Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.

BACKGROUND: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. METHODS: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. FINDINGS: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. INTERPRETATION: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials

HUBUNGAN DUKUNGAN KELUARGA DENGAN PERILAKU HYGIENE REMAJA SAAT MENGHADAPI MENSTRUASI DI SMP NEGERI 5 KOTA KUPANG

Adolescence is a period of transition from children to adulthood where adolescents are undergoing both physical and psychological change. During this period a rapid physical change in the reproductive organs (sexual organs), one of which is the experience of menstruation. When teenage girls have started menstruating, the main thing to consider is hygiene during menstruation (hygiene behavior), so family support is needed to reduce or buffer the effects of stress and teenage hygiene behavior during menstruation. This study was to determine the relationship between family support and Adolescent Hygiene Behavior When Facing Menstruation in Public Junior High School 5 Kupang City. The approach in this research is Cross-Sectional with correlation design. The sampling technique used is simple random sampling and the number of samples is 154 respondents. The statistical test used was the Spearman Rho test. The family support for students in Public Junior High School 5 Kupang City had sufficient family support (79.2 %) and good hygiene behavior (82.5 %). Rho Spearmen results test obtain p value = 0.360 where p> a (0,360> 0.005) so that H1 is rejected, which means there is no relationship between family support with adolescents hygiene behavior when facing menstruation in Public Junior High School 5 Kupang City. Recommendation from this study are expected for families, teachers can still provide and maintain explanations or information to young women about adolescent hygiene behavior when facing menstruation. Keywords: Support, Hygiene Behavior, AdolescentsMasa remaja merupakan masa transisi dari anak-anak ke masa dewasa dimana remaja sedang mengalami perubahan baik fisik maupun psikologis. Pada masa ini terjadi suatu perubahan fisik yang cepat disertai banyak perubahan pada organ reproduksi (organ seksual), salah satunya adalah pengalaman menstruasi. Ketika remaja putri sudah mulai menstruasi, hal utama yang harus diperhatikan adalah kebersihan pada saat menstruasi (perilaku hygiene), sehingga diperlukan dukungan keluarga untuk mengurangi atau menyangga efek stress dan perilaku kebersihan remaja selama menstruasi. Penelitian ini adalah untuk mengetahui Hubungan Dukungan Keluarga Dengan Perilaku Hygiene Remaja Saat Menghadapi Menstruasi di SMP Negeri 5 Kota Kupang.Pendekatan  dalam penelitian ini adalah Cross-Sectional dengan rancangan  korelasional. Teknik pengambilan sampel yang digunakan yaitu  Simple random sampling dan jumlah sampel 154 responden. Uji statistik yang digunakan  adalah uji Spearman Rho. Menunjukkan bahwa Dukungan Keluarga pada siswi   di SMP Negeri 5 Kota Kupang memiliki dukungan keluarga cukup sebanyak (79,2%) dan perilaku hygiene baik sebanyak (82,5%). Hasil uji Spearmen Rho diperoleh nilai ρ value=0,360 dimana ρ>α (0,360>0,005) sehingga H1 ditolak yang berarti tidak ada hubungan antara dukungan kelurga dengan perilaku hygiene remaja saat menghadapi menstruasi di SMP Negeri 5 Kota Kupang. Rekomendasi dari penelitian ini diharapkan keluarga, guru tetap dapat memberikan dan mempertahankan penjelasan atau informasi kepada remaja putri mengenai perilaku hygiene remaja saat menghadapi menstruasi.   Kata Kunci: Dukungan Keluarga, Perilaku Hygiene, Remaja