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A Study to Investigate the Safety, Immunogenicity of Bivalent mRNA Vaccine RQ3027 and RQ3025 as a Booster Dose in Healthy Adults

Sponsor
Affiliated Hospital of Yunnan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05907044
Collaborator
Yunnan University (Other), Kunming Medical University (Other)
420
Enrollment
1
Location
3
Arms
6.5
Anticipated Duration (Months)
64.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: RQ3013
  • Biological: RQ3025
  • Biological: RQ3027
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
420 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
An Interventional, Randomized, Parallel Controlled, Investigator Initiated Study to Investigate the Safety, Immunogenicity of Bivalent RQ3027 and RQ3025 mRNA Vaccine as a Booster Dose in 3 Doses COVID-19 Vaccine-Experienced Healthy Adults
Actual Study Start Date :
May 8, 2023
Actual Primary Completion Date :
Jun 10, 2023
Anticipated Study Completion Date :
Nov 23, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: RQ3013

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

Biological: RQ3013
0.15mL/dose containing mRNA 30μg
Experimental: RQ3025

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

Biological: RQ3025
0.15mL/dose containing mRNA 30μg
Experimental: RQ3027

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

Biological: RQ3027
0.15mL/dose containing mRNA 30μg

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. Number of Participants with Solicited Local and Systemic Averse Events(AEs) [Up to Day 14( 7 days after vaccination)]

Secondary Outcome Measures

  1. 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]

  2. Number of Participants with Unsolicited Local and Systemic Averse Events(AEs) [Up to Day 180( 28 days after vaccination)]

  3. Number of Participants with Serious AEs(SAEs) [Up to Day 180]

  4. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.

  • 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.

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Affiliated Hospital of Yunnan University Kunming Yunnan China 650091

Sponsors and Collaborators

  • Affiliated Hospital of Yunnan University
  • Yunnan University
  • Kunming Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jia Wei, Professor, Affiliated Hospital of Yunnan University
ClinicalTrials.gov Identifier:
NCT05907044
Other Study ID Numbers:
  • YNUVC-2022003
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 26, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jia Wei, Professor, Affiliated Hospital of Yunnan University
mRNA vaccine
SARS-CoV-2
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Jun 26, 2023