- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02325050
A Safety and Immunogenicity Study of Heterologous and Homologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
12. juni 2017 oppdatert av: Janssen Vaccines & Prevention B.V.
A Phase 1, Randomized, Placebo-Controlled, Observer-Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of Heterologous and Homologous Prime-Boost Regimens Using MVA-BN-Filo® and Ad26.ZEBOV Administered in Different Doses, Sequences and Schedules in Healthy Adult Subjects
The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV as heterologous and homologous prime-boost vaccine regimens in healthy adult participants.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study consists of 3 parts: the first and third part with standard doses and the second part with higher doses.
All parts are randomized, placebo-controlled, observer-blind to evaluate the safety, tolerability and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered in different doses, sequences and schedules to healthy adult participants.
The study consists of a screening period of up to 28 days, a vaccination period in which participants will be vaccinated at baseline (Day 1) followed by a boost on Day 15, 29, or 57, and third vaccine 1-year post-prime (3rd vaccination is optional for subjects in groups 1-8).
The total duration of the study will be about 1 year for participants who wiil receive boost vaccine and about 3 months for participants who will receive placebo and 2 year for participants who will receive a 3rd dose.
Safety will be monitored during the study.
Studietype
Intervensjonell
Registrering (Faktiske)
164
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Maryland
-
Rockville, Maryland, Forente stater
-
-
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 50 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Must be healthy on the basis of physical examination, medical history, and the investigator's clinical judgment
- Have a body mass index (BMI) ≥18.5 and <35.0 kg/m2
- Women of childbearing potential must have a negative serum β-human chorionic gonadotropin pregnancy test at screening, a negative urine pregnancy test immediately prior to each study vaccine administration, and practice adequate birth control measures from 28 days before the prime vaccination until at least 3 months after the boost vaccination as specified in the study protocol. If not heterosexually active at screening, must agree to practice adequate birth control measures if they become heterosexually active during their participation in the study (from screening onwards until at least 3 months after the boost vaccination). Agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during participation in the study (from screening onwards until at least 3 months after the boost vaccination)
- Women of non-childbearing potential, defined as postmenopausal (>45 years of age with amenorrhea for ≥2 years or any age with amenorrhea for ≥6 months and serum follicle-stimulating hormone [FSH] >40 mIU/mL) or surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), are not required to use the birth control methods as specified in the study protocol
- A man who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use a double-barrier method of birth control, such as either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. In case the female partner is using an adequate method of birth control, a single-barrier method of birth control for the male subject is acceptable. Men must also agree not to donate sperm during their participation in the study (from screening onwards until at least 3 months after the boost vaccination)
- Must be available and willing to participate for the duration of the study visits and follow-up, provide verifiable identification, and have a means to be contacted
Exclusion Criteria:
- Has been vaccinated with a candidate Ebola vaccine
- Has been diagnosed with Ebola disease or exposed to Ebola including travel to West Africa in the last 12 months. West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone. Participants who anticipate traveling to epidemic Ebola areas before the start of the long-term follow-up period will also be excluded from enrollment into the study
- Has received any Ad26- or MVA-based candidate vaccine in the past
- Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines), including known allergy to egg or aminoglycosides
- A woman who is pregnant or breast-feeding, or planning to become pregnant while enrolled in the study or within 3 months after the boost vaccination
- History of diabetes mellitus type 1 or type 2, including cases controlled with diet alone; thyroidectomy, or thyroid disease requiring medication during the last 12 months; uncontrolled hypertension as defined in the study protocol; or, major psychiatric illness and/or substance abuse problems during the past 12 months that in the opinion of the investigator would preclude participation
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: Group 1
Participants will receive MVA-BN-Filo/ Ad26.ZEBOV (Day 1 /Day 15) or Placebo (Day 1/Day 15).
Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Eksperimentell: Group 2
Participants will receive MVA-BN-Filo/Ad26.ZEBOV (Day 1 /Day 29) or placebo (Day 1/Day 29).
Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Eksperimentell: Group 3
Participants will receive MVA-BN-Filo /Ad26.ZEBOV/ (Day 1/Day 57) or placebo (Day 1/Day 57).
Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Eksperimentell: Group 4
Participants will receive Ad26.ZEBOV/ MVA-BN-Filo (Day 1/Day 29) or placebo (Day 1/Day 29).
Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Eksperimentell: Group 5
Participants will receive MVA-BN-Filo (Day 1 and Day 15) or placebo (Day 1 and Day 15).
Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Eksperimentell: Group 6
Participants will receive Ad26.ZEBOV (Day 1 and Day 15) or placebo (Day 1 and Day 15).
Participants will receive MVA-BN-Filo (1*10^8 TCID50) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Eksperimentell: Group 7
Participants will receive Ad26.ZEBOV/ MVA-BN-Filo (Day 1/Day 15) or Placebo (Day 1/Day 15).
Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Eksperimentell: Group 8
Participants will receive Ad26.ZEBOV/ MVA-BN-Filo (Day 1 /Day 29) or Placebo (Day 1/Day 29).
Participants will receive Ad26.ZEBOV (1x10^11 vp) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Eksperimentell: Group 9
Participants will receive MVA-BN-Filo/ Ad26.ZEBOV (Day 1 /Day 8) or Placebo (Day 1/Day 8).
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Eksperimentell: Group 10
Participants will receive MVA-BN-Filo/ Ad26.ZEBOV (Day 1 /Day 15) or Placebo (Day 1/Day 15).
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Antall deltakere med reaktogenitet (dvs. etterspurte lokale og systemiske bivirkninger)
Tidsramme: 1 uke etter hver studievaksineadministrasjon
|
1 uke etter hver studievaksineadministrasjon
|
Number of participants with adverse events
Tidsramme: Up to 21 days after the last vaccination (up to Day 381)
|
Up to 21 days after the last vaccination (up to Day 381)
|
Number of participants with serious adverse events
Tidsramme: Up to the end of long term follow-up (up to Day 720)
|
Up to the end of long term follow-up (up to Day 720)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Immune responses to the study vaccine regimens as measured by a virus neutralization assay
Tidsramme: up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
|
up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
|
Immune responses to the study vaccine regimens as measured by an enzyme-linked immunosorbent assay (ELISA)
Tidsramme: up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
|
up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
|
Immune responses to the study vaccine regimens as measured by an enzyme-linked immunospot (ELISpot) assay
Tidsramme: up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
|
up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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 (Faktiske)
8. januar 2015
Primær fullføring (Faktiske)
2. juli 2015
Studiet fullført (Faktiske)
8. mai 2017
Datoer for studieregistrering
Først innsendt
19. desember 2014
Først innsendt som oppfylte QC-kriteriene
19. desember 2014
Først lagt ut (Anslag)
24. desember 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. juni 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. juni 2017
Sist bekreftet
1. juni 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- CR106479
- VAC52150EBL1002 (Annen identifikator: Janssen Vaccines & Prevention B.V.)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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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