- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00528489
Safety and Effectiveness of PENNVAX-B Vaccine Alone, With Il-12, or IL-15 in Healthy Adults
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of PENNVAX-B (Gag, Pol, Env) Given Alone, With IL-12 DNA, or With a Dose Escalation of IL-15 DNA, in Healthy, HIV-1-uninfected Adults Participants
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
A vaccine that is effective against multiple strains of HIV remains the best option for preventing the spread of HIV. Plasmid DNA vaccines are inexpensive and easy to construct. When DNA vaccines are administered in combination with cytokines, such as IL-12 or IL-15, the immune response to the vaccine is increased. The purpose of this study is to determine the safety and tolerability of the DNA plasmid vaccine, PENNVAX-B when administered alone, or with IL-12 or IL-15 DNA adjuvants. The most effective and safe dose of IL-15 will also be determined during this study.
This study will last approximately 12 months. Participants will be randomly assigned to one of four groups. Group 1 will receive an injection of PENNVAX-B combined with 0.8 mg IL-15 in each deltoid or placebo. Group 2 will receive an injection of PENNVAX-B alone or placebo. Group 3 will receive an injection of PENNVAX-B combined with IL-12 in each deltoid or placebo. Group 4 will receive PENNVAX-B combined with 2 mg IL-15 or placebo. Injections will occur at study entry, Months 1, 3, and 6. Additional study visits will occur on Days 14, 42, 98, 182, 273, and 364. At these visits a brief physical, blood collection, interview, and risk reduction counseling will occur. At some visits HIV testing, urine collection, and pregnancy tests will also occur.
As of 05/30/08, participants will be enrolled into Groups 3 and 4 at a limited pace to allow for additional safety reviews for the first few participants in these groups. Additionally, safety data will be reviewed for Groups 1 and 2 to determine whether the remainder of participants in Groups 2, 3, and 4 will be enrolled.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35294
- Alabama Vaccine CRS
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California
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San Francisco, California, États-Unis
- San Francisco Vaccine and Prevention CRS
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Massachusetts
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Boston, Massachusetts, États-Unis
- Brigham and Women's Hosp. CRS
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New York
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Bronx, New York, États-Unis, 10456
- NY Blood Ctr./Bronx CRS
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New York, New York, États-Unis, 10003
- NY Blood Ctr./Union Square CRS
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New York, New York, États-Unis, 10032
- HIV Prevention & Treatment CRS
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis
- 3535 Market Street CRS
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Tennessee
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Nashville, Tennessee, États-Unis
- Vanderbilt Vaccine CRS
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- HIV-1 and -2 uninfected
- Willing to receive HIV test results
- Good general health
- Certain laboratory values within normal range or with site physician approval
- Negative for Hepatitis B surface antigen
- Negative Hepatitis C test
- Willing to use acceptable methods of contraception
Exclusion Criteria:
- HIV vaccines or placebos in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
- Immunosuppressive medications within 168 days prior to first study vaccination. Participants using corticosteroid nasal spray for allergies or topical corticosteroids for mild, uncomplicated dermatitis are not excluded.
- Blood products within 120 days prior to first study vaccination
- Receipt of immunoglobulin within 60 days prior to first vaccination
- Live attenuated vaccines within 30 days prior to first study vaccination
- Any vaccine that is not a live attenuated vaccine within 14 days prior to first study vaccination
- Investigational research agents within 60 days prior to first study vaccination
- Current anti-tuberculosis (TB) preventive therapy or treatment clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health. More information about this criterion can be found in the protocol.
- Any medical, psychiatric, social, occupational, or other condition or responsibility that in the opinion of the investigator would interfere with the study. More information about this criterion can be found in the protocol.
- Allergy to amide-type local anesthetics
- Serious adverse reactions to vaccines
- Autoimmune disease or immunodeficiency
- Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded.
- Asthma other than mild, well-controlled asthma. More information on this criterion can be found in the protocol.
- Type 1 or type 2 diabetes mellitus. Participants with histories of isolated gestational diabetes are not excluded.
- Thyroidectomy or thyroid disease requiring medication during the 12 months prior to study entry
- Accumulation of fluid in the blood vessels (angioedema) within 3 years prior to study entry if episodes are considered serious or have required medication in the 2 years prior to study entry
- Uncontrolled hypertension
- Body Mass Index of 40 or greater OR of 35 or greater if certain other criteria apply. More information about these criteria can be found in the protocol
- Bleeding disorder
- Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.
- Seizure disorder
- Absence of the spleen
- Pregnancy or breastfeeding
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 1
PENNVAX-B with 0.8 mg IL-15 administered in both deltoids at Months 0, 1, 3, and 6
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DNA vaccine containing the HIV genes Gag, Pol, and Env
Cytokine injection
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Expérimental: 2
PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6
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DNA vaccine containing the HIV genes Gag, Pol, and Env
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Expérimental: 3
PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6
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DNA vaccine containing the HIV genes Gag, Pol, and Env
Cytokine injection
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Expérimental: 4
PENNVAX-B with 2 mg IL-15 injected into both deltoids at Months 0, 1, 3, and 6
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DNA vaccine containing the HIV genes Gag, Pol, and Env
Cytokine injection
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Safety data including local and systemic reactogenicity sign and symptoms, laboratory measures of safety, and adverse and serious adverse events
Délai: Throughout study
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Throughout study
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Safety data from Groups 1 and 4
Délai: Throughout study
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Throughout study
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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HIV-1 specific interferon gamma ELISpot and/or intracellular cytokine staining T cell response
Délai: 2 weeks after 3rd and 4th vaccinations
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2 weeks after 3rd and 4th vaccinations
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HIV-1 specific neutralizing and binding antibody assays
Délai: 2 weeks after 3rd and 4th vaccinations
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2 weeks after 3rd and 4th vaccinations
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chaise d'étude: Scott Parker, MD, HVTN, FHCRC
Publications et liens utiles
Publications générales
- Jin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.
- Johnston MI, Fauci AS. An HIV vaccine--evolving concepts. N Engl J Med. 2007 May 17;356(20):2073-81. doi: 10.1056/NEJMra066267. No abstract available.
- Ogawa H, Ueno M, Uchibori H, Matsumoto I, Seno N. Direct carbohydrate analysis of glycoproteins electroblotted onto polyvinylidene difluoride membrane from sodium dodecyl sulfate-polyacrylamide gel. Anal Biochem. 1990 Nov 1;190(2):165-9. doi: 10.1016/0003-2697(90)90175-9.
- McBurney SP, Ross TM. Developing broadly reactive HIV-1/AIDS vaccines: a review of polyvalent and centralized HIV-1 vaccines. Curr Pharm Des. 2007;13(19):1957-64. doi: 10.2174/138161207781039841.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Syndromes d'immunodéficience
- Maladies du système immunitaire
- Infections à VIH
Autres numéros d'identification d'étude
- HVTN 070
- 10490 (Autre identifiant: CTEP)
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Essais cliniques sur Infections à 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
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West Virginia UniversityInscription sur invitationInfection de la peau et des tissus mous | Infection gastro-intestinale | Infection pulmonaire | Infection des os et des articulations | Infection endovasculaire | Infection génito-urinaireÉtats-Unis
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Taipei Medical University WanFang HospitalInconnue
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Ondine Biomedical Inc.ComplétéInfection du site opératoire | Infection nosocomiale | Infection associée aux soins de santéÉtats-Unis
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Croydon Health Services NHS TrustComplétéInfection du site opératoire | Infection de la plaie | Césarienne; Infection | Infection périnéaleRoyaume-Uni
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Angela BiancoStryker NordicRésiliéCésarienne | Infection du site opératoire | Infection nosocomialeÉtats-Unis
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Leiden University Medical CenterRadboud University Medical Center; University Medical Center Groningen; Erasmus... et autres collaborateursRecrutementInfection prothétique-articulaire | Infection de la hanche | Infection; Genou, ArticulationPays-Bas
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Cairo UniversityRecrutementInfection postopératoire | Complications de la césarienne | Infection vaginaleEgypte
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Gundersen Lutheran Medical FoundationGundersen Lutheran Health SystemComplétéInfection du site opératoire | Infection superficielle du site opératoire | Infection profonde du site chirurgical | Infection du site chirurgical d'un organe/de l'espaceÉtats-Unis
Essais cliniques sur PennVax B
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National Institute of Allergy and Infectious Diseases...Dynavax Technologies CorporationActif, ne recrute pasInfection par le VIH | Hépatite BÉtats-Unis, Haïti, Bostwana, Philippines, Thaïlande, Brésil, Kenya, Malawi, Inde, Afrique du Sud, Ouganda, Viêt Nam
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BioNTech SEComplétéCOVID-19 [feminine] | Infection par le SRAS-CoV2 | Maladie respiratoire aiguë SARS-CoV-2 | SRAS (maladie)États-Unis, Allemagne, Turquie, Afrique du Sud
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Marya Strand, MDComplétéSyndrome de détresse respiratoireÉtats-Unis
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ChemoCentryxMedpace, Inc.ComplétéGlomérulosclérose segmentaire focale | FSGS | GloméruloscléroseÉtats-Unis, France, Italie, Australie, Royaume-Uni, Canada, Nouvelle-Zélande, Pologne
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Indiana UniversityAlcon ResearchComplétéMyopie | HypermétropieÉtats-Unis
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Eli Lilly and CompanyComplété
-
Epstein, Arthur B., OD, FAAOAlcon ResearchComplété
-
Sonova AGComplétéPerte auditive, neurosensorielleSuisse
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PepsiCo Global R&DComplétéPerformance cognitiveÉtats-Unis
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Wright State UniversityRecrutementCancer de la peauÉtats-Unis