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

Ain Shams University4,000 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

4,000

Conditions

Covid19

Interventions

Astrazeneca/Oxford VaccineBIOLOGICAL

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

Sinopharm vaccineBIOLOGICAL

Inactivated vaccine given intramuscular injection in 2 doses 3 weeks apart

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

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

Cairo, Non-US, Egypt

RECRUITING

Outcomes

Primary Outcomes

Short-term effectiveness

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

Time frame: 21 days of the first dose of vaccine

Central Contacts

Samia Girgis, MD

CONTACT

01223366500 drsamia.girgis@med.asu.edu.eg

Fatma Soliman E Ebeid, MD

CONTACT

01095569596 dr.fatma_ebeid@yahoo.com

Data from ClinicalTrials.gov

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