Immune Response to Third Dose of COVID-19 Vaccine in Solid Organ Transplant
Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Solid Organ Transplant Recipients
The Coronavirus Disease 2019 (COVID-19) pandemic has claimed over 5 million lives globally. Fortunately, a substantial and growing number of SARS-CoV-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. Novel mRNA vaccines such as the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) have reported a stunning >94% efficacy against COVID-19. However, global access has not been equitable, with many low- and middle-income countries having no vaccine access or access under emergency use mainly to traditional inactivated SARS-CoV2-2 vaccines such as BBIBP-CorV (Sinopharm Beijing), CoronaVac (Sinovac) and BBV152 (Bharat Biotech). Emerging studies have shown that lower concentrations of neutralizing antibodies (Nab) are attained after CoronaVac than after an mRNA-based vaccine in healthy individuals. This difference seems to be more pronounced in immunocompromised patients who are at higher risk of severe COVID-19 and death from COVID-19. As such, several countries including the United States, Israel and Chile have recommended a third vaccine dose for high-risk populations. However, it is not currently known which is the best vaccine combination regarding immunogenicity, particularly in these vulnerable patients.
This observational study will explore the humoral and cellular response to a SARS-CoV-2 BNT162b2 vaccine booster in solid organ transplant patients who received two previous doses of the inactivated Coronavac or two doses of BNT162b2 vaccines.
調査の概要
状態
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Santiago、チリ
- Pontificia Universidad Católica de Chile
-
-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Solid organ transplant patients in the last 10 years and currently under immunosuppressive therapy
- Vaccination with two doses of Coronavac vaccine or BNT162b2 vaccines, followed by a booster dose (3d dose) of BNT162b2 vaccine administered in the previous 8-12 weeks.
Exclusion Criteria:
- Previous SARS-CoV-2 infection
- Booster vaccine (3rd dose) administered less than 8 weeks or more than 12 weeks before enrolment
- Intravenous immunoglobulin therapy 60 days before enrolment
- Previous SARS-CoV-2 vaccine different from CoronaVac or BNT162b2
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
- 観測モデル:コホート
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Three doses of BNT162b2 vaccine
Solid organ transplant patients who received three doses of BNT162b2
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Two doses of SARS-CoV-2 BNT162b2 mRNA vaccine, followed by a booster (3rd) dose of SARS-CoV-2 BNT162b2 mRNA vaccine.
|
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Two doses of Coronavac and one of BNT162b2 vaccine
Solid organ transplant patients who received two doses of CoronaVac and one dose of BNT162b2
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Two doses of CoronaVac SARS-CoV-2 inactivated vaccine, followed by a booster (3rd) dose of BNT162b2 mRNA vaccine.
|
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 |
時間枠 |
|---|---|
|
IgG seropositivity 8-12 weeks after third dose BNT162b2 (booster) vaccine.
時間枠:8-12 weeks after booster vaccine
|
8-12 weeks after booster vaccine
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster) vaccine.
時間枠:8-12 weeks after booster vaccine
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8-12 weeks after booster vaccine
|
|
Neutralizing geometric mean titers 8 to 12 weeks after third dose of BNT162b2 (booster) vaccine.
時間枠:8-12 weeks after booster vaccine
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8-12 weeks after booster vaccine
|
その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
The number of IFN-y-spot forming T cells SARS-CoV-2 specific after third dose of BNT162b2 (booster) vaccine.
時間枠:8-12 weeks after booster vaccine
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8-12 weeks after booster vaccine
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
- 210405014E
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
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