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

May 8, 2021 updated by: Samia Girgis, Ain Shams University
This is a prospective intervention study to assess the effectiveness of both the live attenuated and messenger RNA vaccines against SARS-CoV-2 infection

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

4000

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Non-US
      • Cairo, Non-US, Egypt, 11566
        • Recruiting
        • Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
21 days of the first dose of vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2021

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

May 8, 2021

First Submitted That Met QC Criteria

May 8, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 8, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU P01b / 2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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