A Phase 1/2 interventional study of rVSVΔG-ZEBOV-GP, V920 and Fibre and equilibrate breakfast and lunch in Ebola Virus Disease, sponsored by Centre de Recherche Médicale de Lambaréné. Completed at 1 site in Gabon. Open to participants aged 1 Year to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-20.
Sponsored by Centre de Recherche Médicale de Lambaréné · Phase 1/2, Interventional, and Prevention
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.
LA-rVSVΔG-ZEBOV-GP -02-PED is a Phase 1/2, randomized, controlled, open label, trial and is designed to generate further safety, tolerability and immunogenicity data of the 7.8 x 107 PFU rVSVΔG-ZEBOV-GP vaccine in children aged 1 -12 years living in a sub-Saharan Africa. The study will enroll participants into two age groups. A total of 120 children will be enrolled and followed-up for 12 months post injection. In addition, a maximum of 240 relatives of the study participants will be enrolled to assess the transmission of the rVSVΔG-ZEBOV-GP vaccine.
Group 1: 60 participants aged 6-12 years will be randomized in group 1. 40 participants will receive a single intramuscular dose of 7.8 x 107 pfu rVSVΔG-ZEBOV-GP vaccine. 20 participants will receive a single subcutaneous dose of varicella vaccine The participants will be allocated to each treatment at a ratio of 2:1 respectively Group 2: 60 participants aged 1 -5 years will be randomized into group 2. 40 will receive a single intramuscular dose of 7.8 x 107 pfu of rVSV-ZEBOV vaccine. 20 participants will receive a single subcutaneous dose of varicella vaccine The participants will be allocated to each treatment at a ratio of 2:1 respectively
Vaccinations will start in group 2 after the first 10 participants of group 1 have completed the day 28 post vaccination visit and the SMC has done a review of safety data until that point.
For each vaccinee there will be a 365 -day period of follow-up after vaccination. The contact persons of the vaccinees will be followed-up until day 56 after the vaccination of their relative.
Exclusion Criteria:
Participants of the experimental arm will receive a single intramuscular dose of ≥7.8 x 107 pfu of the rVSVΔG-ZEBOV-GP vaccine. In total, 80 participants will receive the experimental vaccine: 40 participants aged 6-12 years and 40 aged 1-5 years.
Biological: rVSVΔG-ZEBOV-GP, V920
The control arm consists of the chickenpox vaccine. Forty children will receive a single subcutaneous dose of Varilix, the active comparator vaccine, 20 aged 6-12 years and 20 aged 1-5 years
Biological: Chikenpox or Varicella vaccine (VARILRIX)
Participants were assigned to receive two meals daily ( breakfast and lunch) for 21 days. About 30 children are randomly assigned to fibre and equilibrate diet.
Dietary Supplement: Fibre and equilibrate breakfast and lunch
The following pathogens: P. falciparum, Ascaris lumbricoides, Trichuris trichiura, Necator americanus, intestinal protozoa, BG+, BG- colonies and pathogens, SARS-CoV2 are actively detected and treated according to the standard of care every month. About 30 children are randomly assigned to this arm.
Diagnostic Test: Active detection and treatment of pathogens
Participants were assigned to receive two meals daily ( breakfast and lunch) for 21 days and concomitantly assigned to active detection of P. falciparum, Ascaris lumbricoides, Trichuris trichiura, Necator americanus, intestinal protozoa, BG+, BG- colonies and pathogens, SARS-CoV2 every month. About 30 children are assigned to receive combined interventions
Combination Product: Fibre and equilibrate breakfast and lunch plus Active detection and treatment of pathogens
About 30 children received no diet and no active detection of pathogens
Other: Placebo
The experimental vaccine is the rVSVΔG-ZEBOV-GP, an Ebola vaccine.
Participants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days.
Monthly diagnostic and treatment of childhood infections Active detection and treatment of pathogens.
Participants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days and diagnostic and treatment of childhood infections Active detection and treatment of pathogens every month for 12 months
The active comparator vaccine, a Varicella vaccine (VARILRIX®)
About 30 children do not receive diet, nor active pathogen detection
Concentration of viral vector in blood, saliva and urine in vaccinees
Concentration of rVSVΔG-ZEBOV-GP in blood, urine, or saliva as detected by RT-PCR and expressed as copy number in vaccinees
Time frame: at days 0, 1, 2/3, 7, 14 and 28
Prevalence and relative risk of sollicited adverse events in vaccinees
Proportion (percent) of participants experiencing sollicited adverse events in vaccinees groups
Time frame: until day 14 post vaccination
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
Time frame: until day 28 after vaccination
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)
Time frame: until day 365
Transmission intensity of the viral vector in blood, saliva and urine among the the relatives of the vaccinees
Concentration of rVSVΔG-ZEBOV-GP in blood, urine, or saliva as detected by RT-PCR and expressed as copy number in the close relatives of the vaccinees
Time frame: days 0, 1, 3, 14, 28, 56
Titres of ZEBOV-GP-specific binding antibody
Titres of ZEBOV-GP-specific binding antibody by ELISA expressed in geometric mean titres (GMTs)
Time frame: days 0, 1, 3, 14, 21, 28, 56, 84, 180, 365
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
Time frame: days 28 and 180
Concentration of IL-1RN (IL-1Ra), IL-6, TNF-α, IL-10, MCP-1/CCL2, and MIP-1β/CCL4
Cytokines (IL-1RN (IL-1Ra), IL-6, TNF-α, IL-10), chemokines and soluble adhesion molecules (MCP-1/CCL2, and MIP-1β/CCL4) plasma expressed in microgram per milliliter .
Time frame: days 0, 1 and 2 or 3
Prevalence of miRNAs
Proportion (percent) of circulating miRNAs using the Human miRNome PCR array v.21 in serum samples
Time frame: at days 0, 1, 2/3, 7
Concentration of Lipids, glutamine, Alanine, Aspargine
Proportion (percent ) and concentration ( microgram/ mililiter) of Lipids, glutamine, Alanine, Aspargine in plasma samples
Time frame: at day 0, day 1, day 2/3 and day 7
Concentrations Nitric oxides species
Profiling nitric oxides species according to vaccines, diet and pathogens
Time frame: days 0, 1, 2/3, 7, 28, 56, 90, 180, 365
Concentration of metabolites of gut bacteria
Measurement of gut metabolites
Time frame: days 0, 7, 28, 56, 90
Titres of antibody induced by diphtheria, tetanus, Bordetella, poliomyelitis, hepatitis B, measles, yellow fever ( EPI vaccines)
Concentration of antibody of EPI vaccines
Time frame: days 0, 7, 14, 28, 90, 180, 365
Concentration of bystander cytokines
Concentration of cytokines that may induce heterologous vaccine induced immune responses
Time frame: days 0, 1, 2/3, 7, 28, 90
Plan to share: Yes — The Principal investigator or his designee will be the data manager with responsibility for delegating the receiving, entering, cleaning, querying, analysing and storing all data that accrues from the study. All data will be entered in paper case record forms and transcribed by double entry into an electronic database. This includes safety data, laboratory data (both clinical and immunological) and outcome data.
Supporting information: Study protocol, Sap, Icf
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Centre de Recherche Médicale de Lambaréné