Procedures
sore throat, nausea or vomiting, diarrhoea, myalgia, delirium, fatigue, fever, dysfunction of arousal and content); (2), dementia, cough, loss of taste or smell, rhinitis, infection, coma, headache, depression, shortness of breath
SORE THROAT, SARS-COV-2 INFECTION, LACK OF APPETITE, ADVERSE EVENTS, ASYMPTOMATIC SARS-COV-2 INFECTION, INFECTION, RHINITIS, ADVERSE EVENT, COMA, EVENTS
The vaccine dNS1-RBD was a liquid preparation, containing 1 × 10All participants were observed for at least 30 min after vaccination for any acute reactions and were trained to record any local and systemic events using a diary card. Monitoring for adverse events included spontaneous reporting from participants and telephone contacts by investigators (once a week for 30 days after each dose for any adverse event, and at least once every 4 weeks after that for serious adverse events, medically attended adverse events, and adverse events of special interest). Definitions of these adverse events are provided in the After the first dose, all participants were monitored for suspected symptoms of COVID-19 by the investigators once per week for the entire efficacy observation period, via telephone or a visit within 30 days, and via telephone after 30 days. Suspected SARS-CoV-2 infection was defined as the presence of one or more of the following: (1) at least two symptoms, persisting for 2 days or longer, which included fever (oral temperature ≥38·0°C or axillary temperature ≥37·8°C), sore throat, generalised weakness or fatigue, rhinitis, myalgia, headache, lack of appetite, nausea or vomiting, diarrhoea, and mental status changes; changes in mental status were described as delirium (acute change in arousal and content), depression (chronic change in arousal), dementia (chronic change in arousal and content), and coma (dysfunction of arousal and content); (2) at least one respiratory sign or symptom, including cough (persisting for ≥2 days), loss of taste or smell (persisting for ≥2 days), and shortness of breath; or (3) clinical or imaging evidence of COVID-19. Once a suspected case was identified by a clinician or clinically qualified investigator, two nasopharyngeal swab samples were simultaneously collected (preferably within 72 h), with one swab sent to the central laboratory (Cerba Research, Paris, France) and the other to a local laboratory near each site or centre if in Colombia, South Africa, and Viet Nam, or to a local professional agency if in the Philippines (Detoxicare, Manila, Philippines). Clinical follow-up was guided by immediate RT-PCR results from the local laboratory. When the initial test result of the sample was negative but symptoms persisted, a second sampling was taken within 3–5 days. When the test result was positive, subsequent sampling occurred every 7–10 days until a negative result was obtained and symptoms resolved. We defined participants with a confirmed symptomatic SARS-CoV-2 infection as those with a suspected infection (according to the aforementioned criteria) who had at least one RT-PCR-positive nasopharyngeal swab tested by the central laboratory. Further details of the monitoring procedures, definition, and classification criteria of symptomatic SARS-CoV-2 infection according to WHO and China's National Health Commission are provided in the 