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Study of Immunogenicity Equivalence of a Homologous Third Dose of Covid-19 (Recombinante) Vaccine

2021年12月1日 更新者：The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Study of Immunogenicity Equivalence After a Homologous Third Dose of Covid-19 (Recombinante) Vaccine, 6 Months After the Second Dose, Comparing Intervals of 8 and 12 Weeks Between the First Two Doses.

The purpose of this study is to evaluate the antibody response, safety and reactogenicity of a third dose Covid-19 (recombinante) vaccine, 6 months after a two-dose vaccine schedule using the same vaccine in all doses.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

After being informed about the study and potential risks, all participants giving written informed consent will be evaluated for eligibility criteria. At day 0, participants who meet the eligibility requirements will undergo a thorough medical evaluation and a urine pregnancy test (if applicable). Previous vaccination information will be collected with the participant and checked via digital Covid-19 vaccine certification from the Brazilian public health national immunization program system (SI-PNI) ou from Fundação Oswaldo Cruz (Fiocruz) institutional occupational medicine data. According to the data collected, participants will be placed in one of two groups: 8 or 12 weeks interval between the first two vaccine doses in the vaccine schedule. Eligible and consenting participants will have a blood sample collected and receive immediately after a third dose of the Covid-19 (recombinante) vaccine. Participants will be instructed to fill out an adverse events journal for solicited adverse events for 7 days and non-solicited adverse events for 28 days after the third dose. The research team will contact the participant remotely at least once during the first two weeks. The participant will return for a follow-up visit to the research center 28 days after the third dose, to evaluate adverse events, collect a second blood sample and undergo a thorough medical evaluation. The participant will return to the research center to collect blood samples in three more follow-up visits: 3 months, 6 months and 12 months after the third dose.

研究の種類

介入

入学 (予想される)

662

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • ブラジル
      • Rio de Janeiro、ブラジル、21040-900
        • 募集
        • Unidade de Ensaios Clínicos em Imunobiológicos
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Employee of Fundação Oswaldo Cruz, stationed in Manguinhos campus, in Rio de Janeiro.
  • Previous two-dose vaccine schedule with Covid-19 (recombinante) in both doses, with an interval of8 or 12 weeks between doses.
  • A 6-month interval (5 to 7 month window) between the second and the third dose of Covid-19 (recombinante) vaccine.
  • Availability to participate during the entire study, and ability to follow study protocol strictly.
  • Consent to supply personal contact information, such as telephone numbers, address and other information so the research team may contact the participant (For example, in case the participant fails to attend a scheduled visit without previous notice)
  • Ability to understand and sign the volunteered and informed consent form, and ability to fill in the adverse events journal at home, according to the evaluation of the principal investigator ou delegated research team members.
  • Understanding the impossibility of participating in another clinical trial while participating in this clinical trial.

Exclusion Criteria:

  • Receiving another Covid-19 vaccine after inclusion in the study
  • Receiving any vaccine 28 days after administration of a third dose of Covid-19 (recombinante) vaccine.
  • Refusal to sign the voluntary and informed consent form or refusal to permit collection of blood samples before the third dose of the Covid-19 (recombinante) vaccine.
  • Receiving any other vaccine 28 days before the inclusion in the study
  • Previous vaccine schedule with other Covid-19 vaccines, in the first and/or second dose.
  • Covid-19 disease confirmed by RT-PCR (Real time polymerase chain reaction) up to 28 days before inclusion in the study.
  • Covid-19 symptoms up to 10 days before the inclusion in the study.
  • Fever (Axillary temperature above 37,8 º C / 100,04 °F) 72 hours before vaccination in the study.
  • Contraindications to the Covid-19 (recombinante) vaccine - Fiocruz/AstraZeneca
  • Use of immunosuppressive medication, such as systemic corticosteroids or chemotherapy, or immunosuppressive diseases. We will consider as immunosuppressive doses of systemic corticosteroids daily doses of prednisone of 10mg or more, for more than 14 days.
  • Incapacitating mental illness
  • Any discoveries made by the principal investigator that would enhance the risk of an adverse result following the participation in the study, or that in some other way justifies exclusion from the study.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：8 week interval
Third dose Covid-19 (recombinante) vaccine 6 months after the second dose of a two dose vaccine schedule with a 8 week interval between the first two doses.
生物学的：Covid -19 (recombinante) vaccine
Third dose of the Covid-19 (recombinante) vaccine, 6 months after the second dose of a two dose Covid-19 (recombinante) homologous vaccine schedule.
アクティブコンパレータ：12 week interval
Third dose Covid-19 (recombinante) vaccine 6 months after the second dose of a two dose vaccine schedule with a 12 week interval between the first two doses.
生物学的：Covid -19 (recombinante) vaccine
Third dose of the Covid-19 (recombinante) vaccine, 6 months after the second dose of a two dose Covid-19 (recombinante) homologous vaccine schedule.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
IgG Anti-S response after a third dose of Covid-19 (recombinante) vaccine
時間枠：28 days
Equivalence of antibody IgG Anti-S response in geometric mean titers, measured immediately before and 28 days after a third dose of Covid-19 (recombinante) vaccine, administered 6 months after the second dose of a two-dose homologous Covid-19 (recombinante) vaccine schedule, between participants with an 8 and 12 week interval between the first two doses.
28 days

二次結果の測定

結果測定
メジャーの説明
時間枠
Duration of Immunogenicity after the third dose of Covid-19 (recombinate) vaccine after 3, 6 and 12 months
時間枠：15 months
Antibody IgG Anti-S collected immediately before, 28 days, 3 months, 6 months and 12 months after the third dose of Covid-19 (recombinante) vaccine.
15 months
Safety and reactogenicity of a third dose of Covid-19 (recombinate) vaccine
時間枠：15 months
Safety and reactogenicity after a third dose of Covid-19 (recombinate) vaccine, 7 days for solicited adverse events, 28 days for non-solicited adverse events and 12 months for serious adverse events.
15 months
Neutralizing antibodies in plaque reduction neutralization test (PRNT) in a smaller sample
時間枠：28 days
Measure neutralizing antibodies in plaque reduction neutralization test (PRNT) in a smaller sample of participants, immediately before and 28 days after the third dose.
28 days
IgG Anti-S response after a third dose of Covid-19 (recombinante) vaccine by age groups
時間枠：1 month
Equivalence of antibody IgG Anti-S response in geometric mean titers, measured immediately before and 28 days after a third dose of Covid-19 (recombinante) vaccine, administered 6 months after the second dose of a two-dose homologous Covid-19 (recombinante) vaccine schedule, between participants with an 8 and 12 week interval between the first two doses. Compare results between participants with 40 years or less, 40 to 60 years, or more than 60 years.
1 month
Duration of Immunogenicity after the third dose of Covid-19 (recombinate) vaccine after 3, 6 and 12 months by age groups
時間枠：15 months
Antibody IgG Anti-S collected immediately before, 28 days, 3 months, 6 months and 12 months after the third dose of Covid-19 (recombinante) vaccine. Compare results between participants with 40 years or less, 40 to 60 years, or more than 60 years.
15 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年11月9日

一次修了 (予想される)

2022年3月30日

研究の完了 (予想される)

2023年3月30日

試験登録日

最初に提出

2021年11月30日

QC基準を満たした最初の提出物

2021年12月1日

最初の投稿 (実際)

2021年12月2日

学習記録の更新

投稿された最後の更新 (実際)

2021年12月2日

QC基準を満たした最後の更新が送信されました

2021年12月1日

最終確認日

2021年12月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • ASCLIN 009/2021

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

COVID-19（新型コロナウイルス感染症）の臨床試験

Covid -19 (recombinante) vaccineの臨床試験

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