- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00695877
Safety and Immune Response to a Recombinant Adenovirus HIV-1 Vaccine in Healthy Adults
A Phase I Randomized, Double-blind, Placebo Controlled Dose Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Adenovirus Serotype 5 HVR48 HIV-1 Vaccine (Ad5HVR48.ENVA.01) in Healthy, HIV-1 Uninfected Adults (Ad5HVR48.ENVA.01 (rAd5HVR48) HIV-1/IPCAVD-002 Vaccine Study)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Control of the HIV pandemic can only be achieved with the development of a safe and effective preventive HIV vaccine. A vaccine that will prevent HIV infection will elicit a strong immune response from both CD4 and CD8 cells. Recombinant adenovirus serotype vectors have been shown to elicit just such a response. The purpose of this study is to determine the safety and immunogenicity of the recombinant adenovirus serotype 5 preventive HIV-1 vaccine.
This study will last 18 to 24 months. Participants will be randomly assigned to one of four arms that will receive vaccine or placebo administered via intramuscular injection. Participants in Arms 1, 2, and 3 will all receive 3 injections. Participants in Arm 4 will receive one injection. For most participants, there will be 10 study visits in this study; for participants in Arm 4, there will be only 7 visits. For Arms 1, 2, and 3, study visits will occur at baseline and on Days 0, 14, 28, 42, 56, 168, 182,196, and 365. Participants in Arms 1, 2, and 3 will receive injections on Days 0, 28, and 168. For participants in Arm 4, study visits will occur at baseline and on Days 0, 14, 28, 56, 168 and 365. Participants in Arm 4 will receive one injection only, on Day 0. Participants will be asked to record their temperature and other side effects in a symptom log for 3 days after each injection. Risk reduction/pregnancy prevention counseling and physical exams will occur at all visits. At most visits, blood, urine, and oral swab collection will occur. Samples collected will be stored for future testing. HIV testing and pregnancy testing will occur at select visits. At Years 2, 3, 4, and 5, participants will be followed-up by telephone, e-mail, or study visit to collect vital status, and information about any development of significant disability or incapacity, hospitalizations, or congenital anomalies. At these follow-up visits, blood collection will be optional.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Brigham and Women's Hosp. Novel Adenoviral Vector Prophylactic HIV Vaccine Non-Network 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:
- Good general health
- Normal hematological, hepatic and renal functions
- Demonstrated understanding of study
- Willing to receive HIV test results
- HIV-1 and -2 uninfected
- Hepatitis B surface antigen negative
- Anti-hepatitis C virus (anti-HCV) negative antibody or negative HCV PCR if anti-HCV is positive
- Adequate contraception. For more information on this criterion can be found in the protocol.
Exclusion Criteria:
- HIV vaccines or placebos in prior HIV vaccine trial
- Immunosuppressive medications within 168 days prior to first injection. Participants taking corticosteroid nasal spray or topical corticosteroids are not excluded.
- Blood products within 120 days prior to first injection
- Immunoglobulin within 60 days prior to first injection
- Investigational agents within 30 days prior to first injections
- Live attenuated vaccine within 30 days prior to first injection
- Any vaccine that is not a live attenuated vaccine within 14 days prior to first injection
- Any clinically significant medical condition that, in the opinion of the investigator, may interfere with the study
- Any medical, psychiatric, occupational, or social condition or responsibility that, in the opinion of the investigator, would interfere with the study
- Serious adverse reaction to vaccines. Participants who had a nonanaphylactic adverse reaction to pertussis vaccine as a child are not excluded.
- Known autoimmune disease
- Known immunodeficiency
- Asthma other than mild, well-controlled asthma
- Diabetes mellitus type 1 or 2
- Thyroidectomy or thyroid disease in the12 months prior to study entry
- Angioedema in the 3 years prior to study entry
- Hypertension. More information on this criterion can be found in the protocol.
- Body mass index (BMI) of 40 or higher OR BMI of 35 or greater, if other cardiovascular risk factors. More information on this criterion can be found in the protocol.
- Bleeding disorder
- Malignancy, unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period
- Seizure disorder or occurrence of seizure in the 3 years prior to study entry. Participants who have not required medications or had a seizure for prior 3 years are not excluded.
- Absence of spleen
- Individuals at high-risk of acquiring HIV infection
- Presence of pre-existing neutralizing antibodies for Adenovirus 5 or 48
- 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: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 1
3 injections of rAd5.ENVA.48
HIV-1 vaccine or placebo at 1 x 10^9 virus particles (VP) given at Days 0, 28, and 168
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Recombinant adenovirus serotype 5 HIV-1 vaccine
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Expérimental: 2
3 injections of rAd5.ENVA.48
HIV-1 vaccine or placebo at 1 x 10^10 virus particles (VP) given at Days 0, 28, and 168
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Recombinant adenovirus serotype 5 HIV-1 vaccine
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Expérimental: 3
3 injections of rAd5.ENVA.48
HIV-1 vaccine or placebo at 1 x 10^11 virus particles (VP) given at Days 0, 28, and 168
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Recombinant adenovirus serotype 5 HIV-1 vaccine
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Expérimental: 4
1 injection of rAd5.ENVA.48
HIV-1 vaccine or placebo at a dose determined by the safety data from Arms 1, 2 and 3 given at Day 0.
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Recombinant adenovirus serotype 5 HIV-1 vaccine
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Local and systemic adverse reactions
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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Génotypage
Délai: Tout au long de l'étude
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Tout au long de l'étude
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Humoral Immune response
Délai: Throughout study
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Throughout study
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Cell mediated immunity
Délai: Throughout study
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Throughout study
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Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Lindsey Baden, MD, Brigham and Women's Hospital
- Chaise d'étude: Dan Barouch, MD, Beth Israel Deaconess Medical Center
Publications et liens utiles
Publications générales
- Priddy FH, Brown D, Kublin J, Monahan K, Wright DP, Lalezari J, Santiago S, Marmor M, Lally M, Novak RM, Brown SJ, Kulkarni P, Dubey SA, Kierstead LS, Casimiro DR, Mogg R, DiNubile MJ, Shiver JW, Leavitt RY, Robertson MN, Mehrotra DV, Quirk E; Merck V520-016 Study Group. Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clin Infect Dis. 2008 Jun 1;46(11):1769-81. doi: 10.1086/587993.
- Stevens W, Kamali A, Karita E, Anzala O, Sanders EJ, Jaoko W, Kaleebu P, Mulenga J, Dally L, Fast P, Gilmour J, Farah B, Birungi J, Hughes P, Manigart O, Stevens G, Yates S, Thomson H, von Lieven A, Krebs M, Price MA, Stoll-Johnson L, Ketter N. Baseline morbidity in 2,990 adult African volunteers recruited to characterize laboratory reference intervals for future HIV vaccine clinical trials. PLoS One. 2008 Apr 30;3(4):e2043. doi: 10.1371/journal.pone.0002043.
- Baden LR, Walsh SR, Seaman MS, Johnson JA, Tucker RP, Kleinjan JA, Gothing JA, Engelson BA, Carey BR, Oza A, Bajimaya S, Peter L, Bleckwehl C, Abbink P, Pau MG, Weijtens M, Kunchai M, Swann EM, Wolff M, Dolin R, Barouch DH. First-in-human evaluation of a hexon chimeric adenovirus vector expressing HIV-1 Env (IPCAVD 002). J Infect Dis. 2014 Oct 1;210(7):1052-61. doi: 10.1093/infdis/jiu217. Epub 2014 Apr 8.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
- Ad5HVR48.ENVA.01/IPCAVD-002
- 10701 (Identificateur de registre: DAIDS ES Registry Number)
- Ad5HVR48.ENVA.01/ IPCAVD-002
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 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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Croydon Health Services NHS TrustComplétéInfection du site opératoire | Infection de la plaie | Césarienne; Infection | Infection périnéaleRoyaume-Uni
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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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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 Ad5.ENVA.48 HIV-1 vaccine
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Merck Sharp & Dohme LLCRésilié