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

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04885764
Collaborator
(none)
4,000
Enrollment
1
Location
9.2
Anticipated Duration (Months)
433.3
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 23, 2021
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Short-term effectiveness [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center Cairo Non-US Egypt 11566

Sponsors and Collaborators

  • Ain Shams University

Investigators

  • Principal Investigator: Samia E Girgis, M.D, Faculty of Medicine Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
Last Update Posted:
May 13, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Samia Girgis, Professor of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt, Ain Shams University
Egypt
Ain Shams University
Vaccine
Additional relevant MeSH terms:
Vaccines

Study Results

No Results Posted as of May 13, 2021