Phase I, Randomized, Observer-blinded, 3-part, Dose Escalation and Expanded Safety and Dose Evaluation Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Prophylactic Vaccine for the Prevention of Genital Lesions Caused by Herpes Simplex Virus (HSV)-2 and Potentially HSV-1
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- BioNTech SE
- 入组人数
- 318
- 试验地点
- 6
- 主要终点
- Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose
研究概览
简要总结
This exploratory trial will have three parts. Part A is a dose escalation part, Part B is an expanded safety and dose evaluation part, and Part C is a safety and immunogenicity evaluation part in individuals with recurrent HSV-2 genital herpes.
Part A will focus on the safety evaluations, and in addition, vaccine-induced immune responses (specifically neutralizing antibodies) will also be analyzed to assess if there is a dose-response.
Part B of the trial will expand the safety characterization for two dose levels of BNT163 selected based on Part A data and will also enable a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on the safety and immune responses to BNT163.
Part C will evaluate safety and immunogenicity of BNT163 compared to a placebo in a three-dose regimen in participants with a history of HSV-2 recurrent genital herpes.
详细描述
In Part A, participants will be randomized 5:1 to BNT163:placebo. In Part B, participants will be randomized 1:1 to either of the two selected dose levels based on data from Part A. In Part C, participants will be randomized 1:1 to BNT163:placebo.
In Part A & B, participants will receive three intramuscular doses of a fixed dose level of the BNT163 vaccine (Part A and B) or placebo (Part A only).
In Part C, participants will receive three intramuscular doses of one fixed dose level of the BNT163 vaccine or placebo. In this part, continuous suppressive antiviral therapy is given over the entire vaccine dosing period (during and between vaccine doses) to prevent administration of the vaccine concomitantly to viral replication and active genital herpes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
observer-blinded trial
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part A - BNT163
Escalating dose levels
干预措施: BNT163 (Biological)
Part A - Placebo
Isotonic NaCl solution (0.9%)
干预措施: Placebo (Other)
Part B - BNT163 Dose 1
干预措施: BNT163 (Biological)
Part B - BNT163 Dose 2
干预措施: BNT163 (Biological)
Part C - BNT163
One fix dose level of BNT163
干预措施: BNT163 (Biological)
Part C - Placebo
Isotonic NaCl solution (0.9%)
干预措施: Placebo (Other)
结局指标
主要结局
Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose
时间窗: Up to 7 days after each dose
For each dose level (DL) per BNT163 dosing schedule and for the combined placebo group.
Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, myalgia, arthralgia, chills, and fever) recorded up to 7 days after each dose
时间窗: Up to 7 days after each dose
For each DL per BNT163 dosing schedule and for the combined placebo group.
Percentage of participants with at least one unsolicited adverse event (AE) occurring up to 28 days after each dose
时间窗: From Day 1 up to Day 197
For each DL per BNT163 dosing schedule and for the combined placebo group.
Percentage of participants in each cohort with at least one serious AE, or AE of special interest, or medically attended AE occurring up to 24 weeks post-Dose 3 (Parts A & B) or post-Dose 2 (Part C)
时间窗: From Day 1 up to Day 337
For each DL per BNT163 dosing schedule and for the combined placebo group.
Number of unsolicited AEs occurring up to 28 days after each dose
时间窗: From Day 1 up to Day 197
For each DL per BNT163 dosing schedule and for the combined placebo group.
Percentage of unsolicited AEs occurring up to 28 days after each dose
时间窗: From Day 1 up to Day 197
For each DL per BNT163 dosing schedule and for the combined placebo group.
次要结局
- Geometric mean titer (GMT) at each time point(From Day 1 up to Day 337)
- Geometric mean fold (GMF) change from baseline of neutralizing and binding antibody titers to each time point after vaccination(From Day 1 up to Day 337)
- Part A and B only - Percentage of participants with seroconversion defined as a minimum of 4-fold increase from baseline of neutralizing and binding antibody titers to each subsequent time point after vaccination(From Day 1 up to Day 337)