A Randomised Controlled Trial to Assess the Immunogenicity, Safety and Reactogenicity of a Second Standard Monovalent (Ancestral) or Bivalent Omicron-specific COVID-19 Vaccine Booster Dose (Pfizer-BioNTech or Moderna) in Healthy Adults in Australia.
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Total incidence of solicited reactions (systemic and local)
研究概览
简要总结
This clinical trial will be a blinded, randomised study to determine the safety, reactogenicity, and immunogenicity of a second booster dose of SARS-CoV-2 vaccines in adults enrolled over two consecutive stages. Stage 1 will commence at the time of study approval and transition to stage 2 once bivalent vaccines are approved and available in Australia.
详细描述
Participants will be adults aged 18 years or older who have been previously primed with two doses of either Pfizer-BioNTech (BNT162b2, or Comirnaty®) or AstraZeneca (ChAdOx1-S, or Vaxzevria®) and boosted at least 3 months earlier with Pfizer BioNTech vaccine (30µg). There will be no upper age limit. Participants will be recruited from the Murdoch Children's Research Institute, the Royal Children's Hospital (RCH), the Peter Doherty Research Institute, and, if necessary, the greater Melbourne area. Ideally, 100 participants will be recruited per group unless bivalent Omicron-specific vaccines are introduced before this target is reached for monovalent ancestral vaccines. There will be 800 participants in total. Procedures will be implemented to ensure participants of all ages (aged 18 and above) are included and that there is an even age distribution in each group (<50 and ≥50 years).
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
- Double (Participant, Investigator)
盲法说明
The participants and those evaluating reactogenicity will be blinded to the vaccine allocation for the first 7 days following vaccination. After that, both clinical investigators and participants will be aware of their investigational product. Laboratory staff will remain blinded to the investigational product.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have completed a primary schedule of two doses of Pfizer-BioNTech or AstraZeneca vaccines and received a booster of Pfizer-BioNTech vaccine (30µg) at least 3 months earlier.
- •No confirmed SARS-CoV-2 infection on PCR or RAT within the last 3 months.
- •Willing and able to give written informed consent.
- •Aged 18 years or above.
- •Willing to complete the follow-up requirements of the study.
排除标准
- •Currently receiving immunosuppressive medication or anti-cancer chemotherapy.
- •Known HIV infection.
- •Congenital immune deficiency syndrome.
- •Received immunoglobulin or other blood products in the three months prior to potential study booster vaccination.
- •Study staff and their relatives.
- •Have a history of a severe allergic reaction to any COVID-19 vaccines or have a medical exemption to receiving further COVID-19 vaccines.
- •Cannot read or understand English.
结局指标
主要结局
Total incidence of solicited reactions (systemic and local)
时间窗: Total incidence of solicited reactions will be measured for 7 days post booster vaccination
Questionnaire to document solicited reactions is developed specifically for this study. Data will be reported as the proportion of participants who report by each intervention arm. Solicited reactions such as pain, tenderness, erythema/redness, induration/swelling, fever, nausea/vomiting, headache, fatigue/malaise, myalgia, arthralgia will be collected from the participants 7 days post-vaccination.
SARS-CoV-2 specific Immunoglobulin (Ig)G antibodies at 28-days post booster vaccination
时间窗: 28-days post booster vaccination
Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using the commercial Euroimmun S1 IgG ELISA. Data will be reported as binding antibody units/mL and presented as geometric mean concentration and 95% confidence intervals
次要结局
- Cytokine concentrations following PBMCs stimulation(Baseline (pre booster), 28 days and 6-months post booster vaccination)
- Interferon gamma (IFNγ) concentrations in International Units (IU)/mL(Baseline (pre booster), 28 days-, and 6-months post booster vaccination)
- Number of IFNγ producing cells/million PBMCs(Baseline (pre booster), 28 days-, and 6-months post booster vaccination)
- SARS-CoV-2 specific IgG antibodies at baseline (pre booster), and 6-months post booster vaccination(Baseline (pre booster), and 6-months post booster vaccination)
- SARS-CoV-2 specific neutralising antibodies at baseline (pre booster), 28 days and 6- months post booster vaccination measured by SARS-CoV-2 microneutralisation assay(Baseline (pre booster), 28 days-, and 6-months post booster vaccination)
- Incidence of serious adverse events (SAE)(6 months post booster vaccination)
- Incidence of medically attended adverse events (AE)(3 months post booster vaccination)
- SARS-CoV-2 specific neutralising antibodies at baseline (pre booster), 28 days and 6-months post booster vaccination measured by surrogate virus neutralization test (sVNT)(Baseline (pre booster), 28 days and 6 months post booster vaccination)
- Frequency of cytokine-expressing T cells(Baseline (pre booster), 28 days-, and 6-months post booster vaccination)
- Incidence of unsolicited adverse events (AE)(28 days-post booster vaccination)