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OpenTrials
Completed

NCT Number: NCT05907044

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Hospital of Yunnan University

Kunming, Yunnan, 650091, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RQ3013

Biological

0.15mL/dose containing mRNA 30μg

RQ3025

Biological

0.15mL/dose containing mRNA 30μg

RQ3027

Biological

0.15mL/dose containing mRNA 30μg

Primary outcomes

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

    Time frame: Day 14

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

    Time frame: Up to Day 14( 7 days after vaccination)

Secondary outcomes

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

    Time frame: Day 0, Day 7, Day 28, Day 90, Day 180

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

    Time frame: Up to Day 180( 28 days after vaccination)

  3. Number of Participants with Serious AEs(SAEs)

    Time frame: Up to Day 180

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

    Time frame: Day 7, Day 28, Day 90, Day 180

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Yunnan University

Other

Collaborators

  • Kunming Medical University
  • Yunnan University

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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