Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) Phase III Clinical Trial
Phase 3
Recruiting
- Conditions
- COVID-19Coronavirus Infections
- Interventions
- Biological: LIBP-Rec-VaccineBiological: BIBP-Rec-VaccineBiological: placebo
- Registration Number
- NCT05599516
- Lead Sponsor
- National Vaccine and Serum Institute, China
- Brief Summary
This clinical trial adopts a randomized, double-blind and placebo-controlled design.
A total of 16000 participants are planned to be enrolled, of which, Cohort 1: 15000 participants vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1:1 with 1 dose of LIBP-Rec-Vaccine, BIBP-Rec-Vaccine or placebo intramuscularly to the deltoid muscle of upper arm.
Cohort 2: 1000 participants vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1 with 1 dose of LIBP-Rec-Vaccine or BIBP-Rec-Vaccine intramuscularly to the deltoid muscle of upper arm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 16000
Inclusion Criteria
- Age range: healthy population aged ≥18;
- Judged by the investigator that the health condition is well after inquiry and physical examination;
- Cohort 1: participants vaccinated with ≥2 doses of inactivated COVID-19 vaccines for ≥6 months since the last dose of vaccination; Cohort 2: participants vaccinated with ≥2 doses of mRNA COVID-19 vaccines for ≥6 months since the last dose of vaccination;
- Be able and willing to complete all prescribed study schedules during the whole study period;
- The participant himself/herself is able and willing to understand study procedures, sign the informed consent form voluntarily after informed consent and comply to requirements of the study protocol.
Exclusion Criteria
- Symptomatic and suspected COVID 19 infection positive ;
- Urine pregnancy test is positive; Women of childbearing age who have positive urine pregnancy test, who are pregnant, lactating, or women who have planned pregnancy within 6 months;
- Auxiliary temperature before vaccination is ≥37.3℃ (tympanic/forehead temperature ≥37.8℃);
- Previous allergy history of vaccine vaccination (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain, etc.) or allergy to known components of COVID-19 vaccine;
- Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders;
- With known immunological impairment or compromised immunological function diagnosed by the hospital;
- Received whole blood, plasma and immunoglobulin therapy within 1 month;
- Known or suspected of suffering from the following diseases: acute or chronic active respiratory diseases, severe cardiovascular diseases [cardiopulmonary failure, hypertension uncontrollable by drugs (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 95 mmHg)], acute infection, active phase of chronic disease, liver and kidney diseases, severe diabetes, malignant tumor, infectious skin diseases or severe skin allergy, HIV infection, etc. (Examination report can be provided)
- Received live attenuated vaccine within one month before vaccination;
- Received inactivated vaccine within 14 days before vaccination;
- Other contraindications related to vaccination that investigators believe.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 LIBP-Rec-Vaccine Group LIBP-Rec-Vaccine Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months Cohort 1 BIBP-Rec-Vaccine Group BIBP-Rec-Vaccine Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months Cohort 2 LIBP-Rec-Vaccine Group LIBP-Rec-Vaccine Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months Cohort 2 BIBP-Rec-Vaccine Group BIBP-Rec-Vaccine Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months Cohort 1 placebo control group placebo Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months
- Primary Outcome Measures
Name Time Method Cohort 1: Efficacy of LIBP-Rec-Vaccine/ BIBP-Rec-Vaccine against COVID-19 of immunization in healthy population aged 18 and above. 14th day after vaccination Rates of cohort 1 subjects not infected with COVID-19
- Secondary Outcome Measures
Name Time Method GMT of subject's anti-SARS-CoV-2 neutralizing antibody is non-inferior to that of Cohort 1（ LIBP-Rec-Vaccine / BIBP-Rec-Vaccine） 14th day after vaccination Cohort 2 Immunogenicity subgroup only
GMI of subject's anti- SARS-CoV-2 neutralizing antibody 3th month、6th month after vaccination Immunogenicity subgroup only
The incidence and severity of unsolicited adverse reactions within 0-7 days after vaccination The incidence of AESI observed Within 6 months of vaccination The incidence and severity of solicited adverse reactions within 8-30 days after vaccination The incidence and severity of any adverse reactions within 30 minutes after vaccination The incidence and severity of solicited adverse events within 8-30 days after vaccination Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 asymptomatic infection in healthy population aged 18 and above 14th day after vaccination Rates of cohort 1 subjects who are not asymptomatic infection with COVID-19
Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 severe cases in healthy population aged 18 and above 14th day after vaccination Rates of cohort 1 subjects who are not severe cases with COVID-19
Cohort 1: Efficacy of LIBP-Rec-Vaccine / BIBP-Rec-Vaccine against COVID-19 related deaths in healthy population aged 18 and above. 14th day after vaccination Rates of cohort 1 subjects who are not related deaths with COVID-19
GMT of subject's anti- SARS-CoV-2 neutralizing antibody 3th month、6th month after vaccination Immunogenicity subgroup only
4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody 3th month、6th month after vaccination Immunogenicity subgroup only
The incidence of SAE observed Within 6 months of vaccination Cross-neutralizing effect of recombinant COVID-19 vaccine against different variants (prototype strain, Delta, Omicron and other potential emerging dominant circulating variants) 14th day after vaccination Immunogenicity subgroup only
Trial Locations
- Locations (1)
Sheikh Khalifa Medical City
🇦🇪Seha, Abu Dhab, United Arab Emirates