Evaluation of Clinical and Antibody Response to Covid-19 Vaccination Strategy in TBRI, Egypt
Panoramica dello studio
Descrizione dettagliata
SARS-CoV-2 has been in the human population for more than a year now, causing severe disease in some and resulting in a pandemic that continues to put severe strain on economies and healthcare infrastructures worldwide. Vaccination is considered as one of the greatest successes in medical history. Based on prior experience with the development of SARS-CoV vaccines, all COVID-19 vaccines must be subjected to the tests for protective effects and harmful risks derived from antibody-dependent enhancement that may contribute to augmented infectivity and/or eosinophilic infiltration. The SARS-CoV-2 vaccine is now being developed urgently in several different ways.
In the UK, the first three vaccines have emergency use authorization, and a national rollout is in progress. Many other countries are also instigating large scale vaccination programmes. Assessment of the safety and efficacy of vaccines against the severe acute respiratory syndrome coronavirus (SARS-CoV-2) in different populations is essential .
The UK government recently decided to extend the interval between the first dose of the Pfizer BioNTech and AstraZeneca COVID-19 vaccines from 3 weeks to 12 weeks to maximise the number of people receiving the initial dose, despite the trials only providing vaccine efficacy data based on a schedule of 21 days between doses.
Many reports were raised claiming Astrazenica vaccine for the development of vascular thrombosis and studies are not finalized regarding this issue .
China is regarded as one of the world's leading countries in SARS-CoV-2 vaccine development, up to date the last inactivated vaccine international clinical (Phase III) trial was launched in the United Arab Emirates by Sinopharm China National Biotec Group (CNBG).The ability to track and trace vaccines through the vaccine supply chain down to persons vaccinated has to be enhanced.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Giza, Egitto
- Reclutamento
- Samia El-Shishtawy
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Contatto:
- Samia H El-Shishtawy, Assi. prof
- Numero di telefono: 01003661563
- Email: crc.tbri@gmai.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- All male and female above 18 years
Exclusion Criteria:
- age below 18 years -pregnancy-
- fever
- IGM positive for covid 19
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Selezione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: 1- Before vaccination:
To detect:
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COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm.
Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
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Altro: 2-7 days after the first dose
Measuring D-dimer
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COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm.
Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
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Altro: 3-Before the second dose:
To detect IgG and IgM To detect the level of Covid-19 Ig G antibodies titer in the blood, Quantitative Ig G titer should be measured.
To detect the response of the immune system to the vaccine.
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COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm.
Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
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Altro: 4-After 3 months from the second dose:
To detect the level ofCovid-19 Ig G antibodies titer in the blood, Quantitative Ig G titer should be measured.
To detect the response of the immune system to the vaccine.
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COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm.
Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
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Altro: 5-After 6 months from the second dose:
To detect the level ofCovid 19 Ig G antibodies titer in the blood, Quantitative Ig G titer should be measured.
To detect the response of the immune system to the vaccine.
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COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm.
Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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to develop IgG antibody
Lasso di tempo: seven to ten days
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These antibodies indicate that you may have had COVID 19 in the recent past and have developed antibodies that may protect you from future infection.
It is unknown at this point how much protectionantibodies might provide against reinfection.
This group of individuals should receive the vaccine.
Quantitative Ig G titer should be measured.
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seven to ten days
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 00022021
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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