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A Heterologous 3rd COVID-19 Vaccine of MVC-COV1901 to Evaluate Immunogenicity and Safety in Adults With ChAdOx1-nCov-19

7 dicembre 2021 aggiornato da: Taoyuan General Hospital

A Parallel Group, Prospective, Randomized, Two-arm, Open-label Study to Evaluate the Immunogenicity, Safety, and Tolerability of Heterologous 3rd Boost of MVC-COV1901 in Adults With 2 Doses of ChAdOx1-nCov-19 in 3 Months and 6 Months

This primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titers in adult participants in order to demonstrate the immunogenicity and safety of heterologous third-boost with MVC-COV1901, in terms of the neutralizing antibody GMTs at 28 days after the study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity by the antigen-specific immunoglobulin as well as the potential efficacy of study intervention in preventing COVID-19. This study is aimed to recruit participants at single study site in Northern Taiwan.

Panoramica dello studio

Descrizione dettagliata

This a parallel group, prospective, randomized, two-arm, open-label, single-center study to be conducted in approximately 200 healthy participants aged 20 to 64 years who have had their two doses of ChAdOx1-nCov-19 (Astra Zeneca). Preparation and administration of study intervention will be performed by authorized unblinded site personnel. Eligible participants will receive MVC-COV1901 vaccine after a 3-month (Group A: < 16 weeks and ≥ 12 weeks) or 6-month (Group B: < 28 weeks and ≥ 24 weeks) interval apart from their second dose of ChAdOx1-nCov-19.

The study consists of 6 on-site visits:

  • Day -28 to Day 1, Visit 1 (Screening)
  • Day 1, Visit 2 (study intervention) : randomization Group A and B

Group A:

  • Day 1, Visit 2: treatment
  • Day 29 ± 3 days, Visit 3
  • Day 85 ± 3 days, Visit 4
  • Day 169 ± 3 days, Visit 5

Group B:

  • Day 1, Visit 2
  • Day 85 ± 3 days, Visit 3: treatment
  • Day 113 ± 3 days, Visit 4
  • Day 169 ± 3 days, Visit 5

Tipo di studio

Interventistico

Iscrizione (Anticipato)

200

Fase

  • Fase 4

Contatti e Sedi

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

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

      • Taoyuan, Taiwan
        • Reclutamento
        • TaoYuan General Hospital
        • Contatto:

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

Età idonea allo studio

Da 20 anni a 64 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Male or female participant aged 20 to 64 years at randomization.
  2. Has received two doses of the ChAdOx1-nCov-19 (Astra-Zeneca) 12 to 16 weeks before randomization.
  3. Female participant must:

    1. Be either of non-childbearing potential, i.e. surgically sterilized (defined as having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal;
    2. Or, if of childbearing potential, be abstinent or agree to use medically effective contraception from 14 days before screening to 30 days following the last administration of study intervention. Acceptable forms include:

    i.Implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system ii.Established use of hormonal methods (injectable, pill, patch or ring) combined with barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository c.Have a negative pregnancy test

  4. Participant is willing and able to comply with all required study visits and follow-up required by this protocol.
  5. Participant or the participant's legal representative must understand the procedures of the study and provide written informed consent.

Exclusion Criteria:

  1. Pregnant or breast feeding or have plan to become pregnant within 30 days after the last administration of study intervention.
  2. Currently receiving or received any investigational intervention within 30 days prior to the first dose of study intervention.
  3. Administered any licensed live-attenuated vaccines within 28 days or other licensed non-live-attenuated vaccines within 7 days prior to the first dose of study intervention.
  4. Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of study intervention.
  5. Currently receiving or anticipate to receive concomitant immunosuppressive or immune-modifying therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone less than 20 mg or equivalent) within 12 weeks prior to the first dose of study intervention.
  6. Currently receiving or anticipate to receive treatment with tumor necrosis factor (TNF)-α inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks prior to the first dose of study intervention.
  7. Major surgery or any radiation therapy within 12 weeks prior to the first dose of study intervention.
  8. Has received any other investigational or licensed COVID-19 vaccine.
  9. Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.
  10. A history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer (exceptions are squamous and basal cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the discretion of the investigator).
  11. Bleeding disorder considered a contraindication to IM injection or phlebotomy.
  12. Known SARS-CoV-2 infection in the recent 3 months prior to the first dose of study intervention.
  13. A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome.
  14. Participant who, in the investigator's judgement, is not in a stable condition and by participating in the study could adversely affect the safety of the participant, interfere with adherence to study requirements or evaluation of any study endpoint. This may include a participant with ongoing acute diseases, severe infections, autoimmune disease, laboratory abnormality or serious medical conditions in the following systems: cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, or psychiatric.
  15. A history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the MVC-COV1901.
  16. Body (oral, rectal, or ear) temperature ≥ 38.0°C or acute illness (not including minor illnesses such as diarrhea or mild upper respiratory tract infection at the discretion of the investigator) within 2 days before the first dose of study intervention.

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: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: MVC-COV1901 vaccine (3-month Interval)
There will be approximately 100 participants (Group A) who had received 2 doses of ChAdOx1-nCov-19 and will be vaccinated with MVC-COV1901 at Day 1
MVC-COV1901 vaccine after a 3-month Interval
Sperimentale: MVC-COV1901 vaccine (6-month Interval)
There will be approximately 100 participants (Group B) who had received 2 doses of ChAdOx1-nCov-19 and will be vaccinated with MVC-COV1901 at Day 85.
MVC-COV1901 vaccine after a 6-month Interval

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Primary Immunogenicity
Lasso di tempo: Day1 to 28 days after vaccination

To evaluate the immunogenicity of heterologous third-boost (MVC-COV1901) in 3 months, compared to 6 months, in terms of neutralizing antibody

Geometric Mean Titers (GMT)

Day1 to 28 days after vaccination
Primary Safety
Lasso di tempo: Day1 to 28 days after vaccination

To evaluate the safety and tolerability of heterologous third-boost (MVC-COV1901) from Day 1 to 28 days after the study intervention

The number and percentage of participants with the occurrence of:

  • Solicited local adverse events (AEs)
  • Solicited systemic AEs
  • Unsolicited AEs
Day1 to 28 days after vaccination

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Secondary Immunogenicity
Lasso di tempo: Day 1 and Day 169

To evaluate the immunogenicity of heterologous third-boost (MVC-COV1901) in terms of antigen-specific immunoglobulin titers

GMT

Day 1 and Day 169
Secondary Safety
Lasso di tempo: Day 1 to Day169

To evaluate the safety of heterologous third-boost (MVC-COV1901), over the study period

The number and percentage of participants with the occurrence of:

  • MAAEs
  • AESIs
  • VAED
  • SAEs
Day 1 to Day169

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Exploratory Efficacy
Lasso di tempo: Day 1 to Day 169

To estimate the efficacy of heterologous third-boost (MVC COV1901), in the prevention of COVID-19

  • Number of laboratory-confirmed COVID-19 cases occurring ≥ 7 days after study intervention.
  • Number of laboratory-confirmed COVID-19 severe cases occurring ≥ 7 days after study intervention.
Day 1 to Day 169

Collaboratori e investigatori

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

Investigatori

  • Investigatore principale: Chieh-Yu Cheng, MD.PhD., TaoYuan General Hospital

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)

7 ottobre 2021

Completamento primario (Anticipato)

1 marzo 2022

Completamento dello studio (Anticipato)

1 luglio 2022

Date di iscrizione allo studio

Primo inviato

17 ottobre 2021

Primo inviato che soddisfa i criteri di controllo qualità

18 ottobre 2021

Primo Inserito (Effettivo)

27 ottobre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 dicembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 dicembre 2021

Ultimo verificato

1 dicembre 2021

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

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

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli 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 .

Prove cliniche su Vaccino contro il covid-19

Prove cliniche su MVC-COV1901(3 Months)

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