A Phase I/II Randomized, Two Parts, Dose-Finding Study To Evaluate The Safety, Tolerability and Immunogenicity Of An Inactivated, Adjuvanted SARS-CoV-2 Virus Vaccine Candidate (VLA2001), Against Covid-19 In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 8
- 主要终点
- Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
研究概览
简要总结
A multicenter, 3-arm randomized dose finding study in the UK to evaluate safety, tolerability and immunogenicity of a vaccine candidate against Covid-19. 150 healthy volunteers will be enrolled and receive two shots of the vaccine candidate. All participants who receive two doses of the vaccine candidate will be invited to participate in the Booster phase.
详细描述
The multicenter, dose finding Phase 1/2 study starts off with an open-label, dose-escalation part, thereafter, during the double-blind part of study, participants will be randomized 1:1:1 to receive the low, medium or high dose of the vaccine (VLA2001). All participants will received a total of two vaccinations intramuscularly, on day 1 and day 22.
The first 5 participants in each dose group will receive VLA2001 open label, starting with the low dose of VLA2001. If no safety concerns are identified, the next 5 subjects will receive the medium dose of the vaccine. Again, if no safety issues are identified, 5 participants will be vaccinated with the high dose of the vaccine. A Data Safety and Monitoring Board (DSMB) will review accrued safety data before randomization of the remaining 135 subjects across all sites will be initiated.
All study participants will be followed up for safety and immunogenicity up to approximately 6 months after receiving their second vaccination.
This study was extended to investigate the tolerability, safety and immungenicity of a booster vaccination with VLA2001. All study participants, in the Booster phase, will be followed up for safety and immunogenicity up to 6 months after receiving their Booster vaccination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
- st phase is open-label
- nd phase is double-blind randomized (Participant, Investigator )
- rd phase is open-label phase
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
结局指标
主要结局
Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
时间窗: within 7 days after any vaccination
Geometric Mean Titre (GMT) for Neutralizing Antibodies Against SARS-CoV-2 Determined by Wild-type Virus Neutralizing Assay
时间窗: Day 36
次要结局
- Frequency and Severity of Any Vaccine-related AE(until Visit 9)
- Frequency and Severity of Any SAE(until Visit 10)
- Frequency and Severity of an AESI(until Day 208)
- Frequency of Any Unsolicited AE(until Day 36)
- Frequency and Severity of Any AE(until Day 208)
- Frequency and Severity of Any Unsolicited AE(until Visit 9)
- Immune Response as Measured by Neutralizing Antibody Titres Against SARS-CoV-2(until Day 208)
- Frequency and Severy of Solicited AEs (Local and Systemic Reactions) After the Booster Vaccination(until Visit 7 plus 6 days)
- Proportion of Participants With Seroconversion in Terms of Neutralizing Antibodies(until Day 208)
- Geometric Mean Titres (GMT) Measured as Neutralizing Antibody Titres Against SARSCoV-2(until Visit 9)
- Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to Neutralizing Antibodies(until Visit 8)
- Frequency of Any Vaccine-related AE(until Day 36)
- Frequency of Any AESI(until Day 36)
- GMTs for IgG Antibodies Against SARS-CoV-2 Determined by ELISA(until Day 208)
- Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to Neutralizing Antibodies(until Visit 9)
- Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to Neutralizing Antibodies(until Visit 9)
- Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to S-protein Binding Antibodies (ELISA)(until Visit 8)
- Geometric Mean Titres (GMT) Measured as IgG Antibodies Against SARS-CoV-2 (ELISA(until Visit 9)
- Frequency of Any SAE(until Day 36)
- Frequency and Severity of Any AESI(until Visit 10)
- Proportion of Participants With Seroconversion in Terms of IgG Antibodies Against SARS-CoV-2, as Determined by ELISA in Participants Negative for SARS-CoV-2 at Screening(until Day 208)
- Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to Neutralizing Antibodies(until Visit 8)
- Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to S-protein Binding Antibodies (ELISA)(until Visit 9)
- Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose in Regards to S-protein Binding Antibodies (ELISA)(until Visit 8)
- Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose in Regards to S-protein Binding Antibodies (ELISA)(until Visit 9)
- Fold Increase of SARS-CoV-2 Neutralizing Antibody Titres Compared With Baseline(until Day 208)