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

Not Applicable

Not yet recruiting

• Conditions: Ebola

• Registration Number: PACTR202105585438650
• Lead Sponsor: Centre de Recherches Medicales de Lambarene

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified