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治験 NCT07197762（対象：Neisseria Meningitidis）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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エモリー大学MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults 第IV相・フェーズ4 125 ワクチン
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07197762 は Neisseria Meningitidis に関する 予防 の研究で、第IV相・フェーズ4 介入研究 臨床試験 です。現在は 募集中 で、2025年11月4日 から開始しています。125 名の参加者 の募集が計画されています。この試験は エモリー大学 によって主導され、2026年12月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年12月22日 です。
概要
The goal of this clinical trial is to determine the immunogenicity of certain vaccines in protecting against meningitis B (MenB) in young adults who have previously received a different MenB vaccine.
The main questions it aims to answer are:
- How many participants are protected against four key types of MenB bacteria before and after getting the new vaccine?
- How strong is the immune response after vaccination, a...
詳細説明
Neisseria meningitidis is a human-restricted pathogen that colonizes the nasopharynx and, in rare cases, invades the bloodstream or central nervous system, leading to invasive meningococcal disease (IMD). Clinical manifestations may include meningitis, septicemia, or both. Among the 12 known serogroups, five-A, B, C, W, and Y-account for the majority of global IMD cases. In the United States, serogroups B, C, W, and ...もっと見る
公式タイトル
Immunogenicity of a Single Dose of MenB-FHbp or MenACWY-TT/MenB-FHbp in MenB-4C Primed Young Adults
疾患名
Neisseria Meningitidisその他の研究識別子
- STUDY00009836
- 2025P011916 (その他の識別子) (Emory IRB)
NCT番号
開始日
2025-11-04
最終更新日
2025-12-22
終了予定日
2026-12
目標参加者数
125
試験の種類
介入研究
治験の相・段階
第IV相・フェーズ4
状況
募集中
キーワード
MenACWY-TT/MenB-FHbp [Penbraya, Pfizer]
Meningococcus B
MenB-FHbp [Trumenba, Pfizer]
Neisseria meningitidis serogroup B
Meningococcus B
MenB-FHbp [Trumenba, Pfizer]
Neisseria meningitidis serogroup B
主目的
予防
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Trumenba group | Trumenba Trumenba is a sterile, recombinant vaccine targeting Neisseria meningitidis serogroup B. It contains two lipidated factor H binding protein (fHbp) variants-A05 from subfamily A and B01 from subfamily B-delivered in a 0.5 mL prefilled syringe. Each dose includes 120 µg of protein (60 µg per variant), 0.018 mg polysorbate 80, and 0.25 mg aluminum as AlPO₄, formulated in histidine-buffered saline at pH 6.0.
A single in...もっと見る |
実験的Penbraya group | Penbraya PENBRAYA is a combination vaccine that protects against meningococcal serogroups A, B, C, W, and Y. It consists of two components:
* A lyophilized MenACWY portion (polysaccharides conjugated to tetanus toxoid)
* A liquid MenB portion (two recombinant fHbp variants: A05 and B01) Each 0.5 mL dose contains 20 µg of polysaccharides (5 µg per serogroup), 44 µg tetanus toxoid, 120 µg of MenB protein (60 µg per variant), p...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Percentage of participants who are seroprotected | Percentage of participants who are seroprotected, defined as a human serum bactericidal antibody assay (hSBA) titer ≥LLOQ-Lower limit of quantification (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB indicator strains (A22, A56, B24, and B44) with Trumenba or Penbraya. Serum samples from V1 and V2 will be shipped in batches to Pfizer, where hSBA assays will be performed. | Baseline, 28 days post-vaccination |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
human Serum bactericidal antibody (hSBA) quantity | Human serum bactericidal antibody (hSBA) Geometric mean titer will be described for all 4 indicator strains of MenB | Baseline, 28 days post-vaccination |
Percentage of participants who have composite seroprotection | Percentage of participants who have composite seroprotection, defined as achieving an hSBA titer ≥ LLOQ- Lower limit of quantification (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for all 4 primary MenB test strains combined (composite) | Baseline, 28 days post-vaccination |
Percentage of participants achieving seroresponse | Percentage of participants achieving seroresponse, defined as ≥4-fold rise in hSBA titer | Baseline to 28 days post-vaccination |
参加アシスタント
適格基準
対象年齢
成人
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Provides written informed consent before any study procedures are performed.
- Be able to understand and agree to comply with planned study procedures and be available for all study visits.
- Subject is in good health as determined by vital signs, medical history, targeted physical examination (if indicated), and the judgment of the investigator.
- Vaccinated with 2-dose Bexsero primary series at least 2.5 years before vaccination. Must confirm vaccination status and dates of administration through GRITS, healthcare provider, or other official documentation
- Women of childbearing potential must agree to use or have practiced true abstinence2 or use at least one acceptable primary form of contraception from 28 days prior through 28 days after vaccination.
- Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours before vaccination
- Subject has an acute illness with fever (temperature ≥100.4 °F) within 72 hours before vaccine administration.
- Subject is currently pregnant or breastfeeding an infant/child.
- Has any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation. (Including acute, subacute, intermittent,t or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. Chronic medical conditions that are stable, with no escalation in medication doses or new medications administered in the preceding 3 months, will not be considered exclusionary.)
- Presence of self-reported or medically documented significant medical or psychiatric condition(s) as determined by the investigator.
- Received or plans to receive a licensed, live vaccine within 4 weeks before or after the study vaccination.
- Received or plans to receive a licensed, inactivated vaccine within 2 weeks before through 4 weeks after the study vaccination.
- Any previous severe hypersensitivity or anaphylactic reaction to any vaccine or vaccine-related component
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- Received any MenB vaccine within the last 2.5 years before vaccination.
- Received more than 2 doses of Bexsero or any other MenB vaccine(s) (e.g. Trumenba or Penbraya)
- Any known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy >20 mg per day for ≥14 days, or those receiving immunosuppressive therapy. Participants with terminal complement deficiency are excluded from participation in this study.
- Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- Any neuroinflammatory condition or autoimmune condition requiring immunomodulatory treatment, including, but not limited to, Guillain-Barré syndrome, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
エモリー大学ファイザー457 件のアクティブな治験を探索責任者
Christina Rostad, 主任研究者, Associate Professor, Emory University
試験中央連絡先
連絡先: Christina Rostad, MD, 404-727-2472, [email protected]
連絡先: Jessica McCaffery, PhD, [email protected]
2 1カ国の場所
Georgia
Emory Children's Center-Vaccine Research Clinic, Atlanta, Georgia, 30329, United States
Christina Rostad, MD, 連絡先, 404-727-2472, [email protected]
募集中
Hope Clinic, Atlanta, Georgia, 30329, United States
Christina Rostad, MD, 連絡先, 404-727-2472, [email protected]
募集中