Rift Valley Fever
Conditions
Interventions
ChAdOx1 RVF vaccine
Menactra vaccine
Sponsors
Institut Pasteur de Dakar
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy individuals aged 12 - 65 years - Written informed consent provided by adult participants OR written informed consent provided by parent/legal guardian and verbal assent provided by adolescent participant - All females (irrespective of menses or birth control): Negative urine and blood pregnancy tests during screening and negative urine pregnancy test (point-of-care test) on the day of vaccination. - All females: Willingness to practice continuous, effective contraception for a minimum of 2 months before and 1 month following study vaccination. - Willing and judged able to participate and comply with study procedures. - Have telephone access.
Exclusion criteria
Exclusion criteria: - Known allergy to vaccine components, serious allergic reaction to any prior vaccination or any history of anaphylaxis/life-threatening allergic reactions. - Acute febrile illness / clinically significant acute illness in the 72-hours prior to vaccination. - Prior receipt of an RVF vaccine. - Concurrent participation in another vaccine trial or use of an investigational product in the 90 days prior to study product administration or plans to receive an investigational product during the trial. - Receipt of any other vaccines within 4 weeks prior to study vaccination or plans to receive any other vaccines within 4 weeks after trial vaccination. - Confirmed infection with HIV, hepatitis B or hepatitis C. - Any Grade 1 or Grade 2, clinically significant abnormalities in baseline screening laboratory parameters - Clinically significant chronic illness. - History of capillary leak syndrome, known thrombosis with thrombocytopenia syndrome (TTS) / vaccine-induced immune thrombotic thrombocytopenia (VITT) following a previous adenoviral vectored vaccine, other thrombotic/thrombo-embolic disease, immune-mediated thrombocytopenia (or persistent thrombocytopenia of unknown cause) and immune-mediated neurological disorders including but not limited to Guillain-Barre syndrome and transverse myelitis. - Chronic administration (defined as more than 14 consecutive days) of immunosuppressant (> 0.5mg/kg/day of prednisolone or equivalent) or other immune modifying drugs within the 12 months prior to the administration of the study vaccine including the use of glucocorticoids. The use of inhaled, per nasal and topical glucocorticoids is permitted. - Immunosuppression or immunodeficiency disorders based on history and physical examination. - Known coagulation or clotting disorder precluding intramuscular vaccine administration. [exclusion criteria truncated by character limits]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local and systemic solicited adverse events following ChAdOx1 RVF vaccination;Safety bloods (biochemistry and haematology);Serious Adverse Events (SAE) following ChAdOx1 RVF vaccination ;Unsolicited adverse events (AEs) following ChAdOx1 RVF vaccination ;Adverse events of special interest (AESI) following ChAdOx1 RVF vaccination (platform/target specific);RVF neutralising antibody (PRNT or FRNT) geometric mean titres (GMT) | — |
Secondary
| Measure | Time frame |
|---|---|
| RVF neutralising antibody geometric mean titres (GMT) ;RVF neutralising antibody titre seroresponse rates;RVF neutralising antibody titre seropositivity rates;RVF neutralising antibody geometric mean titre rises (GMTR);Anti-Gc and anti-Gn IgG antibody geometric mean concentrations (GMC);Anti-Gc and anti-Gn IgG antibody seroresponse rates;Anti-Gc and anti-Gn IgG antibody seropositivity rates;Anti-Gc and anti-Gn IgG antibody geometric mean concentration rises (GMCR) | — |
Countries
Senegal
Contacts
Public ContactLaura Merson
Head of Clinical Research Institut Pasteur de Dakar
Outcome results
None listed