Reactogenicity and Immunogenicity of Third Dose Vaccine Booster Following Two Doses of Inactivated Vaccines

NCT05095298 | Unknown Phase 4

• 1 other identifier: BOOST
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

It is a prospective open-labeled study, We intended to recruit the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before, and volunteered to receive the third dose of vaccine (inactivated vaccine, recombinant subunit protein vaccine or mRNA vaccine) into the experimental group, and the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before without a third dose of vaccination plan into the control group. Participants in the experimental group received the third dose of SARS-CoV-2 vaccination at baseline, and participants in the control group received no intervention. Each subject will be followed up for one year after enrollment, and neutralizing antibodies and total antibodies will be tested at the specified time points, as well as the records of adverse events and adverse reactions.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Immunogenicity of Third Dose Vaccine Booster Following Two Doses of Inactivated Vaccines

  Observe the 28th day of the subjects' pseudovirus neutralizing antibody geometric mean titers (GMTs) and mean geometric titers fold growth (GMFR) changes

  Day 28

• Reactogenicity of Third Dose Vaccine Booster Following Two Doses of Inactivated Vaccines

  All solicited and non-solicited adverse events within 28 days.

  Day 28

Secondary Outcomes (4)

• The seropositive rate of neutralizing antibodies

  3 days/14 days/28days/45days/60 days/90 days/180 days/365 days

• GMT of neutralizing antibodies

  3 days/14 days/28days/45days/60 days/90 days/180 days/365 days

• GMFR of neutralizing antibodies

  3 days/14 days/28days/45days/60 days/90 days/180 days/365 days

• severe adverse events and adverse events of special interest

  up to 1 year

Study Arms (4)

Control Group

NO INTERVENTION

Participants volunteered not to receive the third dose of vaccine, and agreed to be followed-up for 1 year

Inactivated Vaccine Group

EXPERIMENTAL

Participants volunteered to receive the third dose of inactivated vaccine

Drug: Vaccine, COVID19

Recombinant subunit protein vaccine

EXPERIMENTAL

Participants volunteered to receive the third dose of subunit protein vaccine

Drug: Vaccine, COVID19

mRNA vaccine Group

EXPERIMENTAL

Participants volunteered to receive the third dose of mRNA vaccine ( To be enrolled, the vaccine has not been approved in China)

Drug: Vaccine, COVID19

Interventions

Vaccine, COVID19 DRUG

It is a prospective open-labeled study, We intended to recruit the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before, and volunteered to receive the third dose of vaccine (inactivated vaccine, recombinant subunit protein vaccine or mRNA vaccine) into the experimental group, and the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before without a third dose of vaccination plan into the control group. Participants in the experimental group received the third dose of SARS-CoV-2 vaccination at baseline, and participants in the control group received no intervention. Each subject will be followed up for one year after enrollment, and neutralizing antibodies and total antibodies will be tested at the specified time points, as well as the records of adverse events and adverse reactions.

Inactivated Vaccine Group; Recombinant subunit protein vaccine; mRNA vaccine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old,
• Through asking medical history and physical examination, the investigator judged that the health condition is good: the chronic disease is stable and there is no change within 3 months of medication;
• has been completed 2 doses of Covid-19 Inactivated vaccine 4-8 months ago;
• Volunteered to receive the third dose of vaccine.And during the entire follow-up research period, be able and willing to complete the entire prescribed research plan; Have the ability to self-understand research procedures, informed consent \& voluntarily sign informed consent, and be able to comply with the requirements of the plan

You may not qualify if:

• RT-qPCR detects active SARS-Cov-2 infection;
• a history of COVID-19, SARS, MERS infection (self-report, on-site inquiry);
• a high-risk factor for COVID-19 infection:
• a history of close contact with people infected with the new coronavirus, a history of living in high-risk areas, and a history of contact with patients with fever or respiratory symptoms in high-risk areas or abroad.
• Fever, dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, dyspnea, etc. 7 days before enrollment;
• receiving COVID-19 booster vaccination;
• allergic to the active ingredients of the SARS-CoV-2 vaccine, any of the inactive ingredients, the substances used in the production process, or those who have had allergies during previous vaccination of similar vaccines;
• those who have had severe allergic reactions to vaccines in the past (such as acute allergic reactions, angioedema, respiratory Difficulties, urticaria, angioedema or abdominal pain);
• body temperature \>37.0℃ before vaccination;
• blood pregnancy test positive;
• with uncontrolled epilepsy and other serious neurological diseases (such as transmissive myelitis, Guillain-Barre syndrome) , Demyelinating diseases, etc.), or have a history or family history of encephalopathy or mental disease;
• severe liver and kidney disease, uncontrollable hypertension (systolic blood pressure ≥180 mmHg, diastolic blood pressure ≥100 mmHg), diabetic complications, Malignant tumors, various acute diseases or acute attacks of chronic diseases;
• diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
• receiving anti-tuberculosis treatment;
• a history of coagulopathy ( Such as coagulation factor deficiency, coagulation disease) within 3 months of subjects receiving immunotherapy or inhibitor therapy (continuous oral or infusion for more than 14 days), or after 3 months of hormone therapy, the average daily dose is ≥20mg/day (Prednisone);

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (2)

Huashan Hospital affiliated to Fudan University

Shanghai, Jingan, 200041, China

Location

Beijing Ditan Hospital Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 2, 2021
• First Posted: October 27, 2021
• Study Start: August 1, 2021
• Primary Completion: March 15, 2022
• Study Completion: August 1, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

CN (2)