Safety, Reactogenicity, and Immunogenicity of an Mpox mRNA Vaccine Candidate, BNT166a, in Healthy Participants Aged 18 Years and Older in African Countries: A Randomized, Double-blind, Placebo-controlled Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- BioNTech SE
- 入组人数
- 310
- 试验地点
- 7
- 主要终点
- Number (and percentage) of participants with at least one solicited local reaction (pain, erythema/redness, induration/swelling)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, reactogenicity, and immunogenicity after one and two doses of BNT166a or placebo in healthy participants.
详细描述
This study will include the following cohorts:
- Cohort 1: healthy adults aged 18 to 45 years inclusive who are Orthopoxvirus-naïve.
- Cohort 2: healthy adults aged 18 to 64 years inclusive who are Orthopoxvirus-experienced.
All participants will receive two doses of BNT166a or placebo at least 28 days apart.
The planned study duration per participant is ~14 months.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(applicable to all participants unless otherwise specified):
- •Are male or female individuals ≥18 years of age at the time of giving informed consent:
- •Cohort 1: ≥18 to ≤45 years of age
- •Cohort 2: ≥18 to ≤64 years of age
- •Cohort 1: Participants must be Orthopoxvirus-naïve (have no history of smallpox or mpox vaccination or mpox infection).
- •Cohort 2: Participants must be Orthopoxvirus-experienced (have evidence of mpox or smallpox vaccination or mpox infection at least 2 years prior to consent).
排除标准
- •(applicable to all participants unless otherwise specified):
- •Have had recent exposure to mpox (defined as close contact with a probable or confirmed case of mpox within the past 28 days, or have evidence of mpox infection or mpox vaccination within 2 years prior to consent).
- •Have a contraindication, warning and/or precaution to vaccination with a messenger ribonucleic acid (mRNA) Coronavirus disease 2019 (COVID-19) vaccine as specified in the Summary of Product Characteristics for BNT162b2 (COMIRNATY United States Prescribing Information/European Union Summary of Product Characteristics) and BNT166 Investigator Brochure.
- •Have a history of allergies, hypersensitivities, or intolerance to the study treatments including any excipients thereof.
- •Have a current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmias.
- •Have any known bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- •Have a body mass index ≤18.5 kg/m^2 or ≥35 kg/m^
- •NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Cohort 1 - BNT166a DL 2 (Orthopoxvirus-naïve participants, aged 18-45 years)
Two doses of IMP.
干预措施: BNT166a (Biological)
Cohort 1 - Placebo (Orthopoxvirus-naïve participants, aged 18-45 years)
0.9% sodium chloride solution. Two doses of IMP.
干预措施: Placebo (Other)
Cohort 2 - Placebo (Orthopoxvirus-experienced participants, aged 18-64 years)
0.9% sodium chloride solution. Two doses of IMP.
干预措施: Placebo (Other)
Cohort 1 - BNT166a Dose Level (DL) 1 (Orthopoxvirus-naïve participants, aged 18-45 years)
Two doses of investigational medicinal product (IMP).
干预措施: BNT166a (Biological)
Cohort 2 - BNT166a DL 2 (Orthopoxvirus-experienced participants, aged 18-64 years)
Two doses of IMP.
干预措施: BNT166a (Biological)
Cohort 2 - BNT166a DL 1 (Orthopoxvirus-experienced participants, aged 18-64 years)
Two doses of IMP.
干预措施: BNT166a (Biological)
结局指标
主要结局
Number (and percentage) of participants with at least one solicited local reaction (pain, erythema/redness, induration/swelling)
时间窗: For up to 7 days following each dose
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
Number (and percentage) of participants with at least one solicited systemic reaction (fever, headache, fatigue/tiredness, muscle pain/myalgia, joint pain/arthralgia, chills, diarrhea, vomiting)
时间窗: For up to 7 days following each dose
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
Number (and percentage) of participants with at least one use of antipyretics/analgesics
时间窗: For up to 7 days following each dose
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
Number (and percentage) of participants with at least one unsolicited adverse event (AE) (post-Dose 1)
时间窗: From Dose 1 to 28 days post-Dose 1
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
Number (and percentage) of participants with at least one unsolicited AE (post-Dose 2)
时间窗: From Dose 2 to 28 days post-Dose 2
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
Number (and percentage) of participants with at least one serious adverse event
时间窗: From Dose 1 until the end of study, i.e., up to ~14 months
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
Number (and percentage) of participants with at least one AE of special interest
时间窗: From Dose 1 until the end of study, i.e., up to ~14 months
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
Number (and percentage) of participants with at least one medically attended AE
时间窗: From Dose 1 until the end of study, i.e., up to ~14 months
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
Number (and percentage) of participants with at least one AE leading to a participant's withdrawal from the study
时间窗: From Dose 1 until the end of study, i.e., up to ~14 months
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
次要结局
- Geometric mean titers (GMT) of BNT166a antigen-specific (A35, B6, H3, and M1) binding antibody titers(At baseline, 1 month post-Dose 1, and 1 month post- Dose 2)
- Geometric mean fold rise (GMFR) of BNT166a antigen-specific (A35, B6, H3, and M1) binding antibody titers(At 1 month post-Dose 1 and 1 month post-Dose 2)
- GMT of MPXV-specific neutralizing antibody titers(At baseline, 1 month post-Dose 1, and 1 month post-Dose 2)
- GMFR of MPXV-specific neutralizing antibody titers(At 1 month post-Dose 1 and 1 month post-Dose 2)
- GMT of vaccinia virus (VACV)-specific neutralizing antibody titers(At baseline, 1 month post-Dose 1, and 1 month post-Dose 2)
- GMFR of VACV-specific neutralizing antibody titers(At 1 month post-Dose 1 and 1 month post-Dose 2)