Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Children Living in Lambaréné, Gabon
NCT ID: NCT05130398
Last Updated: 2023-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2021-04-09
2022-08-09
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
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.
Study Groups
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the rVSVΔG-ZEBOV-GP vaccine
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.
rVSVΔG-ZEBOV-GP, V920
The experimental vaccine is the rVSVΔG-ZEBOV-GP, an Ebola vaccine.
The Chikenpox or Varicella (Varilix) vaccine
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
Chikenpox or Varicella vaccine (VARILRIX)
The active comparator vaccine, a Varicella vaccine (VARILRIX®)
Fibre and equilibrate diet
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.
Fibre and equilibrate breakfast and lunch
Participants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days.
Active detection and treatment of pathogens according to standard of care
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.
Active detection and treatment of pathogens
Monthly diagnostic and treatment of childhood infections Active detection and treatment of pathogens.
Diet plus Active detection and treatment of pathogens according to standard of care
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
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
No diet and no pathogen detection
About 30 children received no diet and no active detection of pathogens
Placebo
About 30 children do not receive diet, nor active pathogen detection
Interventions
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rVSVΔG-ZEBOV-GP, V920
The experimental vaccine is the rVSVΔG-ZEBOV-GP, an Ebola vaccine.
Fibre and equilibrate breakfast and lunch
Participants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days.
Active detection and treatment of pathogens
Monthly diagnostic and treatment of childhood infections Active detection and treatment of pathogens.
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
Chikenpox or Varicella vaccine (VARILRIX)
The active comparator vaccine, a Varicella vaccine (VARILRIX®)
Placebo
About 30 children do not receive diet, nor active pathogen detection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Year
12 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Centre de Recherche Médicale de Lambaréné
OTHER
Responsible Party
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Selidji Todagbe Todagbe Agnandji
Director
Locations
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Centre de Recherches Médicales de Lambaréné
Lambaréné, Moyen-Ogooué Province, Gabon
Countries
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Other Identifiers
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LA rVSVΔG-ZEBOV-GP -02-PED
Identifier Type: -
Identifier Source: org_study_id
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