Ebola Virus Disease Clinical Trial
— EBOLAPEDOfficial title:
A Phase 1/2, Randomized, Controlled Open-label Trial to Evaluate the Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Healthy Children Aged 1 to 12 Years and in Their Relatives Living in Lambaréné, Gabon
Verified date | April 2023 |
Source | Centre de Recherche Médicale de Lambaréné |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
LA rVSVΔG-ZEBOV-GP -02-PED is a Phase 1/2, randomized, controlled open label trial. The LA rVSVΔG-ZEBOV-GP -02-PED trial aims primarily to assess the clinical significance of shedding of the rVSV RNA following vaccination with the rVSVΔG-ZEBOV-GP vaccine in children. The vaccine doses of ≥7.8 x 107 pfu will be evaluated and compared to vaccination with varicella vaccine as a control. In addition, the closest contact persons of the vaccinees will be monitored for possible transmission of the viral vaccine vector. The study will enroll children of two age groups living in Lambaréné, Gabon. Children will be followed-up for 12 months post vaccination. The 1-2 closest contact persons of each participant will be involved in the monitoring of rVSV transmission. They will be followed until day 56 post- vaccination of their children/ sibling.
Status | Completed |
Enrollment | 120 |
Est. completion date | August 9, 2022 |
Est. primary completion date | September 8, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year to 12 Years |
Eligibility | Inclusion Criteria: - Healthy children aged 1 to 12 years (inclusive) at the time of inclusion. - Willingness of parent or legal guardian to provide written informed consent prior to screening procedures. - 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). - Available, able, and willing to participate in all study visits and procedures Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Gabon | Centre de Recherches Médicales de Lambaréné | Lambarene | Moyen-Ogooué |
Lead Sponsor | Collaborator |
---|---|
Centre de Recherche Médicale de Lambaréné | Merck Sharp & Dohme LLC |
Gabon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of viral vector in blood, saliva and urine in vaccinees | Concentration of rVSV?G-ZEBOV-GP in blood, urine, or saliva as detected by RT-PCR and expressed as copy number in vaccinees | at days 0, 1, 2/3, 7, 14 and 28 | |
Primary | Prevalence and relative risk of sollicited adverse events in vaccinees | Proportion (percent) of participants experiencing sollicited adverse events in vaccinees groups | until day 14 post vaccination | |
Primary | Prevalence and relative risk of unsolicited adverse events and serious adverse events in vaccinees | Proportion (percent ) of participant experiencing unsollicited adverse event (AEs) and serious adverse events (SAEs) and relative risk of AEs and SAEs in participant by vaccine groups | until day 28 after vaccination | |
Secondary | Prevalence and relative risk of serious adverse events | Proportion (percent) of participants experiencing SAEs and relative risk of SAEs in until study last visit (at 365 days) | until day 365 | |
Secondary | Transmission intensity of the viral vector in blood, saliva and urine among the the relatives of the vaccinees | Concentration of rVSV?G-ZEBOV-GP in blood, urine, or saliva as detected by RT-PCR and expressed as copy number in the close relatives of the vaccinees | days 0, 1, 3, 14, 28, 56 | |
Secondary | Titres of ZEBOV-GP-specific binding antibody | Titres of ZEBOV-GP-specific binding antibody by ELISA expressed in geometric mean titres (GMTs) | days 0, 1, 3, 14, 21, 28, 56, 84, 180, 365 | |
Secondary | Affinity/Avidity of antibody induced by vaccination | Affinity/avidity of GP-specific serum antibodies as assessed by Surface Plasmon Resonance platform at D28 and D180 expressed as percent of affinity maturation | days 28 and 180 | |
Secondary | Concentration of IL-1RN (IL-1Ra), IL-6, TNF-a, IL-10, MCP-1/CCL2, and MIP-1ß/CCL4 | Cytokines (IL-1RN (IL-1Ra), IL-6, TNF-a, IL-10), chemokines and soluble adhesion molecules (MCP-1/CCL2, and MIP-1ß/CCL4) plasma expressed in microgram per milliliter . | days 0, 1 and 2 or 3 | |
Secondary | Prevalence of miRNAs | Proportion (percent) of circulating miRNAs using the Human miRNome PCR array v.21 in serum samples | at days 0, 1, 2/3, 7 | |
Secondary | Concentration of Lipids, glutamine, Alanine, Aspargine | Proportion (percent ) and concentration ( microgram/ mililiter) of Lipids, glutamine, Alanine, Aspargine in plasma samples | at day 0, day 1, day 2/3 and day 7 | |
Secondary | Concentrations Nitric oxides species | Profiling nitric oxides species according to vaccines, diet and pathogens | days 0, 1, 2/3, 7, 28, 56, 90, 180, 365 | |
Secondary | Concentration of metabolites of gut bacteria | Measurement of gut metabolites | days 0, 7, 28, 56, 90 | |
Secondary | Titres of antibody induced by diphtheria, tetanus, Bordetella, poliomyelitis, hepatitis B, measles, yellow fever ( EPI vaccines) | Concentration of antibody of EPI vaccines | days 0, 7, 14, 28, 90, 180, 365 | |
Secondary | Concentration of bystander cytokines | Concentration of cytokines that may induce heterologous vaccine induced immune responses | days 0, 1, 2/3, 7, 28, 90 |
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