Profiling Antibody Status and Vaccine Effectiveness in Post Vaccination With SARS CoV2 in Ain Shams University

NCT ID: NCT04885764

Last Updated: 2021-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-23

Study Completion Date

2021-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Covid19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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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

Intervention Type BIOLOGICAL

Sinopharm vaccine

Inactivated vaccine given intramuscular injection in 2 doses 3 weeks apart

Intervention Type BIOLOGICAL

Other Intervention Names

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Vaxzevria

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Samia Girgis

Professor of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samia E Girgis, M.D

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Ain Shams University

Locations

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Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Cairo, Non-US, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Samia Girgis, MD

Role: CONTACT

01223366500

Fatma Soliman E Ebeid, MD

Role: CONTACT

01095569596

Facility Contacts

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Fatma Soliman E Ebeid

Role: primary

01095569596

Other Identifiers

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FMASU P01b / 2021

Identifier Type: -

Identifier Source: org_study_id

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