Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Children Living in Lambaréné, Gabon
EBOLAPED
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
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 9, 2021
CompletedFirst Submitted
Initial submission to the registry
August 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2021
CompletedFirst Posted
Study publicly available on registry
November 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2022
CompletedApril 20, 2023
April 1, 2023
5 months
August 25, 2021
April 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
until day 28 after vaccination
Secondary Outcomes (11)
Prevalence and relative risk of serious adverse events
until day 365
Transmission intensity of the viral vector in blood, saliva and urine among the the relatives of the vaccinees
days 0, 1, 3, 14, 28, 56
Titres of ZEBOV-GP-specific binding antibody
days 0, 1, 3, 14, 21, 28, 56, 84, 180, 365
Affinity/Avidity of antibody induced by vaccination
days 28 and 180
Concentration of IL-1RN (IL-1Ra), IL-6, TNF-α, IL-10, MCP-1/CCL2, and MIP-1β/CCL4
days 0, 1 and 2 or 3
- +6 more secondary outcomes
Study Arms (6)
the rVSVΔG-ZEBOV-GP vaccine
EXPERIMENTALParticipants 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 COMPARATORThe 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
EXPERIMENTALParticipants 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
EXPERIMENTALThe 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
EXPERIMENTALParticipants 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 COMPARATORAbout 30 children received no diet and no active detection of pathogens
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions, or known allergy to the components of the vaccines.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre de Recherche Médicale de Lambarénélead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Centre de Recherches Médicales de Lambaréné
Lambaréné, Moyen-Ogooué Province, 242, Gabon
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
August 25, 2021
First Posted
November 23, 2021
Study Start
April 9, 2021
Primary Completion
September 8, 2021
Study Completion
August 9, 2022
Last Updated
April 20, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- From preliminary intererim analysis until the final report fo the study.The site owns the data and it is agreed that publication will occur in a timely manner.
- Access Criteria
- All files and source documents will be kept confidentially in locked safety cabinets. The Principal investigator, co-investigators and clinical research nurses will have access to records. The investigators will permit authorized representatives of the sponsor, regulatory agencies and the monitors to examine (and when required by applicable law, to copy) clinical records for the purposes of quality assurance reviews, audits and evaluation of the study safety and progress.
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.