A randomized controlled factorial trial to assess the effect of diet and health check-up alone, or combined with the state of the innate immune activation prior to vaccination and innate immune sensing of vaccine components, on the initialization and fine-tuning of adaptive immune responses to two live attenuated viral vaccines

Centre de Recherches Medicales de Lambarene0 个研究点目标入组 346 人开始时间: 2021年2月22日最近更新: 2023年5月29日

适应症

试验速览

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•Inclusion and exclusion criteria are those of the clinical trial. In addition parents/guardians of the participants must express their willingness to enroll their children in this ancillary study and sign its specific informed consent. Mainly:
•Be 1 to 12 years old
•Apparent good health
•Be part of candidate households for the Ebola vaccine clinical trial
•Parents and/or guardians aged 21 or over who wish to have the child participate

•The volunteer will not enter the study if any of the following apply:
•History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions, or known allergy to the components of the vaccines.
•Ongoing participation in another clinical trial
•Participation in previous Ebola vaccine trials
•Receipt of a licensed vaccine within 14 days of planned study immunization (30 days for live vaccines)
•Presence of any febrile illness (fever >38°C) or any moderate to severe illness within one week prior to vaccination;
•Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
•Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study.

发起方

Centre de Recherches Medicales de Lambarene