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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 décembre 2021 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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

Type d'étude

Interventionnel

Inscription (Anticipé)

200

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Chieh-Yu Cheng, MD.PhD.
  • Numéro de téléphone: 8311 +886-3-3699721
  • E-mail: s841060@gm.ym.edu.tw

Sauvegarde des contacts de l'étude

Lieux d'étude

      • Taoyuan, Taïwan
        • Recrutement
        • TaoYuan General Hospital
        • Contact:
          • Chieh-Yu Cheng, M.D., Ph.D.
          • Numéro de téléphone: 8311 +886-3-3699721
          • E-mail: s841060@gm.ym.edu.tw

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans à 64 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Expérimental: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Primary Immunogenicity
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Secondary Immunogenicity
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Exploratory Efficacy
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Chieh-Yu Cheng, MD.PhD., TaoYuan General Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

7 octobre 2021

Achèvement primaire (Anticipé)

1 mars 2022

Achèvement de l'étude (Anticipé)

1 juillet 2022

Dates d'inscription aux études

Première soumission

17 octobre 2021

Première soumission répondant aux critères de contrôle qualité

18 octobre 2021

Première publication (Réel)

27 octobre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 décembre 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 décembre 2021

Dernière vérification

1 décembre 2021

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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Informations sur les médicaments et les dispositifs, documents d'étude

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Étudie un produit d'appareil réglementé par la FDA américaine

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