A Phase 2, Observer-blind, Randomized Study to Assess the Safety and Immunogenicity of Heterologous Prime-boost COVID-19 Vaccines Regimens in Individuals Aged 18 to 65 Years in Mozambique and Madagascar.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies
研究概览
简要总结
This is an observer-blind, randomized study which aims to assess the immune response and the safety of two different approved vaccines for first and second dose in healthy adults.
详细描述
This is a phase 2, observer-blind, randomized study to assess the safety and the immunogenicity of heterologous prime-boost COVID-19 vaccines regimens in healthy adults aged 18 to 65 years using two approved vaccines (Sinopharm / CNBG Vaccine (BBIBP-CorV) and Johnson & Johnson Vaccine (Ad26.COV2.S)).
The study will consist of 2 cohorts, one for main immunology endpoints (N=260, 65 per study arm) and one for more detailed immunological assessment (N=100, 25 per study arm). Two doses of vaccine will be administered intramuscularly 4 week apart. All the study participants will be follow-up for 12 months from the administration of first vaccine dose.
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
- Single (Outcomes Assessor)
盲法说明
This is an observer-blind study. So in this study only the outcome assessors should be blinded namely the clinical staff in charge of the clinical outcomes assessment and the laboratory analysts.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 18 to 65 years old at the time of consent.
- •Residing within the area of the study and planning to stay for the study duration.
- •HIV negative test result on the day of screening (for those who do not have a documented HIV test results in the last three months of screening).
- •Female volunteers of childbearing potential with a negative pregnancy test on the day(s) of screening and vaccination, practicing/willing to practice continuous effective contraception* recommended by the National Health System up to 12 weeks after the booster vaccination..
- •Agreement to refrain from blood donation during the course of the study.
- •Able and willing to comply with all study requirements, based on the assessment of the investigator.
- •Willingness to provide written informed consent before any trial procedure * Effective contraception is defined as follows: contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms, diaphragms, intrauterine device (IUD), and abstinence.
排除标准
- •Pregnancy, lactation, or intention to become pregnant during the vaccination phase through three months after the booster dose.
- •Prior receipt/ planned receipt of any vaccine other than the study intervention within 28 days before and after each study vaccination.
- •Previous participation in any COVID-19 vaccination trial or vaccination campaign.
- •Administration of immunoglobulins and/ or any blood products within the three months preceding the administration of the study vaccine.
- •Known infection with hepatitis B, C virus.
- •Known history of allergy or anaphylaxis to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse reaction.
- •History of bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
- •Continuous use of the anticoagulants, such as coumarins and related anticoagulants.
- •Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, renal disease, liver disease, endocrine disorders, and neurological illness (mild/moderate well controlled comorbidities are allowed).
- •Any clinically significant abnormal finding on screening as judged by the investigator.
- •Confirmed SARS-CoV-2 infection at enrollment.
- •Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within 3 months prior to recruitment (topical steroids are allowed).
- •Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor-quality data.
结局指标
主要结局
Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies
时间窗: Four Weeks after second dose
Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies using a neutralization assay four weeks after the second dose, in COVID-19 seronegative participants following immunization with heterologous and homologous prime-boost COVID-19 vaccines regimens.
Incidence of SAEs and AESI observed at any time point during the entire study period
时间窗: Till 12 months follow-up visit
Incidence of SAEs and AESI observed at any time point during the entire study period, among all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens
Incidence of solicited reactions within 7 days (local reactions) and 14 days (systemic reactions)
时间窗: Within 7 days (local reactions) and 14 days (systemic reactions) following each vaccination
Incidence of solicited reactions within 7 days (local reactions) and 14 days (systemic reactions) following each vaccination in all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens.
Incidence of changes in laboratory safety measures from baseline to day 28 after each vaccination
时间窗: Within 28 days after each vaccination
Incidence of changes in laboratory safety measures from baseline to day 28 after each vaccination, in all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens
Incidence of unsolicited adverse events that are within 28 days after each vaccination
时间窗: Within 28 days after each vaccination
Incidence of unsolicited adverse events that are within 28 days after each vaccination in all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens.
次要结局
- Geometric Mean Titers (GMTs) and Geometric Mean Fold Rise (GMFR)(Till 12 months follow-up visit)