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

Centre de Recherche Médicale de Lambaréné

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ebola Virus Disease

Treatments: Combination Product: Fibre and equilibrate breakfast and lunch plus Active detection and treatment of pathogens; Dietary Supplement: Fibre and equilibrate breakfast and lunch; Other: Placebo; Diagnostic Test: Active detection and treatment of pathogens; Biological: Chikenpox or Varicella vaccine (VARILRIX); Biological: rVSVΔG-ZEBOV-GP, V920

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05130398

LA rVSVΔG-ZEBOV-GP -02-PED

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: Accepts Healthy Volunteers

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 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

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 6 patient groups, including a placebo group

the rVSVΔG-ZEBOV-GP vaccine

Experimental group

Description:

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.

Treatment:

Biological: rVSVΔG-ZEBOV-GP, V920

The Chikenpox or Varicella (Varilix) vaccine

Active Comparator group

Description:

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

Treatment:

Biological: Chikenpox or Varicella vaccine (VARILRIX)

Fibre and equilibrate diet

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fibre and equilibrate breakfast and lunch

Active detection and treatment of pathogens according to standard of care

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Active detection and treatment of pathogens

Diet plus Active detection and treatment of pathogens according to standard of care

Experimental group

Description:

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

Treatment:

Combination Product: Fibre and equilibrate breakfast and lunch plus Active detection and treatment of pathogens

No diet and no pathogen detection

Placebo Comparator group

Description:

About 30 children received no diet and no active detection of pathogens

Treatment:

Other: Placebo