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Browsing Protocol by Subject "COVID vaccine effectiveness"

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    Evaluation of vaccine effectiveness amongst adults living with comorbidities (Diabetes, Hypertension & HIV) following routine introduction of COVID-19 Vaccine in Blantyre, Malawi: a prospective cohort study
    (Kamuzu University of Health Sciences, 2022-01-19) Jambo, Kondwani
    Study design: This is a prospective cohort study Problem: COVID-19 continues to claim lives globally since it was discovered in Wuhan China in December 2019. People with comorbidities like hypertension, diabetes mellitus and HIV have been shown to be at high risk of severe COVID-19 and mortality. To protect against hospitalization, severe disease and death, COVID-19 vaccines have been introduced globally, as well as in Malawi. These vaccines have been deemed highly effective in other settings. However, we do not know their effectiveness in Malawi, especially among high risk individuals. Broad and specific objectives: Broad objective: to assess the effectiveness of COVID-19 vaccination amongst adults living with chronic diseases (Diabetes, Hypertension and HIV) following routine introduction in Malawi. Specific objectives: Primary objective 1. To compare the rate of virologically-confirmed symptomatic COVID-19 disease in vaccinated (after full vaccination) vs. unvaccinated adults (>18 yrs.) with co-morbidities Secondary objectives 1. To determine the rate of virologically-confirmed hospitalised symptomatic COVID-19 disease in vaccinated (after full vaccination) and unvaccinated adults (>18 yrs.) with comorbidities 2. To contrast the rate of virologically-confirmed symptomatic COVID-19 disease in vaccinated (after one-dose) vs. unvaccinated adults (>18 yrs.) with co-morbidities 3. To assess the frequency of adverse events of special interest after immunization Exploratory 1. To compare the risk of virologically-confirmed symptomatic COVID-19 disease in vaccinated (after full vaccination) vs. unvaccinated adults (>18 yrs.) with co-morbidities and documented previous COVID-19 disease 2. To investigate the duration of vaccine-induced immunity in adults with co-morbidities identified by serology 3. To investigate the frequency of new SARS-CoV-2 variants in adults with co-morbidities 4. To assess adherence to COVID-19 vaccination schedule among vaccinated adults(>18yrs.) Methodology: Adult attendees (>18 years) to Blantyre chronic disease clinics (at Limbe, Zingwangwa, Ndirande and QECH) eligible for vaccination, living with co-morbidities (Diabetes, Hypertension & HIV) and are eligible to receive COVID-19 vaccines will be eligible to participate. Participants will be enrolled prior to or during the routine introduction of COVID-19 vaccination in these vulnerable populations, regardless of whether they intend to be vaccinated. Baseline information will be collected on demographics, comorbidities, and work- and community-related infection risk factors. Baseline samples to determine baseline immunity will be collected at enrolment and at 3 months intervals to build a serological profile of the population, testing for antibodies to SARS-CoV-2 that can distinguish between vaccine-induced and natural immunity. Cases of symptomatic and hospitalised COVID-19 will be ascertained through active follow-up, reporting by mobile phone and testing. Case confirmation will be by SARS-CoV-2 RT-PCR of symptomatic participants who meet a suspected case definition. Expected findings: The results of this project will inform strategies of managing COVID-19 in high risk individuals in Malawi, in order to halt the pandemic. Results dissemination: The results will be disseminated at local and international conference and manuscripts will be published in an international peer-reviewed journal, and shared with the Ministry of Health as well as College of Medicine research ethics committee (COMREC) of the Kamuzu University of Health Sciences (KUHeS).