Evaluation of Inactivated Vaccine in Healthy Adults Against Coronavirus Disease of 2019 (COVID-19)
A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Inactivated Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Vaccine Against COVID-19 in Healthy Adults
調査の概要
詳細な説明
This is a Phase I, Randomized, Open-Labeled Clinical trial. Eligible volunteers will be randomized in a 1:1:1 allocation ratio, into one of the three study arms using the Interactive Web Response Technology (IWRS).
Unscheduled visits can occur at any time during the study period outside the initially planned study visits, all the extra visits will be documented in the subjects' files. Volunteers will be randomized into one of the following arms to receive different doses of the Inactivated
SARS-COV-2 Vaccine "NRC-VACC-101" as an intramuscular (IM) Injection or Placebo:
Arm One:
Volunteers will receive two IM doses of the vaccine, concentrations of 3 mcg, 28 days apart.
Arm Two:
Volunteers will receive two IM doses of the vaccine, concentrations of 6 mcg, 28 days apart.
Arm Three (Control arm):
Volunteers will receive two IM doses of the placebo, 28 days apart. The first 9 subjects will be initially vaccinated with their first dose, as per their assigned study arm determined by the randomization procedures and will be followed up until day 14 (visit 03). At this point in the study, the Data Safety and Monitoring Board (DSMB) will review safety data before proceeding with vaccinating the rest of the recruited subjects
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Osama Azmy, MD
- 電話番号:+201223103084
- メール:osamaazmy@yahoo.com
研究連絡先のバックアップ
- 名前:Clinical Trial Unit Clinical Trial Unit National Research Centre, MD
- 電話番号:+20237623009
- メール:ctu.mrce@nrc.sci.eg
研究場所
-
-
Giza
-
Cairo、Giza、エジプト、12622
- 募集
- Medical Research Centre of Excellence National Research Centre
-
コンタクト:
- Osama Azmy, MD
- 電話番号:+201223103084
- メール:osamaazmy@yahoo.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults with age 18 to 50 years.
- Willingness.
- For married females of childbearing age: Willingness to practice continuous effective contraception for one year from the start of the study.
- Agreement to refrain from blood donation during the study.
- Body temperature is within the normal range (36.5 - 37.5°C).
- General good health as established by medical history, physical and laboratory examinations.
Exclusion Criteria:
- Pregnancy or lactation.
- Inability to provide informed consent.
- Recent receipt of any vaccination within 30 days prior to baseline.
- Planning to receive any vaccination during the course of the study.
- Prior receipt of Adenovirus vaccine, or any other Coronavirus vaccine.
- Recent receipt of any immunoglobulin within 90 days prior to baseline.
- Recent receipt of any blood product within 90 days prior to baseline.
Volunteers who are immunosuppressed or receiving immunosuppressive medications, including:
HIV infection, asplenia, recurrent severe infections, and the use of immunosuppressive medications within the past 6 months, except for topical steroids or short-term oral steroids (course lasting < 14 days).
- Currently taking any product (investigational or off-label) for prevention of COVID-19 disease.
- Having any autoimmune disease.
- History of allergic reactions for any of the vaccine components.
- History of angioedema.
- History of anaphylaxis.
- History of cancer.
- History of serious psychiatric conditions that are likely to affect participation in the study.
- Having bleeding disorders.
- Having chronic respiratory diseases.
- Having chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorders, and neurological illness.
- Volunteers with BMI ≥ 40 Kg/m2 or ≤ 18 Kg/m2.
- Current alcohol abuse.
- Drug abuse within 5 years prior to baseline.
- History of laboratory-confirmed COVID-19 or seropositivity for SARS-CoV-2 or positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) to the SARS CoV-2 or abnormal chest CT-Scan (COVID-19 image) or positive pharyngeal/sputum swabs for SARS-CoV-2.
- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
- High-risk population (volunteers who work in front-line health facilities or were in close contact with confirmed COVID-19 cases).
- Living in the same household as anyone at high risk of severe COVID-19.
- Any condition, according to the judgment of the investigator, that would interfere with the subject's ability to comply with all study requirements or that would place the subject at unacceptable risk by his/her participation in the study or impair the interpretation of the study data.
研究計画
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: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 |
|---|---|
|
アクティブコンパレータ:NRC-VACC-101 vaccine 3 microgram
Volunteers will receive two IM doses of the vaccine, concentrations of 3 mcg, 28 days apart.
|
Inactivated SARS-COV-2 Vaccine/alum adjuvant preparation in addition to excipients (NRC-VACC- 101) administered as an IM Injection.
NRC-VACC-101 is provided as a single dose of inactivated vaccine of opaque white liquid free from visible particles filled in injection vial (2R) glass vials.
Each Dose of Covi Vax Vaccine contains 6 mcg antigen of A human coronavirus (hCoV)-19/Egypt/NRC-03/2020 SARS-CoV-2 strain.
他の名前:
|
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アクティブコンパレータ:NRC-VACC-101 vaccine 6 microgram
Volunteers will receive two IM doses of the vaccine, concentrations of 6 mcg, 28 days apart.
|
Inactivated SARS-COV-2 Vaccine/alum adjuvant preparation in addition to excipients (NRC-VACC- 101) administered as an IM Injection.
NRC-VACC-101 is provided as a single dose of inactivated vaccine of opaque white liquid free from visible particles filled in injection vial (2R) glass vials.
Each Dose of Covi Vax Vaccine contains 6 mcg antigen of A human coronavirus (hCoV)-19/Egypt/NRC-03/2020 SARS-CoV-2 strain.
他の名前:
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プラセボコンパレーター:Control arm
Volunteers will receive two IM doses of the placebo (excipients only), 28 days apart.
|
Inactivated SARS-COV-2 Vaccine/alum adjuvant preparation in addition to excipients (NRC-VACC- 101) administered as an IM Injection.
NRC-VACC-101 is provided as a single dose of inactivated vaccine of opaque white liquid free from visible particles filled in injection vial (2R) glass vials.
Each Dose of Covi Vax Vaccine contains 6 mcg antigen of A human coronavirus (hCoV)-19/Egypt/NRC-03/2020 SARS-CoV-2 strain.
他の名前:
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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 |
|---|---|---|
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The safety of NRC-VACC-101 Vaccine
時間枠:Follow up for any solicited adverse event(AE) reported within 7 days
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To evaluate the safety of the proposed regimens of NRC-VACC-101
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Follow up for any solicited adverse event(AE) reported within 7 days
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The tolerability of NRC-VACC-101 Vaccine
時間枠:Follow up for any AE within 28 days of each dose
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To evaluate the tolerability of the proposed regimens of NRC-VACC-101 Vaccine in the healthy population
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Follow up for any AE within 28 days of each 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 |
|---|---|---|
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The seroconversion rate of neutralizing antibodies
時間枠:The evaluation of the antibody will be measured up to one month of each dose
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To evaluate the seroconversion rate of neutralizing antibodies resulting from the NRC-VACC-101 Vaccine
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The evaluation of the antibody will be measured up to one month of each dose
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To recommend the dose level of NRC-VACC-101 Vaccine for the phase II trial.
時間枠:The evaluation of the Microneutralization Assay will be assessed up to one month of each dose
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The evaluation of the Microneutralization Assay curve will give an overview of the dose possible suggested dose of NRC-VACC-101 Vaccine for the phase II trial
|
The evaluation of the Microneutralization Assay will be assessed up to one month of each dose
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協力者と研究者
捜査官
- 主任研究者:Osama Azmy, MD、Medical Research and Clinical Studies Institute National Research Centre, Dokki, Giza, Egypt.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- NO-B041
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
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
米国FDA規制機器製品の研究
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