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Profiling Antibody Status and Vaccine Effectiveness in Post Vaccination With SARS CoV2 in Ain Shams University (ASU-VAC)

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ClinicalTrials.gov Identifier: NCT04885764
Recruitment Status : Recruiting
First Posted : May 13, 2021
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Samia Girgis, Ain Shams University

Brief Summary:
This is a prospective intervention study to assess the effectiveness of both the live attenuated and messenger RNA vaccines against SARS-CoV-2 infection

Condition or disease Intervention/treatment Phase
Covid19 Biological: Astrazeneca/Oxford Vaccine Biological: Sinopharm vaccine Phase 2 Phase 3

Detailed Description:

This is a prospective intervention study to assess the short-term effectiveness of the first dose of both the live attenuated and messenger RNA vaccines against SARS-CoV-2 infection by monitoring the antibodies (IgG, IgM and level of neutralizing antibodies) in sera of post-vaccinated persons.

The study also will monitor the incidence of SARS-CoV-2 infection among vaccinees just before the first dose administration, 3 weeks after immunization, at the administration of the second dose, 14 days following the second dose and after 3 and 6 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Profiling Antibody Status and Vaccine Effectiveness in Post Vaccination With SARS CoV2 in Ain Shams University
Actual Study Start Date : February 23, 2021
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : December 1, 2021

Intervention Details:
  • Biological: Astrazeneca/Oxford Vaccine
    Viral non replicated vector vaccine contains the gene that encodes for the spike protein on the surface of the SARS-CoV-2 virus given Intramuscular injection in 2 doses 3 months apart
    Other Name: Vaxzevria
  • Biological: Sinopharm vaccine
    Inactivated vaccine given intramuscular injection in 2 doses 3 weeks apart


Primary Outcome Measures :
  1. Short-term effectiveness [ Time Frame: 21 days of the first dose of vaccine ]
    Assess the short-term effectiveness of the first dose of both the live attenuated and messenger RNA vaccines against SARS-CoV-2 infection by monitoring the antibodies (IgG, IgM and level of neutralizing antibodies) in sera of postvaccinated persons three weeks after first dose



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age > 18 years old
  2. Candidate for receiving vaccination according to health care authorties prioritaizaton

Exclusion Criteria:

  1. SARS-CoV-2 recovered cases <3 months
  2. Individuals who are currently infected with Sars-COV-2 and/or with respiratory symptoms with fever.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04885764


Contacts
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Contact: Samia Girgis, MD 01223366500 drsamia.girgis@med.asu.edu.eg
Contact: Fatma Soliman E Ebeid, MD 01095569596 dr.fatma_ebeid@yahoo.com

Locations
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Egypt
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center Recruiting
Cairo, Non-US, Egypt, 11566
Contact: Fatma Soliman E Ebeid    01095569596    dr.fatma_ebeid@yahoo.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Samia E Girgis, M.D Faculty of Medicine Ain Shams University
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Responsible Party: Samia Girgis, Professor of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt, Ain Shams University
ClinicalTrials.gov Identifier: NCT04885764    
Other Study ID Numbers: FMASU P01b / 2021
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samia Girgis, Ain Shams University:
Egypt
Ain Shams University
Vaccine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs