A Phase 1/2, randomized, controlled open label trial to evaluate the safety and immunogenicity of the rVSV?G-ZEBOV-GP Ebola Virus vaccine candidate in healthy children aged 1 to 12 years and in their adults and/or children relatives living in Lambaréné, Gabon.
- Conditions
- Ebola
- Registration Number
- PACTR202005733552021
- Lead Sponsor
- centre de recherches medicales de lambarene
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 360
1.Healthy children, aged 1to 12 years(inclusive) at the time of screening
2.Willingness of parent or legal guardian to provide written informed consent prior to screening procedures.
3.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).
4.Available, able, and willing to participate in all study visits and procedures
1.History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions, or known allergy to components of the study vaccines
2.Ongoing participation in another clinical trial
3.Participation in previous Ebola vaccine trial
4.Receipt of licensed vaccines within 30 days of planned study immunization
5.Presence of any febrile illness (fever >38°C) or any moderate to severe illness within one week prior to vaccination
6.Acute or chronic, clinically significant disease
7.Known history of varicella
8.Known hepatitis B, C or HIV infection.
9.Receipt of blood products or immunoglobulin (IVIg or IMIg) within three (3) months of study entry/baseline serologic evaluation
10.Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
11.Any other significant finding that in the opinion of the investigator would increase the risk to the individual of suffering an adverse outcome from participating in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Concentration of rVSV in blood, urine, or saliva as detected by RT-PCR at days 0, 1, 2/3, 7, 14, 21, 28.<br>The frequency and severity of adverse events (AEs) and/or serious adverse events (SAEs) associated with administration of =7.8 x 107 PFU rVSV?G-ZEBOV-GP measured as follow: <br>•Frequency and severity of local signs and symptoms until day 14 post vaccination (solicited local symptoms). <br>•Frequency and severity of systemic signs and symptoms until day 14 post vaccination (solicited systematic symptoms). <br>•Frequency of adverse events (AEs), severity and assessed relationship to study vaccines until day 28 post vaccination (unsolicited AE).<br>•Detailed description of all serious adverse events (SAEs) until day 28 post vaccination.<br>•Values of safety laboratory measures at baseline and at follow-up visits post-vaccination until day 28 post vaccination (reference ranges will be age appropriate).<br>
- Secondary Outcome Measures
Name Time Method