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Completed

NCT Number: NCT05072496

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Center for Disease Control and Prevention

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Durability of humoral and cellular immune responses

    Time frame: 12 months after fully vaccination

    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.

Secondary outcomes

  1. The dynamic variation of the level of antibody

    Time frame: 1，3，6 , 12 month

    RBD-IgG and neutralizing antibody level after vaccination at 1,3 and 6 ,12months vaccination.

  2. Cytokine secretion by peripheral blood mononuclear cells

    Time frame: 1,3,6,12 month

    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.

  3. TCM and TEM amount varies at different time points

    Time frame: 1,3,6,12 month

    The dynamic variation of specificity TCM and TEM after vaccination at 1,3,6 and 12 months vaccination.

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention, China

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 11, 2021
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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