NCT05599516

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16,000

participants targeted

Target at P75+ for phase_3 covid19

Timeline
Completed

Started Nov 2022

Typical duration for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

November 4, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

11 months

First QC Date

October 27, 2022

Last Update Submit

November 7, 2022

Conditions

COVID-19Coronavirus Infections

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Cohort 1: Efficacy of LIBP-Rec-Vaccine/ BIBP-Rec-Vaccine against COVID-19 of immunization in healthy population aged 18 and above.

    Rates of cohort 1 subjects not infected with COVID-19

    14th day after vaccination

Secondary Outcomes (19)

  • 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

  • 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

  • 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

  • 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

  • GMT of subject's anti- SARS-CoV-2 neutralizing antibody

    14th day、28th day after vaccination

  • +14 more secondary outcomes

Other Outcomes (2)

  • Subject's the genotypes of SARS-CoV-2 virus in endpoint cases

    During the study, approximately 14 months

  • Explore the occurrence of ADE/VED following immunization with LIBP-Rec-Vaccine and BIBP-Rec-Vaccine

    During the study, approximately 14 months

Study Arms (5)

Cohort 1 LIBP-Rec-Vaccine Group

EXPERIMENTAL

Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months

Biological: LIBP-Rec-Vaccine

Cohort 1 BIBP-Rec-Vaccine Group

EXPERIMENTAL

Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months

Biological: BIBP-Rec-Vaccine

Cohort 1 placebo control group

PLACEBO COMPARATOR

Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months

Biological: placebo

Cohort 2 LIBP-Rec-Vaccine Group

EXPERIMENTAL

Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months

Biological: LIBP-Rec-Vaccine

Cohort 2 BIBP-Rec-Vaccine Group

EXPERIMENTAL

Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months

Biological: BIBP-Rec-Vaccine

Interventions

LIBP-Rec-VaccineBIOLOGICAL

Intramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm

Cohort 1 LIBP-Rec-Vaccine GroupCohort 2 LIBP-Rec-Vaccine Group
BIBP-Rec-VaccineBIOLOGICAL

Intramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm

Cohort 1 BIBP-Rec-Vaccine GroupCohort 2 BIBP-Rec-Vaccine Group
placeboBIOLOGICAL

Intramuscular injection of placebo in the deltoid muscle of the upper arm

Cohort 1 placebo control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheikh Khalifa Medical City

SEHA, Abu Dhab, 519000, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2022

First Posted

October 31, 2022

Study Start

November 4, 2022

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

November 10, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

AE(1)