NCT05130398

Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Children Living in Lambaréné, Gabon

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Centre de Recherche Médicale de Lambaréné · Academic / Other
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ebola Virus Disease

Interventions

Type	Name	Description
BIOLOGICAL	rVSVΔG-ZEBOV-GP, V920	The experimental vaccine is the rVSVΔG-ZEBOV-GP, an Ebola vaccine.
DIETARY_SUPPLEMENT	Fibre and equilibrate breakfast and lunch	Participants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days.
DIAGNOSTIC_TEST	Active detection and treatment of pathogens	Monthly diagnostic and treatment of childhood infections Active detection and treatment of pathogens.
COMBINATION_PRODUCT	Fibre and equilibrate breakfast and lunch plus 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
BIOLOGICAL	Chikenpox or Varicella vaccine (VARILRIX)	The active comparator vaccine, a Varicella vaccine (VARILRIX®)
OTHER	Placebo	About 30 children do not receive diet, nor active pathogen detection

Timeline

• Start date: 2021-04-09
• Primary completion: 2021-09-08
• Completion: 2022-08-09
• First posted: 2021-11-23
• Last updated: 2023-04-20

Locations

1 site across 1 country: Gabon

Regulatory

• FDA-regulated drug study