- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01889719
A Phase I Study to Evaluate the Safety and Immunogenicity of Heterologous Boost Immunizations With MVA-CMDR
12 février 2016 mis à jour par: Rockefeller University
Phase I Study to Evaluate the Safety/Immunogenicity of Boost Immunizations With MVA-CMDR in Healthy Volunteers Previously Immunized With Anti-DEC-205 Monoclonal Antibody Targeted HIV Gag p24 Vaccine Plus Poly-ICLC (RV 365 / WRAIR #2006)
This trial will investigate whether immunizations with an MVA recombinant HIV vaccine are safe and whether they will boost immune responses generated by immunizations with a dendritic cell (DC) targeted protein vaccine, DCVax-001, plus poly ICLC in healthy HIV-uninfected volunteers.
Aperçu de l'étude
Description détaillée
This trial will investigate whether immunizations with an MVA recombinant HIV vaccine are safe and whether they will boost immune responses generated by immunizations with a dendritic cell (DC) targeted protein vaccine, DCVax-001, plus poly ICLC in healthy HIV-uninfected volunteers.
Investigators propose to assess the quality of immunity elicited by immunizations with MVA-CMDR only or by booster immunizations with MVA-CMDR in volunteers previously immunized with a DC-targeted HIV vaccine.
This vaccination regimen can provide the proof-of-concept that DC targeted protein vaccines can prime strong immune responses and therefore be valuable in combination with other vaccine modalities against HIV or other diseases.
Type d'étude
Interventionnel
Inscription (Réel)
14
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New York
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New York, New York, États-Unis, 10065
- The Rockefeller University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 62 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Have completed protocol SSC-710 and received either DCVax-001 plus poly ICLC, poly ICLC only or sterile saline. If less than 6 volunteers who originally received placebo (poly ICLC only or sterile saline) under protocol SSC_710 are willing to participate and are found eligible to participate in this proposed study, new volunteers can be enrolled as long as they are eligible according to the remaining inclusion and exclusion criteria below.
- Healthy adult males and females, as assessed by a medical history, physical exam, ECG, and laboratory tests;
- Age of at least 18 years of age on the day of screening and no greater than 62 years at time of vaccination;
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 12 months);
- In the opinion of the principal investigator or designee, has understood the information provided. (Written informed consent needs to be given before any study-related procedures are performed);
- Amenable to HIV risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit;
- Assessed by the clinic staff as being at "low risk" for HIV infection on the basis of sexual behaviors within the 12 months prior to enrollment defined as follows:
- Sexually abstinent OR
- Had two or fewer mutually monogamous relationships with partners believed to be HIV-uninfected and who did not use illicit drugs (illicit drug use or abuse that includes any injection drugs, methamphetamines (crystal meth), heroin, cocaine, including crack cocaine or chronic marijuana abuse) OR
- Had two or fewer partners believed to be HIV-uninfected and who did not use illicit drugs (as defined above) and with whom he/she regularly used condoms for vaginal and anal intercourse;
- If sexually active female, willing to use one effective method of contraception (combined oral contraceptive pill; injectable contraceptive; diaphragm; Intra Uterine Device (IUD); condoms; anatomical sterility in self or partner) at least until 3 months after last immunization. All female volunteers must be willing to undergo urine pregnancy tests at time points as indicated in the Schedule of Procedures.
Exclusion Criteria:
- Confirmed HIV-1 or HIV-2 infection
- Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids immunosuppressive anticancer, or other medications considered significant by the trial physician within the last 6 months
- Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, myopericarditis, grand-mal epilepsy, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation
- History of clinically significant eczema or chronic urticaria
- Any laboratory value outside of reference range, with the exception of any non-clinically significant Grade I elevations of liver function tests (AST, ALT, direct/total bilirubin), electrolytes (Na, K, Cl, CO2), CBC, urinalysis as determined by the Principal Investigator or his designee
- Baseline ECG with features that would interfere with interpretation of myo/pericarditis including significant repolarization abnormality, bundle branch block, and AV block
- Within the 12 months prior to enrollment, the volunteer has had excessive daily alcohol use or frequent binge drinking or chronic marijuana abuse or any other use of illicit drugs
- Within the 12 months prior to enrollment, the volunteer has a history of newly-acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), pelvic inflammatory disease (PID), mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, hepatitis B (surface antigen, HbsAg) or hepatitis C (HCV antibodies);
- If female, pregnant, planning a pregnancy during the 3-month follow up period after last immunization, or lactating
- Receipt of a live attenuated vaccine within 30 days or other vaccine within 14 days prior to study vaccination
- Prior use of medications for HIV PrEP
- Receipt of an investigational product (not vaccine-related) within the last 12 months. Receipt of a non-HIV experimental vaccine(s) within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by the FDA. For subjects who have received control/placebo in an experimental vaccine trial, or who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the investigators on a case-by-case basis.
- History of severe local or systemic reaction to vaccination defined as:
- Local: extensive, indurated redness and swelling involving most of the major circumference of the arm, not resolving within 72 hours;
- Systemic: fever > 39.5°C within 48 hours, anaphylaxis, bronchospasm, laryngeal edema, circulatory collapse, convulsions or encephalopathy within 72 hours
- History of immediate type hypersensitivity reaction to eggs or egg products
- Major psychiatric illness
- In the opinion of the investigator, unlikely to comply with protocol
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Vaccination with MVA-CMDR Group 1
Six to 27 subjects who previously received vaccination with DEC-205, will receive vaccination with MVA-CMDR
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injections of MVA-CMDR vaccine
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Comparateur actif: Vaccination with MVA-CMDR Group 2
Six to 27 subjects who previously did not receive vaccination with DEC-205, will receive vaccination with MVA-CMDR
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injections of MVA-CMDR vaccine
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
safety and tolerability of MVA-CMDR vaccine
Délai: 16 weeks
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safety and tolerability of two intramuscular injections of MVA-CMDR vaccine candidate in healthy HIV-uninfected volunteers
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16 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Sarah Schlesinger, MD, Rockefeller Univesrity
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2014
Achèvement primaire (Réel)
1 mai 2015
Achèvement de l'étude (Réel)
1 mai 2015
Dates d'inscription aux études
Première soumission
20 juin 2013
Première soumission répondant aux critères de contrôle qualité
26 juin 2013
Première publication (Estimation)
28 juin 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
17 février 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 février 2016
Dernière vérification
1 février 2016
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- SSC-0803
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur VIH
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Icahn School of Medicine at Mount SinaiIRRASRecrutementHémorragie intraventriculaire (HIV)États-Unis
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Yale UniversityComplétéPrématurité | Nourrissons de très faible poids à la naissance | Hémorragie intraventriculaire (HIV) | Saignement dans le cerveauÉtats-Unis
Essais cliniques sur MVA-CMDR
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Henry M. Jackson Foundation for the Advancement...Johns Hopkins University; Karolinska Institutet; University of Miami; Chulalongkorn... et autres collaborateursRecrutementInfections à VIHAfrique du Sud
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National Institute of Allergy and Infectious Diseases...HIV Vaccine Trials Network; IPPOX Foundation; CHAVI; MHRPComplété
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Instituto Nacional de Saúde, MozambiqueEuropean and Developing Countries Clinical Trials Partnership (EDCTP); Swedish...Complété
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University of OxfordComplété
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TransgeneComplété
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Bavarian NordicJPM CBRN MedicalComplétéEncéphalite équineÉtats-Unis
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Bavarian NordicComplétéInfections par le virus respiratoire syncytialÉtats-Unis
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National Institute of Allergy and Infectious Diseases...Recrutement
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Universitätsklinikum Hamburg-EppendorfErasmus Medical Center; German Center for Infection Research; Coalition for... et autres collaborateursActif, ne recrute pasMERS (syndrome respiratoire du Moyen-Orient)Allemagne, Pays-Bas
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Vaccitech (UK) LimitedRecrutement