A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V330 in Healthy Younger (18 to 49 Years Inclusive) and Healthy Older Participants (60 to 79 Years Inclusive).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 4
- 主要终点
- Number of Participants with Solicited Injection Site Adverse Events (AEs)
研究概览
简要总结
The goal of this study is to learn whether a new vaccine, V330, is safe and learn how well the body's immune system responds by making antibodies after receiving V330.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The key inclusion criteria include but are not limited to the following:
- •Is in good health prior to randomization
- •Is an individual from 18 to 49 years of age inclusive or from 60 to 79 years of age inclusive
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a history of myocarditis, pericarditis, and/or myopericarditis
- •Has a history of cancer
研究组 & 干预措施
Dose Escalation Panel F
Participants 60 to 79 years old will be randomized to receive V330 DL 1 or placebo via intramuscular injection on Day 1.
干预措施: Placebo (Biological)
Dose Escalation Panel A
Participants 18 to 49 years old will be randomized to receive V330 dose level (DL) 1 or placebo via intramuscular injection on Day 1 and Day 57.
干预措施: V330 (Biological)
Dose Escalation Panel A
Participants 18 to 49 years old will be randomized to receive V330 dose level (DL) 1 or placebo via intramuscular injection on Day 1 and Day 57.
干预措施: Placebo (Biological)
Dose Escalation Panel B
Participants 18 to 49 years old will be randomized to receive V330 DL 3 or placebo via intramuscular injection on Day 1 and Day 57.
干预措施: V330 (Biological)
Dose Escalation Panel B
Participants 18 to 49 years old will be randomized to receive V330 DL 3 or placebo via intramuscular injection on Day 1 and Day 57.
干预措施: Placebo (Biological)
Dose Escalation Panel C
Participants 18 to 49 years old will be randomized to receive V330 DL 6 or placebo via intramuscular injection on Day 1 and Day 57.
干预措施: V330 (Biological)
Dose Escalation Panel C
Participants 18 to 49 years old will be randomized to receive V330 DL 6 or placebo via intramuscular injection on Day 1 and Day 57.
干预措施: Placebo (Biological)
Dose Expansion Panel D
Participants 18 to 49 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1.
干预措施: V330 (Biological)
Dose Expansion Panel D
Participants 18 to 49 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1.
干预措施: Placebo (Biological)
Dose Expansion Panel E
Participants 18 to 49 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1.
干预措施: V330 (Biological)
Dose Expansion Panel E
Participants 18 to 49 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1.
干预措施: Placebo (Biological)
Dose Escalation Panel F
Participants 60 to 79 years old will be randomized to receive V330 DL 1 or placebo via intramuscular injection on Day 1.
干预措施: V330 (Biological)
Dose Escalation Panel G
Participants 60 to 79 years old will be randomized to receive V330 DL 3 or placebo via intramuscular injection on Day 1.
干预措施: V330 (Biological)
Dose Escalation Panel G
Participants 60 to 79 years old will be randomized to receive V330 DL 3 or placebo via intramuscular injection on Day 1.
干预措施: Placebo (Biological)
Dose Escalation Panel H
Participants 60 to 79 years old will be randomized to receive V330 DL 6 or placebo via intramuscular injection on Day 1.
干预措施: V330 (Biological)
Dose Escalation Panel H
Participants 60 to 79 years old will be randomized to receive V330 DL 6 or placebo via intramuscular injection on Day 1.
干预措施: Placebo (Biological)
Dose Expansion Panel I
Participants 60 to 79 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1.
干预措施: V330 (Biological)
Dose Expansion Panel I
Participants 60 to 79 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1.
干预措施: Placebo (Biological)
Dose Expansion Panel J
Participants 60 to 79 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1.
干预措施: V330 (Biological)
Dose Expansion Panel J
Participants 60 to 79 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1.
干预措施: Placebo (Biological)
Dose Escalation Panel A1
Participants 18 to 49 years old will be randomized to receive V330 DL 2 or placebo via intramuscular injection on Day 1.
干预措施: V330 (Biological)
Dose Escalation Panel A1
Participants 18 to 49 years old will be randomized to receive V330 DL 2 or placebo via intramuscular injection on Day 1.
干预措施: Placebo (Biological)
Dose Escalation Panel B1
Participants 18 to 49 years old will be randomized to receive V330 DL 5 or placebo via intramuscular injection on Day 1.
干预措施: V330 (Biological)
Dose Escalation Panel B1
Participants 18 to 49 years old will be randomized to receive V330 DL 5 or placebo via intramuscular injection on Day 1.
干预措施: Placebo (Biological)
Dose Escalation Panel F1
Participants 60 to 79 years old will be randomized to receive V330 DL 2 or placebo via intramuscular injection on Day 1.
干预措施: V330 (Biological)
Dose Escalation Panel F1
Participants 60 to 79 years old will be randomized to receive V330 DL 2 or placebo via intramuscular injection on Day 1.
干预措施: Placebo (Biological)
Dose Escalation Panel G1
Participants 60 to 79 years old will be randomized to receive V330 DL 5 or placebo via intramuscular injection on Day 1.
干预措施: V330 (Biological)
Dose Escalation Panel G1
Participants 60 to 79 years old will be randomized to receive V330 DL 5 or placebo via intramuscular injection on Day 1.
干预措施: Placebo (Biological)
Dose Escalation Panel H1
Participants 60 to 79 years old will be randomized to receive V330 DL 4 or placebo via intramuscular injection on Day 1.
干预措施: V330 (Biological)
Dose Escalation Panel H1
Participants 60 to 79 years old will be randomized to receive V330 DL 4 or placebo via intramuscular injection on Day 1.
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Participants with Solicited Injection Site Adverse Events (AEs)
时间窗: Up to approximately 7 days after each vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs will be recorded on a vaccination report card (VRC).
Number of Participants with Solicited Systemic AEs
时间窗: Up to approximately 7 days after each vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs will be recorded on a VRC.
Number of Participants with Solicited Local AEs of Axillary Lymphadenopathy
时间窗: Up to approximately 28 days after each vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Participants will be assessed for local AEs related to axillary lymphadenopathy.
Number of Participants with Immediate AEs Following Vaccinations
时间窗: Up to approximately 30 minutes after each vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Participants will be observed following vaccination for immediate AEs.
Number of Participants with Unsolicited AEs
时间窗: Up to approximately 28 days after each vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Unsolicited AEs will be recorded on a VRC.
Number of Participants with Serious AEs
时间窗: Up to approximately 6 months after final vaccination
A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.
Number of Participants with Medically Attended Adverse Events (MAAEs)
时间窗: Up to approximately 6 months after final vaccination
A MAAE is an AE in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Routine visits are not considered MAAEs.
Number of Participants with Events of Clinical Interest (ECIs)
时间窗: Up to approximately 6 months after final vaccination
ECIs are selected serious and nonserious AEs which include but are not limited to: 1) an elevated aspartate aminotransferase or alanine aminotransferase value greater than or equal to three times the upper limit of normal (ULN) and an elevated bilirubin value of greater than two times the ULN and, at the same time, an alkaline phosphatase value of less than two times the ULN, 2) an overdose of V330.
次要结局
- Geometric Mean Titers (GMT) of Histo-Blood Group Antigen (HBGA) Blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes(Up to 28 days post vaccination)
- GMT of IgG Antibodies Response Against Vaccine-matched NoV Genotypes(Up to 28 days post vaccination)