Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rVSVΔG-ZEBOV-GP, V920 · 1 trial · 1 indication
Concentration of rVSVΔG-ZEBOV-GP in blood, urine, or saliva as detected by RT-PCR and expressed as copy number in vaccinees
Proportion (percent) of participants experiencing sollicited adverse events in vaccinees groups
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
| Arm | Type | Description |
|---|---|---|
| the rVSVΔG-ZEBOV-GP vaccine | EXPERIMENTAL | 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. |
| The Chikenpox or Varicella (Varilix) vaccine | ACTIVE_COMPARATOR | 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 |
| Fibre and equilibrate diet | EXPERIMENTAL | 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. |
| Active detection and treatment of pathogens according to standard of care | EXPERIMENTAL | 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. |
| Diet plus Active detection and treatment of pathogens according to standard of care | EXPERIMENTAL | 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 |
| No diet and no pathogen detection | PLACEBO_COMPARATOR | About 30 children received no diet and no active detection of pathogens |
| Name | Type | Description |
|---|---|---|
| rVSVΔG-ZEBOV-GP, V920 | BIOLOGICAL | The experimental vaccine is the rVSVΔG-ZEBOV-GP, an Ebola vaccine. |
| Fibre and equilibrate breakfast and lunch | DIETARY_SUPPLEMENT | Participants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days. |
| Active detection and treatment of pathogens | DIAGNOSTIC_TEST | 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 | COMBINATION_PRODUCT | 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) | BIOLOGICAL | The active comparator vaccine, a Varicella vaccine (VARILRIX®) |
| Placebo | OTHER | About 30 children do not receive diet, nor active pathogen detection |
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 ...
rVSVΔG-ZEBOV-GP is an investigational vaccine candidate being studied for the prevention of Ebola Virus Disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The vaccine is designed to elicit an immune response against the Ebola virus.
rVSVΔG-ZEBOV-GP is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the safety and immunogenicity of this Ebola vaccine candidate.
rVSVΔG-ZEBOV-GP is in Phase 1 clinical development. A Phase 1 trial has been completed, and the vaccine remains investigational. It has not received FDA approval or any other regulatory approval, and it is still undergoing clinical evaluation for safety and immune response.
rVSVΔG-ZEBOV-GP has one completed Phase 1 clinical trial, registered as NCT05130398. This trial, titled 'Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Children Living in Lambaréné, Gabon,' enrolled 120 participants aged 1 year and older in Gabon.
Yes, rVSVΔG-ZEBOV-GP is also known as V920. Both names refer to the same investigational Ebola virus vaccine candidate being developed by Merck & Company, Inc. The vaccine is currently in Phase 1 clinical trials for the prevention of Ebola Virus Disease.