in-man phase I clinical safety trial. These vaccines will be beneficial for neonates by providing long-lasting immunity against respiratory infections especially in developing countries where booster vaccinations may be difficult to implement.

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