COVID 19 ANTOBODIES IN PREGNANT WOMEN AND THEIR CONNECTION TO BETA CELL FUNCTION IN THE FETUS
DOES COVID-19 INFECTION AND/OR VACCINATION OF PREGNANT WOMEN AFFECT THE PANCREATIC BETA CELLS OF THE FETUS BECOMING A TRIGGER FOR FUTURE DEVELOPMENT OF CHILDHOOD TYPE 1 DIABETES
調査の概要
状態
詳細な説明
T1D is caused by an autoimmune reaction to proteins that cause the destruction of the pancreatic beta cells. The incidence of childhood Type 1 diabetes (T1D) is continuously increasing, caused by environmental factors, mainly viruses (1).
The most implicated viruses are coxsackie B4 (2) and rotaviruses (3,4). In the past mumps and rubella viruses gave been found to cause early childhood T1D and the introduction of mumps and rubella vaccination have stopped this process (5).
Recently we (6) and others (7-9) have shown that Rotavirus vaccination to infants attenuates the incidence of T1D in children aged 0-5 (in press). Covid-19 has not yet been investigated.
Aim of study To determine whether anti-Covid-19 antibodies generated by infection and/or vaccination of pregnant mothers, pass the placenta and affect the fetal beta-cells, by damaging or protecting these insulin producing cells.
Subjects 100 pregnant women with Covid-19 infection or vaccination who are followed and delivered at the Mayanei HaYeshua Medical Center will be enrolled in the study.
Method
Blood from the pregnant mothers will be taken at delivery (and before if possible) as well as from the cordblood. The following βcell specific antibodies will be tested in the laboratory of the Schneider Children's Hospital:
Covid-19, GAD-65, IA-2, ICA. (ml blood from the mother and 1ml cordblood) The bloods will have to be centrifuged within 20-30 minutes and the sera kept at -20ºC until delivery.
Background Whether the Covid-19 epidemic affects childhood T1D is controversial (10). Flannery et al (11) and Atyeo et al., reported that SARS-Cov-2 infected mothers transmit SARS-Cov-2 antibodies via the placenta to the fetus Fernandez reported protective Covid-19 antibodies in breast milk of infected mothers (13). Kamrath et al from Germany (14) and Rabbone et al from Italy (15) reported a high prevalence of DKA in children diagnosed with T1D during the recent pandemic.
As the Covid-19 virus with its various mutations is known to affect several organs and cells in the human body it is of great interest to know whether it affects also the pancreatic βcells of the fetus.
Hypothesis We assume that unvaccinated mothers transfer the virus antibodies to the fetus, and which may be the first damage to the βcells endangering future development of future type 1 childhood diabetes. Transfer of Covid protecting antibodies may beneficially affect the infant at risk.
Discussion and importance of the study To the best of our knowledge, no such study has been performed.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:MIRRA MANEVICH, MD
- 電話番号:0526001068
- メール:MIRRA.MANEVICH@GMAIL.COM
研究連絡先のバックアップ
- 名前:Bari Kaplan, Prof
- 電話番号:0505200143
- メール:prof@barikaplan.com
研究場所
-
-
Merkaz
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Bnei Brak、Merkaz、イスラエル
- 募集
- Maayanei Hayeshua Medical Center
-
コンタクト:
- MIRRA MANEVICH, MD
- 電話番号:0526001068
- メール:MIRRA.MANEVICH@GMAIL.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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- exposure to the COVID 19 virus or vaccine during pregnancy
Exclusion Criteria:
- Age under 18 or over 48 IUFD
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 |
|---|---|
|
covid exposed
women who were exposed to covid 19 during pregnancy
|
no intervention, observation only
|
|
covid vaccinated
women who were vaccinated to covid 19 during pregnancy
|
no intervention, observation only
|
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 |
|---|---|---|
|
Presence of anti COVID 19 antibodies in maternal and cord blood
時間枠:ONE YEAR
|
Covid-19, GAD-65, IA-2, ICA
|
ONE YEAR
|
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 (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
- MaayneiHMC
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 共有サポート情報タイプ
- 研究プロトコル
- インフォームド コンセント フォーム (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
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。
no intervention, observation onlyの臨床試験
-
University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了