Seroconversion, Vaccine Adverse Reaction
Conditions
Brief summary
After SARS-COV-2 inactivated vaccine authorization for use in different countries including Egypt, investigating its immunogenicity, safety, and efficacy in preventing COVID-19 infection is highly needed. In Egypt, immunization of HCWs in isolation hospitals by SARS-COV-2 inactivated vaccine is now a national priority. Moreover, data and reports regarding the application of vaccine are still limited and deficient.
Detailed description
This study will be conducted at Zagazig University hospital. Laboratory work will be implemented at Immunology Research Laboratory at Microbiology and Immunology Department, Faculty of Medicine, Zagazig University. A representative sample will be drawn from healthcare workers (HCWs) at Zagazig University Hospital. Assessment of inclusion and exclusion criteria by history taking. Blood samples will be drawn from HCWs by direct venipuncture before the start of immunization and 14 days after immunization. The incidence of any adverse reactions after each immunization will be recorded. SARS-CoV-2 neutralizing antibodies will be detected by enzyme-linked immunosorbent assay.
Interventions
BIOLOGICALSARS-Cov-2 neutralizing antibody titer
Quantitation of SARS-Cov-2 antibody titer at baseline after each dose of the vaccine
Sponsors
Zagazig University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
-Healthy healthcare workers
Exclusion criteria
* Healthy healthcare workers' refusal. * Pregnancy and lactation. * Confirmed acute cases of SARS-CoV-2 Infection * Having a history of SARS-CoV-2 infection in the past 3 months. * Fever (body temperature \> 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination. * History of allergy to any vaccines * Previous vaccination within the last 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse reactions | 7 days after each dose | Incidence of adverse reactions after each dose of the vaccine |
| Seroconversion rate of neutralizing antibody | 84 days after each dose | Neutralizing antibody assay will be performed after each dose of the vaccine |
Countries
Egypt
Outcome results
None listed