Sikkerheds- og immunogenicitetsundersøgelse af selvforstærkende RNA-pandemisk influenzavaccine hos voksne
12. august 2026 opdateret af: Arcturus Therapeutics, Inc.
Et fase 1, først-i-menneskeligt, randomiseret, observatørblindt, parallelt design, kontrolleret, dosisniveau og skemabestemt undersøgelse for at evaluere sikkerheden, reaktogeniciteten og immunogeniciteten af en selvforstærkende MRNA pandemisk influenzavaccine (ARCT-2304) ) Når det administreres til raske voksne
Målet med dette kliniske forsøg er at evaluere sikkerheden og immunresponsen af tre forskellige dosisniveauer af en selvforstærkende RNA pandemisk influenzavaccine (ARCT-2304) hos voksne. De vigtigste mål for undersøgelsen er:
- At evaluere sikkerhed og reaktogenicitet af forskellige dosisniveauer af ARCT-2304-vaccinen
- At beskrive immunresponserne af forskellige dosisniveauer af ARCT-2304-vaccinen målt ved hæmagglutinationshæmning (HAI) og neuraminidase-enzymbundet lektin (ELLA) antistofrespons
Forskere vil sammenligne resultaterne med licenserede influenzavacciner for at vælge det mest optimale dosisniveau og tidsplan for vaccineadministration med hensyn til sikkerhed og immunogenicitet for yderligere udvikling af vaccinen.
Deltagerne vil modtage 2 doser af ARCT-2304-vaccinen eller 1 dosis godkendt influenzavaccine og 1 dosis placebo.
De vil blive spurgt:
- at udfylde en daglig dagbog i 7 dage efter hver vaccination og besvare spørgsmål, hvordan de har haft det den dag.
- at give blodprøver ved hvert besøg i klinikken
- at overholde alle undersøgelsesbesøg og procedurer (f.eks. være tilgængelig for planlagte telefonkontakter og uplanlagte klinikbesøg, hvis det kræves)
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Fase 1, first-in-human, randomiseret, kontrolleret, observatørblind, dosisniveau- og tidsplanfindende undersøgelse, for at evaluere sikkerheden, reaktogeniciteten og immunogeniciteten af en selvforstærkende mRNA pandemisk influenza (H5N1) vaccine (ARCT-2304) når det administreres som en 2-dosis vaccinationsserie til raske voksne sammenlignet med en inaktiveret influenzavaccine.
Studielægemidlet (ARCT-2304 eller kontrol) vil blive administreret som en 2-dosis vaccinationsserie som en intramuskulær (IM) injektion. Undersøgelsen består af to dele.
I del 1 vil 120 deltagere (unge voksne) blive randomiseret til et af de tre dosisniveauer af ARCT-2304-vaccinen eller kontrolvaccinen. Deltagerne vil blive randomiseret yderligere til et af de to forskellige vaccinationsskemaer.
I del 2 vil 80 deltagere (ældre voksne) blive randomiseret til et af de tre dosisniveauer af ARCT-2304-vaccinen eller kontrolvaccinen. Deltagerne vil blive randomiseret yderligere til et af de to forskellige vaccinationsskemaer.
Undersøgelsesvaccine: ARCT-2304
Kontrolvacciner: licenserede influenzavacciner
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
212
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
La Mesa, California, Forenede Stater, 91942
- Velocity Clinical Research
-
San Bernardino, California, Forenede Stater, 92408
- Velocity Clinical Research
-
-
Colorado
-
Longmont, Colorado, Forenede Stater, 80501
- Tekton Research
-
-
Ohio
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Cincinnati, Ohio, Forenede Stater, 45212
- CTI Clinical Research Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Hovedinkluderingskriterier:
- Personer er mandlige eller kvindelige voksne i alderen 18-80 år.
- Raske deltagere eller deltagere med allerede eksisterende stabile medicinske tilstande.
- Personer i den fødedygtige alder skal være villige til at overholde præventionskravene.
Vigtigste ekskluderingskriterier:
- Personer med akutte medicinske tilstande eller febersygdom, herunder kropstemperatur ≥100,4°F (≥38,0°C målt ved en hvilken som helst metode) inden for 3 dage før randomisering.
- Personer med en kendt historie med alvorlige overfølsomhedsreaktioner, herunder anafylaksi, eller andre signifikante bivirkninger på enhver mRNA-vaccine, influenzavaccine eller hjælpestoffer.
- Personer med en historie med myokarditis, pericarditis, myopericarditis eller kardiomyopati.
- Personer, der har modtaget en influenzavaccine inden for 3 måneder før første vaccineindgivelse eller planlægger at modtage en influenzavaccine i løbet af undersøgelsesperioden.
- Personer, der har modtaget mRNA-vaccination inden for 60 dage før den første vaccineindgivelse.
- Personer, der har modtaget eller planlægger at modtage en A/H5N1-influenzavaccine og/eller personer, der har været udsat for eller direkte kontakt med fjerkræ, vilde fugle, levende kvæg eller rå mælk.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Lav dosis af ARCT-2304, skema 1, unge voksne
Lav dosis af ARCT-2304 administreret gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 1 undersøgelsesvaccine: ARCT-2304 |
Hver deltager vil modtage 2-dosis regimen intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
|
Eksperimentel: Mellemdosis af ARCT-2304, skema 1, unge voksne
Midt dosis af ARCT-2304 administreret gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 1 undersøgelsesvaccine: ARCT-2304 |
Hver deltager vil modtage 2-dosis regimen intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
|
Eksperimentel: Høj dosis af ARCT-2304, skema 1, unge voksne
Høj dosis af ARCT-2304 administreret gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 1 undersøgelsesvaccine: ARCT-2304 |
Hver deltager vil modtage 2-dosis regimen intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
|
Aktiv komparator: Kontrol, skema 1, unge voksne
Kontrolvaccine (dosis 1) og placebo (dosis 2) indgivet gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 1 Undersøgelsesvaccine: Sammenligningsvaccine for yngre voksne og placebovaccine med saltvand |
Hver deltager vil modtage en intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
Hver deltager vil modtage en intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
|
Eksperimentel: Lav dosis af ARCT-2304, skema 1, ældre voksne
Lav dosis af ARCT-2304 administreret gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 1 undersøgelsesvaccine: ARCT-2304 |
Hver deltager vil modtage 2-dosis regimen intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
|
Eksperimentel: Mellemdosis af ARCT-2304, skema 1, ældre voksne
Midt dosis af ARCT-2304 administreret gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 1 undersøgelsesvaccine: ARCT-2304 |
Hver deltager vil modtage 2-dosis regimen intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
|
Eksperimentel: Høj dosis af ARCT-2304, skema 1, ældre voksne
Høj dosis af ARCT-2304 administreret gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 1 undersøgelsesvaccine: ARCT-2304 |
Hver deltager vil modtage 2-dosis regimen intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
|
Aktiv komparator: Kontrol, skema 1, ældre voksne
Ældre voksne kontrolvaccine (dosis 1) og placebo (dosis 2) indgivet gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 1 Undersøgelsesvaccine: Sammenligningsvaccine til ældre voksne og saltvand |
Hver deltager vil modtage en intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
Hver deltager vil modtage en intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
|
Eksperimentel: Lav dosis af ARCT-2304, skema 2, unge voksne
Lav dosis af ARCT-2304 administreret gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 2 Undersøgelsesvaccine: ARCT-2304 |
Hver deltager vil modtage 2-dosis regimen intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
|
Eksperimentel: Mellemdosis af ARCT-2304, skema 2, unge voksne
Midt dosis af ARCT-2304 administreret gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 2 Undersøgelsesvaccine: ARCT-2304 |
Hver deltager vil modtage 2-dosis regimen intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
|
Eksperimentel: Høj dosis af ARCT-2304, skema 2, unge voksne
Høj dosis af ARCT-2304 administreret gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 2 Undersøgelsesvaccine: ARCT-2304 |
Hver deltager vil modtage 2-dosis regimen intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
|
Aktiv komparator: Kontrol, skema 2, unge voksne
Unge voksne kontrolvaccine (dosis 1) og placebo (dosis 2) indgivet gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 2 Undersøgelsesvaccine: Sammenligningsvaccine for yngre voksne og placebovaccine med saltvand |
Hver deltager vil modtage en intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
Hver deltager vil modtage en intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
|
Eksperimentel: Lav dosis af ARCT-2304, skema 2, ældre voksne
Lav dosis af ARCT-2304 administreret gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 2 Undersøgelsesvaccine: ARCT-2304 |
Hver deltager vil modtage 2-dosis regimen intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
|
Eksperimentel: Mellemdosis af ARCT-2304, skema 2, ældre voksne
Midt dosis af ARCT-2304 administreret gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 2 Undersøgelsesvaccine: ARCT-2304 |
Hver deltager vil modtage 2-dosis regimen intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
|
Eksperimentel: Høj dosis af ARCT-2304, skema 2, ældre voksne
Høj dosis af ARCT-2304 administreret gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 2 Undersøgelsesvaccine: ARCT-2304 |
Hver deltager vil modtage 2-dosis regimen intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
|
Aktiv komparator: Kontrol, skema 2, ældre voksne
Ældre voksne kontrolvaccine (dosis 1) og placebo (dosis 2) indgivet gennem intramuskulær injektion i deltamusklen. Interventioner: 2-dosis regime, skema 2 Undersøgelsesvaccine: Sammenligningsvaccine ældre voksne og saltvand placebovaccine |
Hver deltager vil modtage en intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
Hver deltager vil modtage en intramuskulær (IM) dosis ind i deltamusklen.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Solicited Adverse Events (AEs) Within 7 Days After Each Vaccination
Tidsramme: 7 days post each dose
|
The following solicited local and systemic AEs were recorded from Day 1 to 7 days after each vaccination (dose): Injection site pain, Erythema, Swelling, Fatigue, Headache, Myalgia, Arthralgia, Dizziness, Nausea, Chills, Fever (≥100.4
°Fahrenheit [F] /≥38.0 °Celsius [C]).
A summary of all Serious Adverse Events and Other Adverse Events (non-serious) regardless of causality is located in the 'Reported Adverse Events' Section.
|
7 days post each dose
|
|
Number of Participants With Unsolicited AEs Within 28 Days After Each Vaccination
Tidsramme: D1,29 Cohorts: up to Day 29 and up to Day 57 (28 days post each dose), D1,57 Cohorts: up to Day 29 and up to Day 85 (28 days post each dose)
|
An AE was any untoward medical occurrence in a participant or participant administered a medicinal product, whether or not considered related to the trial vaccine.
An unsolicited AE was defined as any AE not included in the list of solicited AEs (i.e., any event other than injection site pain, erythema, swelling, fatigue, headache, myalgia, arthralgia, dizziness, nausea, chills, or fever (≥100.4
°F / ≥38.0 °C).
Solicited AEs that lasted for more than 7 days were considered as unsolicited AEs.
Unsolicited AEs were recorded from Day 1 up to 28 days after each vaccination (dose).
A summary of all Serious Adverse Events and Other Adverse Events (non-serious) regardless of causality is located in the 'Reported Adverse Events' Section'.
|
D1,29 Cohorts: up to Day 29 and up to Day 57 (28 days post each dose), D1,57 Cohorts: up to Day 29 and up to Day 85 (28 days post each dose)
|
|
Number of Participants With Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs of Special Interest (AESIs), and AEs Leading To Early Termination From Day 1 to 28 Days After Second Vaccination
Tidsramme: D1,29 Cohorts: up to Day 57, D1,57 Cohorts: up to Day 85
|
An SAE was defined as any AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity, or required inpatient hospitalization or prolongation of existing hospitalization.
AEs potentially associated with messenger ribonucleic acid (mRNA) vaccines and influenza vaccines were reported as AESIs.
MAAEs were defined as AEs with medically attended visits including hospital, emergency room, urgent care clinic, or other visits (including phone/telehealth visits) to or from medical personnel for any reason but did not fulfil seriousness criteria.
A summary of all Serious Adverse Events and Other Adverse Events (non-serious) regardless of causality is located in the 'Reported Adverse Events' Section'.
|
D1,29 Cohorts: up to Day 57, D1,57 Cohorts: up to Day 85
|
|
Geometric Mean Titer of Antibody Response to Hemagglutinin (HA) Glycoprotein Measured By Hemagglutinin Inhibition (HAI) Assay
Tidsramme: D1,29 Cohorts: Day 1, Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 1, Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
|
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
Antibody titers were expressed as Geometric Mean Titers.
|
D1,29 Cohorts: Day 1, Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 1, Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
|
|
Geometric Mean Titer of Antibody Response to Neuraminidase (NA) Glycoprotein Measured By Enzyme-linked Lectin Assay (ELLA)
Tidsramme: D1,29 Cohorts: Day 1, Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 1, Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
|
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
Antibody titers were expressed as Geometric Mean Titers.
|
D1,29 Cohorts: Day 1, Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 1, Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
|
|
Geometric Mean Fold Rise of Antibody Response to HA Glycoprotein Measured By HAI Assay
Tidsramme: D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
|
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
Geometric Mean Fold Rise was reported as a ratio to Day 1.
|
D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
|
|
Geometric Mean Fold Rise of Antibody Response to NA Glycoprotein Measured By ELLA
Tidsramme: D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
|
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
Geometric Mean Fold Rise was reported as a ratio to Day 1.
|
D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
|
|
Percentage of Participants With Seroconversion of Antibody Response to HA Glycoprotein Measured By HAI Assay
Tidsramme: D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
|
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
Seroconversion was recorded if participant had pre-vaccination antibody titer < Lower Limit Of Quantitation (LLOQ) and a post-vaccination antibody titer ≥ 4 x LLOQ, or a pre-vaccination antibody titer ≥LLOQ and a ≥4-fold increase in post-vaccination antibody titer.
|
D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
|
|
Percentage of Participants With Seroconversion of Antibody Response to NA Glycoprotein Measured By ELLA
Tidsramme: D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
|
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
Seroconversion was recorded if participant had pre-vaccination antibody titer < LLOQ and a post-vaccination antibody titer ≥ 4 x LLOQ, or a pre-vaccination antibody titer ≥LLOQ and a ≥4-fold increase in post-vaccination antibody titer.
|
D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
|
|
Percentage of Participants With HAI Titers Above or Equal to Prespecified Thresholds
Tidsramme: D1,29 Cohorts: Day 57 (28 days post dose 2), D1,57 Cohorts: Day 85 (28 days post dose 2)
|
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
The prespecified antibody threshold levels were as follows: ≥1:10, ≥1:20, ≥1:40, ≥1:80, ≥1:160, and ≥1:320.
|
D1,29 Cohorts: Day 57 (28 days post dose 2), D1,57 Cohorts: Day 85 (28 days post dose 2)
|
|
Percentage of Participants With ELLA Titers Above or Equal to Prespecified Thresholds
Tidsramme: D1,29 Cohorts: Day 57 (28 days post dose 2), D1,57 Cohorts: Day 85 (28 days post dose 2)
|
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
The prespecified antibody threshold levels were as follows: ≥1:10, ≥1:20, ≥1:40, ≥1:80, ≥1:160, and ≥1:320.
|
D1,29 Cohorts: Day 57 (28 days post dose 2), D1,57 Cohorts: Day 85 (28 days post dose 2)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With SAEs, MAAEs, AESIs, and AEs Leading To Early Termination From Day 1 to Day 240
Tidsramme: Day 1 to Day 240
|
A SAE was defined as any AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity, or required inpatient hospitalization or prolongation of existing hospitalization.
AEs potentially associated with mRNA vaccines and influenza vaccines were reported as AESIs.
MAAEs were defined as AEs with medically attended visits including hospital, emergency room, urgent care clinic, or other visits (including phone/telehealth visits) to or from medical personnel for any reason, but did not fulfil seriousness criteria.
A summary of all Serious Adverse Events and Other Adverse Events (non-serious) regardless of causality is located in the 'Reported Adverse Events' Section.
|
Day 1 to Day 240
|
|
Geometric Mean Titer of Antibody Response To HA Glycoprotein Measured By HAI Assay at Day 240
Tidsramme: Day 240
|
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
Antibody titers were expressed as Geometric Mean Titers.
|
Day 240
|
|
Geometric Mean Titer of Antibody Response to NA Glycoprotein Measured By ELLA at Day 240
Tidsramme: Day 240
|
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
Antibody titers were expressed as Geometric Mean Titers.
|
Day 240
|
|
Geometric Mean Fold Rise of Antibody Response to HA Glycoprotein Measured By HAI Assay at Day 240
Tidsramme: Day 240
|
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
Geometric Mean Fold Rise was reported as a ratio to Day 1.
|
Day 240
|
|
Geometric Mean Fold Rise of Antibody Response to NA Glycoprotein Measured By ELLA at Day 240
Tidsramme: Day 240
|
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
Geometric Mean Fold Rise was reported as a ratio to Day 1.
|
Day 240
|
|
Percentage of Participants With Seroconversion of Antibody Response to HA Glycoprotein Measured By HAI Assay At Day 240
Tidsramme: Day 240
|
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
Seroconversion was recorded if participant had pre-vaccination antibody titer < LLOQ and a post-vaccination antibody titer ≥ 4 x LLOQ, or a pre-vaccination antibody titer ≥LLOQ and a ≥4-fold increase in post-vaccination antibody titer.
|
Day 240
|
|
Percentage of Participants With Seroconversion of Antibody Response to NA Glycoprotein Measured By ELLA At Day 240
Tidsramme: Day 240
|
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
Seroconversion was recorded if participant had pre-vaccination antibody titer < LLOQ and a post-vaccination antibody titer ≥ 4 x LLOQ, or a pre-vaccination antibody titer ≥LLOQ and a ≥4-fold increase in post-vaccination antibody titer.
|
Day 240
|
|
Percentage of Participants With HAI Titers Above Or Equal To Prespecified Thresholds At Day 240
Tidsramme: Day 240
|
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
The prespecified antibody threshold levels were as follows: ≥1:10, ≥1:20, ≥1:40, ≥1:80, ≥1:160, and ≥1:320.
|
Day 240
|
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Percentage of Participants With ELLA Titers Above Or Equal to Prespecified Thresholds At Day 240
Tidsramme: Day 240
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A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain.
The prespecified antibody threshold levels were as follows: ≥1:10, ≥1:20, ≥1:40, ≥1:80, ≥1:160, and ≥1:320.
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Day 240
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Geometric Mean Titer of Antibody Response Against HA Glycoprotein Measured By Microneutralization (MN) Assay
Tidsramme: D1,29 Cohorts: Day 1, Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 1, Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
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Neutralizing antibody response to H5 hemagglutinin was measured by MN assay.
Antibody titers were expressed as Geometric Mean Titers.
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D1,29 Cohorts: Day 1, Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 1, Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
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Geometric Mean Fold Rise of Antibody Response to HA Glycoprotein Measured By MN Assay
Tidsramme: D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
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Neutralizing antibody response to H5 hemagglutinin was measured by MN assay.
Geometric Mean Fold Rise was reported as a ratio to Day 1.
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D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
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Percentage of Participants With Seroconversion of Antibody Response to HA Glycoprotein Measured By MN Assay
Tidsramme: D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
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Neutralizing antibody response to H5 hemagglutinin was measured by MN assay.
Seroconversion was recorded if participant had pre-vaccination antibody titer < LLOQ and a post-vaccination antibody titer ≥ 4 x LLOQ, or a pre-vaccination antibody titer ≥LLOQ and a ≥4-fold increase in post-vaccination antibody titer.
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D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)
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Percentage of Participants With MN Titers Above Or Equal To Prespecified Thresholds
Tidsramme: D1,29 Cohorts: Day 57 (28 days post dose 2), D1,57 Cohorts: Day 85 (28 days post dose 2)
|
Neutralizing antibody response to H5 hemagglutinin was measured by MN assay.
The prespecified antibody threshold levels were as follows: ≥1:10, ≥1:20, ≥1:40, ≥1:80, ≥1:160, and ≥1:320.
|
D1,29 Cohorts: Day 57 (28 days post dose 2), D1,57 Cohorts: Day 85 (28 days post dose 2)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Clinical Program Director, Arcturus Therapeutics
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. december 2024
Primær færdiggørelse (Faktiske)
13. juni 2025
Studieafslutning (Faktiske)
5. december 2025
Datoer for studieregistrering
Først indsendt
16. september 2024
Først indsendt, der opfyldte QC-kriterier
17. september 2024
Først opslået (Faktiske)
19. september 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejsinfektioner
- Infektioner
- Orthomyxoviridae infektioner
- RNA-virusinfektioner
- Virussygdomme
- Luftvejssygdomme
- Influenza, menneske
- Uorganiske kemikalier
- Klorforbindelser
- Biologiske produkter
- Komplekse blandinger
- Vacciner
- Natriumforbindelser
- Virale vacciner
- Chlorider
- Hydrochlorsyre
- Influenza -vacciner
- Natriumchlorid
Andre undersøgelses-id-numre
- ARCT-2304-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Individuelle deltagerdata vil kun blive gjort tilgængelige for undersøgelsesforskere på nuværende tidspunkt.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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