Rift Valley Fever
Conditions
Interventions
DDvax
Placebo
Sponsors
One Health Institute University of California Davis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 45 years 2. Signed an Informed Consent Form 3. Correctly answered all questions on the protocol and study procedures on the “understanding the study” questionnaire within 2 attempts 4. Able and willing to comply with the protocol schedule and procedures 5. Agreement to release medical and other information concerning contra-indications for participation in the study, and to be attended by a study investigator for physical examination and any other clinical investigations. 6. No known ongoing, symptomatic acute or chronic illness requiring medical or surgical care 7. Female participants must not be pregnant or nursing and must have a negative pregnancy test at screening. Women of childbearing potential must use an acceptable contraceptive method for at least 30 days before and through 180 days after vaccination. Acceptable methods include hormonal contraceptives (eg, injectable, implant, patch, ring) or an intrauterine device (IUD). Barrier methods alone are not considered sufficient 8. Male participants must use an acceptable method of contraception (eg, condom with spermicide or condom with diaphragm) or another approved contraception method, for at least 3 months after vaccination. 9. Agrees not to donate blood for 6 months after vaccination. 10. Planned long-term (at least 12 months) or permanent residence in Bagamoyo district. 11. Has regular access to a working mobile phone for communication purposes. 12. Agrees to provide personal contact information and contact information of a third-party household member or close friend (in case clinic personnel cannot reach the participant) to the study team.
Exclusion criteria
Exclusion criteria: 1. Serologic evidence of RVFV infection/prior vaccination with any RVF vaccine 2. Participation in another study involving receipt of an IP in the 30 days preceding randomization or receipt of a biologic within 90 days prior to randomization/planned use during the study period 3. History of allergic reaction to other vaccines/DDvax components or seizure disorder/encephalitic process or Guillain-Barre Syndrome 4. Frequent/moderate/severe headaches 5. Chronic/severe/recurrent joint pain/arthritis 6. Hemoglobin A1c >6.5% 7. Lab screening tests: o Absolute Neutrophil Count: 95.3 µmol/L o ALT: >46.8 U/L (1.25 × ULN) o AST: >93.4 U/L (1.25 × ULN) o Total Bilirubin: >31.1 µmol/L 8. Any confirmed/suspected immunosuppressive/immunodeficient state 9. Current use of antiviral/systemic immunomodulatory pharmacotherapy 10.Chronic use of immunosuppressive agents/corticosteroids 11. Vaccination with any attenuated live-vaccine 37.8°C at the time just prior to vaccine administration 15. BMI >30 kg/m2 or <18 kg/m2 16. History of multiple sclerosis 17. Signs/symptoms/medical conditions indicating intercurrent/new illness during the screening period or at the time of planned vaccine administration 18. Known disturbance of coagulation 19. Screening tests positive for HIV/active Hepatitis B/C Virus 20. Drug/alcohol abuse in the previous 5 years 21. Previous diagnosis of any serious psychiatric disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of solicited local reactogenicity signs and symptoms 7 days following vaccination (D0 to D7);Occurrence of solicited systemic reactogenicity signs and symptoms 7 days following vaccination (D0 to D7);Occurrence of unsolicited adverse events (AEs) 28 days following vaccination (D0 to D28).;Change from baseline (D0) for safety laboratory measures (D2, D7, and D28);Summaries of vital signs and physical examination (D0 to D28);Serious Adverse Events (SAEs), adverse events of special interest (AESIs), and Newly Diagnosed Chronic Medical Conditions (NDCMCs) (D0 to D28);Occurrence SAEs, AESI, and NDCMCs post D28 until the end of the study;Changes in clinical laboratory measurements at additional time points, summaries of vital signs, ECG, and physical examination results throughout the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| RVFV-specific serological indicator as measured by ELISA following vaccination with DDvax vaccine;Anti-RVFV neutralizing effect of DDvax-induced antibodies following vaccination with the DDvax vaccine (ie, increase in RVFV-specific neutralizing antibodies from baseline D0 to >limit of detection / quantification) | — |
Countries
United Republic of Tanzania
Contacts
Public ContactMichelle Botha
Associate Director Global Site Activation
Outcome results
None listed