Efficacy, Immunogenicity and Safety of Inactivated Vaccine (Coronavac) Against SARS-COV2 in Children and Adolescents - Curumim Project
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,120
- 试验地点
- 2
- 主要终点
- B lymphocytes
研究概览
简要总结
To evaluate the efficacy and safety of vaccinating children and adolescents, aged 3 to 17 years, with a two-dose schedule of the inactivated vaccine (Coronavac) against SARS-Cov-2.
详细描述
Nine hundred sixty (960) participants will be randomized into 2 groups, in a 2:1 ratio, to receive the inactivated Coronavac/Butantan vaccine (VACC, N=640) and a group to receive the immunizing BNT162b2 (Pfizer) (BNTC, N=320). The VACC group will also be compared to a group of adults aged 18 to 49 who received Coronavac (ADU, N=160). The main outcome will be the geometric title of neutralizing antibodies and the secondary outcomes will be the incidence of the number of cases confirmed by RT-PCR, the cellular immune response and frequency of adverse events. Outcomes will be evaluated before the first dose, and 28 and 90 days after the second dose, and followup after 6 and 12 months. The study hypothesis is that the cellular and humoral immune response of children and adolescents is not inferior to the age group 18 to 49 years, who received Coronavac and compared to children vaccinated with the immunizing BNT162b2 (Pfizer) and that the inactivated vaccine presents lower reactogenicity for the age group studied.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
For blinding, the vaccine dose will be prepared by a pharmacist, who will be the only one who will know which immunizer will be administered. Vaccinators, participants and evaluators will not know which immunizer will be given.
入排标准
- 年龄范围
- 3 Years 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 3 and 17 years old (VACC and BNTC groups)
- •Age between 18 and 49 years old (ADU group)
排除标准
- •Pregnant teenagers;
- •History of severe allergic reaction (anaphylaxis, urticaria or angioedema) to any previously administered vaccine;
- •Have previously received a vaccine against COVID-19;
- •Personal history of SARS-CoV-2-related Multisystem Inflammatory Syndrome (MIS-C);
- •Immunosuppressed due to conditions such as inborn error of metabolism, HIV infection, neoplasia or use of immunosuppressive drugs (systemic corticosteroids for more than 14 days or another immunosuppressant).
结局指标
主要结局
B lymphocytes
时间窗: 12 months
The results will be expressed as a positive percentage frequency for a given cell phenotype.
intracytoplasmic cytokines
时间窗: 12 months
The results will be expressed as a positive percentage frequency for a given cell phenotype.
Viral neutralization assay
时间窗: 3 months
Neutralizing antibody titers will be expressed by the ability of antibodies to neutralize up to 50% the number of plaques (PRNT50). Title \> 1:50 will be considered positive.
T lymphocytes
时间窗: 12 months
The results will be expressed as a positive percentage frequency for a given cell phenotype.
Chemiluminescence serological assay for qualitative and quantitative determination of neutralizing antibodies against Spike protein (anti-SARS-Cov-2 anti-IgG-S)
时间窗: 3 months
Results are expressed in AU/mL and data interpretation will be as follows: \<50 AU/mL = negative; ≥50 U/mL = positive.
Serological assay by chemiluminescence for qualitative and quantitative determination of specific IgG antibodies against the nucleocapsid protein of SARS-Cov-2
时间窗: 3 months
Results will be expressed as fluorescence intensity or pg/mL. The cutoff is 1.4 and \<1.4 = negative; ≥1.4 = positive.
Dosage of systemic soluble factors
时间窗: 12 months
Chemokines, cytokines and growth factors - biomarkers of humoral and cellular response. Results will be expressed in pg/mL.
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro
时间窗: 2 months
The results will be expressed as a positive percentage frequency for a given cell phenotype.
次要结局
- RT-PCR confirmed cases(6 months)
- Adverse events(6 months)
研究者
Valéria Valim
Prof Dr
Federal University of Espirito Santo