Effectiveness of the Adsorbed Vaccine COVID-19 (Coronavac) Among Education and Public Safety Workers With Risk Factors for Severity (COVACMANAUS)
2021年7月22日 更新者：Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Phase IV Study to Evaluate the Effectiveness of the Inactivated Adsorbed Vaccine Against COVID-19 CoronaVac, Among Public Safety and Education Workers With Risk Factors for Severity, in Manaus (Amazonas)
This is a quasi-experimental study with risk-based allocation.
Public security and education professionals from the state government will be included.
In the initial evaluation, the presence of comorbidities associated with an increased risk of serious disease due to COVID-19 will be evaluated, according to the national plan for the implementation of vaccination against COVID-19.
Those with at least one of these comorbidities will be invited to receive the study vaccine in two doses, with an interval of 28 days (±7 days).
Participants with low risk (without comorbidities as a risk factor for severe COVID-19 according to the national plan for the implementation of vaccination against COVID-19) will not receive the vaccine within the scope of the research project.
If, after 12 months, the participant in the low-risk group (no vaccine) has not received CoronaVac, or any other vaccine available, he/she will receive the vaccine, exactly as offered in the other group (two doses of CoronaVac with an interval of 28 days - with a tolerance of 7 days before or after).
All participants will be followed up for 12 months from inclusion in the study.
Immunization is expected to reduce the risk of moderate to severe disease of those with comorbidities to the level of those of the same age group who do not have these comorbidities but face similar occupational risks.
調査の概要
研究の種類
介入
入学 (実際)
6233
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。
研究場所
-
-
Amazonas
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Manaus、Amazonas、ブラジル、69050-010
- Escola Normal Superior - Universidade do Estado do Amazonas
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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～49年 (大人)
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:
- Age between 18 and 49 years
- Demonstrate availability to be accompanied during the follow-up time defined in the study, through visits, telephone contacts, or other means of digital communication.
Exclusion Criteria:
- Prior vaccination for COVID-19;
- Diagnosis of COVID-19 in the last 28 days (nasal and oropharyngeal swab);
- History of severe allergic reaction or anaphylaxis to study vaccine components;
- Report of fever in the 72 hours prior to vaccination (the inclusion may be postponed until the participant completes 72 hours without fever);
- Possible or confirmed of COVID-19 on the day of vaccination (in this situation, vaccination can be postponed until the participant completes 72 hours without symptoms or the diagnosis is ruled out);
- Have received live attenuated virus vaccine in the last 28 days or inactivated vaccine in the last 14 days prior to inclusion in the study, or have immunization scheduled for the first 28 days after their inclusion in the study;
- Any other condition that, in the opinion of the principal investigator or his medical representative, could endanger the safety or rights of a potential participant or that would prevent him or her from complying with this protocol;
- Pregnancy or breastfeeding.
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：処理
- 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 |
|---|---|
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アクティブコンパレータ：High-risk individuals (with comorbidities)
Public safety and security (police officers and law enforcement, fire department), and high school and college/university professionals of the state government public education network who present at least one of the comorbidities included in the National Plan for the Operationalization of Vaccination Against COVID-19 will be invited to receive the CoronaVac vaccine
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600 SU/dose; Two doses separated by 28 days (± 7 days).
Intramuscular (deltoid) administration.
他の名前：
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介入なし：Low-risk individuals (without comorbidities)
Participants with low risk (without comorbidities as a risk factor for severe COVID-19 according to the national plan for the implementation of vaccination against COVID-19) will not receive the vaccine within the scope of the research project.
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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 |
|---|---|---|
|
Incidence density of moderate and severe clinical cases of COVID-19
時間枠：2 weeks after the second vaccine dose
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Incidence density of moderate and severe clinical cases of COVID-19 (Grade 4 or higher according to the WHO clinical progression scale), after the second week after the second dose of the vaccine.
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2 weeks after the second vaccine dose
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence density of moderate and severe clinical cases of COVID-19 after first dose
時間枠：After first dose, up to 12 months.
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Incidence density of moderate and severe clinical cases of COVID-19 (grade 4 or higher according to the WHO clinical progression scale) from the first dose
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After first dose, up to 12 months.
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Incidence density of moderate and severe clinical cases of COVID-19 after second dose
時間枠：After second dose, up to 12 months.
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Incidence density of moderate and severe clinical cases of COVID-19 (grade 4 or higher according to the WHO clinical progression scale) from the second dose
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After second dose, up to 12 months.
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Incidence density of severe clinical cases of COVID-19 after second dose
時間枠：After second dose, up to 12 months.
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Incidence density of severe clinical cases of COVID-19 (grade 6 or higher according to the WHO clinical progression scale) from the second dose
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After second dose, up to 12 months.
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Median of clinical progression scores between moderate and severe cases
時間枠：After first dose, up to 12 months.
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Comparison of the median clinical progression scores according to the WHO clinical progression scale between groups
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After first dose, up to 12 months.
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Incidence density of clinical cases virologically confirmed as COVID-19
時間枠：After first dose, up to 12 months.
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After first dose, up to 12 months.
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Mortality confirmed as COVID-19
時間枠：After first dose, up to 12 months.
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Incidence density of deaths confirmed as COVID-19
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After first dose, up to 12 months.
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Incidence density of hospitalizations for any cause
時間枠：After first dose, up to 12 months.
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After first dose, up to 12 months.
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Mortality from any cause
時間枠：After first dose, up to 12 months.
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Density of mortality from any cause
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After first dose, up to 12 months.
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Adverse events
時間枠：Up to 7 days after each dose of the vaccine (Day 7 and Day 35)
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Frequency of adverse events associated with the need for medical care
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Up to 7 days after each dose of the vaccine (Day 7 and Day 35)
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Humoral and cell-mediated immune response
時間枠：Before each vaccine dose and every 3 months, up to 12 months of follow-up.
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Quantification of humoral and cell-mediated immune response to vaccination in samples of a subgroup of participants
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Before each vaccine dose and every 3 months, up to 12 months of follow-up.
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Detection of antibodies against SARS-CoV-2 in samples
時間枠：Before each vaccine dose and every 3 months, up to 12 months of follow-up
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Before each vaccine dose and every 3 months, up to 12 months of follow-up
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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。
捜査官
- 主任研究者：Marcus Lacerda, MD、Fundação de Medicina Tropical Heitor Vieira Dourado
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3月18日
一次修了 (実際)
2021年7月5日
研究の完了 (予想される)
2022年3月1日
試験登録日
最初に提出
2021年3月5日
QC基準を満たした最初の提出物
2021年3月8日
最初の投稿 (実際)
2021年3月9日
学習記録の更新
投稿された最後の更新 (実際)
2021年7月26日
QC基準を満たした最後の更新が送信されました
2021年7月22日
最終確認日
2021年7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
- CAAE: 44076721.5.0000.0005
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
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
米国で製造され、米国から輸出された製品。
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。
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