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Study on safety and immunogenicity of the third dose of inactivated SARS-CoV-2 vaccine (Vero cells) in a population that did not respond to the first two doses of inactivated vaccine

Phase IV clinical study evaluating the safety and immunogenicity of the third dose of inactivated SARS-CoV-2 vaccine (Vero cells) in a population that did not respond to the first two doses of inactivated vaccine

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050589
Enrollment
Unknown
Registered
2021-08-31
Start date
2021-08-02
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Third dose of SARS-CoV-2 vaccine group:administering third dose of SARS-CoV-2 vaccine

Sponsors

The Afiliated Hospital of Yunnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The participants were 18 to 75 years old, male or female; 2. Two doses of inactivated SARS-CoV-2 vaccine were administered recently and the interval between two doses was 3-5 weeks; 3. The neutralization antibody levels were negative or less than 20% average antibody level of COVID-19 recovered patients in 14 days after administering two doses of SARS-CoV-2 vaccine; 4. It is now in 4-24 weeks after administering second dose of SARS-CoV-2 vaccine; 5. Participants can follow the researchers guidance to accomplish the research process.

Exclusion criteria

Exclusion criteria: 1. The history of SARS-CoV-2 infection; 2. The History of vaccination against other types of SARS-CoV-2 vaccine other than inactivated SARS-CoV-2 vaccine; 3. Severe mental and neurological disease; 4. The following common disease (coronary heart disease, hypertension, diabetes, chronic respiratory diseases, tumors, etc.) and poorly controlled; 5. Immune deficiency or immunosuppressive therapy patients; 6. According to the researchers, any other factors that the subjects do not fit to participate in this clinical trials.

Design outcomes

Primary

MeasureTime frame
Neutralizing antibody level;Antigen-specific memory T cells;

Secondary

MeasureTime frame
Incidence of adverse events;Incidence of serious adverse events;

Countries

China

Contacts

Public ContactWei Jia

The Affiliated Hospital of Yunnan University

weijia19631225@163.com+86 871 65815279

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026