Sikkerhet, tolerabilitet og immunogenitet av VAX-31 hos voksne ≥50 år med tidligere pneumokokkvaksinasjon
En fase 3, randomisert, dobbeltblind, aktivkontrollert klinisk studie for å evaluere sikkerheten, toleransen og immunogeniteten til VAX-31 hos friske forsøkspersoner 50 år og eldre med tidligere pneumokokkvaksinasjon
The study will evaluate the safety, tolerability, and immunogenicity of VAX-31 in adults ≥50 years of age.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Arizona
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Chinle, Arizona, Forente stater, 86503
- Chinle Center for Indigenous Health
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Phoenix, Arizona, Forente stater, 85044
- Avacare (CCT Research)
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Whiteriver, Arizona, Forente stater, 85941
- Whiteriver Center for Indigenous Health
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Connecticut
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Waterbury, Connecticut, Forente stater, 06708
- Chase Medical Research
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Florida
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Hollywood, Florida, Forente stater, 33024
- CenExel (RCA)
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Jupiter, Florida, Forente stater, 33458
- Eximia (Health Awareness)
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Port Saint Lucie, Florida, Forente stater, 34952
- Eximia (Health Awareness)
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Sunrise, Florida, Forente stater, 33351
- Precision Clinical Research
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The Villages, Florida, Forente stater, 32162
- The Villages
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Georgia
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Stockbridge, Georgia, Forente stater, 30281
- DelRicht Clinical Research
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Indiana
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Valparaiso, Indiana, Forente stater, 46383
- Velocity Clinical Valparaiso
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Kansas
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Lenexa, Kansas, Forente stater, 66219
- Johnson County Clin-Trials, LLC
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Louisiana
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New Orleans, Louisiana, Forente stater, 70115
- DelRicht Clinical Research
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Maryland
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Rockville, Maryland, Forente stater, 20854
- Velocity (Meridian Clinical Research)
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Michigan
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Southfield, Michigan, Forente stater, 48076
- DM Clinical Research-Detroit
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Missouri
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Kansas City, Missouri, Forente stater, 64114
- AMR
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Springfield, Missouri, Forente stater, 65807
- DelRicht Research (Command Family Medicine)
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Nebraska
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Omaha, Nebraska, Forente stater, 68114
- Quality Clinical Research
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New Mexico
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Gallup, New Mexico, Forente stater, 87301
- Center of American Indian Health
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Shiprock, New Mexico, Forente stater, 87420
- Shiprock Center for Indigenous Health
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New York
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Rochester, New York, Forente stater, 14609
- Rochester Clinical Research, Inc.
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North Carolina
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Wilmington, North Carolina, Forente stater, 28403
- Headlands (Trial Management Associates)
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Oklahoma
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Edmond, Oklahoma, Forente stater, 73013
- Tekton Research
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Tennessee
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Hendersonville, Tennessee, Forente stater, 37075
- DelRicht Research
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Texas
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Austin, Texas, Forente stater, 78745
- Tekton Research
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Beaumont, Texas, Forente stater, 77701
- REX Clinical Trials
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San Antonio, Texas, Forente stater, 78229
- Flourish Research
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Sugar Land, Texas, Forente stater, 77478
- DM Clinical Research
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Virginia
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Charlottesville, Virginia, Forente stater, 22911
- Alcanza (Charlottesville Medical Research)
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Newport News, Virginia, Forente stater, 23606
- Health Research of Hampton Roads, Inc.
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Prosentandel av forsøkspersoner som rapporterte forespurte lokale bivirkninger (AE) (rødhet, hevelse og smerte på injeksjonsstedet)
Tidsramme: opptil 7 dager etter vaksinasjon
|
opptil 7 dager etter vaksinasjon
|
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Prosentandel av forsøkspersoner som rapporterte forespurte systemiske bivirkninger (feber, hodepine, tretthet, muskel- og leddsmerter)
Tidsramme: opptil 7 dager etter vaksinasjon
|
opptil 7 dager etter vaksinasjon
|
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Prosentandel av forsøkspersoner som rapporterer uoppfordrede bivirkninger
Tidsramme: opptil 31 dager etter vaksinasjon
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opptil 31 dager etter vaksinasjon
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Serotype-spesifikke OPA geometriske gjennomsnittstiter (GMT)
Tidsramme: 1 måned etter VAX-31-vaksinering
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1 måned etter VAX-31-vaksinering
|
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Serotypespesifikk OPA geometrisk gjennomsnittlig fold-økning (GMFR) fra baseline
Tidsramme: 1 måned etter VAX-31-vaksinasjon
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1 måned etter VAX-31-vaksinasjon
|
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Prosentandel av forsøkspersoner som rapporterer nyoppstått kronisk sykdom (NOCI), medisinsk behandlet bivirkning (MAAE) og alvorlige bivirkninger (SAE)
Tidsramme: opptil 6 måneder etter vaksinasjon
|
opptil 6 måneder etter vaksinasjon
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Serotype-spesifikk IgG geometrisk gjennomsnittskonsentrasjon (GMC)
Tidsramme: 1 måned etter VAX-31-vaksinasjon
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1 måned etter VAX-31-vaksinasjon
|
|
Serotype-spesifikk IgG geometrisk gjennomsnittlig fold-økning (GMFR) fra baseline
Tidsramme: 1 måned etter VAX-31-vaksinering
|
1 måned etter VAX-31-vaksinering
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VAX31-105
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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