- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00712634
Cytomegalovirus Vaccine in Healthy Participants
A Phase I Dose Escalation Study of Lipopeptide Vaccines With Activity Against Human Cytomegalovirus
RATIONALE: Vaccines may help the body build an effective immune response against cytomegalovirus.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of cytomegalovirus vaccine in healthy participants.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- To establish whether 4 dose levels of the CMVpp65-A*0201 peptide vaccine are safe and well tolerated in cytomegalovirus (CMV)-seropositive participants.
- To determine whether the CMVpp65-A*0201 peptide vaccine, when given as a single injection followed by one booster injection at a safe and well-tolerated dose, is capable of stimulating a memory response in CMV-seropositive participants.
- To evaluate whether CMV-seronegative participants generate a de novo immune response against CMV after immunization with CMVpp65-A*0201 peptide vaccine given as a single injection followed by three booster injections.
- To determine the duration of immune enhancement of CMV-specific cytotoxic T-lymphocyte function as assessed for up to 12 months after primary or secondary immunization with the CMVpp65-A*0201 peptide vaccine.
OUTLINE: This is a dose-escalation study of CMVpp65-A*0201 peptide vaccine in cytomegalovirus (CMV)-seropositive participants. Once a safe dose is established, CMV-seronegative participants are accrued and immunized at that dose. Participants are stratified according to gender.
- CMV-seropositive participants: Participants are randomized to receive 1 of 4 escalating doses of CMVpp65-A*0201 peptide vaccine containing either helper T-lymphocyte (HTL) PADRE peptide or HTL tetanus toxoid peptide. Within each vaccine dose group, two participants are randomized to receive a placebo. Participants receive the vaccine or a placebo subcutaneously (SC) on days 0 and 28 in the absence of unacceptable toxicity.
- CMV-seronegative participants: Participants are randomized to receive 1 of 4 established doses (established in CMV-seropositive participants) of CMVpp65-A*0201 peptide vaccine containing either HTL PADRE peptide or HTL tetanus toxoid peptide. Participants receive the vaccine on days 0, 28, and 56 in the absence of unacceptable toxicity. Participants with a partial or low-level immune response receive one additional booster vaccine on day 90.
Participants undergo blood sample collection at baseline and periodically during study for immunologic laboratory studies. Participants also undergo skin biopsy at baseline. Laboratory studies include assessment of human cytotoxic T-lymphocyte activity and response by ^51chromium-release assay, limiting-dilution analysis, and T-cell proliferation assay; and CD4/CD8 phenotyping by FACScan® flow cytometry.
After completion of study therapy, participants are followed for 12 months.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
California
-
Duarte, California, Forenede Stater, 91010-3000
- City of Hope Comprehensive Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
- Healthy participant
- Cytomegalovirus seropositive or seronegative
- HLA-A*0201-positive
PATIENT CHARACTERISTICS:
- CBC within 1.5 times normal
- SMA-18 within 1.5 times normal
- Hepatitis B virus antigen seronegative
- Hepatitis C virus seronegative
- No diagnosis that is associated with immunodeficiency, including HIV infection
- No serious abnormalities by EKG (in participants ≥ 50 years of age)
- Not pregnant
PRIOR CONCURRENT THERAPY:
- More than 6 months since prior surgery
No concurrent daily medications for chronic or current illness, except for the following:
- Thyroid replacement therapy
- Estrogen replacement therapy
- Dietary vitamins and protein supplements
- Antihistamine medication
- Anticholesterol medication
- Cardiac and antihypertensive medication
- Any medication, as determined by the principal investigator, that is not known or likely to be immunosuppressive
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: CMV-seropositive participants
Participants are randomized to receive 1 of 4 escalating doses of CMVpp65-A*0201 peptide vaccine containing either helper T-lymphocyte (HTL) PADRE peptide or HTL tetanus toxoid peptide.
Within each vaccine dose group, two participants are randomized to receive a placebo.
Participants receive the vaccine or a placebo subcutaneously (SC) on days 0 and 28 in the absence of unacceptable toxicity.
|
Vaccine received on either days 0 and 28 or on days 0, 28, and 56 and perhaps day 90
|
Eksperimentel: CMV-seronegative participants
Participants are randomized to receive 1 of 4 established doses (established in CMV-seropositive participants) of CMVpp65-A*0201 peptide vaccine containing either HTL PADRE peptide or HTL tetanus toxoid peptide.
Participants receive the vaccine on days 0, 28, and 56 in the absence of unacceptable toxicity.
Participants with a partial or low-level immune response receive one additional booster vaccine on day 90.
|
Vaccine received on either days 0 and 28 or on days 0, 28, and 56 and perhaps day 90
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
Sikkerhed og toksicitet
|
Immunologisk respons
|
Duration of immunologic response
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Don Diamond, PhD, City of Hope Comprehensive Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000599675
- P01CA030206 (U.S. NIH-bevilling/kontrakt)
- CHNMC-97092
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 CMVpp65-A*0201 peptide vaccine
-
City of Hope Medical CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeHæmatopoietisk og lymfoid celle-neoplasma | Myelofibrose | Kronisk lymfatisk leukæmi | Voksen akut myeloid leukæmi i remission | Myelodysplastisk syndrom | Voksen akut lymfatisk leukæmi i remission | Myeloproliferativ neoplasma | Kronisk fase Kronisk myelogen leukæmi, BCR-ABL1 positiv | Lymfoblastisk lymfom... og andre forholdForenede Stater
-
Shiga UniversityTokyo UniversityAfsluttet
-
Shiga UniversityHuman Genome Center, Institute of Medical Science, University of TokyoAfsluttetIkke-småcellet lungekræftJapan
-
Shiga UniversityTokyo UniversityAfsluttet
-
University of Lausanne HospitalsFond'action contre le cancer; Barletta Foundation; NCCR (National Center...Suspenderet
-
European Organisation for Research and Treatment...Afsluttet
-
University of ChicagoAfsluttetMetastatisk melanomForenede Stater
-
Sciwind Biosciences APAC CO Pty. Ltd.Hangzhou Sciwind Biosciences Co., Ltd.AfsluttetFedme | Type 2 diabetes mellitus | Ikke-alkoholisk SteatohepatitisAustralien
-
Regeneron PharmaceuticalsAktiv, ikke rekrutterende