ISRCTN12022293进行中（未招募）4 期
Persistence of binding and neutralizing antibodies against SARS-CoV2 strains at 6 months or more after a third dose with recombinant COVID-19 vaccine (AstraZeneca/Fiocruz), mRNA COVID-19 vaccine (Comirnaty, Pfizer/Wyeth), recombinant COVID-19 vaccine (Janssen) or adsorbed inactivated COVID-19 vaccine Coronavac (Sinovac/Butantan) in subjects primed with two Sinovac/Butantan doses – extension of study RHH_001; and assessment of safety and immunogenicity of 4th dose with recombinant COVID-19 vaccine (AstraZeneca/Fiocruz) or mRNA covid-19 vaccine (Comirnaty, Pfizer/Wyeth).
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,168
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Participants in study RHH_001 per-protocol population who were fully evaluable. Participants included in previous neutralization assay subsets will be targeted for enrolment first if operationally feasible.
- •2. Willing and able to provide informed consent prior to any study procedure
- •3. Willing and able to comply with the study procedure
- •4. Received heterologous or homologous third vaccine dose =6 months prior to this study
- •5. For people of childbearing potential:
- •5.1. Willing to practice continuous effective contraception during the study
- •5.2. Negative pregnancy test on the day(s) at screening
- •Additional inclusion criteria for part 2 only:
- •1. Informed consent to receive 4th vaccine dose, AstraZeneca/Fiocruz or Pfizer/Wyeth
- •2. No contraindication against AstraZeneca/Fiocruz or Pfizer/Wyeth SARS-C0V-2 vaccine
排除标准
- •1. Any additional SARS-CoV-2 vaccine after the 3rd dose in study RHH_001
- •2. Fever >37.5 °C (axillary) or any acute disease at baseline (Day 0) or within the 3 days prior to randomization. Febrile participants with mild diseases may be enrolled at the investigator’s discretion once fever has resolved.
- •3. Participants with a history of serious vaccine-related adverse reaction or serious allergic reaction (e.g. anaphylaxis) to any study vaccine component, as described in the last summary of product characteristics for AstraZeneca/Fiocruz or Pfizer/Wyeth
- •4. Known bleeding disorder that, in the investigator’s opinion, would contraindicate intramuscular injection
- •5. Any progressive or serious neurological disorder, seizure disorder, or history of Guillian-Barré syndrome
- •6. Given treatment with immunosuppressant therapy within the last 90 days, including cytotoxic agents or systemic corticosteroids, or planned receipt during the study period. If a short-term cycle of immunosuppressant systemic corticosteroid dose has been used to treat acute disease, the participant should not be enrolled in the study until corticosteroid therapy has been discontinued for =15 days prior to the first study vaccination. In case the participant has been on an immunosuppressant dose of a depot, intramuscular or intra-articular corticosteroid, they should wait 60 days for their enrolment in the study. Inhaled/nebulized, intra-articular, intrabursal or topical (skin or eyes) corticosteroids are allowed.
- •7. Autoimmune diseases other than: Hashimoto thyroiditis, vitiligo, psoriasis, discoid lupus, and similar diseases.
- •8. HIV-positive and/or in treatment for HIV
- •9. Given any other investigational product within the 30 days prior to Day 1, or intending to take part in another clinical trial at any time during this study conduction
- •10. Given any other licensed vaccine within 14 days prior to enrolment in this study or planning to receive any vaccine up to 28 days after vaccination
- •11. Given treatment with Rituximab or any other anti-CD20 monoclonal antibody within 9 months prior to Day 1 or planned during the study period
- •12. Administration of intravenous immunoglobulins and/or any blood products within 3 months prior to enrolment or planned dosing during the study period
- •13. Participants with any condition that, in the investigator’s opinion, could interfere with the status primary objectives or represent an additional risk for the participant
- •Temporary exclusion criteria:
- •1. Participants with a recent history of COVID-19 (=4 weeks prior to visit 1) will be delayed until 4 weeks after diagnosis
研究者
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