tetano
Editor, Senior Moderator
Vaccine
. 2024 Dec 14:45:126582.
doi: 10.1016/j.vaccine.2024.126582. Online ahead of print. Predictors of severity of SARS-CoV-2 infections in Brazil: Post hoc analyses of a randomised controlled trial
Kerry Conlin[SUP] 1 [/SUP], Daniel Jenkin[SUP] 2 [/SUP], Philip de Whalley[SUP] 3 [/SUP], Lily Yin Weckx[SUP] 4 [/SUP], Pedro M Folegatti[SUP] 5 [/SUP], Sagida Bibi[SUP] 6 [/SUP], Teresa Lambe[SUP] 7 [/SUP], Parvinder K Aley[SUP] 8 [/SUP], Andrew J Pollard[SUP] 9 [/SUP], Merryn Voysey[SUP] 10 [/SUP], Sue Ann Costa Clemens[SUP] 11 [/SUP]; COV003 Study Group
Affiliations
Objectives: To identify demographic, clinical and immunological factors associated with adverse COVID-19 outcomes.
Methods: A large randomised controlled trial of ChAdOx1 nCoV-19 was undertaken in Brazil. Participants were randomised 1:1 either to receive ChAdOx1 nCov-19 or to a control group. COVID-19 infections were confirmed by nucleic acid amplification test (NAAT) and classified using the WHO clinical progression scale. Anti-spike antibody responses and serum neutralising activity were measured 28 days after second vaccination in some participants. Exploratory analyses were conducted into factors associated with COVID-19 infection severity and hospitalisation, using logistic regression models adjusted for demographic and clinical factors.
Results: 10,416 participants were enrolled; 1790 had NAAT-positive COVID-19 infection; 63 cases required hospitalisation. More severe infection was associated with greater body-mass index (BMI) (odds ratio [OR] = 1.06 [95 %CI: 1.01-1.10], p = 0.01) and diabetes (OR = 3.67 [1.59-8.07], p = 0.003). Hospitalisation risk increased with greater age (OR = 1.06 [1.03-1.08], p < 0.001) and BMI (OR = 1.10 [1.05-1.16], p < 0.001). More severe infection and hospitalisation risks increased >180 days after last vaccination. In the fully vaccinated subgroup (n = 841), only greater age predicted hospitalisation (OR = 1.07 [1.03-1.12], p < 0.001). Serological responses to two vaccine doses diminished with age.
Conclusions: Unvaccinated individuals with high BMI and diabetes risked more severe COVID-19 outcomes. Vaccination mitigated this risk.
Clinical trial registration number: NCT04536051.
Keywords: Coronavirus; Epidemiology; Immunisation; Pandemic; Vaccine effectiveness.
. 2024 Dec 14:45:126582.
doi: 10.1016/j.vaccine.2024.126582. Online ahead of print. Predictors of severity of SARS-CoV-2 infections in Brazil: Post hoc analyses of a randomised controlled trial
Kerry Conlin[SUP] 1 [/SUP], Daniel Jenkin[SUP] 2 [/SUP], Philip de Whalley[SUP] 3 [/SUP], Lily Yin Weckx[SUP] 4 [/SUP], Pedro M Folegatti[SUP] 5 [/SUP], Sagida Bibi[SUP] 6 [/SUP], Teresa Lambe[SUP] 7 [/SUP], Parvinder K Aley[SUP] 8 [/SUP], Andrew J Pollard[SUP] 9 [/SUP], Merryn Voysey[SUP] 10 [/SUP], Sue Ann Costa Clemens[SUP] 11 [/SUP]; COV003 Study Group
Affiliations
- PMID: 39675209
- DOI: 10.1016/j.vaccine.2024.126582
Objectives: To identify demographic, clinical and immunological factors associated with adverse COVID-19 outcomes.
Methods: A large randomised controlled trial of ChAdOx1 nCoV-19 was undertaken in Brazil. Participants were randomised 1:1 either to receive ChAdOx1 nCov-19 or to a control group. COVID-19 infections were confirmed by nucleic acid amplification test (NAAT) and classified using the WHO clinical progression scale. Anti-spike antibody responses and serum neutralising activity were measured 28 days after second vaccination in some participants. Exploratory analyses were conducted into factors associated with COVID-19 infection severity and hospitalisation, using logistic regression models adjusted for demographic and clinical factors.
Results: 10,416 participants were enrolled; 1790 had NAAT-positive COVID-19 infection; 63 cases required hospitalisation. More severe infection was associated with greater body-mass index (BMI) (odds ratio [OR] = 1.06 [95 %CI: 1.01-1.10], p = 0.01) and diabetes (OR = 3.67 [1.59-8.07], p = 0.003). Hospitalisation risk increased with greater age (OR = 1.06 [1.03-1.08], p < 0.001) and BMI (OR = 1.10 [1.05-1.16], p < 0.001). More severe infection and hospitalisation risks increased >180 days after last vaccination. In the fully vaccinated subgroup (n = 841), only greater age predicted hospitalisation (OR = 1.07 [1.03-1.12], p < 0.001). Serological responses to two vaccine doses diminished with age.
Conclusions: Unvaccinated individuals with high BMI and diabetes risked more severe COVID-19 outcomes. Vaccination mitigated this risk.
Clinical trial registration number: NCT04536051.
Keywords: Coronavirus; Epidemiology; Immunisation; Pandemic; Vaccine effectiveness.