Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year.
25 mei 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
1330
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
California
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Redding, California, Verenigde Staten, 96001
- Nothern California Clinical Research
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Georgia
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Stockbridge, Georgia, Verenigde Staten, 30281
- Clinical Research Atlanta
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Kansas
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Lenexa, Kansas, Verenigde Staten, 66219
- Johnson County Clin-Trials
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44122
- Rapid Medical Research
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37203
- Clinical Research Associates
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Texas
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Dallas, Texas, Verenigde Staten, 75234
- Research Across America
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San Antonio, Texas, Verenigde Staten, 78229
- Clinical Trials of Texas
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Utah
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West Jordan, Utah, Verenigde Staten, 84088
- Advanced Clinical Research
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Washington
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Seattle, Washington, Verenigde Staten, 98101
- Group Health Research Institute
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Wisconsin
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Wausau, Wisconsin, Verenigde Staten, 54401
- Marshfield Clinical Research Foundation
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
60 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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).
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Treatment Group A
RSV-F Vaccine ( 0.5mL Injection)
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|
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Placebo-vergelijker: Behandelgroep B
Fosfaatbuffer Placebo (injectie van 0,5 ml)
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.
Tijdsspanne: Day 0 to Day 364
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Derived/calculated endpoints based on these data will include:
|
Day 0 to Day 364
|
|
Numbers and percentages of subjects with solicited local and systemic AEs
Tijdsspanne: Day 0 to Day 364
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA
Tijdsspanne: Day 0 to Day 182
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Summarized by:
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Day 0 to Day 182
|
|
Neutralizing antibody titer to at least one RSV/A and one RSV/B strain.
Tijdsspanne: Day 0 to Day 182
|
Summarized by:
|
Day 0 to Day 182
|
Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Number and percentages of subjects fulfilling the definitions of RSV-associated respiratory disease and/or RSV-lower respiratory tract disease in various treatment groups.
Tijdsspanne: 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.
Tijdsspanne: Day 0 to Day 182
|
Day 0 to Day 182
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2015
Primaire voltooiing (Werkelijk)
1 november 2016
Studie voltooiing (Werkelijk)
1 november 2016
Studieregistratiedata
Eerst ingediend
22 oktober 2015
Eerst ingediend dat voldeed aan de QC-criteria
29 oktober 2015
Eerst geplaatst (Schatting)
30 oktober 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 mei 2022
Laatste update ingediend die voldeed aan QC-criteria
25 mei 2022
Laatst geverifieerd
1 mei 2022
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- RSV-E-202
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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