Clinical Trials Directory

Trials / Completed

CompletedNCT04709003

Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI)

Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI): A Prospective Cohort Study

Status
Completed
Phase
Study type
Observational
Enrollment
1,567 (actual)
Sponsor
Clalit Health Services · Academic / Other
Sex
All
Age
18 Years – 120 Years
Healthy volunteers
Accepted

Summary

Although clinical trials for approved COVID-19 vaccines demonstrated efficacy of the vaccine in preventing symptomatic infection, many questions about vaccine effectiveness, such as the effectiveness of COVID-19 vaccine in preventing asymptomatic infection, a surrogate for transmission, and duration of protection, can only be evaluated in real-world trials. The objective of the study is to evaluate COVID-19 vaccine effectiveness (Pfizer vaccine, and, if available, Moderna vaccine) in preventing infection in healthcare personnel in Israel. HCP who are Clalit members and working in Soroka, Beilinson, Meir, Haemek, Kaplan and Schneider hospitals, 18 years or older, and eligible to get COVID-19 vaccine according to Ministry of Health guidelines, will be recruited, regardless of their intention to get the COVID-19 vaccine. A baseline serology sample and respiratory sample will be collected. Participants will be asked to provide a respiratory sample weekly for 3 months, and then monthly for the remainder of the study. Participants will also have blood drawn at 1 month, 3 months, 6 months, 9 months and 12 months. Respiratory samples will be tested for SARS-CoV-2 by RT-PCR; serology will be tested for SARS-CoV-2 antibodies. The study will last for 12 months. For each participant, data will be extracted from the Electronic Medical Record for the period of the study and retrospectively from 2010.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTSerologic testA blood test to check antibodies type and amount
DIAGNOSTIC_TESTRespiratory swabsPCR test to Covid-19

Timeline

Start date
2020-12-23
Primary completion
2021-06-30
Completion
2021-06-30
First posted
2021-01-14
Last updated
2022-07-20

Locations

6 sites across 1 country: Israel

Source: ClinicalTrials.gov record NCT04709003. Inclusion in this directory is not an endorsement.