Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Children Living in Lambaréné, Gabon
Condition: Ebola Virus Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): rVSVΔG-ZEBOV-GP, V920; Fibre and equilibrate breakfast and lunch; Active detection and treatment of pathogens; Fibre and equilibrate breakfast and lunch plus Active detection and treatment of pathogens; Chikenpox or Varicella vaccine (VARILRIX); Placebo
Intervention type(s): Biological; Dietary Supplement; Diagnostic Test; Combination Product; Biological; Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Phase 1/2, randomized, controlled, open label clinical trial.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sub-Saharan Africa Africa ,; Children; rVSV-ZEBOV-GP vaccine; Shedding; Safety; Tolerability