Sikkerhed, tolerabilitet og immunogenicitet af VAX-31 hos voksne ≥50 år med tidligere pneumokokvaccination
En fase 3, randomiseret, dobbeltblind, aktivkontrolleret klinisk undersøgelse for at evaluere sikkerheden, tolerabiliteten og immunogeniteten af VAX-31 hos raske personer på 50 år og derover med tidligere pneumokokvaccination
The study will evaluate the safety, tolerability, and immunogenicity of VAX-31 in adults ≥50 years of age.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Arizona
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Chinle, Arizona, Forenede Stater, 86503
- Chinle Center for Indigenous Health
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Phoenix, Arizona, Forenede Stater, 85044
- Avacare (CCT Research)
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Whiteriver, Arizona, Forenede Stater, 85941
- Whiteriver Center for Indigenous Health
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Connecticut
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Waterbury, Connecticut, Forenede Stater, 06708
- Chase Medical Research
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Florida
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Hollywood, Florida, Forenede Stater, 33024
- CenExel (RCA)
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Jupiter, Florida, Forenede Stater, 33458
- Eximia (Health Awareness)
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Port Saint Lucie, Florida, Forenede Stater, 34952
- Eximia (Health Awareness)
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Sunrise, Florida, Forenede Stater, 33351
- Precision Clinical Research
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The Villages, Florida, Forenede Stater, 32162
- The Villages
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Georgia
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Stockbridge, Georgia, Forenede Stater, 30281
- DelRicht Clinical Research
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Indiana
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Valparaiso, Indiana, Forenede Stater, 46383
- Velocity Clinical Valparaiso
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Kansas
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Lenexa, Kansas, Forenede Stater, 66219
- Johnson County Clin-Trials, LLC
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70115
- DelRicht Clinical Research
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Maryland
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Rockville, Maryland, Forenede Stater, 20854
- Velocity (Meridian Clinical Research)
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Michigan
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Southfield, Michigan, Forenede Stater, 48076
- DM Clinical Research-Detroit
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Missouri
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Kansas City, Missouri, Forenede Stater, 64114
- AMR
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Springfield, Missouri, Forenede Stater, 65807
- DelRicht Research (Command Family Medicine)
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68114
- Quality Clinical Research
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New Mexico
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Gallup, New Mexico, Forenede Stater, 87301
- Center of American Indian Health
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Shiprock, New Mexico, Forenede Stater, 87420
- Shiprock Center for Indigenous Health
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New York
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Rochester, New York, Forenede Stater, 14609
- Rochester Clinical Research, Inc.
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North Carolina
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Wilmington, North Carolina, Forenede Stater, 28403
- Headlands (Trial Management Associates)
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Oklahoma
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Edmond, Oklahoma, Forenede Stater, 73013
- Tekton Research
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Tennessee
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Hendersonville, Tennessee, Forenede Stater, 37075
- DelRicht Research
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Texas
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Austin, Texas, Forenede Stater, 78745
- Tekton Research
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Beaumont, Texas, Forenede Stater, 77701
- REX Clinical Trials
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San Antonio, Texas, Forenede Stater, 78229
- Flourish Research
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Sugar Land, Texas, Forenede Stater, 77478
- DM Clinical Research
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22911
- Alcanza (Charlottesville Medical Research)
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Newport News, Virginia, Forenede Stater, 23606
- Health Research of Hampton Roads, Inc.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Male or female ≥50 years of age (inclusive) at the time of randomization into the study.
- Previous receipt of a licensed pneumococcal vaccine or combination of licensed vaccines, with most recent vaccination ≥1 year prior to randomization; the exception is PCV21, which may have been received ≥6 months prior to randomization (confirmed).
- Able and willing to complete the informed consent process.
- Available for clinical follow-up through the last study visit.
- In good general health or with stable underlying chronic condition(s), as determined by medical history, oral temperature, physical examination, and clinical judgment of the Investigator (ongoing chronic conditions must be documented as stable per Investigator).
- Willing to have blood samples collected and used for research purposes.
- Able to provide proof of identity to the satisfaction of the site personnel completing the enrollment process.
- Female participants of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test immediately prior to randomization and agree to use acceptable contraception. Male subjects with partners of childbearing potential must agree to practice an acceptable contraception method.
- Able to access and use a device connected to Wi-Fi or cellular network for completion of an electronic diary (eDiary).
Exclusion Criteria:
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Previous invasive pneumococcal disease (IPD) or pneumococcal pneumonia (either confirmed or self-reported) at any age.
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Previous receipt of an investigational pneumococcal vaccine at any age.
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Receipt of any investigational product within 30 days prior to Day 1, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
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Receipt of any live vaccine within 30 days prior to Day 1, or receipt of any non-live (including inactivated) vaccine within 14 days prior to Day 1.
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Body temperature >38.0°C (>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescreened).
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Current diagnosis of human immunodeficiency virus, Hepatitis B, or Hepatitis C.
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History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any previous vaccination.
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Individual who is pregnant, breastfeeding, or planning to become pregnant during study participation.
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Has a known or suspected immunocompromising condition, including, but not limited to, leukemia, lymphoma, chronic renal failure, or congenital or acquired immunodeficiency.
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Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM injections or blood draws.
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Receipt of blood or blood product (including polyclonal intravenous immunoglobulin) within 60 days prior to enrollment into the study.
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Is currently receiving immunosuppressive or immune-modifying therapy, including systemic corticosteroids (this includes ≥3 months of prednisone equivalent from 5 to ≤10 mg/day and ≥2 weeks of prednisone equivalent >10 mg/day).
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Received any part of a ≥14-day course of systemic corticosteroids (prednisone equivalent >10 mg/day) within 14 days of study vaccination
• History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
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Any medical, psychiatric, or social condition that in the judgment of the Investigator is a contraindication to protocol participation or impairs a subject's ability to give informed consent.
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Employee of, or first-degree relative of, any person employed by the Sponsor, the contract research organization (CRO), the Investigator, site personnel, or site
Studieplan
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: Cohort 1 (VAX-31): Prior PPSV23
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
0.5 mL of VAX-31 will be administered into the deltoid muscle |
|
Aktiv komparator: Cohort 1 (PCV20): Prior PPSV23
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
0.5 mL of the 20-valent pneumococcal conjugate vaccine will be administered into the deltoid muscle |
|
Eksperimentel: Cohort 2 (VAX-31): Prior PCV20
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
0.5 mL of VAX-31 will be administered into the deltoid muscle |
|
Aktiv komparator: Cohort 2 (PCV20): Prior PCV20
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
0.5 mL of the 20-valent pneumococcal conjugate vaccine will be administered into the deltoid muscle |
|
Eksperimentel: Cohort 3 (VAX-31): Other prior licensed pneumococcal vaccine or combination
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
0.5 mL of VAX-31 will be administered into the deltoid muscle |
|
Aktiv komparator: Cohort 3 (PCV20): Other prior licensed pneumococcal vaccine or combination
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
0.5 mL of the 20-valent pneumococcal conjugate vaccine will be administered into the deltoid muscle |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Procentdel af forsøgspersoner, der rapporterer forespurgte lokale bivirkninger (AE) (rødme, hævelse og smerte på injektionsstedet)
Tidsramme: op til 7 dage efter vaccination
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op til 7 dage efter vaccination
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Procentdel af forsøgspersoner, der rapporterede ønskede systemiske bivirkninger (feber, hovedpine, træthed, muskel- og ledsmerter)
Tidsramme: op til 7 dage efter vaccination
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op til 7 dage efter vaccination
|
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Procentdel af forsøgspersoner, der rapporterede uopfordrede bivirkninger
Tidsramme: op til 31 dage efter vaccination
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op til 31 dage efter vaccination
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Serotype-specifikke OPA geometriske middelværdi-titreringer (GMT)
Tidsramme: 1 måned efter VAX-31-vaccination
|
1 måned efter VAX-31-vaccination
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Serotype-specifik OPA geometrisk middelværdifoldstigning (GMFR) fra baseline
Tidsramme: 1 måned efter VAX-31 vaccination
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1 måned efter VAX-31 vaccination
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Procentdel af forsøgspersoner, der rapporterer nyopstået kronisk sygdom (NOCI), lægekontrollerede bivirkninger (MAAE) og alvorlige bivirkninger (SAE)
Tidsramme: op til 6 måneder efter vaccination
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op til 6 måneder efter vaccination
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Serotype-specifik IgG geometrisk middelkoncentration (GMC)
Tidsramme: 1 måned efter VAX-31 vaccination
|
1 måned efter VAX-31 vaccination
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Serotype-specifik IgG geometrisk middelværdi-fold-stigning (GMFR) fra baseline
Tidsramme: 1 måned efter VAX-31 vaccination
|
1 måned efter VAX-31 vaccination
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VAX31-105
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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