Clinical Study of Recombinant Novel Coronavirus(COVID-19) Vaccine (CHO Cell) Combined With Influenza...
Coronavirus Disease 2019Popular topic:Clinical study of recombinant Novel Coronavirus vaccine (CHO cell) combined with influenza vaccine. Research purpose:Main purpose:To evaluate the immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Secondary purpose:To evaluate the safety of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Overall design:An open experimental design was adopted in this study, and 300 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) in combination with influenza vaccine. Study population:The study involved people 18 years of age and older. Test groups:A total of 300 cases were enrolled. 240 patients in 18-59 years old group, 60 patients in ≥60 years old group. There were 150 cases in group A, 120 cases in 18-59 years old group, and 30 cases in ≥60 years old group. There were 150 cases in group B, 120 cases in 18-59 years old group and 30 cases in ≥60 years old group.
BBV152/BBV154 Heterologus Prime-Boost Study
Corona Virus InfectionAll participants will be assessed for immunogenicity and safety endpoints and provide a blood sample before the administration of the first dose of IP. Blood samples will be collected on days 0, 9 (Groups 1, 3 and 4), 28,37 (Groups 2 and 4), 56, 90 and 180 to assess the neutralizing antibody titer against the SARSCoV-2 virus. A subset of 160 Participants (40 participants from each group) will be assessed for immunogenicity analysis, among these subset 10mL of blood and 5mL of saliva will be collected on days 0, 9 (Groups 1, 3 and 4), 28, 37 (Groups 2 and 4), 56, 90 and 180 to assess cell-mediated immunity and mucosal immunogenicity. Group 1 (COVAXIN® + COVAXIN®): In this group, 152 participants will be recruited who will receive COVAXIN® on day 0 and on day 28 via the intramuscular route. Group 2 (COVAXIN® + BBV154): In this group, 152 participants will be recruited who will receive COVAXIN® (Intramuscular) on day 0 and BBV154 (Intranasal) day 28. *Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® viaintramuscular route. Group 3 (BBV154 + COVAXIN®): In this group, 152 participants will be recruited who will receive BBV154 (Intranasal) on day 0 and COVAXIN® (Intramuscular) on day 28. *Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® via intramuscular route. Group 4 (BBV154 + BBV154): In this group, 152 participants will be recruited who will receive BBV154 on day 0 and on day 28 via the intranasal route.
The Doctors for Coronavirus Prevention Project Thanksgiving / Christmas Messaging Campaign
Covid19Facebook ads with physician-delivered videos were shown before the Thanksgiving and Christmas holidays and focused on staying safe during the COVID pandemic by limiting travel and mask-wearing.
Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013)
Coronavirus Disease (COVID-19)The purpose of the study is to assess if the study medication (molnupiravir, MK-4482) will prevent symptomatic coronavirus disease 2019 (COVID-19) in adults who live with someone with confirmed COVID-19 infection. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study; half of the study participants will receive molnupiravir twice daily by mouth and the other half will receive a placebo. The primary objectives of the study are to determine if molnupiravir prevents symptomatic COVID-19 disease and to evaluate its safety and tolerability. All participants who develop COVID-19 during the study are still eligible for any COVID-19 treatment recommended by their doctor.
The Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With COVID-19...
Coronavirus Disease 2019Novel Coronavirus PneumoniaThis is an open-label, randomized, blank-controlled treatment clinical study. The objective of this study is to investigate the effect of T89 on improving oxygen saturation and clinical symptoms in patients with Coronavirus Disease 2019 (COVID-19). In this study, estimated total of 120-240 male and female patients who have been diagnosed with non-critical type of coronavirus pneumonia (COVID-19) will be enrolled and randomly assigned to one of two study groups, the T89 treatment group and the blank control group, to T89 or nothing on the base of a recommended standard treatment for up to 14 days . The primary efficacy parameters include the time to oxygen saturation recovery to normal level (≥97%), the proportion of patients with normal level of oxygen saturation after treatment, and the total duration of oxygen inhalation, oxygen flow change by time, oxygen concentration change by time during treatment.
Safety, Tolerability and Immunogenicinity of a Coronavirus-Like Particle COVID-19 Vaccine in Adults...
SARS-CoV 2The study will be a randomized, partially-blinded, prime-boost, staggered dose-escalation Phase 1 study intended to assess the safety, tolerability, and immunogenicity of the Coronavirus-Like Particle COVID-19 Vaccine at three dose levels (3.75 µg, 7.5 µg, and 15 µg VLP) unadjuvanted or adjuvanted with either CpG 1018 or AS03 in healthy adults 18 to 55 years of age, who have been tested for the absence of SARS-CoV-2 antibodies. At each dose level, the vaccine will initially be administered to a small number of subjects. Vaccinations of the first 6 subjects at the lowest dose level will be staggered so that each vaccination must be performed at least 30 minutes apart. Vaccination of the remaining subjects at the same dose level and the next higher vaccine dose level will be administered with approval of the Independent Data Monitoring Committee (IDMC). The same process will be followed for the second vaccine administration. All subjects will be followed for a period of 12 months after the second administration of the vaccine for safety and immunogenicity testing at the end of the follow-up period.
Immunogenicity and Safety Evaluation of Recombinant Novel Coronavirus Vaccine (CHO Cells) in Enhancing...
Coronavirus Disease 2019Popular topic: Clinical study on immunogenicity and safety evaluation of sequentially enhanced immunity with recombinant Novel Coronavirus vaccine (CHO cells) Research purpose:Main purpose:To evaluate the immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) after sequential booster immunization in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine.Secondary purpose:To evaluate the safety of recombinant Novel Coronavirus vaccine (CHO cells) after sequential booster immunization in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine. Overall design:An open experimental design was used in this study Study population:The study involved people 18 years of age and older. Test groups: All subjects recruited must have received two doses of Novel Coronavirus inactivated vaccine for 3 to 13 months (the interval between booster and basic immunization is divided into 3 groups:120 subjects at 3-4 months (91-120 days), 6-8 months (181-240 days) and 11-13 months (331-390 days) were vaccinated with one dose of recombinant Novel Coronavirus vaccine (CHO cells).
Recombinant New Coronavirus Vaccine (CHO Cells) to Prevent SARS-CoV-2(COVID-19) Phase I Clinical...
CoronavirusPopular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (3~17 years old) Research purpose:Main purpose:To evaluate the safety and tolerability of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17. Secondary purpose: To explore the immunogenicity and persistence of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17. Overall design:A single center, randomized, blind, placebo-controlled trial design was adopted. Study population: 75 healthy people aged 3 to 17 years old, both male and female. Test groups: 3 to 5 years old: 20 cases in experimental group and 5 cases in placebo group; 6 to 11 years old: 20 patients in the experimental group and 5 patients in the placebo group; 12 to 17 years old: 20 patients in experimental group and 5 patients in placebo group.
This is a Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity...
Coronavirus InfectionsVaccineRandomized, double-blind, placebo controlled, multi-center clinical trials of the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified vaccine against COVID-19, manufactured by FSBSI "Chumakov FSC R&D IBP RAS", on adult volunteers aged 18-60" (Clinical trials, phase I/II). Study purpose is to assess the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified coronavirus vaccine sorbed on adult volunteers aged 18-60.
SARS-CoV-2 Human Challenge Characterisation Study
Covid19SARS-CoV Infection3 moreThis is a dose optimisation study in healthy adults aged 18-30 who will be experimentally inoculated with SARS-CoV-2. The aim is to cause PCR-confirmed upper respiratory infection in the majority of challenged individuals with minimal or no illness, providing data on the course of COVID-19 and the immune response to SARS-CoV-2 infection. This will establish an optimised dose and study design that will then be used to evaluate the efficacy of treatment and vaccine candidates plus level and duration of immune protection in follow-on trials.