Sistematični pregled kliničnih raziskav o učinkovitosti in varnosti cepiv za preprečevanje bolezni COVID-19

Toman, Polona (author), Locatelli, Igor (mentor), Čebron Lipovec, Nanča (co-mentor)

Virus Sars-Cov-2, ki so ga prvič potrdili decembra 2019 v Wuhanu na Kitajskem, se je hitro razširil po celem svetu. Marca 2020 je bila razglašena pandemija Covid-19, in da bi jo lahko kontrolirali ter preprečili okužbe z virusom Sars-Cov-2, je bilo treba hitro začeti razvijati cepiva za preprečevanje bolezni, ki jo virus povzroča. Cepiva so po razvoju prešla v klinična preskušanja, ki so bila pospešena zaradi velike potrebe po cepljenju prebivalstva. Izvedene so bile študije prve, druge in tretje faze preskušanj, v vsaki je bilo zajeto večje število ljudi. Avtorji študij so proučevali lastnosti cepiv, kot so imunogenost, varnost, učinkovitost, itd. Namen magistrskega dela je bilo oceniti imunogenost, učinkovitost in varnost cepiv, ki so bila odobrena v Republiki Sloveniji in popisati značilnosti študij, ki so ocenjevale imunogenost, učinkovitost in varnost vseh dotedanjih cepiv za preprečevanje bolezni Covid-19. V bibliografskih bazah Pubmed in Clinicaltrials smo na podlagi predhodno določenega iskalnega profila našli 4740 člankov, izbor smo potem zožili na 110 člankov. Po prvem branju povzetkov in nato celotnih člankov, smo na podlagi izključitvenih kriterijev izključili 69 člankov. V sistematični pregled smo vključili 41 člankov, v katerih so avtorji opisovali 53 študij. Popisali smo lastnosti vseh študij (53) in za študije cepiv, ki so bila do julija 2021 odobrena za uporabo v Republiki Sloveniji (18 študij), popisali metode in rezultate vrednotenja imunogenosti, učinkovitosti in varnosti. Vsa cepiva so bila izdelana proti prvotni različici virusa Sars-Cov-2. Izmed vseh študij, ki smo jih vključili v sistematični pregled, je največ študij vrednotilo varnost (47 študij), nato imunogenost (40 študij), najmanj študij pa učinkovitost (18 študij). Prišli smo do zaključkov, da rezultati vrednotenja imunogenosti med študijami niso primerljivi, kar lahko pripišemo izvedbi različnih metod analize imunogenosti. Ugotovili smo, da imajo različna cepiva na osnovi RNK med sabo podobno učinkovitost in varnost, prav tako vektorska cepiva. Učinkovitost cepiva Comirnaty je bila 95 % (ena študija), cepiva Spikevax 94,1 % (ena študija), cepivo Vaxzevria je imelo učinkovitost od 55,0 % do 75,4 % (štiri študije) in cepivo Janssen 67,2 % (ena študija). Po cepljenju s cepivi je najpogosteje prišlo do bolečine na mestu vboda, glavobola in izčrpanost. Pojavile so se tudi ostale lokalne in sistemske reakcije, a v manjši meri kot prej navedene.

• Language: Slovenian
• Keywords: Covid-19, cepivo, imunogenost, učinkovitost, varnost, sistematični pregled
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2022
• PID: 20.500.12556/RUL-137330
• Publication date in RUL: 11.06.2022

Secondary language

• Language: English
• Title: A systematic review of clinical trials assessing the efficacy and safety of COVID-19 vaccines

Abstract

The Sars-Cov-2 virus, which was first confirmed in December 2019 in Wuhan, China, quickly spread across the globe. In March 2020 the Covid-19 pandemic was declared, in an effort to control it and prevent infection with the Sars-Cov-2 virus, the development of vaccines that would prevent the disease caused by the virus, had to begin quickly. After development, clinical trials were started and were sped up due to the need to vaccinate the population. Clinical study phases I-III were carried out, each involving larger number of people. In these studies, immunogenicity, efficacy and safety of the vaccines were evaluated. The purpose of this Master’s thesis is to determine the immunogenicity, efficacy and safety of the vaccines approved in the Republic of Slovenia and to document the characteristics of the studies that assessed the immunogenicity, efficacy and safety of all then available vaccines for the prevention of Covid-19. The bibliographic bases Pubmed and Clinicaltrials yielded 4740 articles based on a predetermined search profile, which we then narrowed down to 110 articles. After reading the abstracts, then complete articles and applying the exclusion criteria, we excluded 69 articles. In systematic review we included a total of 41 articles, in which authors described 53 studies. We summarised the characteristics of all included studies (53). We documented the methods and results of the immunogenicity, efficacy and safety, found in the studies of the vaccines, which had been approved for use in the Republic of Slovenia by July 2021 (18 studies). All studies were performed on the original strain of the Sars-Cov-2 virus. Of all the studies, included in the systematic review, immunogenicity was evaluated in 32 studies, efficacy in 14 and safety in 36 studies. We concluded that the results of the immunogenicity assessments are incomparable among the studies, which can be attributed to the use of different methods of analyses. We have discovered that different mRNA vaccines are similar to each other in efficacy and safety, the same applies to viral vector vaccines. The Comirnaty vaccine had a 95% efficacy (one study), the Spikevax vaccine a 94.1% (one study), the Vaxzevria vaccine a 55.0 to 75.4% efficacy (four studies), and the Janssen vaccine a 67.2% (one study). The most common side effects of vaccination were pain around the area where the shot was administered, headache and exhaustion. Other local and systemic reactions were also reported but less frequently than previously mentioned.

• Keywords: Covid-19, vaccine, immunogenicity, efficacy, safety, systematic review