Study on Antibody Persistence and Immune Memory of Inactivated COVID-19 Vaccine

COVID-19 Clinical Trial

Official title:

A Prospective Cohort Study on Antibody Persistence and Immune Memory After Two Doses of Inactivated COVID-19 Vaccine in 150 People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072496
• Other study ID #: BJCDCWJ202101
• Status: Completed
• Start date: July 20, 2020
• Est. completion date: September 27, 2021

Study information

• Verified date: October 2021
• Source: Centers for Disease Control and Prevention, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study describe 1 year durability of humoral and cellular immune responses in 150 individuals who received COVID-19 inactivated vaccine. all participants were recruited aged between 18 and 59 years old. Every participant was familiarized with the aim of the study and asked to sign an informed consent agreement, and be required blood sampling at the day 0 of first dose vaccine and 1 month, 3 months, 6 months and 12 months after fully vaccination separately. From every sample, 10 ml, 10 ml, and 5 ml were dispensed in three vacuum blood collection tubes. Peripheral blood lymphocytes cell (PBMC) were isolated with the two 10 ml samples contained heparin to detect immune memory cells and cytokines. RBD-IgG and neutralizing antibody be detected by 5ml sample from separating gel vacuum tubes. every individual conducted a detailed analysis comparing neutralizing antibody, TEM, TCM , and report on the cellular and humoral immunity 1 year after accept COVID-19 vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 27, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• Working at the CDC

• Between the ages of 18 and 59

• Healthy

• Not vaccinated with COVID-19 vaccine

• Agreed to take a blood sample

Exclusion Criteria:

• who cannot take the COVID-19 vaccine due to some personal reasons

• history of SARS-CoV, SARS-CoV-2, or Middle East respiratory syndrome infection

• high-risk epidemiology history within 14 days before enrolment (eg, travel or residence history in communities with case reports, or contact history with someone infected with SARS-CoV-2)

• axillary temperature of more than 37·0?

• history of allergy to any vaccine component.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
China	Beijing Center for Disease Control and Prevention	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Durability of humoral and cellular immune responses	The humoral immunogenicity outcomes include the RBD-specific IgG titers and neutralising antibodies amounts at 1, 3, 6, and 12 months after the second shot. The positive cutoff for RBD-specific IgG antibodies was defined as the sample cutoff (S/CO) value =1.0. Seroconversion of neutralising antibodies was defined as a change from seronegative at baseline to seropositive or a four-fold titre increase. The positive cutoff of the titre for neutralising antibodies was 1/4.; The cellular immune response outcomes measured by ICS assays across the blood collection time points.the percentage of RBD-specific CD4+ CD8+ memory T cells after vaccination.	12 months after fully vaccination
Secondary	The dynamic variation of the level of antibody	RBD-IgG and neutralizing antibody level after vaccination at 1,3 and 6 ,12months vaccination.	1,3,6 , 12 month
Secondary	Cytokine secretion by peripheral blood mononuclear cells	To study the cytokine production of PBMC after stimulation with RBD after vaccination at 1,3,6 and 12 months vaccination,for examples IL-2,IL-5,IFN and GrB.	1,3,6,12 month
Secondary	TCM and TEM amount varies at different time points	The dynamic variation of specificity TCM and TEM after vaccination at 1,3,6 and 12 months vaccination.	1,3,6,12 month