Immunogenicity of an Intradermal Qdenga Vaccine Among Healthy Volunteers: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Dengue IgG Level
研究概览
简要总结
Official title: Immunogenicity of an intradermal Qdenga vaccine among healthy volunteers: A pilot study
详细描述
As in the setting of low- to middle-income countries, to demonstrating that lower doses of vaccine via intradermal route can still elicit robust immune responses, thereby lowering the overall cost of vaccination might be particularly meaningful ,with possible extra benefit of experiencing fewer side effects or risk of allergy. This study goal is to explores the potential of intradermal administration of Qdenga, hypothesizing that a lower dose via this route could achieve adequate immunogenicity compared to the standard subcutaneous administration, thus offering a cost-effective alternative particularly in low-resource settings where dengue is most prevalent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Thai adult aged 18-60 years, who not previously received dengue vaccine.
- •The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 3-month follow-up of the study.
- •Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization
- •The subject can provide with informed consent and sign informed consent form
排除标准
- •Have a medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
- •Be allergic to any component of the research vaccines or used to have a history of hypersensitivity or serious reactions to vaccination.
- •Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months.
- •Have acute infectious diseases, including dengue infection
- •Have severe chronic diseases or condition in progress cannot be controlled. For example, poor controlled DM and uncontrolled HT.
- •Have the history of urticaria 1 year before receiving the investigational vaccine.
- •Have known underlying diseases of thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection).
- •Have needle sickness.
- •Have the history of immunosuppressive therapy, cytotoxic therapy or systemic corticosteroids
- •Have received blood products within 4 months before injection of investigational vaccines.
- •Under anti-tuberculosis treatment.
- •Not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to various medical, psychological, social or other conditions.
研究组 & 干预措施
SC ID
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
干预措施: Vaccine (Biological)
SC SC
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
干预措施: Vaccine (Biological)
结局指标
主要结局
Dengue IgG Level
时间窗: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)
To measure Antibody level for dengue by ELISA on day 0, day 30 and day 120 after 1st vaccination
CD4 T Cell Responses
时间窗: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)
To measure T cell responses to dengue antigen by ELISpot on day 0, day 30 and day 120 after 1st vaccination.
CD8 T Cell Response
时间窗: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)
To measure T cell responses to dengue antigen by ELISpot on day 0, day 30 and day 120 after 1st vaccination.
次要结局
- All-Cause Mortality(at day 7 and 30 post each vaccination)
- Serious Adverse Events(at day 7 and 30 post each vaccination)
- Local Reactions(at day 7 and 30 post each vaccination)
- Systemic Reactions(at day 7 and 30 post each vaccination)
- Pain at Vaccination Site, 7 Day Post 1st Vaccination(7 day post 1st vaccination)
- Erythema at Vaccination Site, 7 Day Post 1st Vaccination(7 day post 1st vaccination)
- Malaise, 7 Day Post 1st Vaccination(7 day post 1st vaccination)
- Headache, 7 Day Post 1st Vaccination(7 day post 1st vaccination)
- Erythema at Vaccination Site, 7 Day Post 2nd Vaccination(7 day post 2nd vaccination)
研究者
Sarunyou Chusri
Assoc. Prof. Sarunyou Chusri M.D. Ph.D.
Prince of Songkla University