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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04885764
Acronym
ASU-VAC
Enrollment
4000
Registered
2021-05-13
Start date
2021-02-23
Completion date
2021-12-01
Last updated
2021-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

Egypt, Ain Shams University, Vaccine

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

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.

Interventions

BIOLOGICALAstrazeneca/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

Inactivated vaccine given intramuscular injection in 2 doses 3 weeks apart

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Short-term effectiveness21 days of the first dose of vaccineAssess 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

Countries

Egypt

Contacts

Primary ContactSamia Girgis, MD
drsamia.girgis@med.asu.edu.eg01223366500
Backup ContactFatma Soliman E Ebeid, MD
dr.fatma_ebeid@yahoo.com01095569596

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026