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La risposta al vaccino COVID-19 e la co-somministrazione nei pazienti reumatologici (COVER-CoAd)

21 settembre 2026 aggiornato da: Kevin Winthrop, Oregon Health and Science University

La risposta al vaccino contro il COvid19 e la co-somministrazione nei pazienti reumatologici (COVER-CoAd)

Based on the experience with influenza, pneumococcal, and shingles vaccinations in rheumatic disease populations, it is clear that some disease modifying anti-rheumatic drugs and the immunomodulatory therapies used to treat immune-mediated inflammatory diseases have the capacity to blunt immune responses to COVID-19 vaccines.

Several studies have suggested that patients with autoimmune conditions may be at increased risk of poor COVID-19 outcomes. There is an urgent need to better clarify the immunogenicity and safety of COVID-19 vaccines in people living with rheumatic disease who use immunomodulatory therapies. Boosters at annual or other frequency are available, and there is a need to understand whether these vaccines can be given concurrently with other routine vaccines.

Panoramica dello studio

Stato

Stato

Indica lo stato di reclutamento attuale o lo stato di accesso ampliato.
Terminato

Condizioni

Condizioni

La malattia, il disturbo, la sindrome, la malattia o la lesione oggetto di studio. Su ClinicalTrials.gov, le condizioni possono includere anche altri problemi relativi alla salute, come la durata della vita, la qualità della vita e i rischi per la salute.

Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.

Descrizione dettagliata

The COVID-19 pandemic, caused by the coronavirus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), has infected a substantial portion of the world population, leading to millions of deaths since its first description in December of 2019. Recently, several SARS-CoV-2 vaccines have shown excellent efficacy and tolerability in the general population and have been either fully approved or given emergency use authorization by the US Food and Drug Administration (FDA), while several other vaccines are in late-stage clinical trials.

Patients with autoimmune conditions, however, particularly those receiving immunomodulatory therapies, have largely been excluded from clinical trials. Yet, certain immunomodulatory therapies have been shown to affect responses to vaccines, with effects varying depending on the medication and type of vaccine. In line with the experience with influenza, pneumococcal and shingles vaccinations in rheumatic disease populations, it is clear that some disease modifying anti-rheumatic drugs (DMARDs) and the immunomodulatory therapies used to treat immune-mediated inflammatory diseases have the capacity to blunt immune responses to COVID-19 vaccines. In addition, a hypothetical concern is that stimulation of the immune system could lead to flares of autoimmune conditions, or new onset autoimmune manifestations. Concerns about flare or disease worsening with vaccination is also substantial among patients themselves, and can sometimes be a reason for vaccine hesitancy or refusal.

Due to recent development and subsequent massive deployment of SARS-CoV-2 vaccines to combat the pandemic, their safety and immunogenicity in patients receiving immunomodulatory therapies had received limited evaluation to date. At the same time, several studies have suggested that patients with autoimmune conditions may be at increased risk of poor COVID-19 outcomes, including hospitalization and death, raising the importance of effective vaccination in this setting. In this context, there is an urgent need to better clarify the immunogenicity and safety of COVID-19 vaccines in people living with rheumatic disease who use immunomodulatory therapies. Additionally, the likelihood that patients will need to be vaccinated in the future again for COVID-19 is high. Boosters at annual or other frequency are likely for all (and have now already been recommended for immunocompromised individuals), and the need to understand whether these vaccines can be given concurrently with other routine vaccines will be important for both patients and clinicians, as well as public health officials. The "vaccine moment" clinically frequently offers the opportunity to give multiple vaccines at one time. Vaccines for other respiratory pathogens (e.g. influenza), hepatitis A, pertussis, and other disease are indicated in large segments of the population, including being of utmost importance in the elderly and those with various chronic conditions and/or immunosuppression. It is imperative to understand whether co-administrated vaccines affect the immunogenicity, efficacy, or safety of COVID-19 vaccines and those vaccines of public health significance given concurrently.

With this background in mind and the momentum of the vaccine campaign in the US to date, whereby the majority of at-risk rheumatology and other populations have received their initial vaccine series, this protocol will focus on evaluating vaccine responses in those receiving a booster mRNA SARS-CoV-2 vaccination. This is important, as boosters are now recommended for all adult patients in the US who have received any prior SARS-CoV-2 vaccination. Further, given a large percentage of rheumatology patients can have sub-optimal or lower immune responses, booster vaccinations will be likely of utmost importance to these and other immunosuppressed groups.

Tipo di studio

Tipo di studio

Descrive la natura di uno studio clinico. I tipi di studio includono studi interventistici (chiamati anche studi clinici), studi osservazionali (compresi i registri dei pazienti) e accesso allargato.
Interventistico

Iscrizione (Effettivo)

Iscrizione

Il numero di partecipanti a uno studio clinico. L'iscrizione "anticipata" è il numero target di partecipanti di cui i ricercatori hanno bisogno per lo studio.
129

Fase

Fase

La fase di una sperimentazione clinica che studia un farmaco o un prodotto biologico, sulla base delle definizioni sviluppate dalla Food and Drug Administration (FDA) statunitense. La fase si basa sull'obiettivo dello studio, sul numero di partecipanti e su altre caratteristiche. Ci sono cinque fasi: Early Phase 1 (precedentemente indicata come Fase 0), Phase 1, Phase 2, Phase 3 e Phase 4. Not Applicable è usato per descrivere sperimentazioni senza fasi definite dalla FDA, incluse sperimentazioni di dispositivi o interventi comportamentali.
  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Northport, Alabama, Stati Uniti, 35473
        • Center for Rheumatic Diseases
    • Florida
      • Riverview, Florida, Stati Uniti, 33569
        • Southwest Florida Rheumatology
    • Idaho
      • Boise, Idaho, Stati Uniti, 83702
        • St. Luke's Rheumatology
    • New Mexico
      • Clovis, New Mexico, Stati Uniti, 88101
        • Jayashree Sinha, MD
    • Oregon
      • Portland, Oregon, Stati Uniti, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Duncansville, Pennsylvania, Stati Uniti, 16635
        • Altoona Center for Clinical Research
    • Tennessee
      • Crossville, Tennessee, Stati Uniti, 38555
        • Cumberland Rheumatology

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Criteri di ammissibilità

I requisiti chiave che devono soddisfare le persone che vogliono partecipare a uno studio clinico o le caratteristiche che devono avere. I criteri di ammissibilità sono costituiti sia da criteri di inclusione (necessari a una persona per partecipare allo studio) sia da criteri di esclusione (che impediscono a una persona di partecipare). I tipi di criteri di ammissibilità includono se uno studio accetta volontari sani, ha requisiti di età o gruppo di età o è limitato dal sesso.

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patients must meet all of the inclusion criteria at the time of screening
  • Must be 18 years of age or older
  • Must live in the United States
  • Scheduled for SARS-CoV-2 booster vaccination
  • Patients in Rheumatic Disease arm (arm 4) must have inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis, other) and be receiving stable doses of one of the following medication classes: TNF antagonists, B-cell depletion agents, IL-6 inhibitors, JAK inhibitors, IL-12/23 or IL-23 blockers, IL-17 inhibitors, methotrexate, sulfasalazine, leflunamide, or chronic prednisone (>15mg/day). Stable dosing is defined as no change in dose in the 30 days prior to enrolment.
  • For Arms 1-3: patients seen by rheumatologists who do not have active rheumatic disease requiring immunosuppressive therapy. These will include patients with a past history of auto-immune disease that is no longer active, as well as those with other chronic conditions not associated with autoimmune condition such as osteoarthritis, osteoporosis, or other.
  • Patients in the Co-administration arms (arms 2 and 3) must meet ACIP recommendations for the use of HAVRIX® (i.e. not previously vaccinated) and BOOSTRIX® (i.e. last immunization >9 years ago).
  • Patients who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the REDCap/diary cards, capable of receiving text messages and/or have a personal email address, return for follow-up visits).

Exclusion Criteria:

  • Active infection with SARS-CoV-2 (symptom onset or first positive test in the 14 days prior to recruitment) / disease
  • Any known contraindication to SARS-CoV-2 (booster) vaccination, including severe allergy to vaccine components
  • Prior use of adenoviral COVID-19 vaccination
  • Known or history of HIV/AIDS
  • Currently receiving radiation or chemotherapy for any type of malignancy
  • Receipt of any immunizations other than SARS-CoV-2 within two weeks prior planned SARS-CoV-2 vaccination, or scheduled within 10 weeks after visit 1
  • Significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to < 1 year)
  • Patients who have a previous history of pericarditis/myocarditis associated with vaccination
  • Any other reason that, in the opinion of the site investigator, would interfere with required study related evaluations (e.g. uncontrolled comorbidity)
  • Prior receipt of any hepatitis A containing vaccine
  • Prior receipt of diphtheria, acellular pertussis, or tetanus vaccination within the last 9 years
  • History of physician-diagnosed or laboratory confirmed pertussis within the past 5 years; any history of diphtheria, tetanus disease, or hepatitis A.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm

Gruppo di partecipanti / Arm

Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.
Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Comparatore attivo: Arm 1 (control group, sequential administration)

Individuals with other chronic conditions and not active rheumatic disease (defined as being treated), who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination.

This arm will receive sequential administration of both tdap booster and hepA vaccinations.
Biologico: Hepatitis A vaccine

Vaccination series administered to prevent hepA infection.

Altri nomi:
  • Havrix
Biologico: Diphtheria, pertussis, and tetanus booster vaccine

Vaccination booster administered to prevent diphtheria, pertussis, and tetanus

Altri nomi:
  • Boostrix
Comparatore attivo: Arm 2 (co-administration group)

Individuals with other chronic conditions and not active rheumatic disease (defined as being treated), who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination.

This arm will receive co-administration of hepA vaccination.
Biologico: Hepatitis A vaccine

Vaccination series administered to prevent hepA infection.

Altri nomi:
  • Havrix
Comparatore attivo: Arm 3 (co-administration group)

Individuals with other chronic conditions and not active rheumatic disease (defined as being treated), who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination.

This arm will receive co-administration of tdap booster vaccination.
Biologico: Diphtheria, pertussis, and tetanus booster vaccine

Vaccination booster administered to prevent diphtheria, pertussis, and tetanus

Altri nomi:
  • Boostrix
Nessun intervento: Arm 4 (Inflammatory arthritis patients using DMARDS)

Individuals with inflammatory arthritis patients using DMARDS, who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination.

This arm will only receive the standard of care COVID-19 booster vaccination.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misure di risultato primarie

Nel protocollo di uno studio clinico, la misura dell'esito pianificato più importante per valutare l'effetto di un intervento/trattamento. La maggior parte degli studi clinici ha una misura di esito primaria, ma alcuni ne hanno più di una.
Misura del risultato
Misura Descrizione
Lasso di tempo
Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 measured post-vaccination for those who received only the SARS-CoV-2 booster compared to those who received sequential vaccination with the SARS-CoV-2 booster.
Lasso di tempo: 2 years

Descriptively evaluate the immunogenicity of anti-spike IgG among patients receiving SARS-CoV-2 booster vaccines alone (Arm 4 N=100) as compared to patients receiving SARS-CoV-2 booster vaccine with sequential vaccination (Arm 1 N=100). The geometric mean concentration ratio (GMC) of Arm 4 to Arm 1 at Week 4 will be reported.
2 years
Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 for those who received sequential vaccination with the SARS-CoV-2 booster compared to those who received a tdap booster co-administered with the SARS-CoV-2 booster.
Lasso di tempo: 2 years

Descriptively evaluate the immunogenicity of anti-spike IgG among patients receiving SARS-CoV-2 booster vaccines with sequential vaccination (Arm 1 N=100) as compared to patient receiving SARS-CoV-2 booster vaccine with co-administration of BOOSTRIX® (Arm 2 N=100). The geometric mean concentration ratio (GMC) of Arm 1 to Arm 2 at each 4-week interval for Arm 1 (e.g. Week 4, 8, and 36) will be reported.
2 years
Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 for those who received sequential vaccination with the SARS-CoV-2 booster compared to those who received a hepA vaccination co-administered with the SARS-CoV-2 booster.
Lasso di tempo: 2 years

Descriptively evaluate the immunogenicity of anti-spike IgG among patients receiving SARS-CoV-2 booster vaccines with sequential vaccination (Arm 1 N=100) as compared to patient receiving SARS-CoV-2 booster vaccine with co-administration of HAVRIX® (Arm 3 N=100). The geometric mean concentration ratio (GMC) of Arm 1 to Arm 3 at each 4-week interval for Arm 1 (e.g. Week 4, 8, and 36) will be reported.
2 years
Number of participants with solicited localized and general symptoms (Arm 4 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines alone (Arm 4 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine with sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of participants with solicited local and general symptoms that occur within an 8 day period following each vaccine dose administered as assessed by CTCAE will be reported.
2 years
Number of participants with unsolicited events (Arm 4 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines alone (Arm 4 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine with sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of participants with unsolicited events occurring within a 31 day period following each vaccine dose administered as assessed by CTCAE will be reported.
2 years
Number of medically attended events (Arm 4 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) or co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). All medically attended events.
2 years
Number of confirmed cases of COVID-19 (Arm 4 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) or co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of confirmed cases of COVID-19 as diagnosed by PCR or antigen-based testing.
2 years
Number of potential immune-mediated diseases (Arm 4 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) or co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of potential immune-mediated diseases (pIMDs; new onset or exacerbation of current).
2 years
Number of serious adverse events (Arm 4 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) or co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of serious adverse events as assessed by CTCAE.
2 years
Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 for those who received a tdap booster co-administered with the SARS-CoV-2 booster compared to those who received sequential vaccination with the SARS-CoV-2 booster.
Lasso di tempo: 2 years

Descriptively evaluate the immunogenicity of anti-spike IgG among patients receiving SARS-CoV-2 booster vaccine with co-administration of BOOSTRIX® (Arm 2 N=100) as compared to patients receiving SARS-CoV-2 booster vaccine with sequential vaccination (Arm 1 N=100). The geometric mean concentration ratio (GMC) of Arm 2 to Arm 1 at 4 weeks post-vaccination for SARS CoV-2 and BOOSTRIX®.
2 years
Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 for those who received a hepA vaccination co-administered with the SARS-CoV-2 booster compared to those who received sequential vaccination with the SARS-CoV-2 booster.
Lasso di tempo: 2 years

Descriptively evaluate the immunogenicity of anti-spike IgG among patients receiving SARS-CoV-2 booster vaccine with co-administration of HAVRIX® (Arm 3 N=100) as compared to patients receiving SARS-CoV-2 booster vaccine with sequential vaccination (Arm 1 N=100). The geometric mean concentration ratio (GMC) of Arm 3 to Arm 1 at 4 weeks post-vaccination for dose 2 of HAVRIX® will be reported.
2 years
Number of participants with solicited localized and general symptoms (Arm 2 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of participants with solicited local and general symptoms that occur within an 8 day period following each vaccine dose administered as assessed by CTCAE.
2 years
Number of participants with unsolicited events (Arm 2 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of participants with unsolicited events occurring within a 31 day period following each vaccine dose administered as assessed by CTCAE.
2 years
Number of medically attended events (Arm 2 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). All medically attended events.
2 years
Number of confirmed cases of COVID-19 (Arm 2 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of confirmed cases of COVID-19 as diagnosed by PCR or antigen-based testing.
2 years
Number of potential immune-mediated diseases (Arm 2 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of potential immune-mediated diseases (pIMDs; new onset or exacerbation of current).
2 years
Number of serious adverse events (Arm 2 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of serious adverse events.
2 years
Number of participants with solicited localized and general symptoms (Arm 3 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of participants with solicited local and general symptoms that occur within an 8 day period following each vaccine dose administered as assessed by CTCAE.
2 years
Number of participants with unsolicited events (Arm 3 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of participants with unsolicited events occurring within a 31 day period following each vaccine dose administered as assessed by CTCAE
2 years
Number of medically attended events (Arm 3 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). All medically attended events
2 years
Number of confirmed cases of COVID-19 (Arm 3 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of confirmed cases of COVID-19 as diagnosed by PCR or antigen-based testing
2 years
Number of potential immune-mediated diseases (Arm 3 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of potential immune-mediated diseases (pIMDs; new onset or exacerbation of current).
2 years
Number of serious adverse events (Arm 3 to Arm 1)
Lasso di tempo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of serious adverse events as assessed by CTCAE.
2 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sponsor

L'organizzazione o la persona che avvia lo studio e che ha autorità e controllo sullo studio.
Oregon Health and Science University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

Inizio studio

La data effettiva in cui il primo partecipante è stato arruolato in uno studio clinico. La data di inizio dello studio "prevista" è la data che i ricercatori pensano sarà la data di inizio dello studio.
11 ottobre 2022

Completamento primario (Effettivo)

Completamento primario

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento per raccogliere i dati finali per la misura dell'esito primario. Il fatto che lo studio clinico sia terminato secondo il protocollo o sia stato interrotto non influisce su questa data. Per gli studi clinici con più di una misura di esito primario con diverse date di completamento, questo termine si riferisce alla data in cui la raccolta dei dati è completata per tutte le misure di esito primario. La data di completamento principale "prevista" è la data che i ricercatori ritengono sarà la data di completamento principale per lo studio.
1 aprile 2025

Completamento dello studio (Effettivo)

Completamento dello studio

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento/trattamento per raccogliere i dati finali per le misure di esito primarie, le misure di esito secondarie e gli eventi avversi (ovvero l'ultima visita dell'ultimo partecipante). La data di completamento dello studio "prevista" è la data che i ricercatori ritengono sarà la data di completamento dello studio.
14 agosto 2026

Date di iscrizione allo studio

Primo inviato

Primo inviato

La data in cui lo sponsor o il ricercatore dello studio ha inviato per la prima volta un record di studio a ClinicalTrials.gov. In genere c'è un ritardo di alcuni giorni tra la prima data di invio e la disponibilità del record su ClinicalTrials.gov (la prima data di invio).
2 settembre 2022

Primo inviato che soddisfa i criteri di controllo qualità

Primo inviato che soddisfa i criteri di controllo qualità

La data in cui lo sponsor dello studio o il ricercatore invia per la prima volta un record di studio che è coerente con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). Lo sponsor o lo sperimentatore potrebbe dover rivedere e inviare un record di studio una o più volte prima che i criteri di revisione QC di NLM siano soddisfatti. È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
14 settembre 2022

Primo Inserito (Effettivo)

Primo Inserito

La data in cui il record dello studio è stato disponibile per la prima volta su ClinicalTrials.gov dopo la conclusione della revisione del controllo di qualità (QC) della National Library of Medicine (NLM). In genere c'è un ritardo di alcuni giorni tra la data in cui lo sponsor dello studio o lo sperimentatore ha presentato il record dello studio e la prima data pubblicata.
16 settembre 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento pubblicato

La data più recente in cui le modifiche al record di uno studio sono state rese disponibili su ClinicalTrials.gov. Potrebbe esserci un ritardo tra il momento in cui le modifiche sono state inviate a ClinicalTrials.gov dallo sponsor o dallo sperimentatore dello studio (data di invio dell'ultimo aggiornamento) e la data di pubblicazione dell'ultimo aggiornamento.
24 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo aggiornamento inviato che soddisfa i criteri QC

La data più recente in cui lo sponsor dello studio o il ricercatore ha presentato modifiche a un record di studio che sono coerenti con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
21 settembre 2026

Ultimo verificato

Ultimo verificato

La data più recente in cui lo sponsor dello studio o il ricercatore ha confermato che le informazioni su uno studio clinico su ClinicalTrials.gov sono accurate e aggiornate. Se uno studio con stato di reclutamento di reclutamento; non ancora reclutamento; o attivo, non reclutamento non è stato confermato negli ultimi 2 anni, lo stato di reclutamento dello studio viene mostrato come sconosciuto.
1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Altri numeri di identificazione dello studio

Identificatori o numeri ID diversi dal numero NCT assegnati a uno studio clinico dallo sponsor, dai finanziatori o da altri dello studio. Questi numeri possono includere identificatori univoci di altri registri di sperimentazione e numeri di sovvenzioni del National Institutes of Health.
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Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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