COVID-19
Conditions
Sponsors
Kilimanjaro Clinical Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Healthy individuals aged between 18 to 45 years • Willingly given written informed consent • Willing to undergo COVID-19 testing. • Satisfactory completion of an assessment of understanding prior to enrolment defined as 80% and above • Resident in Dar es Salaam or Mbeya, and willing to remain in the same region for the duration of the study • Assurance that adequate birth control measures are used • For women, have a negative urine pregnancy test
Exclusion criteria
Exclusion criteria: • Active tuberculosis or other systemic infectious process elicited by review of systems, physical examination, and laboratory detection • History of immunodeficiency, chronic illness requiring continuous or frequent medical intervention • HIV, Hepatitis B and/or C infection • Hives or recurrent hives and severe eczema • History of psychiatric, medical, and/or substance abuse problems during the past six months • History of grand mal epilepsy, or currently taking anti-epileptics • Received blood or blood products or immunoglobulins in the past three months • Receiving immunosuppressive therapy • Receiving experimental therapeutic agents at the moments or within a few months • Reception of any live, attenuated vaccine within 90 days of study entry • Previously received COVID-19 candidate vaccines like Janssen, Sputnik, Sinovac, Sinopharm, Pfizer, and Moderna. • History of severe local or general reaction to vaccination • Lactating mother • Unlikely to comply with protocol procedures as judged by the investigator(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, which will be assessed by clinical and laboratory parameters. We will grade clinical, haematological, and biochemical tests. We will look at the frequency, severity, and duration of the side effects/adverse events. Grading of adverse events will be done as per DAIDS grading tables;Humoral and cellular Immunogenicity (IgG, IgM, and CD4/CD8) will be assessed by HI and ELISA tests and by ELISPOT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Build expertise and capability in evaluating TANCoV vaccine candidates in Tanzania;Perception, attitude, and knowledge towards the TANCoV vaccine trial within study participants and their social environment;Characteristics of antibodies produced by TANCoV vaccines | — |
Countries
United Republic of Tanzania
Contacts
Public ContactMbazi Senkoro
Principal Research Scientist
Outcome results
None listed