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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202105585438650

Enrollment

346

Registered

2021-05-05

Start date

2021-03-14

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ebola

Interventions

Balance diet

Reduce effect

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
-To quantify zymosan particles within neutrophils and macrophages	—

Secondary

Measure	Time frame
• To identify and quantify peptidoglycan from the microbiota in peripheral blood ( serum or plasma) at day-14, day-7, day-1, day1, day7, day14, day28 • To quantify the cytokine secretions at day-14, day-7, day-1, day1, day7, day14, day28, day 56, day 84. • To quantify serum triglyceride, hemoglobin A1c (HbA1c) and C-reactive protein at day-14, day-7, day7, day14, day28 • To categorise the levels of scarcity among the households involved in the study according to a consumption household survey performed day-14 and day 28 and/ Months 6 and month 12	—

Measure

Time frame

• To identify and quantify peptidoglycan from the microbiota in peripheral blood ( serum or plasma) at day-14, day-7, day-1, day1, day7, day14, day28 • To quantify the cytokine secretions at day-14, day-7, day-1, day1, day7, day14, day28, day 56, day 84. • To quantify serum triglyceride, hemoglobin A1c (HbA1c) and C-reactive protein at day-14, day-7, day7, day14, day28 • To categorise the levels of scarcity among the households involved in the study according to a consumption household survey performed day-14 and day 28 and/ Months 6 and month 12

—

Countries

Gabon

Contacts

Public ContactSelidji Todagbe AGNANDJI

Scientist

agnandjis@cermel.org0024177353114

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026