Reactogenicidad, Seguridad e Inmunogenicidad de Dosis de Refuerzo de Vacunas Contra SARS-CoV-2 en Chile (Estudio REFUERZO)
试验速览
- 阶段
- 2 期
- 入组人数
- 534
- 试验地点
- 2
- 主要终点
- Early humoral response
研究概览
简要总结
Preliminary data suggest that inactivated vaccine-induced neutralizing antibodies against SARS-CoV-2 decrease at six months after vaccination. Observational, unpublished data also indicate that vaccine effectiveness against Covid-19 wanes over time. Thus, the investigators aimed to determine the reactogenicity, safety, and immunogenicity of a homologous or heterologous booster of SARS-CoV-2 vaccines among people already immunized with an inactivated SARS-CoV-2 vaccine. The study focuses on the elderly population and healthcare workers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Full immunization with CoronaVac (2 doses; 0,28) prior to April 15, 2021
- •Being a resident of any of the eligible Nursing Homes (located in the Metropolitan Region of Chile)
- •Healthcare workers of one of the eligible Nursing Homes.
- •Healthcare workers of Hospital de Urgencia Asistencia Publica (HUAP, Santiago, Chile)
排除标准
- •Prior history of Covid-19
- •Not able to consent
研究组 & 干预措施
Inactivated vaccine booster
One standard IM CoronaVac dose (0.5 mL)
干预措施: Inactivated vaccine booster (Biological)
mRNA vaccine booster
One standard IM BNT162b2 dose (0.3 mL)
干预措施: mRNA vaccine booster (Biological)
Viral vector vaccine booster
One standard IM ChAdOx1 dose (0.5 mL)
干预措施: Viral vector vaccine booster (Drug)
Placebo
Saline solution IM (0.3 mL)
干预措施: Placebo (Biological)
结局指标
主要结局
Early humoral response
时间窗: Baseline (90-120 days after second dose of CoronaVac) and 15 days post booster dose
Change in SARS-CoV-2 neutralizing antibody levels
Immunogenicity
时间窗: Baseline, 15, 30, 60, and 90 days post booster dose
Change in SARS-CoV-2 neutralizing antibody levels
次要结局
- Reactogenicity(days 7, 28, and 3 months post booster dose)
- Safety of booster dose(In addition to the scheduled visits mentioned in Outcome 3, Telephone numbers, including the PI´s cell phone will be available 24/7 throughout the study (1 year) for reporting any unsolicited reaction.)
研究者
Rafael Araos
Assistant Professor of Medicine, Principal Investigator
Universidad del Desarrollo