Safety and immunogenicity of ChAdOx1 MERS vaccine candidate in healthy Middle Eastern adults (MERS002): an open-label, non-randomised, dose-escalation, phase 1b trial.

BACKGROUND: ChAdOx1-vectored vaccine candidates against several pathogens have been developed and tested in clinical trials and ChAdOx1 nCoV-19 has now been licensed for emergency use for COVID-19. We assessed the safety and immunogenicity of the ChAdOx1 MERS vaccine in a phase 1b trial in healthy Middle Eastern adults. METHOD: MERS002 is an open-label, non-randomised, dose-escalation, phase 1b trial. Healthy Middle Eastern adults aged 18-50 years were included in the study. ChAdOx1 MERS was administered as a single intramuscular injection into the deltoid muscle of the non-dominant arm at three different dose groups: 5·0 × 109 viral particles in a low-dose group, 2·5 × 1010 viral particles in an intermediate-dose group, and 5·0 × 1010 viral particles in a high-dose group. The primary objective was to assess the safety and tolerability of ChAdOx1 MERS, measured by the occurrence of solicited and unsolicited adverse events after vaccination for up to 28 days and occurrence of serious adverse events up to 6 months. The study is registered with ClinicalTrials.gov, NCT04170829. FINDINGS: Between Dec 17, 2019, and June 1, 2020, 24 participants were enrolled (six to the low-dose, nine to the intermediate-dose, and nine to the high-dose group) and received a dose; 23 were available for follow-up at 6 months. The one dose of ChAdOx1 MERS vaccine was well tolerated with no serious adverse event reported during the 6 months of follow-up. Most adverse events were mild (67, 74%) and moderate (17, 19%). Six (7%) severe adverse events were reported by two participants in the intermediate-dose group (two feverish, two headache, one joint pain, and one muscle pain). Pain at the injection site was the most common local and overall adverse event, reported by 15 (63%) of the 24 participants. The most common systemic adverse event was headache, reported by 14 (58%), followed by muscle pain reported by 13 (54%). The vaccine induced both antibody and T cell immune responses in all volunteers; antibodies peaked at day 28 and T cell responses peaked at day 14; and continued until the end of follow-up at 6 months. INTERPRETATION: The acceptable safety and immunogenicity data from this phase 1b trial of ChAdOx1 MERS vaccine candidate in Healthy Middle Eastern adults, combined with previous safety and immunogenicity data from a trial in the UK, support selecting the ChAdOx1 MERS vaccine for advancement into phase 2 clinical evaluation. FUNDING: UK Department of Health and Social Care, using UK Aid funding, managed by the UK National Institute for Health Research; and King Abdullah International Medical Research Center.

Pattern and factors associated with cardiovascular diseases among patients attending the cardiac center in Arar City, Northern Saudi Arabia.

BACKGROUND: Cardiovascular diseases (CVD) are among the main causes of premature death and hospital admission worldwide, constituting a great economic burden on health care systems. Additionally, thyroid diseases may exert a deleterious effect on the outcomes of CVD patients. AIM: This study was conducted to identify the pattern and factors associated with CVD distribution and the relation with thyroid dysfunction in the study population. METHODS: This cross sectional study was conducted on 181 participants in the cardiac center in Arar, Kingdom of Saudi Arabia (KSA), from September 2016 to March 2017. A questionnaire was designed for collecting data about socio-demographic variables, smoking, types of CVD, and thyroid dysfunction among participants. RESULTS: Findings showed that 42.5% of the participants were hypertensive, 11.6% had myocardial infarction, 8.9% were ischemic and 7.2 % had arrhythmia. The majority of participants (80.6%) were euthyroid. In contrast, 13.3% of the participants had hypothyroidism and 6.1% were hyperthyroid. Most of the studied factors had no significant effect on CVD distribution while smoking showed a remarkable variation among patients with different CVD types (p=0.013). Data were analyzed by SPSS version 15, using descriptive statistics and Chi-square test. CONCLUSION: Our findings indicated the urgent need for stressing on tobacco use control measures and increasing public awareness about hazards of tobacco especially among CVD patients.