- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT04809948
Effects of COVID 19 Vaccine on Egyptian Population
Impact of COVID 19 Vaccine on Safety, Blood Elements, and Immunogenicity of the Egyptian Population
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
Coronavirus disease 2019 (COVID-19) is an emerging respiratory infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that had infected more than 100 million individuals and caused more than 2 million deaths worldwide by February 13, 2021. A safe and effective vaccination trials against COVID-19 is urgently needed. There are currently more than 160 COVID-19 candidate vaccines in development worldwide, and 25 are in different phases of clinical trials using different platforms.
The efficacy and immunogenicity of vaccines varies depending on the study cohort. Race and ethnicity were shown to affect the antibody responses to the rubella vaccine, which elicited significantly higher titers in children of African ethnicity compared to those of European descent or Hispanic ethnicity, likely, disparities in serologic responses to vaccines were also observed between different ethnic groups for the Haemophilus influenzae type b-tetanus toxoid conjugate vaccine , or the Haemophilus influenzae type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine . thus keeping the race an important factor in studding its effect on immunogenicity of vaccine. Thus keeping the race an important factor in studding its effect on immunogenicity of vaccine, which pushed us to estimate immunogenicity in Egyptian population after vaccination with the inactivated COVID-19 vaccine.
Heamatological changes after vaccination had been detected in many researches; lecuocytosis was found shortly after vaccination of infants, which was primarily a neutrophilia but no participant received antibiotics and all remained well at follow-up . In a case series study, also leukocytosis with fever was detected following pneumococcal vaccine administration . On the other hand, neutropenia was detected following a new vaccine against Shigella sonnei . Platelets abnormalities also had been detected following vaccination, a previous example is idiopathic thrombocytopenic purpura, linked to the administration of measles-containing vaccines .
Opintotyyppi
Ilmoittautuminen (Odotettu)
Yhteystiedot ja paikat
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- People aged 18-80 years.
- Negative for serum-specific IgM/IgG antibodies against SARS-CoV-2, as measured by a commercial kit (Innovita, China) at the time of screening.
Exclusion Criteria:
- A history of infection with SARS-CoV 3 months before the vaccine.
- Fever, cough, runny nose, sore throat, diarrhoea, dyspnoea, or tachypnoea in the 14 days before vaccination.
- Pregnancy.
- A history of seizures or mental illness.
- Being on immunosuppressive agents.
- Being on anticoagulation therapy.
- Being unable to comply with the study schedule.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
serological antibodies against SARS-CoV-2 e
Aikaikkuna: change from baseline at one month after first dose
|
Total IgG titer
|
change from baseline at one month after first dose
|
|
serological antibodies against SARS-CoV-2 e
Aikaikkuna: one month after second dose
|
Total IgG titer
|
one month after second dose
|
|
Complete blood count (CBC)
Aikaikkuna: change from baseline at one month after first dose
|
to evaluate total leucocyte count TLC
|
change from baseline at one month after first dose
|
|
Complete blood count (CBC)
Aikaikkuna: one month after second dose
|
to evaluate total leucocyte count TLC
|
one month after second dose
|
|
Complete blood count (CBC)
Aikaikkuna: change from baseline at one month after first dose
|
absolute neutrophilic count (ANC)
|
change from baseline at one month after first dose
|
|
Complete blood count (CBC)
Aikaikkuna: one month after second dose
|
absolute neutrophilic count (ANC)
|
one month after second dose
|
|
Complete blood count (CBC)
Aikaikkuna: change from baseline at one month after first dose
|
platelets (PLTs)
|
change from baseline at one month after first dose
|
|
Complete blood count (CBC)
Aikaikkuna: one month after second dose
|
platelets (PLTs)
|
one month after second dose
|
|
Complete blood count (CBC)
Aikaikkuna: change from baseline at one month after first dose
|
hemoglobin level
|
change from baseline at one month after first dose
|
|
Complete blood count (CBC)
Aikaikkuna: one month after second dose
|
hemoglobin level
|
one month after second dose
|
|
Adverse clinical symptoms after vaccine
Aikaikkuna: up to one week after first dose
|
asking about possible recorded side effects as
|
up to one week after first dose
|
Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Xia S, Duan K, Zhang Y, Zhao D, Zhang H, Xie Z, Li X, Peng C, Zhang Y, Zhang W, Yang Y, Chen W, Gao X, You W, Wang X, Wang Z, Shi Z, Wang Y, Yang X, Zhang L, Huang L, Wang Q, Lu J, Yang Y, Guo J, Zhou W, Wan X, Wu C, Wang W, Huang S, Du J, Meng Z, Pan A, Yuan Z, Shen S, Guo W, Yang X. Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials. JAMA. 2020 Sep 8;324(10):951-960. doi: 10.1001/jama.2020.15543.
- Spinelli A, Pellino G. COVID-19 pandemic: perspectives on an unfolding crisis. Br J Surg. 2020 Jun;107(7):785-787. doi: 10.1002/bjs.11627. Epub 2020 Mar 23. No abstract available.
- Stern PL. Key steps in vaccine development. Ann Allergy Asthma Immunol. 2020 Jul;125(1):17-27. doi: 10.1016/j.anai.2020.01.025. Epub 2020 Feb 7.
- Haralambieva IH, Salk HM, Lambert ND, Ovsyannikova IG, Kennedy RB, Warner ND, Pankratz VS, Poland GA. Associations between race, sex and immune response variations to rubella vaccination in two independent cohorts. Vaccine. 2014 Apr 7;32(17):1946-53. doi: 10.1016/j.vaccine.2014.01.090. Epub 2014 Feb 13.
- Prentice S, Kamushaaga Z, Nash SB, Elliott AM, Dockrell HM, Cose S. Post-immunization leucocytosis and its implications for the management of febrile infants. Vaccine. 2018 May 11;36(20):2870-2875. doi: 10.1016/j.vaccine.2018.03.026. Epub 2018 Apr 11.
- von Elten KA, Duran LL, Banks TA, Banks TA, Collins LC, Collins LC. Systemic inflammatory reaction after pneumococcal vaccine: a case series. Hum Vaccin Immunother. 2014;10(6):1767-70. doi: 10.4161/hv.28559. Epub 2014 Mar 18.
- Muturi-Kioi V, Lewis D, Launay O, Leroux-Roels G, Anemona A, Loulergue P, Bodinham CL, Aerssens A, Groth N, Saul A, Podda A. Neutropenia as an Adverse Event following Vaccination: Results from Randomized Clinical Trials in Healthy Adults and Systematic Review. PLoS One. 2016 Aug 4;11(8):e0157385. doi: 10.1371/journal.pone.0157385. eCollection 2016.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Odotettu)
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- COVID 19 Vaccine
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