- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
- Phase 1
Kontakte und Standorte
Studienorte
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Créteil, Frankreich, 94010
- Hôpital Henri Mondor
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Lausanne, Schweiz, 1011
- Centre hospitalier universitaire vaudois CHUV
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 3 DNA-C + 1 NYVAC-C
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1.0mg per ml of DNA HIV-C vaccine 2x2 ml IM
NYVAC-C 1 ml IM
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Aktiver Komparator: 2 DNA-C + 2 NYVAC-C
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1.0mg per ml of DNA HIV-C vaccine 2x2 ml IM
NYVAC-C 1 ml IM
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
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
Zeitfenster: week 26 and week 28
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week 26 and week 28
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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.
Zeitfenster: within 72 weeks
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within 72 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Cellular responses: CD8/CD4+ T cell mean IFNgamma Spot Forming Units (SFU) per million cells across the peptide pools
Zeitfenster: at weeks 26 and 28
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at weeks 26 and 28
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Cellular responses: CD8/CD4+ T cell mean Spot Forming Units (SFU) per million cells across the peptide pools
Zeitfenster: at any week following the first immunisation including weeks 48 and 72
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at any week following the first immunisation including weeks 48 and 72
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Cellular responses: mean proportion of CD4/CD8+ T cells producing IL-2 and/or IFNgamma following ex-vivo stimulation with HIV-1 peptide pools
Zeitfenster: at weeks 26 and 28, 48 and 72
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at weeks 26 and 28, 48 and 72
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Cellular responses: number of different epitopes that can be characterised
Zeitfenster: to be determined at a later stage
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to be determined at a later stage
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Antibody responses
Zeitfenster: to be determined at a later stage
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to be determined at a later stage
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All grade 1 and 2 adverse events
Zeitfenster: within 72 weeks
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within 72 weeks
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All events including those considered unrelated
Zeitfenster: within the 72 weeks
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within the 72 weeks
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Yves LEVY, MD; PhD, Hôpital Henri Mondor-Créteil-France
- Hauptermittler: Giuseppe PANTALEO, MD; PhD, Hospices CHUV-Lausanne-Switzerland
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- HIV-Infektionen
Andere Studien-ID-Nummern
- 2006-006141-13
- EV03/ANRSVAC20
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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