Ebola
Conditions
Interventions
Intervention group
control group
Active detection of infectious diseases plus treatment according to local guidelines
Diet and Health status
No diet No pathogen detection
Sponsors
centre de recherches medicales de lambarene
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy children, aged 1to 12 years(inclusive) at the time of screening 2. Willingness of parent or legal guardian to provide written informed consent prior to screening procedures. 3. Willingness of the relatives of the participant to provide written informed consent if they are = 18 years (or an assent when they are 13 to 17 years old). 4. Available, able, and willing to participate in all study visits and procedures
Exclusion criteria
Exclusion criteria: 1. History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions, or known allergy to components of the study vaccines 2. Ongoing participation in another clinical trial 3. Participation in previous Ebola vaccine trial 4. Receipt of licensed vaccines within 30 days of planned study immunization 5. Presence of any febrile illness (fever >38°C) or any moderate to severe illness within one week prior to vaccination 6. Acute or chronic, clinically significant disease 7. Known history of varicella 8. Known hepatitis B, C or HIV infection. 9. Receipt of blood products or immunoglobulin (IVIg or IMIg) within three (3) months of study entry/baseline serologic evaluation 10. Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period 11. Any other significant finding that in the opinion of the investigator would increase the risk to the individual of suffering an adverse outcome from participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Concentration of rVSV in blood, urine, or saliva as detected by RT-PCR at days 0, 1, 2/3, 7, 14, 21, 28. The frequency and severity of adverse events (AEs) and/or serious adverse events (SAEs) associated with administration of =7.8 x 107 PFU rVSV?G-ZEBOV-GP measured as follow: •Frequency and severity of local signs and symptoms until day 14 post vaccination (solicited local symptoms). •Frequency and severity of systemic signs and symptoms until day 14 post vaccination (solicited systematic symptoms). •Frequency of adverse events (AEs), severity and assessed relationship to study vaccines until day 28 post vaccination (unsolicited AE). •Detailed description of all serious adverse events (SAEs) until day 28 post vaccination. •Values of safety laboratory measures at baseline and at follow-up visits post-vaccination until day 28 post vaccination (reference ranges will be age appropriate). | — |
Secondary
| Measure | Time frame |
|---|---|
| Description of all serious adverse events (SAEs) until the study's last visit (at 365 days). The concentration of rVSV?G-ZEBOV-GP in blood, urine, or saliva of vaccinees in close contact persons as detected by RT-PCR. The concentration of ZEBOV-GP-specific binding antibody by ELISA Affinity/avidity of GP-specific serum antibodies as assessed by Surface Plasmon Resonance platform at D28 and D180 (affinity maturation) Neutralizing epitopes on the Ebola virus GP by an in-house competitive Surface Plasmon Resonance assay, Cytokines, chemokines and soluble adhesion molecules in fresh frozen plasma Profile and quantify circulating miRNAs using the Human miRNome PCR array Transcriptomic profiles of the immune response following rVSV?G-ZEBOV-GP immunization. Analysis of adaptive cellular immune responses Metabolomics analysis of plasma samples Characterize the immunogenicity and immune responses induced by vaccination according to diet and health status Characterize the profile of Nitric Oxides species before and after vaccination, diet and health status To assess the translocation of gut microbial molecules in the peripheral blood • To assess the state of cytokine secretions in all groups according to diet and reduction/elimination of the effects of pathogens • To assess the vaccine-induced immune responses according to the states of immune activation within the causal groups • To profile the type and quality of diets among the participants | — |
Countries
Gabon
Contacts
Public ContactSelidji Todagbe ;Ferdie Chyssie AGNANDJI;AGNANDJI
Scientist;Project manager
Outcome results
None listed