- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00000904
Safety and Effectiveness of Anti-HIV Vaccines in HIV-Negative Adults
A Phase I Trial to Compare the Safety and Immunogenicity of the Live Recombinant Canarypox ALVAC-HIV Vaccines, vCP205, vCP1433, and vCP1452, in HIV-1 Uninfected Adult Volunteers
The purpose of this study is to find out whether three different anti-HIV vaccines are safe and whether they help prevent HIV infection. These vaccines are called vCP205, vCP1433, and vCP1452. Some patients also receive another anti-HIV vaccine, gp160. The vaccines are made up of small pieces of HIV, which help the body learn to recognize and destroy HIV. You cannot get HIV from these vaccines.
There are two different ways a vaccine can protect the body from infection. First, a vaccine may help the immune system make antibodies, which are proteins that recognize invading viruses or bacteria. Second, a vaccine may help the body make immune cells that destroy infected cells. The second type of vaccine is more powerful against HIV. In this study, doctors will see whether vCP205, vCP1433, vCP1452, and gp160 are good vaccines by seeing whether they help the body make immune cells.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Previous studies in humans have shown that immunization with certain vaccine combinations (that is, ALVAC-HIV construct and an envelope subunit vaccine) can elicit CTL activity, antibody-dependent cellular toxicity (ADCC), neutralizing antibodies, and other antibody responses more often and at higher levels than either vaccine alone. This study examines improved vaccine candidates that can elicit broader, longer-lasting CTL activity in the majority of vaccine recipients.
Volunteers are randomized to one of four groups. Group I receives vCP205. Group II receives vCP1433. Group III receives vCP1452. Group IV receives an ALVAC rabies vaccine, as a control. Immunizations are administered at Months 0, 1, 3, and 6. At Months 3 and 6, patients in Groups I, II, and III also receive gp160 MN/LAI-2, the subunit boost vaccine. Group IV receives another placebo vaccine. Participants have regular clinic visits and blood is drawn to determine humoral and cellular immune responses to the vaccines. [AS PER AMENDMENT 10/23/98: A cell-mediated immunity substudy has been added at selected institutions following the fourth vaccination at 6 months; this study will assess the newer assays of CD8+ T cells and the kinetic response following immunization. The 6-month immunization may be rescheduled by up to 14 days to accommodate clinical, laboratory, or volunteer scheduling issues.] [AS PER AMENDMENT 6/17/99: Three study arms are added. Group V receives vCP1452 at Months 0,1,3, and 6. Group VI receives vCP205 at Months 0,1,3, and 6. Group VII receives placebo at Months 0,1,3, and 6. Patients in Groups V, VI, and VII do not receive the subunit boost, gp160 MN/LAI-2. Consenting volunteers enrolled in the three new groups at Johns Hopkins University undergo PET scanning as part of an ancillary study.]
Studientyp
Einschreibung
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35294
- UAB AVEG
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21205
- JHU AVEG
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Missouri
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Saint Louis, Missouri, Vereinigte Staaten, 63110
- St. Louis Univ. School of Medicine AVEG
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New York
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Rochester, New York, Vereinigte Staaten, 14642
- Univ. of Rochester AVEG
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Tennessee
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Nashville, Tennessee, Vereinigte Staaten, 37232
- Vanderbilt Univ. Hosp. AVEG
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Washington
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Seattle, Washington, Vereinigte Staaten, 98104
- UW - Seattle AVEG
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria
You may be eligible for this study if you:
- Are 18-60 years old.
- Are HIV-negative and are in good health.
- Have a CD4 count of at least 400 cells/mm3.
- Test negative for hepatitis B.
- Agree to use effective methods of birth control for 1 month before and during the study.
Exclusion Criteria
You will not be eligible for this study if you:
- Are at high risk for being infected with HIV (risky sex behavior or injection drug use within 12 months prior to study entry).
- Have a serious medical condition, or if you have had chronic sickness, diseases of the immune system, or cancer that was not cured through surgery.
- Have a serious psychiatric condition or if you have been suicidal.
- Have a work commitment that would keep you from completing the study.
- Have syphilis or tuberculosis.
- Are allergic to eggs, neomycin, vaccines, or have ever had severe allergic reactions.
- Have taken certain medicines, including medicines that affect the immune system or experimental medicines.
- Have participated in another HIV vaccine trial.
- Have received any vaccines within 2 weeks of study entry.
- Have received a blood transfusion within 6 months prior to study entry.
- Are pregnant or breast-feeding.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Maskierung: Doppelt
Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: David Schwartz, Johns Hopkins Bloomberg School of Public Health
- Studienstuhl: Clayton Harro, Johns Hopkins Bloomberg School of Public Health
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Fang ZY, Limbach K, Tartaglia J, Spearman P. A canarypox HIV vaccine candidate elicits efficient gag-env pseudovirion formation from human muscle cells. 36th Annual Meeting, Infectious Diseases Society of America. 1998 Nov 12-15 [Poster 710]
- Bures R, Gaitan A, Zhu T, Graziosi C, McGrath KM, Tartaglia J, Caudrelier P, El Habib R, Klein M, Lazzarin A, Stablein DM, Deers M, Corey L, Greenberg ML, Schwartz DH, Montefiori DC. Immunization with recombinant canarypox vectors expressing membrane-anchored glycoprotein 120 followed by glycoprotein 160 boosting fails to generate antibodies that neutralize R5 primary isolates of human immunodeficiency virus type 1. AIDS Res Hum Retroviruses. 2000 Dec 10;16(18):2019-35. doi: 10.1089/088922200750054756.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
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
- Physiologische Wirkungen von Arzneimitteln
- Antiinfektiva
- Antivirale Mittel
- Antineoplastische Mittel
- Immunologische Faktoren
- Schutzmittel
- Adjuvantien, Immunologische
- Antibiotika, antineoplastische
- Interferon-Induktoren
- Strahlenschutzmittel
- Polysaccharid-K
Andere Studien-ID-Nummern
- AVEG 034
- 10583 (DAIDS ES Registry Number)
- AVEG 034A
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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Johns Hopkins UniversityAbgeschlossenCLABSI – Central Line Associated Bloodstream InfectionVereinigte Staaten
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National Taiwan University HospitalAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Taiwan
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University of ZurichNoch keine RekrutierungCentral Line-associated Bloodstream Infection (CLABSI) | Katheterbedingte Blutstrominfektion
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Klinische Studien zur ALVAC-HIV MN120TMG (vCP205)
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Walter Reed Army Institute of Research (WRAIR)UnbekanntHIV-Infektionen | HIV SeronegativitätVereinigte Staaten
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National Institute of Allergy and Infectious Diseases...AbgeschlossenHIV-Infektionen | HIV SeronegativitätVereinigte Staaten
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Walter Reed Army Institute of Research (WRAIR)AbgeschlossenHIV-Infektionen | HIV SeronegativitätVereinigte Staaten
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National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...AbgeschlossenHIV-Infektionen | HIV SeronegativitätVereinigte Staaten
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National Institute of Allergy and Infectious Diseases...Abgeschlossen
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National Institute of Allergy and Infectious Diseases...AbgeschlossenHIV-InfektionenVereinigte Staaten
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National Institute of Allergy and Infectious Diseases...AbgeschlossenHIV-Infektionen | HIV SeronegativitätVereinigte Staaten
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National Institute of Allergy and Infectious Diseases...MRC/UVRI and LSHTM Uganda Research Unit; Fogarty International Center of the... und andere MitarbeiterAbgeschlossen
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National Institute of Allergy and Infectious Diseases...Abgeschlossen
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National Institute of Allergy and Infectious Diseases...Abgeschlossen