A Study to Evaluate Safety & Immunogenicity of SARS-CoV-2 DNA Vaccine Delivered Intramuscularly Followed by Electroporation for COVID-19
A Phase 1, Randomized, Double-blinded, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 DNA Vaccine Delivered Intramuscularly Followed by Electroporation for COVID-19 in Healthy Adults
調査の概要
詳細な説明
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:Volunteer Resource Centre
- 電話番号:85296812309
- メール:ctcvrc@hku.hk
研究場所
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Hong Kong、香港
- 募集
- HKU Phase 1 Clinical Trials Centre
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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:
- Informed Consent: The subject (or the subject's legally acceptable representative, if applicable) must be capable of giving written informed consent and, prior to the commencement of any study-specific procedure, must sign an ICF indicating the consent on the subject's voluntary participation in the study and compliance with the requirements and restrictions listed on the ICF.
- Gender and Age: Male or female, at the age of ≥ 18 and ≤ 55 on the day of signing the ICF.
- Body Weight and BMI: Body weight ≥ 50 kg and BMI ≥ 18.5 kg/m2 and < 25 kg/m2 at screening and baseline.
Medical Conditions or Diagnoses: Existence of all of the following medical conditions or diagnoses:
- Generally in good health with no clinically significant abnormality, as determined by medical history, physical examination, 12-lead ECG and clinical laboratory tests at screening and baseline;
Normal vital signs at screening and baseline, as defined by:
- Body (tympanic) temperature ≤ 37.5oC;
- Resting pulse rate ≥ 50 and ≤ 100 bpm; and
- DBP ≥ 50 and ≤ 90 mmHg and SBP ≥ 90 and ≤ 140 mmHg.
Contraception: Willingness and agreement to undertake measures to avoid pregnancy of the subject or the subject's sexual partner(s) as detailed below:
- A female subject who is a woman of childbearing potential (WOCBP) must be willing and agree to remain abstinent or practise at least one effective contraceptive method from at least 30 days prior to the first vaccination until 60 days after the second vaccination;
- A male subject (i) who is sexually active with a WOCBP (except who is permanently sterile by bilateral orchiectomy or vasectomy) must be willing and agree to remain abstinent or practise at least one effective contraceptive method from the first vaccination until 60 days after the second vaccination; and (ii) must be willing and agree to refrain from sperm donation during the aforesaid period.
- Breastfeeding: A female subject must be willing and agree to avoid engagement in breastfeeding at any time from the first vaccination until 60 days after the second vaccination.
- Blood Donation: Willingness and agreement to avoid blood donation from screening to the end of the period of participation in this study.
Exclusion Criteria:
Medical History: History of any of the following diseases or conditions:
- COVID-19;
- SARS;
- Any significant respiratory diseases (e.g. COPD, asthma);
- Any significant cardiovascular disease (e.g. angina, cardiac arrhythmias);
- Blood dyscrasias or any significant disorder of coagulation;
- Any chronic liver disease (e.g. autoimmune hepatitis and cirrhosis);
- Any chronic infection (e.g. hepatitis B, hepatitis C and HIV);
- Any malignant neoplastic disease;
- Encephalopathy, neuropathy or unstable central nervous system (CNS) pathology;
- Any psychiatric disorder, psychotic disorder, major affective disorder or suicidal ideation;
- Any immunodeficiency or autoimmune disease;
- Any severe allergic reaction (e.g. anaphylaxis) to any vaccine or substance, which requires hospitalization or emergency medical care;
- History of alcohol or illicit drug abuse, or used any illicit drug within 6 months prior to screening.
Medical Conditions or Diagnoses: Existence of any of the following medical conditions or diagnoses:
- Positive serum pregnancy test at screening or positive urine pregnancy test at baseline (for WOCBP);
- IgE level > 1,000 IU/ml at screening;
- Positive SARS-CoV-2 test result in serum or deep throat saliva (DTS) within 4 days prior to baseline;
- T3, T4 or TSH < LLN or > ULN at screening;
- Positive HIV test result at screening;
- Positive HBsAg test result at screening;
- Positive HCV antibody test result at screening;
- Positive urine drug screen test result or positive blood alcohol test result at screening or baseline;
- Any clinically significant findings (e.g. active or acute cardiac/pulmonary diseases) from chest X-ray examination performed at or within 4 months prior to screening.
Prior/Concomitant Interventions: Use of or undergoing any of the following prior or concomitant medications, therapies or interventions:
- Any COVID-19 or coronavirus vaccine at any time prior to the first vaccination, or planned use of any such vaccine throughout the study;
- Any vaccine other than COVID-19 or coronavirus vaccines within 28 days prior to the first vaccination, or planned use of any such vaccine up to 28 days after the second vaccination;
- Any immune-modifying medication/therapy (e.g. immunomodulator and immunosuppressant) within 6 months prior to the first vaccination, or planned use of any such medication/therapy throughout the study;
- Any blood product (including blood transfusion) or immunoglobulin within 3 months prior to the first vaccination, or planned use of any such therapy throughout the study;
- Any anticoagulation medication within 28 days prior to the first vaccination, or planned use of any such medication up to 28 days after the second vaccination;
- Any psychotropic medication within 28 days prior to the first vaccination, or planned use of any such medication up to 28 days after the second vaccination;
- Regular use of any topical corticosteroids at or near the intended administration site (upper arm);
- Any influenza antiviral medication within 48 hours prior to the first vaccination, or planned use of any such medication up to 14 days after the second vaccination;
- Any prescription or over-the-counter medication or supplement product (e.g. vitamin, dietary supplement, herbal preparation) within 7 days prior to the first vaccination, unless with the investigator's approval for managing a chronic condition;
- Donated ≥ 450 ml of blood within 28 days prior to the first vaccination.
Prior/Concurrent Clinical Study: Prior or concurrent participation in any other clinical study, including:
- Prior or current participation in another COVID-19 vaccine study;
- Prior participation in any interventional clinical study and use of any investigational intervention within 90 days prior to the first vaccination;
- Concurrent participation or plan for participation in another interventional clinical study during participation in this study.
- Other Significant Medical Conditions: Any clinically significant concomitant disease or condition that, in the reasonable opinion of the investigator, may interfere with the subject's participation in this study or pose an unacceptable safety risk for the subject's participation in this study.
Special Conditions: Existence of any of the following special conditions:
- Close contact with anyone known to have COVID-19 within 30 days prior to the first vaccination;
- Travelled outside Hong Kong within 14 days prior to the first vaccination;
- Planned to travel outside Hong Kong at any time during the period from screening to Day 50(±3) visit.
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:順次割り当て
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Test Product
SARS-CoV-2 DNA Vaccine at 1mg and 2mg, 2 doses 3 weeks apart, intramuscular injection followed by electroporation
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A novel vaccine developed for prophylaxis of COVID-19 based on HKU's PD-1-based DNA vaccine platform.
It encodes a recombinant antigen comprising a soluble human PD-1 domain (i.e.
programmed cell death protein, a member of the Cluster of Differentiation 28 (CD28) family) and the receptor binding domain (RBD) of SARS-CoV-2 (i.e. the key viral entry element).
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プラセボコンパレーター:Reference Product
Matching placebo, 2 doses 3 weeks apart, intramuscular injection followed by electroporation
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Solution for intramuscular injection
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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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Reactogenicity
時間枠:Days 1 to 15 and Days 22 to 36
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Occurrence of solicited local events (pain, tenderness, redness, warmth, itch, swelling, induration) and solicited systemic events (fever, headache, malaise, myalgia, joint pain, nausea, vomiting, diarrhea, abdominal pain, chills and sweating) for a 14-day period after each vaccination
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Days 1 to 15 and Days 22 to 36
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Adverse Events
時間枠:Days 1 to 50(±3)
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Occurrence of unsolicited AEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
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Days 1 to 50(±3)
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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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Binding Antibodies in Serum against SARS-CoV-2 RBD Measured by ELISA
時間枠:Day 1(pre-dose), 8(+1), 15(+1), 22(pre-dose), 29(+1), 36(+1) and 50(±3) visits
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Measurement of binding antibody responses by ELISA in serum samples
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Day 1(pre-dose), 8(+1), 15(+1), 22(pre-dose), 29(+1), 36(+1) and 50(±3) visits
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Neutralizing Antibodies in Serum against Live SARS-CoV-2 Measured by Neutralization Assay
時間枠:Day 1(pre-dose), 8(+1), 15(+1), 22(pre-dose), 29(+1), 36(+1) and 50(±3) visits
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Measurement of neutralizing antibody levels by microneutralization (MN) assay in serum samples
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Day 1(pre-dose), 8(+1), 15(+1), 22(pre-dose), 29(+1), 36(+1) and 50(±3) visits
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Wang P, Zheng M, Lau SY, Chen P, Mok BW, Liu S, Liu H, Huang X, Cremin CJ, Song W, Chen Y, Wong YC, Huang H, To KK, Chen Z, Xia N, Yuen KY, Chen H. Generation of DelNS1 Influenza Viruses: a Strategy for Optimizing Live Attenuated Influenza Vaccines. mBio. 2019 Sep 17;10(5):e02180-19. doi: 10.1128/mBio.02180-19.
- Modjarrad K, Roberts CC, Mills KT, Castellano AR, Paolino K, Muthumani K, Reuschel EL, Robb ML, Racine T, Oh MD, Lamarre C, Zaidi FI, Boyer J, Kudchodkar SB, Jeong M, Darden JM, Park YK, Scott PT, Remigio C, Parikh AP, Wise MC, Patel A, Duperret EK, Kim KY, Choi H, White S, Bagarazzi M, May JM, Kane D, Lee H, Kobinger G, Michael NL, Weiner DB, Thomas SJ, Maslow JN. Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial. Lancet Infect Dis. 2019 Sep;19(9):1013-1022. doi: 10.1016/S1473-3099(19)30266-X. Epub 2019 Jul 24.
- Martin JE, Sullivan NJ, Enama ME, Gordon IJ, Roederer M, Koup RA, Bailer RT, Chakrabarti BK, Bailey MA, Gomez PL, Andrews CA, Moodie Z, Gu L, Stein JA, Nabel GJ, Graham BS. A DNA vaccine for Ebola virus is safe and immunogenic in a phase I clinical trial. Clin Vaccine Immunol. 2006 Nov;13(11):1267-77. doi: 10.1128/CVI.00162-06. Epub 2006 Sep 20.
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- SARS-CoV-2 DNA Vaccine - Investigator's Brochure (Version 1.0, Dated 24-Sep-2021).
- Alter G, Yu J, Liu J, Chandrashekar A, Borducchi EN, Tostanoski LH, McMahan K, Jacob-Dolan C, Martinez DR, Chang A, Anioke T, Lifton M, Nkolola J, Stephenson KE, Atyeo C, Shin S, Fields P, Kaplan I, Robins H, Amanat F, Krammer F, Baric RS, Le Gars M, Sadoff J, de Groot AM, Heerwegh D, Struyf F, Douoguih M, van Hoof J, Schuitemaker H, Barouch DH. Immunogenicity of Ad26.COV2.S vaccine against SARS-CoV-2 variants in humans. Nature. 2021 Aug;596(7871):268-272. doi: 10.1038/s41586-021-03681-2. Epub 2021 Jun 9.
- Gallagher, K., Leick, M. B., Larson, R. C., Berger, T. R., Katsis, K., Yam, J. Y., Brini, G., Grauwet, K., MGH COVID-19 Collection & Processing Team, & Maus, M. V. (2021) 'SARS -CoV-2 T-cell immunity to variants of concern following vaccination', bioRxiv 2021.05.03.442455, Advance online publication. doi:10.1101/2021.05.03.442455.
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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
追加の関連 MeSH 用語
その他の研究ID番号
- CTC2107
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
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
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。
COVID19の臨床試験
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Israel Institute for Biological Research (IIBR)完了
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Colgate Palmolive完了
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University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital Zürich招待による登録
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Immuno Cure 3 LimitedThe University of Hong Kong積極的、募集していない
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