- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02375256
A Leukapheresis Study for Immune Responses in Healthy US Adults Who Receive BCG Vaccination Followed by Boosting With AERAS-402 (C-021-402)
27. februar 2015 oppdatert av: Aeras
A Phase I, Double-Blind, Randomized, Placebo-controlled Leukapheresis Study to Obtain Lymphocytes for the Study of Immune Responses in Healthy Adult Volunteers in the U.S. Who Receive BCG Vaccination Followed by Boosting With AERAS-402
Healthy adults received BCG on Study Day -84, followed by randomization on Study Day 0 to receive 2 booster doses in a blinded fashion of either AERAS-402 (N=9) or placebo (N=2) on Study Days 0 and 28.
Subjects were followed for a total of 98 days.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This was a double-blind, randomized, placebo-controlled study.
At least 13, but no more than 16, subjects who met all eligibility criteria were to receive a prime vaccination with BCG (1-8 x 105 colony forming units [CFU] intradermally [ID]) at Study Day -84.
Thirteen of the BCG-vaccinated subjects who completed all protocol-specified procedures and continued to meet eligibility criteria were to be enrolled and randomized on Study Day 0 in a 10:3 ratio to receive study vaccine (either AERAS-402 3 x 1010 virus particles [vp] intramuscularly [IM] or placebo IM) at Study Days 0 and 28, based on time of completion of screening.
Eleven subjects were randomized (N=9 AERAS-402; N=2 placebo) and analyzed.
Enrollment was stopped when 11 of the planned 13 subjects had been randomized, as it was felt that this number of subjects was sufficient to address the objectives of the study.
Studietype
Intervensjonell
Registrering (Faktiske)
11
Fase
- Fase 1
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 45 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Is male or female
- Provided written informed consent prior to any study related procedures
- Is age ≥18 years and ≤45 years on Study Day -84.
- Has Body Mass Index (BMI) ≥19 and <33 by nomogram (see appendices)
- Has general good health, confirmed by medical history and physical examination
- Females physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must avoid pregnancy with an acceptable method of avoiding pregnancy from 28 days prior to Study Day -84 through the end of the study.
- Females physically capable of pregnancy must have a negative serum pregnancy test within 7 days prior to Study Day -84 AND a negative urine pregnancy test on Study Day -84, Study Day 0, and Study Day 28.
- Has committed to avoid elective surgery for the duration of the study
- Has ability to complete all study visits as required per the protocol and is able to be contacted by telephone
Exclusion Criteria:
- Acute illness, oral temperature ≥37.5°C, or axillary lymphadenopathy on Study Day -84, Study Day 0, or Study Day 28.
Any of the following laboratory results from blood and urine collected within 7 days prior to Study Day -84 (evaluated per local laboratory parameters):
- Abnormal hemoglobin or hematocrit
- Abnormal white blood cell count, absolute neutrophil count, or absolute lymphocyte count
- Elevated creatinine, total bilirubin, AST, ALT, or alkaline phosphatase (ALP)
- Evidence of chronic hepatitis (e.g., hepatitis B core antibody, or hepatitis C antibody, or other)
- Laboratory test (e.g., QuantiFERON®-TB) evidence of Mycobacterium tuberculosis (Mtb) infection
- History of residence in a tuberculosis-endemic country, per WHO 2008 "high-burden" definition
- History of treatment for active or latent tuberculosis infection
- History or evidence (including chest X-ray) of active tuberculosis
- Shared a residence within the last year with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis
- History of allergic disease or reactions likely to be exacerbated by any component of the BCG or study vaccines
- History of autoimmune disease or immunosuppression
- Current household contact or occupational exposure to an individual with known significant immunosuppression
- History or evidence on physical examination of any systemic disease, or acute or chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine, including axillary lymphadenopathy
- History or laboratory evidence of any past, present or future possible immunodeficiency state which will include (but is not limited to) any laboratory indication of HIV infection
- History of alcohol or drug abuse within the past 2 years
- History of cheloid formation
- Previous medical history that may compromise the safety of the subject in the study
- Any current medical, psychiatric, occupational, or substance abuse problems which, in the opinion of the investigator, will make it unlikely the subject will comply with the protocol
Inability to discontinue daily medications during the study period except the following:
- Contraceptives
- Multivitamins
- Inhaled or topical corticosteroids
- Tobacco smoking of a pack or more of cigarettes a day, or cannabis smoking three or more days per week
- Received immunosuppressive medication within 45 days prior to Study Day -84 (inhaled and topical corticosteroids are permitted)
- Received investigational drugs or vaccine products within 182 days prior to Study Day -84 or planned participation in any other investigational study during the study period
- Received investigational Mtb vaccine at any time prior to Study Day -84
- Received vaccination or immunotherapy with a BCG product at any time prior to Study Day -84.
- Received immunoglobulin or blood products within 45 days prior to Study Day -84.
- Received any standard vaccine within 45 days prior to Study Day -84 except inactivated influenza vaccine which may have been received within 2 weeks prior to Study Day -84.
- History of high risk sexual behaviors since 1977.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: AERAS-402
3 x10^10 viral particles per 0.5 mL suspended in 10 mM Tris buffer, 1 mM MgCl2, 75 mM NaCl, 5% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80), 0.1 mM EDTA, 10 mM l-histidine, 0.5% v/v ethanol and water.
The dose volume administered was 0.5 mL.
|
Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of 3 Mycobacterium tuberculosis antigens (Ag85A, Ag85B, and TB10.4).
BCG given to all participants at day -84 prior to a boost with either Aeras-402 or placebo.
|
Aktiv komparator: Placebo
1.0 mL sterile vaccine buffer containing 10mM Tris buffer, 1 mM MgCl2, 75 mM NaCl, 5% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80), 0.1 mM EDTA, 10 mM l-histidine, 0.5% v/v ethanol and water.
The dose volume administered was 0.5 mL
|
BCG given to all participants at day -84 prior to a boost with either Aeras-402 or placebo.
Identical buffer solution in which AERAS-402 is formulated.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Cellular immune responses to AERAS-402 in healthy adult volunteers who received two booster doses of AERAS-402 administered 84 and 112 days after BCG vaccination, through leukapheresis and cryopreservation of cells followed by in vitro assay.
Tidsramme: Up to study day 98
|
percentage of CD4 and CD8 T cells from leukapheresis that produce any of three cytokines (IFN γ, TNF α, and/or IL 2).
|
Up to study day 98
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Evaluation of adverse events (AEs) and serious adverse events (SAEs).
Tidsramme: Up to study day 98
|
Up to study day 98
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Ann M Ginsberg, MD PhD, Aeras
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2009
Primær fullføring (Faktiske)
1. desember 2010
Studiet fullført (Faktiske)
1. desember 2013
Datoer for studieregistrering
Først innsendt
24. februar 2015
Først innsendt som oppfylte QC-kriteriene
26. februar 2015
Først lagt ut (Anslag)
2. mars 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
3. mars 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. februar 2015
Sist bekreftet
1. februar 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- C-021-402
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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