临床试验/NCT07215520

NCT07215520进行中（未招募）2 期

A Double-blind, Randomized, Controlled, Phase 2a Study to Evaluate the Safety and Tolerability of a Newcastle Disease Virus-based Mucosal Vaccine (NDV-HXP-S-KP.2) Relative to an Approved Systemic mRNA Vaccine in Previously Vaccinated Adults

CastleVax Inc.3 个研究点分布在 1 个国家目标入组 200 人开始时间: 2025年11月3日最近更新: 2026年7月22日

干预措施

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方
入组人数: 200
试验地点: 3
主要终点: Safety and Tolerability of the NDV-HXP-S-KP.2 Vaccine Compared With an Approved mRNA COVID-19 Vaccine

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A Double-blind, Randomized, Controlled, Phase 2a Study to Evaluate the Safety and Tolerability of a Newcastle Disease Virus-based Mucosal Vaccine (NDV-HXP-S-KP.2) Relative to an Approved Systemic mRNA Vaccine in Previously Vaccinated Adults

详细描述

This is a double-blind (supported by a double-dummy design), randomized, active comparator-controlled Phase 2a safety and tolerability study. The study will enroll approximately 200 previously COVID-19-vaccinated, male and nonpregnant female adult participants aged ≥18 years. Participants 18 through 64 years of age must have at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Is an adult 18 through 64 years of age at time of screening with at least 1 underlying condition that puts the participant at high risk for severe outcomes of COVID-19 per self-report OR is an adult ≥65 years of age at time of screening (with or without at least 1 underlying condition).
•Has completed any WHO/FDA-authorized or approved primary COVID-19 vaccination series per self-report.
•Has received last COVID-19 vaccine ≥6 months prior to study vaccination.
•If a female of childbearing potential who is sexually active, agrees to use an adequate method of birth control from Screening through 90 days after study vaccination, and has used an adequate birth control method for at least 30 days prior to Screening. Sexually active male participants, unless the participant is sterile or otherwise unable to produce sperm, or has exclusively male sexual partners, must agree to abstinence or to use a barrier method (e.g., male condom) from vaccination through 90 days after study vaccination. Male participants must also agree to not donate sperm from vaccination through 90 days after study vaccination.
•Is medically stable, as determined by the site investigator (based on review of health status, vital signs, medical history, and physical examination).
•Agrees to not participate in any other SARS-CoV-2 infection prevention trial (vaccine, drug, biologic, pre-exposure prophylaxis [PrEP]) during participation in the study.
•Willing and able to provide informed consent prior to initiation of study procedures.
•Is available for all study visits, willing to participate in all study procedures, and not planning to relocate from the area for the duration of the study.

排除标准

•Has an acute illness, as determined by the site investigator, within 72 hours prior to Screening or study vaccination.
•Has had a positive COVID-19 test within the 90 days prior to Screening or study vaccination.
•Current or planned participation in any other interventional clinical trial.
•Participation in research involving any investigational product within 45 days prior to Screening or study vaccination.
•Receipt of any approved or authorized products intended to prevent SARS-CoV-2 infection within 6 months prior to Screening or study vaccination.
•Receipt of blood products or immunoglobulins within 60 days prior to Screening or study vaccination.
•Received influenza vaccination within 14 days prior to Screening or study vaccination, or any other vaccine within 30 days prior to Screening or study vaccination.
•Any significant autoimmune, immunodeficiency disease/condition, or auto inflammatory disorder (e.g., any known immunoglobulin A [IgA] deficiency, human immunodeficiency virus [HIV] infection, acquired immunodeficiency syndrome [AIDS])
•Has current active hepatitis B or hepatitis C infection (based on self-reported medical history).
•Has a peripheral arterial oxygen saturation (SpO2) level <92% at Screening, uncontrolled or severe asthma (e.g., more than 1 hospitalization for asthma exacerbation within the 12 months prior to Screening), or other uncontrolled or severe chronic lung disease or known bronchial hyper-reactivity to viruses that, in the opinion of the site investigator, would pose a health risk to the individual if enrolled.
•Has known active tuberculosis.
•Unstable non-cardiac illness (acute or chronic illness) requiring hospitalization or medical procedure during the 90 days prior to Screening or study vaccination, or cardiac condition (acute or chronic) requiring hospitalization or medical procedure (e.g., stenting, cardiac surgery, etc.) during the 1 year prior to Screening or study vaccination.
•History of myocarditis, pericarditis, myopericarditis, or idiopathic cardiomyopathy, or presence of any medical condition (e.g., viral illness within 30 days of Screening or study vaccination) that, in the opinion of the investigator, increases risk of myocarditis, pericarditis, or myopericarditis.
•Chronic kidney disease requiring dialysis or any type of ultrafiltration. Individuals with chronic kidney disease that does not require dialysis or ultrafiltration may be included.
•Individuals with advanced or decompensated chronic liver disease as determined by the site investigator.
•Presence of any transplanted solid organs (heart, kidney, lung, liver, pancreas, and/or intestine) or prior receipt of a blood stem cell transplant.
•Administration of immunosuppressants, systemic glucocorticoids, or other immune-modifying drugs within the following timeframes:
•B-cell therapies within the 6 months prior to Screening or study vaccination.
•Prednisone, ≥20 mg or equivalent for more than 2 weeks, within the 30 days prior to Screening or study vaccination.
•Monoclonal antibodies that may suppress aspects of immune response (e.g., Dupixent) within the 6 months prior to Screening or study vaccination.
•Other medications in this category, including but not limited to high-dose inhaled corticosteroids (>800 mcg/day of beclomethasone dipropionate or equivalent); antimetabolites; transplant immunosuppressive agents; alkylating agents; cell-depleting agents; or cancer chemotherapeutics, within the 90 days prior to Screening or study vaccination.
•Any medication for any period of time that, in the opinion of the site investigator, could impede immune response to vaccination.
•Known contraindication to IM injection (e.g., bleeding diathesis, acquired coagulopathy) or to IN administration (e.g., significant nasal abnormality or severe nasal obstruction, significant chronic rhinitis or history of chronic rhinitis, nasal septal defect causing significant breathing problems, unrepaired cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration).
•Receipt or anticipated receipt, within 7 days prior through 7 days after study vaccination, of any Intranasal medication, including FDA-approved prescription or over-the-counter products or non-FDA-approved alternative medicine products (e.g., Ayurvedic oil or other naturopathic substances).
•Anticipated use of nasal irrigation (e.g., Neti PotTM) from Screening through 30 days after study vaccination.
•Any known allergies to components contained in NDV-HXP-S (including egg products) or the comparator vaccine (including polyethylene glycol [PEG] allergies).
•Women who are pregnant, breastfeeding, or who plan to become pregnant during the study.
•Current or prior potential for NDV exposure (e.g., prior NDV-based vaccination, NDV-based oncologic immunotherapy, prior or current experience as a bird-handler, poultry farmer, or scientist conducting research with NDV).
•Individuals who will have close or household high-risk contacts, within 14 days following study vaccination, including but not limited to:
•Any other condition that, in the opinion of the site investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the investigational product or interpretation of study results.
•Study team member or first-degree relative of any study team member (inclusive of CastleVax and site personnel involved in the study).

研究组 & 干预措施

IN administration of study drug plus placebo via IM

Experimental

Nasal Administration of NDV-HXP-S-KP.2 and administration of placebo via Intramuscular Injection

干预措施: NDV-HXP-S-KP.2 (Biological)

IN administration of placebo plus COVID-19 vaccine via IM

Active Comparator

Nasal Administration of Placebo plus administration of COVID-19 mRNA vaccine via Intramuscular Injection

干预措施: COVID-19 mRNA Vaccine (Biological)

结局指标

主要结局

Safety and Tolerability of the NDV-HXP-S-KP.2 Vaccine Compared With an Approved mRNA COVID-19 Vaccine

时间窗: Up to 180 days after vaccination

Safety and tolerability of the NDV-HXP-S-KP.2 vaccine given intranasally and an approved mRNA COVID-19 vaccine given intramuscularly will be assessed in previously immunized adults. Outcomes include the percentage of participants with solicited local and systemic reactogenicity symptoms through 7 days, unsolicited adverse events through 30 days, and serious, medically attended, or special interest adverse events through 180 days. Clinically significant abnormal lab results (chemistry and hematology) will also be assessed through 7 days post-vaccination.

次要结局

Humoral Immune Response to the NDV-HXP-S-KP.2 Vaccine Compared With the Comparator Vaccine(From Day 1 through Day 181 post-vaccination)
Mucosal Immune Response to the NDV-HXP-S-KP.2 Vaccine Compared With the Comparator Vaccine(From Day 1 through Day 181 post-vaccination)
Percentage of Participants With Viral Vector-Related Illness or Shedding After Vaccination(Through Day 31 post-vaccination)

研究者

发起方

CastleVax Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (3)

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