COVID-19 (SARS-CoV-2 infection) Infections and Infestations COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
Four vaccine candidates selected for evaluation. Candidate vaccines are selected on a rolling basis by the WHO Working Group on vaccine prioritization
Trial entry, randomization: Once electronic data
for each candidate vaccine, the primary efficacy results are expected within 3-6 months of the vaccine entering the trial. By using a shared placebo/control group and a common Core protocol to evaluat
Sponsors
World Health Organization
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Male or female participants between the ages of 16 and above at randomization 2. Living in the area and planning to reside in the area for at least 6 months 3. Capable of giving personal signed informed consent/have parent(s)/legal guardian capable of giving signed informed consent as described in SOP-03 4. Healthy participants who are determined by the clinical judgment of the investigator to be eligible for inclusion in the study 5. Participants who are willing and able to comply with all scheduled visits, vaccination plans, laboratory tests (if randomised and consent given, lifestyle considerations, and other study procedures
Exclusion criteria
Exclusion criteria: 1. Previous laboratory-confirmed diagnosis of COVID 19. 2. Previous vaccination with any COVID-19 vaccine. 3. Receipt of medications intended to prevent COVID 19. 4. Participation in other studies involving a study intervention within 28 days prior to study entry and/or during study participation. 5. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 6. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. 7. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 8. Women who are pregnant or breastfeeding will be informed that there is no data on the safety of these vaccines among these groups and will be given the opportunity to decide if they are willing to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virologically confirmed COVID-19 disease, through SARS-CoV2 RNA isolation and RRT-PCR amplification in oro-nasopharyngeal specimen, regardless of disease severity, at 14, 180, 365 days after the last dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at dose 1, dose 2, 7, 180, and 365 days after dose 2: 1. Serious adverse events (SAEs), adverse events of special interest (AESIs) as requested, collected for all participants throughout the study. 2. Severe COVID-19 (as per WHO classification) and death with recently confirmed COVID-19. 3. COVID-19 and severe COVID-19 diagnosed starting 14 days after the final dose through the final study visit. 4. SARS-CoV-2-specific neutralization antibody, binding antibody, and T-cell immune responses measured using blood test in a subset of participants at selected sites. 5. COVID-19 viral load and other disease progression biomarkers measured using blood test. | — |
Countries
Colombia, Kenya, Mali, Philippines, Sierra Leone, Switzerland
Outcome results
None listed