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

Ain Shams University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Covid19

Treatments: Biological: Sinopharm vaccine; Biological: Astrazeneca/Oxford Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT04885764

FMASU P01b / 2021

Details and patient eligibility

About

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

Full 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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)