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

NCT04885764 | Unknown Phase 2

• 1 other identifier: FMASU P01b / 2021
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Keywords

Egypt; Ain Shams University; Vaccine

Outcome Measures

Primary Outcomes (1)

• 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

  21 days of the first dose of vaccine

Interventions

Astrazeneca/Oxford Vaccine BIOLOGICAL

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

Also known as: Vaxzevria

Sinopharm vaccine BIOLOGICAL

Inactivated vaccine given intramuscular injection in 2 doses 3 weeks apart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Candidate for receiving vaccination according to health care authorties prioritaizaton

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, Non-US, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

ChAdOx1 nCoV-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines

Study Officials

• Samia E Girgis, M.D

  Faculty of Medicine Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samia Girgis, MD

CONTACT

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

Fatma Soliman E Ebeid, MD

CONTACT

01095569596; dr.fatma_ebeid@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt

Study Record Dates

• First Submitted: May 8, 2021
• First Posted: May 13, 2021
• Study Start: February 23, 2021
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Locations

EG (1)