- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00490074
Study to Compare the Immunogenicity and Safety of Two HIV Preventive Vaccinations in Healthy Volunteers (EV03/ANRSVAC20)
A Phase I/II Trial to Compare the Immunogenicity and Safety of 3 DNA C Prime Followed by 1 NYVAC C Boost to 2 DNA C Prime Followed by 2 NYVAC C Boost
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Methods: randomised phase I/II international trial with a parallel group design, open to participants and investigators but blind to laboratory personnel, in healthy volunteers.
Vaccines strategies: 70 volunteers will receive 3 DNA-C vaccinations and 1 NYVAC-C vaccination; 70 volunteers will receive 2 DNA-C vaccinations and 2 NYVAC-C vaccination.
DNA-C: 2x2ml intra muscular in right and left vastus lateralis; NYVAC-C: 1 ml intramuscular in non-dominant deltoid.
Main outcome:
the presence of CD8/CD4+ T cell responses defined according to internationally agreed criteria for evaluation of IFNgamma ELISPOT assays:
- in response to env plus at least one of the gag, pol, nef peptide pools,
- at weeks 26 or 28;
- the safety parameters.
Secondary outcomes:
- cellular responses,
- antibody responses,
- all grade 1 and 2 adverse events,
- all events including those considered unrelated.
Sample size: 140 volunteers
Enrollment period: 9 months
Patient's participation duration: 78 weeks
Study duration: 27 months
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- age between 18 and 55 years on the day of screening
- available for follow-up for the duration of the study (78 weeks from screening)
- able to give written informed consent
at low risk of HIV and willing to remain so for the duration of the study low risk of HIV infection defined as:
- no history of injecting drug use in the previous ten years
- no gonorrhoea or syphilis in the last six months
- no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months
- no unprotected anal intercourse in the last six months, outside a relationship with a regular partner known to be HIV negative
- no unprotected vaginal intercourse in the last six months outside a relationship with a regular known/presumed HIV negative partner
- willing to undergo a HIV test
- willing to undergo a genital infection screen
- if heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; IUCD; consistent record with condoms if using these; physiological or anatomical sterility in self or partner) from 14 days prior to the first vaccination until 4 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination
- if heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination
for French volunteers only :
- subjects registered in French Health ministry computerised file and authorised to participate in a clinical trial
- subjects covered by Health Insurance
- subjects included in the ANRS vaccine research network of volunteers
Exclusion Criteria:
- pregnant or lactating
- clinically relevant abnormality on history or examination including history of grand-mal epilepsy; severe eczema; allergy to eggs or gentamicin; severe allergic diseases; liver disease with inadequate hepatic function; haematological, metabolic or gastrointestinal disorders; uncontrolled infection; autoimmune disease, immunodeficiency or use of immunosuppressives in preceding 3 months
- receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment
- receipt of blood products or immunoglobin within 4 months of screening
- participation in another trial of a medicinal product, completed less than 30 days prior to enrolment
history of severe local or general reaction to vaccination defined as
- local: extensive, indurated redness and swelling involving most of the anterolateral thigh or the major circumference of the arm, not resolving within 72 hours
- general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
- HIV 1/2 positive or indeterminate on screening
- positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
- positive for DNA/ANA antibodies at titre considered clinically relevant by immunology laboratory
- grade 1 or above routine laboratory parameters (see section 4.1.4 & appendix 4 for definitions) Note of clarification 18th april 2008: hyperbilirubinemia has to be considered as an exclusion criterion only when confirmed to be conjugated bilirubinemia
- unlikely to comply with protocol
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 3 DNA-C + 1 NYVAC-C
|
1.0mg per ml of DNA HIV-C vaccine 2x2 ml IM
NYVAC-C 1 ml IM
|
Comparatore attivo: 2 DNA-C + 2 NYVAC-C
|
1.0mg per ml of DNA HIV-C vaccine 2x2 ml IM
NYVAC-C 1 ml IM
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Immunogenicity parameter: presence of CD8/CD4+ T cell responses defined according to internationally agreed criteria for evaluation of IFNgamma ELISPOT assays, in response to env plus at least one of the gag, pol, nef peptide pools
Lasso di tempo: week 26 and week 28
|
week 26 and week 28
|
Safety parameter: grade 3 or above local adverse event, grade 3 or above systemic adverse event, grade 3 or above other clinical or laboratory adverse event,any event attributable to vaccine leading to discontinuation of the immunisation regimen.
Lasso di tempo: within 72 weeks
|
within 72 weeks
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Cellular responses: CD8/CD4+ T cell mean IFNgamma Spot Forming Units (SFU) per million cells across the peptide pools
Lasso di tempo: at weeks 26 and 28
|
at weeks 26 and 28
|
Cellular responses: CD8/CD4+ T cell mean Spot Forming Units (SFU) per million cells across the peptide pools
Lasso di tempo: at any week following the first immunisation including weeks 48 and 72
|
at any week following the first immunisation including weeks 48 and 72
|
Cellular responses: mean proportion of CD4/CD8+ T cells producing IL-2 and/or IFNgamma following ex-vivo stimulation with HIV-1 peptide pools
Lasso di tempo: at weeks 26 and 28, 48 and 72
|
at weeks 26 and 28, 48 and 72
|
Cellular responses: number of different epitopes that can be characterised
Lasso di tempo: to be determined at a later stage
|
to be determined at a later stage
|
Antibody responses
Lasso di tempo: to be determined at a later stage
|
to be determined at a later stage
|
All grade 1 and 2 adverse events
Lasso di tempo: within 72 weeks
|
within 72 weeks
|
All events including those considered unrelated
Lasso di tempo: within the 72 weeks
|
within the 72 weeks
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Yves LEVY, MD; PhD, Hôpital Henri Mondor-Créteil-France
- Investigatore principale: Giuseppe PANTALEO, MD; PhD, Hospices CHUV-Lausanne-Switzerland
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie del sistema immunitario
- Infezioni da HIV
Altri numeri di identificazione dello studio
- 2006-006141-13
- EV03/ANRSVAC20
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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