A Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of YKYY025 Injection
A Phase 1, Randomized, Double-Blind, Ascending-Dose Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Respiratory Syncytial Virus mRNA Vaccine YKYY025 Injection in Healthy Adult Participants
A Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of YKYY025 Injection
調査の概要
詳細な説明
This is a randomized, double-blind, ascending-dose Phase 1 clinical study to investigate the safety, reactogenicity, and immunogenicity of YKYY025 when administered in healthy adult male and female participants
研究の種類
介入
入学 (推定)
180
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:Yuting Zhou
- 電話番号:+86 18606417018
- メール:zhouyuting@bjykkc.com
研究場所
-
-
Yunnan
-
Anning、Yunnan、中国
- 募集
- Anning First People's Hospital
-
コンタクト:
- Mingxuan Zhao
- 電話番号:zhaomx@yn-cprc.com
- メール:zhouyuting@bjykkc.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
Male or female participants aged ≥18 to 49 years of age (Part 1) or
≥ 50 years of age (Part 2),can provide legal proof of identity.
- Can understand the study procedures, voluntarily sign the informed consent form after informed consent.
- Able and willing to complete the study procedures during the entire study Follow-up period.
- Body temperature < 37.0°C (Axillary temperature) on the day of enrollment (before vaccination).
- For all women of childbearing potential (WOCBP) females must use an effective contraceptive method from at least 2 weeks prior to study vaccination. All male and female subjects of childbearing potential agree to use a reliable method of contraception (Oral contraceptives (excluding emergency contraceptives), injectable or buried contraceptives, slow-release local contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (male), diaphragm, cervical cap) until at least 6 months after study vaccination.
Exclusion Criteria:
- Previously received RSV vaccine or have participated or are currently participating in RSV vaccine clinical trials and have received the trial vaccine.
- A history of confirmed RSV infection or respiratory diseases related to RSV infection within 6 months prior to vaccination.
- Long term (defined as 14 days or more) treatment with immunosuppressants or other immunomodulatory drugs within 6 months prior to vaccination, or planned to receive such treatment within 30 days after vaccination, such as long-term use of systemic corticosteroids (continuous use for 2 weeks or more, dose ≥ 20mg/day prednisone or equivalent prednisone dose, excluding topical medications such as ointments, eye drops, inhalants, or nasal sprays);
- Received immunoglobulin and/or any blood products (such as blood, plasma) within 4 months of vaccination, or planning to receive during the study.
- Have used other experimental or unregistered products (drugs or vaccines) within 30 days before vaccination, or are currently participating in other clinical trials, or planning to participate in other clinical trials during the study.
- Received any live attenuated vaccines/ mRNA vaccine ≤ 28 days prior to vaccination or received any other non live vaccines (recombinant vaccines, subunit vaccines, inactivated vaccines, and other craft vaccines) within 14 days prior to vaccination.
- Donate blood or lose a large amount of blood (>450 ml) within 30 days prior to vaccination, or plan to donate blood within 30 days after vaccination.
- Within 3 days prior to vaccination, suffering from acute illness or being in the acute phase of chronic illness, or using antipyretic, analgesic, anti-inflammatory, and/or anti allergic drugs.
- History of severe hypersensitivity reactions to any vaccine or medication, or known to be allergic to any component of the test vaccine, including rapid onset severe allergic reactions or other serious adverse reactions to mRNA vaccine administration.
- Previous or current congenital or acquired immunodeficiency disease (such as AIDS), systemic lupus erythematosus or other autoimmune diseases (such as Guillain Barre syndrome, multiple sclerosis, neuromyelitis optica and other inflammatory demyelinating neuropathy history); Other diseases that affect immune function (such as splenomegaly or functional splenomegaly).
- History of heart diseases such as myocarditis and pericarditis, or having any diseases that increase the risk of myocarditis or pericarditis (including cardiomyopathy, endocardial fibrosis, eosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomas with polyangitis, persistent myocardial viral (such as enterovirus or adenovirus) infection, etc.).
- Previous or current serious cardiovascular and cerebrovascular diseases (such as congenital heart disease (except for cured atrial septal defect, patent foramen ovale, etc.), supraventricular tachycardia, atrial fibrillation, stroke, cerebral hemorrhage, etc.), liver and kidney diseases (such as chronic hepatitis active or suspected active hepatitis, nephrotic syndrome, uremia, etc.), respiratory diseases (such as chronic obstructive pulmonary disease, asthma, etc.), diabetes with serious complications, malignant tumors, etc.
- Currently or previously suffering from neurological disorders such as epilepsy (if there is a history of seizures), acute disseminated encephalomyelitis, or mental illnesses that affect normal behavior
- Suffering from thrombocytopenia, coagulation dysfunction, or any condition that can be a contraindication for intramuscular injection
- Participants aged 18-59: those with hypertension that cannot be controlled by medication or with systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg during pre enrollment blood pressure measurement; Participants aged ≥ 60: those with hypertension that cannot be controlled by medication or with systolic blood pressure ≥ 150mmHg and/or diastolic blood pressure ≥ 100mmHg measured before enrollment.
- Planning to become pregnant during the study or Women of Childbearing Potential who have a positive pregnancy test before vaccination or are pregnant or lactating at screening or prior to vaccination.
- Prior to vaccination, if the laboratory testing indicators and/or electrocardiogram examination specified in the protocol show abnormalities that meet the grading standards of level 2 or above, or if the abnormal results are clinically significant and deemed unsuitable for vaccination with the experimental vaccine by the investigator.
- Participants have a positive result for hepatitis B surface antigen, hepatitis C antibody , HIV antibody and anti-Treponema pallidum antibody.
- Any other reason to be excluded in the opinion of the Investigator
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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:ダブル
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:YKYY025 group
|
intramuscular, a single intramuscular injection of the corresponding dose of YKYY025 for injection
|
|
プラセボコンパレーター:YKYY025 Placebo group
|
intramuscular, a single intramuscular injection of the corresponding dose of YKYY025 Placebo
|
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 |
|---|---|
|
Adverse events(AEs)
時間枠:within 30 days after vaccination
|
within 30 days after vaccination
|
|
Serious adverse events (SAEs)
時間枠:within 12 months after vaccination
|
within 12 months after vaccination
|
|
Heart rate in 12-lead electrocardiogram (ECG)
時間枠:within 4 days after vaccination
|
within 4 days after vaccination
|
|
PR interval in 12-lead electrocardiogram (ECG)
時間枠:within 4 days after vaccination
|
within 4 days after vaccination
|
|
RS duration in 12-lead electrocardiogram (ECG)
時間枠:within 4 days after vaccination
|
within 4 days after vaccination
|
|
QT/QTC in 12-lead electrocardiogram
時間枠:within 4 days after vaccination
|
within 4 days after vaccination
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
vaccine response rate (defined as at least 2-fold or 4-fold increase in titer/concentration from Baseline to post-vaccination))
時間枠:through 12 months post-initial
|
through 12 months post-initial
|
|
Antigen-specific T cell levels in PBMC (ELISpot-IFN-γ)
時間枠:sampling at Day14, Day30, 3 months and 6 months after vaccination
|
sampling at Day14, Day30, 3 months and 6 months after vaccination
|
|
Antigen-specific T cell levels in PBMC (ELISpot-IL-4)
時間枠:sampling at Day14, Day30, 3 months and 6 months after vaccination
|
sampling at Day14, Day30, 3 months and 6 months after vaccination
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月29日
一次修了 (推定)
2028年7月1日
研究の完了 (推定)
2028年10月1日
試験登録日
最初に提出
2026年7月2日
QC基準を満たした最初の提出物
2026年7月9日
最初の投稿 (実際)
2026年7月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月10日
QC基準を満たした最後の更新が送信されました
2026年9月7日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- CLSP-YKYY025-Z01
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
いいえ
米国FDA規制機器製品の研究
いいえ
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。