Clinical trial NCT05382871: Sequential Immunization of Two Doses of Inactivated COVID-19 Vaccine (Omicron) in Vaccinated Population Aged 18 Years and Above
Official title: A Randomized, Double-Blinded, Cohort Clinical Study on Evaluating the Safety and Immunogenicity of Sequential Immunization of Two Doses of BIBP Inactivated COVID-19 Vaccine (Omicron), WIBP Inactivated COVID-19 Vaccine (Omicron) or Inactivated COVID-19 Vaccine (Prototype) in Population Aged 18 Years and Above Who Have Completed Two or Three Doses of Inactivated or mRNA Vaccine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: China National Biotec Group Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Beijing Institute of Biological Products Co Ltd.
name: Wuhan Institute of Biological Products Co., Ltd
name: The University of Hong Kong
First posted: 2022-05-19
Enrollment: 1804
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial adopts a randomized, double-blind and positive control design, it is planned to recruit 1800 healthy participants who have been vaccinated with 2/3 doses of COVID-19 inactivated vaccine or mRNA vaccine for 3 months. The participants will be divided into two strata according to the types of vaccines administered, including 900 participants of COVID-19 inactivated vaccine and 900 participants of mRNA vaccine. According to the ratio of 1:1:1, each stratum was randomly assigned to three groups: sequential BIBP- COVID-19 inactivated vaccine (Omicron), WIBP-COVID-19 inactivated vaccine (Omicron) or COVID-19 inactivated vaccine (prototype strain). And according to D0, D28 immunization schedule, two doses of corresponding group vaccines are sequentially administered.


Eligibility criteria: Inclusion Criteria:

* Age range: populations aged 18 years and above.
* Judged by the investigator that the health condition is well after inquiry and physical examination.
* Vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine or mRNA vaccine for ≥ 3 months.
* Female participants who are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 7 months after enrollment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
* During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan.
* With self ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and is able to comply with the requirements of the clinical study protocol.

Exclusion Criteria:

* Confirmed cases, suspected cases or asymptomatic cases of COVID-19;
* With a history of Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS) (self-report, on-site inquiry);
* Has vaccinated with one or four doses and above COVID-19 vaccine;
* Axillary temperature ≥37.3℃ (Tympanic temperature ≥ 37.6 ℃);
* Previous allergic reactions to drug or vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known components of COVID-19 vaccine (self-report, onsite enquiry);
* Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders (self-report, onsite enquiry);
* With known immunological impairment or immunocompromised diagnosed by the hospital (self-report, onsite enquiry);
* Have an uncontrolled epilepsy and other progressive neurological diseases or a history of Guillain-Barre syndrome (self-report, onsite enquiry);
* Received whole blood, plasma and immunoglobulin therapy within 1 month (self-report, onsite enquiry);
* Known or suspected severe illness includes: respiratory illness, acute infection or active attacks of chronic illness, liver and kidney disease, severe diabetes mellitus, malignant tumor, infectious or allergic skin disease, Human Immunodeficiency Virus (HIV) infection (self-report, onsite enquiry, provide test report if available);
* With hospital-diagnosed serious cardiovascular diseases (cardiopulmonary failure, drug-uncontrolled hypertension (physical examination of systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg), acute attacks of chronic respiratory illness (self-report, onsite enquiry);
* Received live attenuated vaccines within 1 month before vaccination (self-report, onsite enquiry);
* Received inactivated vaccines within 14 days before vaccination (self-report, onsite enquiry);
* Participating or planning to participate in other interventional vaccine clinical trials during this study
* Other vaccination-related contraindications considered by investigators.

Primary outcomes:
measure: The Geometric Mean Titer （GMT） of anti-omicron neutralizing antibody
timeFrame: 28 days after sequential vaccination of 2 doses
measure: The 4-fold rise rate of anti-omicron neutralizing antibody
timeFrame: 28 days after sequential vaccination of 2 doses
Secondary outcomes:
measure: The GMT of anti-omicron neutralizing antibody
timeFrame: 14 days after sequential vaccination of 2 doses
measure: The 4-fold rise rate of anti-omicron neutralizing antibody
timeFrame: 14 days after sequential vaccination of 2 doses
measure: Specific cellular immune response
timeFrame: within 28 days after vaccination
measure: The GMT of anti-omicron Immunoglobulin G (IgG) antibody
timeFrame: 28 days after sequential vaccination of 2 doses
measure: The proportions of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64
timeFrame: 28 days after sequential vaccination of 2 doses
measure: The proportion of subjects with neutralizing antibody GMT ≥1:16，≥1:32 and ≥1:64
timeFrame: on 3rd month, 6th month, 9th month, and 12th month after vaccination
measure: The incidence of any adverse reactions/events
timeFrame: 28 days after each immunization
measure: The incidence of serious adverse events (SAE) and adverse events special interest (AESI)
timeFrame: from 1st booster dose and up to 6 months following 2nd booster dose
Other outcomes:
measure: The incidence of COVID-19 cases , including severe cases and deaths accompanied by COVID-19
timeFrame: From 14 day after vaccination
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Ivan Hung, Clinical Professor
role: PRINCIPAL_INVESTIGATOR
References: