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

NCT05394012 | Unknown Phase 1 DMC

• 1 other identifier: RQ3013-004
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase Ⅰa, randomized, double-blind, positive control trial in healthy adults, intended to evaluate the safety and immunogenicity profile of RQ3013. The study vaccine is administered IM at upper arm deltoid as a two-dose primary series on day 0, 28.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Immediate adverse events (AEs) within 30 minutes after each vaccination, solicited local and systemic AEs for within 14 days and unsolicited AEs within 28 days following each vaccination

  within 14 days and 28 days following each vaccination

Secondary Outcomes (8)

• Serious adverse events (SAEs) and adverse event of special interest (AESI) from first vaccination to 12 months after full immunization

  from first vaccination to 12 months after full immunization

• Changes of laboratory safety measures at day 4 following each vaccination in comparison to pre-vaccination levels

  day 4 following each vaccination in comparison to pre-vaccination levels

• Live virus GMT, GMFR and seroconversion rates against Beta and Omicron in serum at pre dose 1, 28 days post dose 1 (pre-dose 2), 14, 28 days post dose 2

  pre dose 1, 28 days post dose 1 (pre-dose 2), 14, 28 days post dose 2

• Pseudovirus GMT, GMFR and seroconversion rates against SARS-CoV-2 Beta and Omicron strain in serum at pre dose 1, 28 days post dose 1 (pre-dose 2), 14, 28 days post dose 2

  pre dose 1, 28 days post dose 1 (pre-dose 2), 14, 28 days post dose 2

• GMT, GMFR and seroconversion rates of S-Protein Specific IgGs at pre dose 1, 28 days post dose 1 (pre-dose 2), 14, 28 days post dose 2

  pre dose 1, 28 days post dose 1 (pre-dose 2), 14, 28 days post dose 2

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) at baseline and day 7, 14 after the second dose

  at baseline and day 7, 14 after the second dose

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

  at baseline and day 7, 14 after the second dose

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

  at baseline and 28 days, 3, 6 months after the second dose

Study Arms (2)

RQ3013

EXPERIMENTAL

Biological: RQ3013

Comirnaty

ACTIVE COMPARATOR

Biological: Comirnaty

Interventions

RQ3013 BIOLOGICAL

Two doses of 30 μg/0.15 mL at an interval of 28 days, or two doses of 60 μg/0.3 mL at an interval of 28 days

RQ3013

Comirnaty BIOLOGICAL

Two doses of 30 μg/0.3 mL at an interval of 28 days

Comirnaty

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants 18-59 years, and both males and females should be included;
• Participants who agree to participate in this clinical trial voluntarily and sign the informed consent form, capable of providing valid identification, understanding and complying with the requirements of the clinical protocol.
• 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 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.).
• Body mass index within range of 18\~30 kg/m2

You may not qualify if:

• Abnormal results of laboratory screening tests (exceeding the upper or lower limit of the normal reference range by a factor of 1.2) which was clinically significant judged by clinicians at screening;
• Abnormal vital signs with clinical significance at screening, with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, or pulse \<50 beats/min or \>100 beats/min under conscious state, or axillary temperature ≥ 37.3°C at screening;
• Known allergy, or history of anaphylaxis, or other serious adverse reactions to study vaccine or its excipients;
• History of human coronavirus infection/diseases, such as 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 either SARS-CoV-2 nucleic acid or antibody tests (IgG and IgM) at screening;
• Administration of antipyretics or painkillers within 24 hours prior to vaccination;
• Receipt of any COVID-19 vaccine, live attenuated vaccine within 28 days prior to vaccination, subunit and inactivated vaccine within 14 days prior to vaccination;
• Blood donation or blood loss (≥450 mL), or receipt of blood or blood-related products, including immunoglobulins, within 3 months prior to vaccination; or any planned blood donation or blood products use during the study period.
• Participants with the following disease:
• Any acute diseases or acute attacks of chronic diseases within 7 days prior to vaccination；
• 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 27, 2022
• Study Start: December 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: June 1, 2023
• Last Updated: November 18, 2022

Record last verified: 2022-11