Great expectations to control the pandemic are placed in vaccines against COVID-19. Currently, the four COVID-19 vaccines approved in the European Union. The investigators designed a study assessing the anti-SARS-CoV-2 IgG antibody titer after vaccination cycle with the BNT162b2 vaccine in several time points relating these results to the COVID-19 history and severity of symptoms during the disease and after the first and second vaccine dose.

Coronavirus disease 2019 (COVID-19) which is caused by the virus Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres throughout the United Kingdom. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments. Associations will be examined between socio-demographic and clinical variables and serologic testing. The investigators will also examine the effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies. As pwCF receive COVID-19 vaccination the investigators will perform a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time. https://clinicaltrials.gov/show/NCT05158829

<h2>Condition:</h2>COVID-19;Organ Transplant<br><br><h2>Intervention:</h2>Drug: Casirivimab and Imdevimab Antibody Cocktail<br><br><h2>Primary outcome:</h2>Monitoring for SARS-CoV-2 infection<br><br><h2>Criteria:</h2><br> Inclusion Criteria: <br><br> 1. Subject provides written informed consent prior to initiation of any study procedures. <br><br> 2. Understands and agrees to comply with planned study procedures. <br><br> 3. Adult =18 years of age at time of enrollment, pediatric ages will be excluded. <br><br> 4. Subject consents to receiving a COVID-19 positive organ (kidney, liver, or heart) <br><br> a. Deceased immunocompetent donor with positive SARS-CoV-2 RT-PCR testing from the <br> respiratory tract (upper or lower): i. Within 21 days since the date of COVID-19 <br> diagnosis OR ii. Within 90 days since the date of COVID-19 diagnosis <br><br> 5. Subject is confirmed COVID-19 negative confirmed by PCR at time of transplant with no <br> signs and symptoms consistent with COVID-19 <br><br> 6. All candidates must be fully vaccinated 2 weeks prior to enrollment a. When applicable <br> candidates can receive a booster vaccine as defined by the FDA/CDC <br><br> Exclusion Criteria: <br><br> 1. Any exposure to investigational medications targeting COVID-19 <br><br> 2. Previous use of casirivimab with imdevimab antibody cocktail (REGEN-COV) <br><br> 3. Previous treatment of COVID-19 with a monoclonal antibody <br><br> 4. Active COVID-19 infection <br><br> 5. Allergy to casirivimab with imdevimab <br><br> 6. Pregnant patients <br><br> 7. Prior transplant <br><br> 8. Hepatitis C virus/NCT positive deceased donors <br><br><br>

Coronavirus disease 2019 (COVID-19) is caused by a novel coronavirus that has resulted in a global pandemic. COVID-19 infection stimulates Human Leukocyte Antigen (HLA) to produce cytokine proteins, which leads to inflammation-causing lung damage. COVID-19 is associated with significant illness and death in patients with End-Stage Kidney Disease (ESKD). However, SARS-CoV-2 vaccination studies excluded patients with severe or uncontrolled medical conditions, such as patients with ESKD. Also, the immune response to either the infection or vaccination can cause the inducement of HLA antibodies. The aim of this study is to determine the scale of antibody-based immune response 21 days after the first and second dose of the SARS-CoV-2 vaccine in dialysis and renal transplant patients. https://www.isrctn.com/ISRCTN52588893

The Coronavirus Disease 2019 (COVID-19) pandemic has claimed over 5 million lives globally. Fortunately, a substantial and growing number of SARS-CoV-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. Novel mRNA vaccines such as the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) have reported a stunning >94% efficacy against COVID-19. However, global access has not been equitable, with many low- and middle-income countries having no vaccine access or access under emergency use mainly to traditional inactivated SARS-CoV2-2 vaccines such as BBIBP-CorV (Sinopharm Beijing), CoronaVac (Sinovac) and BBV152 (Bharat Biotech). Emerging studies have shown that lower concentrations of neutralizing antibodies (Nab) are attained after CoronaVac than after an mRNA-based vaccine in healthy individuals. This difference seems to be more pronounced in immunocompromised patients who are at higher risk of severe COVID-19 and death from COVID-19. As such, several countries including the United States, Israel and Chile have recommended a third vaccine dose for high-risk populations. However, it is not currently known which is the best vaccine combination regarding immunogenicity, particularly in these vulnerable patients. This observational study will explore the humoral and cellular response to a SARS-CoV-2 BNT162b2 vaccine booster in solid organ transplant patients who received two previous doses of the inactivated Coronavac or two doses of BNT162b2 vaccines. https://clinicaltrials.gov/ct2/show/NCT05124509

All adult kidney transplant recipients who were fully vaccinated with SARS-CoV-2 vaccine however with inadequate immune response will be offered for an additional dose of vaccine either viral-vectored or mRNA vaccine (randomized control trial). www.thaiclinicaltrials.org/show/TCTR20211102003

The RIVASTIM trials aim to identify strategies to improve immunological responses to a 3rd booster dose of the mRNA Pfizer Comirnaty COVID-19 vaccine in a cohort of kidney transplant patients who have failed to achieve an adequate immune response to a standard two-dose COVID-19 vaccine course. Kidney transplant patients are a highly vulnerable group of immunosuppressed patients who suffer from disproportionately high COVID-19-related morbidity and mortality. The dietary fibre supplement inulin shows promise in enhancing immune responses to vaccination. In this study kidney transplant patients will be randomised to either take inulin supplements or placebo. Four weeks after randomisation, participants will receive a 3rd COVID-19 vaccine dose, and immunological responses will be assessed 4-6 weeks later. https://anzctr.org.au/ACTRN12621001465842.aspx

Condition:Immune response after ChAdOx1 nCoV-19 Vaccine in kidney transplant patients compared to healthy volunteers. www.thaiclinicaltrials.org/show/TCTR20211025004

The RIVASTIM trials aim to identify strategies to improve immunological responses to a 3rd booster dose of the mRNA Pfizer Comirnaty COVID-19 vaccine in a cohort of kidney transplant patients who have failed to achieve an adequate immune response to a standard two-dose COVID-19 vaccine course. Kidney transplant patients are a highly vulnerable group of immunosuppressed patients who suffer from disproportionately high COVID-19-related morbidity and mortality. The transplant medication sirolimus shows promise in enhancing immune responses to COVID-19 vaccination. In this study kidney transplant patients receiving standard of care immunosuppression with tacrolimus, mycophenolate, and steroids will be randomised to either switch from mycophenolate to sirolimus, or remain on standard of care immunosuppression. Four weeks after randomisation, participants will receive a 3rd COVID-19 vaccine dose, and immunological responses will be assessed 4-6 weeks later. https://anzctr.org.au/ACTRN12621001412820.aspx