临床试验/NCT05037097

NCT05037097已完成1 期

A Phase 1/2 Randomized, Observer-Blind Study of the Safety, Reactogenicity, and Immunogenicity of 3 SARS-CoV-2 RNA Vaccine Candidates in Adults Previously Vaccinated and Not Previously Vaccinated Against SARS-CoV-2

Arcturus Therapeutics, Inc.4 个研究点分布在 3 个国家目标入组 72 人开始时间: 2021年8月30日最近更新: 2025年10月15日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Arcturus Therapeutics, Inc.
入组人数: 72
试验地点: 4
主要终点: Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs)

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

This is a Phase 1/2, randomized, observer-blind study in healthy adults. The study will evaluate the safety, reactogenicity, and immunogenicity of 3 SARS-CoV-2 self-amplifying RNA vaccine candidates against COVID-19 in adults previously vaccinated and not previously vaccinated against SARS-CoV-2.

详细描述

The study will initially enroll approximately 72 adult participants into 2 cohorts (A and B). Cohort A is further sub-divided into two sub-cohorts which include 12 participants who are seronegative, not previously vaccinated at screening (Sub-cohort A1) and 24 participants who are seropositive, not previously vaccinated at screening (Sub-cohort A2).

Within the first cohort (Cohort A), Sub-cohort A1 will include a total of 12 adult participants ≥21 to ≤65 years of age who have not been previously vaccinated with a SARS-CoV-2 vaccine. Sub-cohort A2 will include a total of 24 adult participants ≥21 to ≤65 years of age who have not been previously vaccinated with a SARS-CoV-2 vaccine. Study vaccines will be given as 2 doses separated by 28 days.

The second cohort (Cohort B) will include a total of 36 adult participants ≥21 to ≤65 years of age who have been previously vaccinated (5 months or longer prior to study enrollment) with SARS-CoV-2 vaccine. Study vaccines will be given as single doses.

Additional cohorts may increase the age range of participants up to 80 years of age.

研究设计

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

盲法说明

Observer Blind

入排标准

年龄范围: 21 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Individuals who:
•Are able to provide consent
•Agree to comply with all study visits and procedures
•Are willing and able to adhere to study restrictions
•Are sexually active and willing to adhere to contraceptive requirements
•Are male, female, or transgender ≥21 to ≤80 years of age
•For the previously vaccinated groups only, received 2 doses of SARS-CoV-2 vaccine 5 months or longer prior to study enrollment

排除标准

•Individuals who:
•For the unvaccinated groups only, previously received any investigational or authorized MERS-CoV, SARS-CoV, and SARS-CoV-2 vaccines (including ARCT-021)
•For the previously vaccinated groups only, previously received BNT162b2 but have not received 2 doses within at least 5 months prior to study enrollment
•Are planning to receive other COVID-19 vaccines during the study period
•Recently received other vaccines
•Have a fever or are feeling sick close to the time of the first study vaccination
•Have a known history of COVID-19 disease or asymptomatic SARS-CoV-2 infection
•Are pregnant or breastfeeding
•Have had a severe reaction to previous vaccines
•Have a severe or uncontrolled disease(s) that may interfere with the interpretation of the study
•Have some respiratory diseases
•Have some significant heart diseases
•Have some neurological conditions
•Have sickle cell disease or some other blood disorders
•Have had a major surgery within the past 6 months
•Have a history of chronic liver disease
•Have a history of autoimmune disease or immunodeficiency
•Have received allergy injections, interferon, immunomodulators, cytotoxic drugs or other similar toxic drugs.
•Have received blood products
•Have a positive test for hepatitis B or C or human immunodeficiency virus
•Have uncontrolled hypertension
•Have had cancer except for cancers that were treated and that have low risk of returning
•Are Investigator site staff members, employees of Arcturus or the contract research organization (CRO) directly involved in the conduct of the study, or site staff members otherwise supervised by the Investigator or immediate family members of any of the previously mentioned individuals

研究组 & 干预措施

Study Group 1, Adult Participants Seronegative, Not Previously Vaccinated randomized to ARCT-165

Experimental

Participants will receive one dose of ARCT-165 on Day 1 and one dose of ARCT-165 on Day 29

干预措施: ARCT-165 (Biological)

Study Group 2, Adult Participants Seronegative, Not Previously Vaccinated randomized to ARCT-154

Experimental

Participants will receive one dose of ARCT-154 on Day 1 and one dose of ARCT-154 on Day 29

干预措施: ARCT-154 (Biological)

Study Group 3, Adult Participants Seronegative, Not Previously Vaccinated to receive ARCT-021

Experimental

Participants will receive one dose of ARCT-021 on Day 1 and one dose of ARCT-021 on Day 29

干预措施: ARCT-021 (Biological)

Study Group 4, Adult Participants Seropositive, Not Previously Vaccinated to receive ARCT-021

Experimental

Participants will receive one dose of ARCT-021 on Day 1 and one dose of ARCT-021 on Day 29

干预措施: ARCT-021 (Biological)

Study Group 5, Adult Participants Seropositive, Not Previously Vaccinated randomized to ARCT-154

Experimental

Participants will receive one dose of ARCT-154 on Day 1 and one dose of ARCT-154 on Day 29

干预措施: ARCT-154 (Biological)

Study Group 6, Adult Participants Previously Vaccinated randomized to receive ARCT-165

Experimental

Participants will receive one dose of ARCT-165 on Day 1

干预措施: ARCT-165 (Biological)

Study Group 7, Adult Participants Previously Vaccinated randomized to receive ARCT-154

Experimental

Participants will receive one dose of ARCT-154 on Day 1

干预措施: ARCT-154 (Biological)

Study Group 8, Adult Participants Previously Vaccinated randomized to receive ARCT-021

Experimental

Participants will receive one dose of ARCT-021 on Day 1

干预措施: ARCT-021 (Biological)

结局指标

主要结局

Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs)

时间窗: Up to Day 8 (7 days after first vaccine administration for Cohorts A1, A2 and B), and up to Day 36 (7 days after second vaccine administration for Cohorts A1 and A2)

Solicited local AEs were defined as injection site erythema, injection site pain, injection site induration, and injection site tenderness. Solicited systemic AEs were defined as arthralgia, chills, diarrhea, dizziness, fatigue, fever (categorized by measured body temperature), headache, myalgia, nausea and vomiting. Data are reported for the number of participants with solicited local and solicited systemic AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Number of Participants Reporting Unsolicited AEs

时间窗: Up to Day 29 (28 days after vaccine administration for Cohort B), and up to Day 57 (up to 28 days after each vaccine administration for Cohorts A1 and A2)

Unsolicited AEs were defined as any spontaneously reported or discovered AE. Data are reported for the number of participants with unsolicited AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs)

时间窗: Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days

An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) with a health care provider (HCP) (e.g., nurse, nurse practitioner, physician's assistant, physician), including visits to a study site for unscheduled assessments (e.g., rash assessment, abnormal laboratory follow up, coronavirus disease 2019 \[COVID-19\]) and visits to HCPs external to the study site (e.g., urgent care, primary care physician). An SAE was defined as any event that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC)

时间窗: Baseline, Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2; Baseline, Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B

Blood samples were collected to assess participants' immune response. GMC data are reported for the pseudoviral D614G variant. Data are reported in international units per milliliter (IU/mL).

SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC

时间窗: Baseline, Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2; Baseline, Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B

Blood samples were collected to assess participants' immune response. GMC data are reported for the pseudoviral B.1.351 (beta) variant. Data are reported in arbitrary units per milliliter (AU/mL).

SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR)