A Phase 1b Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine Against COVID-19

NCT05396573 | Unknown Phase 1 DMC

• 1 other identifier: RQ3013-005
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase 1b, randomized, double-blind, positive control trial in healthy adults, intended to evaluate the safety and immunogenicity profile of RQ3013 in healthy adults primed with a two-dose inactivated vaccine 6-9 months earlier. The study vaccine is administered IM in the upper arm deltoid as single booster shot on day 0.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Immediate AEs within 30 minutes after booster vaccination, solicited local and systemic AEs for within 7 days and unsolicited AEs within 28 days following booster vaccination

  within 28 days following booster vaccination

Secondary Outcomes (8)

• Live virus GMT, GMFR and seroconversion rate against Beta and Omicron strain in serum measured at pre booster dose and day 7, 14, 28 after booster dose

  pre booster dose and day 7, 14, 28 after booster dose

• Pseudovirus GMT, GMFR and seroconversion rate against SARS-CoV-2 Beta and Omicron strain in serum measured at pre booster dose and day 7, 14, 28 after booster dose

  pre booster dose and day 7, 14, 28 after booster dose

• GMT, GMFR and seroconversion rate of S-Protein Specific IgGs in serum measured at pre booster dose and day 7, 14, 28 after booster dose

  pre booster dose and day 7, 14, 28 after booster dose

• Live virus GMT, GMFR and seroconversion rate against Beta and Omicron strain in serum measured at 3, 6, 12 months after booster dose

  3, 6, 12 months after booster dose

• Pseudovirus GMT, GMFR and seroconversion rate against SARS-CoV-2 Beta and Omicron strain in serum measured at 3, 6, 12 months after booster dose

  3, 6, 12 months after booster dose

Other Outcomes (3)

• Spike protein specific CD4+, CD8+, CD4+IFN-γ+, CD4+IL-2+, CD4+TNFα+, CD4+IL-4+, CD4+IL-13+, CD8+IFN-γ+, CD8+IL-2+, CD8+TNFα+ cytokine profiling (flow cytometry) by flow cytometry at baseline and day 7, 14 after booster

  baseline and day 7, 14 after booster

• Spike protein specific cytokine responses by enzyme-linked immunospot (ELISPOT) assay, IFN-γ, IL-2, IL-4 at baseline and day 7, 14 after booster

  baseline and day 7, 14 after booster

• Spike protein specific T memory cell responses: CD4+ and CD8+ TCM(CCR7+CD45RA-), TEM(CCR7-CD45RA-) and TSCM(CCR7+CD45RA+CD95+) at baseline and 28 days, 3, 6 months after booster

  baseline and 28 days, 3, 6 months after booster

Study Arms (2)

RQ3013

EXPERIMENTAL

Biological: RQ3013

Comirnaty

ACTIVE COMPARATOR

Biological: Comirnaty

Interventions

RQ3013 BIOLOGICAL

A single dose of 30 μg/0.15 mL, a single dose of 60 μg/0.3 mL

RQ3013

Comirnaty BIOLOGICAL

A single dose of 30 μg/0.3 mL

Comirnaty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy participants 18-59 years and 60 years and older, and both males and females should be included;
• Participants who agree to participate in this clinical trial voluntarily and sign the informed consent form, are capable of providing valid identification, understanding and complying with the requirements of the clinical protocol.
• Participants who have been primed with a two-dose inactivated vaccine 6-9 months earlier, and the intervals between the two inactivated vaccines was between 21 and 42 days.
• For female participants of childbearing potential, effective contraception measures should be used within 2 weeks prior to participation in this study and the results of the pregnancy test must be negative. Participants must voluntarily agree to use effective contraceptive measures from the time of signing the informed consent form to the end of the study (effective contraceptive measures including oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release topical contraceptives, hormonal patches, intrauterine device, sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.).

You may not qualify if:

• Receipt of any COVID-19 prophylactic medication other than a primary series of inactivated vaccine (e.g., receipt history of any approved or under developing COVID-19 vaccines, or other COVID-19 prophylactic medication, etc.), or non-standard primary series of inactivated vaccine;
• Abnormal vital signs with clinical significance at screening, with systolic blood pressure ≥140 mmHg (≥150 mmHg for participants aged ≥ 60 years) and/or diastolic blood pressure ≥90 mmHg, or axillary body temperature ≥ 37.3°C, or abnormal results of laboratory screening tests which was clinically significant at screening;
• Known allergy, or history of anaphylaxis or other serious adverse reactions to the study vaccine or its excipients;
• History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS);
• History of COVID-19, or history of close contact with confirmed/suspected COVID-19 patients, or positive results for SARS-CoV-2 nucleic acid tests at screening;
• Administration of antipyretics or painkillers within 24 hours prior to vaccination;
• Receipt of any live attenuated vaccine within 28 days prior to vaccination, or subunit and inactivated vaccine within 14 days prior to vaccination;
• Receipt of blood or blood-related products, including immunoglobulins, within 3 months prior to vaccination; or any planned use during the study period.
• Participants with the following diseases:
• Any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment；
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.；
• Congenital or acquired immunodeficiency or autoimmune disease, or long-term receipt (\>14 consecutive days) of glucocorticoid (reference value for dose: ≥20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 6 months, with exception of inhaled or topical steroids, or short-term use (≤14 consecutive days) of oral corticosteroids；
• Currently suffering from or previously diagnosed with infectious diseases, positive screening results for hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, human immunodeficiency virus antibody；
• History or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders；
• Asplenia, or functional asplenia；

Sponsors & Collaborators

• Walvax Biotechnology Co., Ltd.: lead
• Shanghai RNACure Biopharma Co., Ltd.: collaborator

MeSH Terms

Conditions

COVID-19

Interventions

RQ3013 COVID-19 vaccine; BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Lin Yuan

  Walvax Biotechnology Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Shuyuan Yang

CONTACT

(+86)18687832269; ynwsysy@walvax.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: July 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: July 1, 2023
• Last Updated: May 31, 2022

Record last verified: 2022-05