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- Klinische proef NCT00091416
Safety of and Immune Response to an HIV-1 Vaccine Boost (VRC-HIVADV014-00-VP) in HIV Uninfected Adults Who Participated in HVTN 052
A Phase I Clinical Trial to Evaluate the Safety of a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Administered to Healthy, HIV-1 Uninfected, Adult Participants Who Received DNA Plasmid Vaccine or Placebo in the HVTN 052 Clinical Trial
Studie Overzicht
Gedetailleerde beschrijving
The worldwide HIV epidemic highlights the importance of developing an affordable, globally successful vaccine for HIV prevention. The VRC-HIVADV014-00-VP adenoviral vector vaccine used in this study was developed to stimulate strong virus-specific CD8 cytotoxic T-lymphocyte (CTL) responses thought to be crucial in an effective preventive HIV vaccine. The purpose of this study is to determine the safety and immunogenicity of a VRC-HIVADV014-00-VP vaccine boost given to healthy, HIV uninfected individuals who participated in HVTN 052, which evaluated the VRC-HIVDNA009-00-VP DNA plasmid vaccine. In that study, participants received either 3 injections of vaccine, 2 injections of vaccine and 1 injection of placebo, or 3 injections of placebo over a 2-month period.
This study will last one year. Participants will be randomly assigned to receive vaccine boost or placebo by intramuscular injection. The injections will be given 6 to 9 months after each participant's first HVTN 052 study injection, preferably as close to 6 months after the first HVTN 052 injection as possible. After a screening visit, study visits will occur at enrollment (when the injection will be given), at Week 2, and at Months 1, 3, 6, and 12. Blood collection, physical exam, and medication assessment will occur at every study visit; urine collection will occur at selected visits.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21205-1901
- Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02115
- Fenway Community Health Clinical Research Site (FCHCRS)
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Missouri
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Saint Louis, Missouri, Verenigde Staten, 63110-2500
- Saint Louis Univ. School of Medicine, HVTU
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New York
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New York, New York, Verenigde Staten
- HIV Prevention & Treatment CRS
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Rochester, New York, Verenigde Staten, 14642-0001
- Univ. of Rochester HVTN CRS
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Rhode Island
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Providence, Rhode Island, Verenigde Staten, 02906
- Miriam Hospital's HVTU
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37232
- Vanderbilt Vaccine CRS
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Washington
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Seattle, Washington, Verenigde Staten, 98104
- FHCRC/UW Vaccine CRS
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Previously enrolled in and have completed all 3 study vaccine injections for HVTN 052
- Understanding of vaccination procedure
- Good general health
- HIV uninfected
- Hepatitis B surface antigen negative
- Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive
- Willing to use acceptable forms of contraception
Exclusion Criteria:
- Immunosuppressive medications within 168 days prior to study
- Blood products within 120 days prior to study
- Immunoglobulin within 60 days prior to study
- Live attenuated vaccines within 30 days prior to study
- Investigational research agents within 30 days prior to study
- Medically indicated subunit or killed vaccines within 14 days prior to study
- Allergy shots within 30 days prior to study
- Current anti-tuberculosis prophylaxis or therapy
- Anaphylaxis or other serious adverse reactions to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
- Autoimmune disease or immunodeficiency
- Active syphilis infection
- Unstable asthma (e.g., daily symptoms; use of oral or orally inhaled corticosteroids or other treatments; emergent care, urgent care, hospitalization, or intubation during the past 2 years)
- Diabetes mellitus. A participant with past gestational diabetes is not excluded.
- Thyroid disease, including removal of thyroid and diagnoses requiring medication. A participant not requiring thyroid medication during the last year is not excluded.
- Serious angioedema. A participant who has had an episode of angioedema over 3 years prior to the study, and has not required medications for at least 2 years, is not excluded.
- Uncontrolled hypertension
- Diagnosis of bleeding disorder
- Malignancy, except those with a surgical excision that has a reasonable assurance of sustained cure and/or is unlikely to recur during the period of the study
- Seizure disorder requiring medication within the last 3 years
- Absence of the spleen
- Mental illness that would interfere with compliance with the protocol
- Pregnancy or breastfeeding
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Larry Peiperl, MD, San Francisco Department of Public Health / University of California - San Francisco
- Studie stoel: Julie McElrath, MD, PhD, Fred Hutchinson Cancer Research Center / University of Washington
Publicaties en nuttige links
Algemene publicaties
- Gomez-Roman VR, Robert-Guroff M. Adenoviruses as vectors for HIV vaccines. AIDS Rev. 2003 Jul-Sep;5(3):178-85.
- McShane H. Prime-boost immunization strategies for infectious diseases. Curr Opin Mol Ther. 2002 Feb;4(1):23-7.
- Pinto AR, Fitzgerald JC, Giles-Davis W, Gao GP, Wilson JM, Ertl HC. Induction of CD8+ T cells to an HIV-1 antigen through a prime boost regimen with heterologous E1-deleted adenoviral vaccine carriers. J Immunol. 2003 Dec 15;171(12):6774-9. doi: 10.4049/jimmunol.171.12.6774.
- Shiver JW, Emini EA. Recent advances in the development of HIV-1 vaccines using replication-incompetent adenovirus vectors. Annu Rev Med. 2004;55:355-72. doi: 10.1146/annurev.med.55.091902.104344.
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Seksueel overdraagbare aandoeningen, viraal
- Seksueel overdraagbare aandoeningen
- Lentivirus-infecties
- Retroviridae-infecties
- Immunologische deficiëntie syndromen
- Ziekten van het immuunsysteem
- HIV-infecties
Andere studie-ID-nummers
- HVTN 057
- 10123 (Register-ID: DAIDS ES Registry Number)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op HIV-infecties
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University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthWervingHiv | HIV-testen | Hiv-koppeling naar zorg | HIV-behandelingVerenigde Staten
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ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur du Cameroun en andere medewerkersOnbekendHiv | HIV-niet-geïnfecteerde kinderen | Kinderen blootgesteld aan HIVKameroen
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationVoltooidPartner hiv-testen | HIV-counseling voor koppels | Paar communicatie | HIV-incidentieKameroen, Dominicaanse Republiek, Georgië, Indië
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University of MinnesotaIngetrokkenHIV-infecties | Hiv/aids | Hiv | AIDS | Aids/Hiv probleem | AIDS en infectiesVerenigde Staten
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Erasmus Medical CenterNog niet aan het wervenHIV-infecties | Hiv | HIV-1-infectie | HIV I-infectieNederland
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Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... en andere medewerkersWervingHiv | HIV-testen | Koppeling aan zorgZuid-Afrika
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CDC FoundationGilead SciencesOnbekendHIV Pre-expositie profylaxe | Hiv-chemoprofylaxeVerenigde Staten
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University of Maryland, BaltimoreIngetrokkenHiv | Niertransplantatie | HIV-reservoir | CCR5Verenigde Staten
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Hospital Clinic of BarcelonaVoltooidIntegrase-remmers, HIV; HIV PROTEASE INHIBSpanje
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National Taiwan UniversityWerving
Klinische onderzoeken op VRC-HIVADV014-00-VP
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National Institute of Allergy and Infectious Diseases...Centers for Disease Control and Prevention; International AIDS Vaccine Initiative en andere medewerkersIngetrokken
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National Institute of Allergy and Infectious Diseases...VoltooidHIV-infecties | GezondVerenigde Staten
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National Institute of Allergy and Infectious Diseases...Voltooid
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National Institute of Allergy and Infectious Diseases...Voltooid
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National Institute of Allergy and Infectious Diseases...HIV Vaccine Trials NetworkVoltooid
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National Institute of Allergy and Infectious Diseases...VoltooidAangeboren immuniteit | Hiv-negatief | Adaptieve immuniteitVerenigde Staten
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National Institute of Allergy and Infectious Diseases...Voltooid
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National Institute of Allergy and Infectious Diseases...Voltooid
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National Institute of Allergy and Infectious Diseases...International AIDS Vaccine InitiativeIngetrokken
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National Institute of Allergy and Infectious Diseases...VoltooidHIV-infecties | GezondVerenigde Staten