Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year.
25. mai 2022 oppdatert av: Novavax
A Phase II Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) Recombinant F Nanoparticle Vaccine in Healthy Older Adult Subjects Previously Treated With the Same Vaccine, or Placebo, in the Prior Year; and to Estimate the Incidence Rate of RSV Disease and Vaccine Efficacy in Subjects Based on Their RSV F Vaccine Experience Over Two Consecutive Years.
This study will enroll subjects who received the RSV F vaccine or placebo in the earlier study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a second season.
This design will permit evaluation of the safety and immunogenicity of revaccination in a second RSV season, and the safety and immunogenicity of revaccination over two years.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
1330
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
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Redding, California, Forente stater, 96001
- Nothern California Clinical Research
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Georgia
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Stockbridge, Georgia, Forente stater, 30281
- Clinical Research Atlanta
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Kansas
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Lenexa, Kansas, Forente stater, 66219
- Johnson County Clin-Trials
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Ohio
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Cleveland, Ohio, Forente stater, 44122
- Rapid Medical Research
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- Clinical Research Associates
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Texas
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Dallas, Texas, Forente stater, 75234
- Research Across America
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San Antonio, Texas, Forente stater, 78229
- Clinical Trials of Texas
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Utah
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West Jordan, Utah, Forente stater, 84088
- Advanced Clinical Research
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Washington
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Seattle, Washington, Forente stater, 98101
- Group Health Research Institute
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Wisconsin
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Wausau, Wisconsin, Forente stater, 54401
- Marshfield Clinical Research Foundation
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-
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
60 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
Males and females ≥60 years of age who are veterans of the RSV-E-201 clinical trial and who are ambulatory and live in the community or in residential facilities which provide minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Subjects may have one or more chronic medical diagnoses, but should be clinically stable as assessed by:
- Absence of changes in medical therapy within one month due to treatment failure or toxicity,
- Absence of medical events qualifying as SAEs within two months, and
- Absence of known, current, life-limiting diagnoses that, in the opinion of the investigator, render survival to trial completion unlikely.
- Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.
- Able to comply with study requirements, including access to transportation for study visits. The investigator may use his/her discretion to assess potential ability and willingness to comply based on performance in the prior trial, RSV-E-201.
- Access to inbound and outbound communication by telephone with caregivers and study staff.
Exclusion Criteria:
- Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination, with the exception of participation in the preceding study RSV-E-201.
- History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization, or withdrawal from the preceding RSV-E-201 clinical trial due to an adverse event deemed test article-related or at the advice of the investigator.
- Receipt of any vaccine other than IIV in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time unless administered in the preceding study, RSV-E-201.
- Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
- Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
- Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature ≥38.0°C on the planned day of vaccine administration).
- Known disturbance of coagulation. Potential subjects receiving aspirin, clopidogrel, prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban or warfarin under good control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or stroke in the setting of atrial fibrillation will NOT be excluded.
- Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
- Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic, cognitive, or psychiatric conditions deemed likely to impair the quality of study compliance or safety reporting).
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: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Treatment Group A
RSV-F Vaccine ( 0.5mL Injection)
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Placebo komparator: Behandlingsgruppe B
Fosfatbuffer placebo (0,5 ml injeksjon)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.
Tidsramme: Day 0 to Day 364
|
Derived/calculated endpoints based on these data will include:
|
Day 0 to Day 364
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Numbers and percentages of subjects with solicited local and systemic AEs
Tidsramme: Day 0 to Day 364
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Solicited local and systemic AEs over the seven days post-injection; and all adverse events, solicited and unsolicited, over 56 days post-dosing (Year 2).
In addition, MAEs, SAEs, and SNMCs will be collected for 1 year (approximately 364 days) post-dosing
|
Day 0 to Day 364
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA
Tidsramme: Day 0 to Day 182
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Summarized by:
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Day 0 to Day 182
|
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Neutralizing antibody titer to at least one RSV/A and one RSV/B strain.
Tidsramme: Day 0 to Day 182
|
Summarized by:
|
Day 0 to Day 182
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number and percentages of subjects fulfilling the definitions of RSV-associated respiratory disease and/or RSV-lower respiratory tract disease in various treatment groups.
Tidsramme: Day 0 to Day 182
|
Day 0 to Day 182
|
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Number and percentages of subjects with respiratory illnesses for which a non-RSV viral respiratory pathogen (with or without concurrent RSV infection) is identified by RT-PCR.
Tidsramme: Day 0 to Day 182
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Day 0 to Day 182
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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 2015
Primær fullføring (Faktiske)
1. november 2016
Studiet fullført (Faktiske)
1. november 2016
Datoer for studieregistrering
Først innsendt
22. oktober 2015
Først innsendt som oppfylte QC-kriteriene
29. oktober 2015
Først lagt ut (Anslag)
30. oktober 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. mai 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. mai 2022
Sist bekreftet
1. mai 2022
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- RSV-E-202
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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