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Background: A vaccine against COVID-19 is urgently needed for older adults, in whom morbidity and mortality due to the disease are increased. We aimed to assess the safety, tolerability, and immunogenicity of a candidate COVID-19 vaccine, CoronaVac, containing inactivated SARS-CoV-2, in adults aged 60 years and older.Methods: We did a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial of CoronaVac in healthy adults aged 60 years and older in Renqiu (Hebei, China). Vaccine or placebo was given by intramuscular injection in two doses (days 0 and 28). Phase 1 comprised a dose-escalation study, in which participants were allocated to two blocks: block 1 (3 μg inactivated virus in 0·5 mL of aluminium hydroxide solution per injection) and block 2 (6 μg per injection). Within each block, participants were randomly assigned (2:1) using block randomisation to receive CoronaVac or placebo (aluminium hydroxide solution only). In phase 2, participants were randomly assigned (2:2:2:1) using block randomisation to receive either CoronaVac at 1·5 μg, 3 μg, or 6 μg per dose, or placebo. All participants, investigators, and laboratory staff were masked to treatment allocation. The primary safety endpoint was adverse reactions within 28 days after each injection in all participants who received at least one dose. The primary immunogenicity endpoint was seroconversion rate at 28 days after the second injection (which was assessed in all participants who had received the two doses of vaccine according to their random assignment, had antibody results available, and did not violate the trial protocol). Seroconversion was defined as a change from seronegative at baseline to seropositive for neutralising antibodies to live SARS-CoV-2 (positive cutoff titre 1/8), or a four-fold titre increase if the participant was seropositive at baseline. This study is ongoing and is registered with ClinicalTrials.gov (NCT04383574).Findings: Between May 22 and June 1, 2020, 72 participants (24 in each intervention group and 24 in the placebo group; mean age 65·8 years [SD 4·8]) were enrolled in phase 1, and between June 12 and June 15, 2020, 350 participants were enrolled in phase 2 (100 in each intervention group and 50 in the placebo group; mean age 66·6 years [SD 4·7] in 349 participants). In the safety populations from both phases, any adverse reaction within 28 days after injection occurred in 20 (20%) of 100 participants in the 1·5 μg group, 25 (20%) of 125 in the 3 μg group, 27 (22%) of 123 in the 6 μg group, and 15 (21%) of 73 in the placebo group. All adverse reactions were mild or moderate in severity and injection site pain (39 [9%] of 421 participants) was the most frequently reported event. As of Aug 28, 2020, eight serious adverse events, considered unrelated to vaccination, have been reported by seven (2%) participants. In phase 1, seroconversion after the second dose was observed in 24 of 24 participants (100·0% [95% CI 85·8-100·0]) in the 3 μg group and 22 of 23 (95·7% [78·1-99·9]) in the 6 μg group. In phase 2, seroconversion was seen in 88 of 97 participants in the 1·5 μg group (90·7% [83·1-95·7]), 96 of 98 in the 3 μg group (98·0% [92·8-99·8]), and 97 of 98 (99·0% [94·5-100·0]) in the 6 μg group. There were no detectable antibody responses in the placebo groups.Interpretation: CoronaVac is safe and well tolerated in older adults. Neutralising antibody titres induced by the 3 μg dose were similar to those of the 6 μg dose, and higher than those of the 1·5 μg dose, supporting the use of the 3 μg dose CoronaVac in phase 3 trials to assess protection against COVID-19.Funding: Chinese National Key Research and Development Program and Beijing Science and Technology Program. [ABSTRACT FROM AUTHOR]

The purpose of this study is to examine the association between hourly air pollution on hourly physical activity (PA) and sedentary behavior (SB) among college students in Beijing, China. The secondary aim was to examine such associations varied at specific time. A total of 340 participants were recruited from the Tsinghua University, in Beijing, China. Accelerometers provided PA measures, including moderate-to-vigorous physical activity (MVPA), walking steps, energy expenditure and sedentary time for 7 consecutive days. Corresponding air pollution data by the Beijing Municipal Ecological Environment Bureau in the closed site (Wan Liu site) in Tsinghua University were collected including average hourly air quality index (AQI) and PM 2.5 (μg/m³). Associations were estimated using linear individual fixed-effect regressions. We also conducted an air pollution risk perception survey among 2307 freshmen (76.6% males) who were enrolled in Tsinghua in 2016, and the survey was done in May 22–26, 2017. A one level increase in hourly air quality index (AQI) was associated with a reduction in 1-h PA by 0.083 (95% confidence interval [CI] = -0.137, −0.029) minutes of MVPA, 8.8 (95% CI = −15.0, −2.6) walking steps, 0.65 (95% CI = -1.03, −0.27) kcals of energy expenditure. A 10 μg/m³ increase in air pollution concentration in hourly PM 2.5 was associated with a reduction in 1-h PA by 0.021 (95% confidence interval [CI] = -0.033, −0.010) minutes of MVPA, 2.2 (95% CI = −3.5, −0.9) walking steps, 0.170 (95% CI = -0.250, −0.089) kcals of energy expenditure an increase in 1-h sedentary behavior 0.045 (0.005, 0.0845). At specific time, stronger negative associations of AQI and PM 2.5 air pollution with PA at 8 a.m., 4 p.m., 5 p.m. and 7 p.m. Similarly, stronger positive associations of 1 h AQI and PM 2.5 air pollution with SB at 8 a.m., 9 a.m., 11 a.m., and 7 p.m. A total of 94.9% participants (n = 2235) responded "yes" to air pollution change activities in the survey, which may partially explain PA change. Air pollution may discourage physical activity and increases sedentary behavior among freshman students living in Beijing, China. This is preliminary study. The impact of air pollution on physical activity and sedentary behavior at a specific time may be different. There are large variations in walking steps in specific time. Trend for walking steps in specific time in one day among the freshman. Image 1 • Air pollution may discourage physical activity behavior. • Air pollution may increase sedentary behavior. • The impact of air pollution on health behavior may be different at a specific time. [ABSTRACT FROM AUTHOR]