- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21205-1901
- Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02115
- Fenway Community Health Clinical Research Site (FCHCRS)
-
-
Missouri
-
Saint Louis, Missouri, Forenede Stater, 63110-2500
- Saint Louis Univ. School of Medicine, HVTU
-
-
New York
-
New York, New York, Forenede Stater
- HIV Prevention & Treatment CRS
-
Rochester, New York, Forenede Stater, 14642-0001
- Univ. of Rochester HVTN CRS
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02906
- Miriam Hospital's HVTU
-
-
Tennessee
-
Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt Vaccine CRS
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98104
- FHCRC/UW Vaccine CRS
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Larry Peiperl, MD, San Francisco Department of Public Health / University of California - San Francisco
- Studiestol: Julie McElrath, MD, PhD, Fred Hutchinson Cancer Research Center / University of Washington
Publikationer og nyttige links
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HVTN 057
- 10123 (Registry Identifier: DAIDS ES Registry Number)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med HIV-infektioner
-
University of Santiago de CompostelaOsteology FoundationRekruttering
-
Institut PasteurRekruttering
-
Universidad del DesarrolloAfsluttetHealthcare Associated InfectionChile
-
The University of Texas Health Science Center,...EurofinsAfsluttetOdontogen Deep Space Neck InfectionForenede Stater
-
Imelda Hospital, BonheidenAfsluttetHealthcare Associated InfectionBelgien
-
Centre Hospitalier Universitaire de NīmesRekrutteringÆldre | Healthcare Associated InfectionFrankrig
-
Centre Hospitalier Universitaire, AmiensAfsluttetHealthcare Associated Infection | IglerFrankrig
-
University of PennsylvaniaAfsluttetAntimikrobiel resistensForenede Stater, Botswana
-
University of Maryland, BaltimoreVA Office of Research and DevelopmentAfsluttetMenneskelig mikrobiomForenede Stater
-
Universidad Autonoma de Nuevo LeonUkendtSundhedsrelaterede infektioner
Kliniske forsøg med VRC-HIVADV014-00-VP
-
National Institute of Allergy and Infectious Diseases...Centers for Disease Control and Prevention; International AIDS Vaccine... og andre samarbejdspartnereTrukket tilbage
-
National Institute of Allergy and Infectious Diseases...AfsluttetHIV-infektioner | Sund og raskForenede Stater
-
National Institute of Allergy and Infectious Diseases...Afsluttet
-
National Institute of Allergy and Infectious Diseases...Afsluttet
-
National Institute of Allergy and Infectious Diseases...HIV Vaccine Trials NetworkAfsluttetHIV-infektionerForenede Stater, Peru
-
National Institute of Allergy and Infectious Diseases...AfsluttetMedfødt immunitet | HIV negativ | Adaptiv immunitetForenede Stater
-
National Institute of Allergy and Infectious Diseases...Afsluttet
-
National Institute of Allergy and Infectious Diseases...Afsluttet
-
National Institute of Allergy and Infectious Diseases...International AIDS Vaccine InitiativeTrukket tilbage
-
National Institute of Allergy and Infectious Diseases...AfsluttetHIV-infektioner | Sund og raskForenede Stater