NCT05907044

Brief Summary

This clinical trial aimed to gather safety and immunogenicity data in COVID-19 vaccine-experienced healthy adults. The main questions it aims to answer are:

  • The neutralizing antibodies levels of bivalent mRNA vaccines RQ3027(Alpha/Beta+Omicron XBB.1.5) and RQ3025(Alpha/Beta+Omicron BA.2/4/5) and monovalent mRNA vaccine RQ3013 against the current SARS-CoV-2 circulating variant.
  • The safety profile of RQ3027 and RQ3025 given as a second booster dose to COVID-19 vaccine-experienced participants 18 through 55 years of age.
  • Explore the protective efficacy by documenting confirmed COVID-19 cases after vaccination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
376

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 8, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2023

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

1 month

First QC Date

June 8, 2023

Last Update Submit

January 23, 2024

Conditions

COVID-19

Keywords

mRNA vaccineSARS-CoV-2

Outcome Measures

Primary Outcomes (2)

  • Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5

    Day 14

  • Number of Participants with Solicited Local and Systemic Averse Events(AEs)

    Up to Day 14( 7 days after vaccination)

Secondary Outcomes (4)

  • Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5

    Day 0, Day 7, Day 28, Day 90, Day 180

  • Number of Participants with Unsolicited Local and Systemic Averse Events(AEs)

    Up to Day 180( 28 days after vaccination)

  • Number of Participants with Serious AEs(SAEs)

    Up to Day 180

  • The proportion of T cell subsets which secreted by S protein-specific cytokines (IFN-γ, IL-4)

    Day 7, Day 28, Day 90, Day 180

Study Arms (3)

RQ3013

ACTIVE COMPARATOR

C-3013B-202211005, Alpha/Beta, mRNA 30μg dose

Biological: RQ3013

RQ3025

EXPERIMENTAL

INDA-3025TB-20221002, Alpha/Beta + Omicron BA.2/4/5, mRNA 30μg dose

Biological: RQ3025

RQ3027

EXPERIMENTAL

IND-3027TB-202304001, Alpha/Beta + Omicron XBB.1.5, mRNA 30μg dose

Biological: RQ3027

Interventions

RQ3013BIOLOGICAL

0.15mL/dose containing mRNA 30μg

RQ3013
RQ3025BIOLOGICAL

0.15mL/dose containing mRNA 30μg

RQ3025
RQ3027BIOLOGICAL

0.15mL/dose containing mRNA 30μg

RQ3027

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants 18 through 55 years of ages.
  • Participants who have received at least 3 doses COVID-19 vaccine.
  • Participants with the last prior dose being 90 or more days before Visit 1(Day 0) or recovered from COVID-19 at least 28 days.
  • Participants able to comply with all scheduled visits, laboratory tests and investigator's instruction.

You may not qualify if:

  • Women who are pregnant or breastfeeding.
  • Enrolling in or planning to participate other interventional clinical study.
  • Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening.
  • History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
  • Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
  • Continued using anticoagulants such as coumarin and related anticoagulants (i.e., warfarin) or oral anticoagulants (i.e., apixaban, rivaroxaban, dabigatran, and edoxaban).
  • Having coronary heart disease, hypertension, diabetes, chronic respiratory diseases, tumors and poorly controlled.
  • Immunocompromised or having immunosuppressive therapy.
  • Suspected or confirmed alcohol/drug dependence.
  • Investigator decide unsuitable factors for participating in clinical trials in the investigator's judgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Yunnan University

Kunming, Yunnan, 650091, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

RQ3013 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 8, 2023

First Posted

June 18, 2023

Study Start

May 8, 2023

Primary Completion

June 10, 2023

Study Completion

November 23, 2023

Last Updated

January 24, 2024

Record last verified: 2024-01

Locations

CN(1)