- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00027261
Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults
A Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of High-Dose Live Recombinant Canarypox ALVAC-HIV Vaccine (vCP1452) in Healthy, HIV-1 Uninfected Adult Participants
The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe and to study how the immune system responds to the vaccine. This trial is designed to determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune response.
As of May 2001, over 200 people received the ALVAC-HIV (vCP1452) vaccine at the lower dose. The higher dose of the vaccine to be used in this study has not been given to humans previously. High doses of a similar vaccine have been given to a few people without serious side effects. In a recent study done in mice, higher doses of ALVAC-HIV produced stronger immune responses. It is possible that the doses of ALVAC-HIV given to humans are below the amount needed for the maximum immune response. Because the exact relationship between an increased immune response and its effectiveness in preventing HIV infection is uncertain, the HVTN will use the highest dose that can be manufactured.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
To date, adverse reactions to immunization with the various ALVAC-HIV candidate vaccines, including ALVAC-HIV (vCP1452), have been similar to those observed in healthy adults who have received other licensed vaccines of similar types. In a previous trial, even high doses of recombinant ALVAC vaccine were well tolerated in a group of participants that were significantly immunocompromised. In a recent study done in mice concerning dose escalation using the ALVAC-HIV vectors, the data demonstrated more robust immune responses with higher doses of ALVAC-HIV (vCP1452) in mice. It is certainly possible that the doses of ALVAC-HIV given to humans are well below the amount needed for a maximal cytotoxic T lymphocyte (CTL) response. As the predictive value of a CTL response is at present unknown with respect to its efficacy in preventing or ameliorating HIV acquisition or infection, the HVTN will utilize the highest dose that can be currently manufactured.
All study products are to be administered intramuscularly. Participants will receive 1 of 3 injections. Group A will receive a high dose of vaccine, group B will receive a low dose of vaccine, and group C will receive a placebo. Participants are inoculated at 4 time points. Assessment of product safety includes clinical observation, monitoring of hematological, chemical, and immunologic parameters, and a social harms questionnaire. Safety will be evaluated by monitoring of participants for local and systemic adverse reactions during the course of the trial. Participants will be monitored longitudinally for HIV-specific serologic and cellular immune responses.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
Alabama
-
Birmingham, Alabama, États-Unis, 35294
- Alabama Vaccine CRS
-
-
California
-
San Francisco, California, États-Unis, 94102
- San Francisco Vaccine and Prevention CRS
-
San Francisco, California, États-Unis
- UCSF, Gen. Clinical Research Ctr., Mt. Zion Hosp.
-
-
Maryland
-
Baltimore, Maryland, États-Unis
- Project Brave HIV Vaccine CRS
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis, 02115
- Brigham and Women's Hosp. CRS
-
Boston, Massachusetts, États-Unis, 02115
- Fenway Community Health Clinical Research Site (FCHCRS)
-
-
Missouri
-
Saint Louis, Missouri, États-Unis, 63110
- Saint Louis Univ Health Sciences Ctr
-
-
New York
-
New York, New York, États-Unis, 10021
- NY Blood Ctr./Union Square CRS
-
Rochester, New York, États-Unis, 14642
- Univ. of Rochester HVTN CRS
-
-
Rhode Island
-
Providence, Rhode Island, États-Unis, 02906
- Miriam Hospital's HVTU
-
-
Tennessee
-
Nashville, Tennessee, États-Unis, 37232
- Vanderbilt Vaccine CRS
-
-
Virginia
-
Annandale, Virginia, États-Unis
- Infectious Diseases Physicians, Inc.
-
-
Washington
-
Seattle, Washington, États-Unis, 98109
- FHCRC/UW Vaccine CRS
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria
Participants may be eligible for this study if they:
- Are between the ages of 18 and 60.
- Are in good general health.
- Have a CD4 count of 400 or more cells/mm3.
- Do not have hepatitis C or active hepatitis B.
- Have had a negative HIV blood test within 8 weeks prior to enrollment.
- Use approved methods of contraception.
- Have access to a participating site and are available for follow-up for 18 months.
- Complete a questionnaire evaluating the participant's understanding of the study prior to enrollment.
- Give written informed consent.
Exclusion Criteria
Participants may not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Have received a live vaccine within 30 days prior to enrollment.
- Have received a killed vaccine or allergy treatment with injections within 14 days prior to study vaccine.
- Have used experimental research agents within 30 days prior to enrollment.
- Have received HIV-1 vaccines or placebo in a previous HIV vaccine trial.
- Have received blood products 120 days before HIV screening.
- Have received immunoglobulin 60 days before HIV screening.
- Have a history of serious harmful reactions to vaccines.
- Have a history of disease of the immune system.
- Have a history of cancer, unless it has been surgically removed and in the estimate of the investigator is not likely to happen again during the study period.
- Are using or have used (within past 6 months) drugs that interfere with the immune system.
- Have a history of type I or type II diabetes.
- Have thyroid disease.
- Have unstable asthma.
- Are currently taking preventive anti-TB therapy.
- Have a seizure disorder.
- Have a bleeding disorder that was diagnosed by a physician.
- Have had their spleen removed.
- Have angioedema with serious episodes.
- Have active syphilis.
- Have hypertension.
- Have mental problems that would interfere with the protocol.
- Have any other problems that, in the judgment of the investigator, would interfere with the study.
- Have a body mass index less than 20.
- Are allergic or sensitive to egg products.
- Have active tuberculosis.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Masquage: Double
Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Paul Goepfert
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
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
Mots clés
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 039
- 10200 (Autre identifiant: CTEP)
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
-
Icahn School of Medicine at Mount SinaiIRRASRecrutementHémorragie intraventriculaire (HIV)États-Unis
-
Yale UniversityComplétéPrématurité | Nourrissons de très faible poids à la naissance | Hémorragie intraventriculaire (HIV) | Saignement dans le cerveauÉtats-Unis
-
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
-
Taipei Medical University WanFang HospitalInconnue
-
Ondine Biomedical Inc.ComplétéInfection du site opératoire | Infection nosocomiale | Infection associée aux soins de santéÉtats-Unis
-
Croydon Health Services NHS TrustComplétéInfection du site opératoire | Infection de la plaie | Césarienne; Infection | Infection périnéaleRoyaume-Uni
-
Angela BiancoStryker NordicRésiliéCésarienne | Infection du site opératoire | Infection nosocomialeÉtats-Unis
-
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
-
Cairo UniversityRecrutementInfection postopératoire | Complications de la césarienne | Infection vaginaleEgypte
-
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 ALVAC(2)120(B,MN)PNB (vCP1452)
-
National Institute of Allergy and Infectious Diseases...ComplétéInfections à VIH | Séronégativité VIHBrésil, Pérou, Haïti, Trinité-et-Tobago
-
National Institute of Allergy and Infectious Diseases...Complété
-
National Institute of Allergy and Infectious Diseases...Complété
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...ComplétéInfections à VIH | Séronégativité VIHÉtats-Unis
-
National Institute of Allergy and Infectious Diseases...ComplétéInfections à VIHÉtats-Unis
-
National Institute of Allergy and Infectious Diseases...ComplétéInfections à VIHÉtats-Unis
-
National Institute of Allergy and Infectious Diseases...Complété
-
National Institute of Allergy and Infectious Diseases...ComplétéInfections à VIHÉtats-Unis, Porto Rico
-
National Institute of Allergy and Infectious Diseases...Complété
-
National Institute of Allergy and Infectious Diseases...New York Presbyterian HospitalComplétéInfections à VIHÉtats-Unis