Publication Xia N, Research Square, 2023
Dates: 2021-12-16 to 2022-05-31
Funding: Mixed (National Science and Technology Major731 Project, National Natural Science Foundation of China , Fujian Provincial Science and Technology Plan Project,Provincial Natural Science Foundation of Fujian, Xiamen Science and Technology Plan Special Projects, Ministry of Education, Xiamen University,Bill & Melinda Gates Foundation and by Beijing Wantai Biological Pharmacy Enterprise)
Conflict of interest: no COI
Multicenter / Multinational |
Follow-up duration (months): 6
|CA4-dNS1-nCoV-RBD (n = 8600) Placebo (n = 8610)|
2 IN doses of 0.2×10^7 cell culture infective dose 50% (CCID50) dNS1-RBD, 14 days apart, at least 6 months (median 201 days) after any COVID-19 prime vaccine.
2 IN doses of placebo, 14 days apart, at least 6 months (median 201 days) after any COVID-19 prime vaccine.
|Characteristics of participants|
Type of participants: Adults
Pregnant women: 0
Immunocompromized patients: 0
Age range: 18-89
|Description of participants|
Adultsincluding healthy and mild stable co-morbidities without prior COVID-19 history in 33 centres in Philippines, South Africa, Colombia and Vietnam
|In the register|
1) Virologically confirmed (RT-PCR-positive) symptomatic COVID-19 cases of any severity that occurs for the first time at least 14 days (= 15 days) after the second vaccination; 2) All serious adverse events (SAEs), other medically attended AEs (MAAEs), and adverse events of special interest (AESIs) from the first dose to 12 months after the second dose in all subjects; 3) All solicited adverse events within 7 days following the first and second vaccinations in all subjects; 4) All unsolicited adverse events that occur during the interval between doses and within 30 days after the second vaccination in all subjects.
|In the report|
Serious adverse events (SAE), medically attended adverse events (MAAE) and adverse events of special interest (AESI) from day 0 (after the first dose) through 12 months after the final dose; solicited adverse events (AE) for 7 days after each dose; and unsolicited adverse events for 30 days after each dose; Symptomatic COVID-19 confirmed by reverse-transcriptase-polymerase-chain-reaction (RT-PCR) test occurring at least 14 days after the second dose in the per-protocol population (participants who were followed-up for at least two weeks after the second dose and had no major protocol deviatiations)
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||n addition to the pre-print article, the study registry was used in data extraction and risk of bias assessment. Preliminary analysis as of the cutoff date July 31, 2022. Extracted here only the stratum of participants with COVID-19 vaccination history.Included participants might have been previously vaccinated with 1, 2 3 or 4 doses of COVID-19 vaccine before receiving the intervention.The target sample size specified in the registry for both strata combined (N=31,038) was achieved. There is no change from the trial registration in the intervention and control treatments.|