A Phase III Clinical Study of a SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine Candidate Against COVID-19 in Population Aged 18 Years and Above

NCT04847102 | Unknown Phase 3

• 1 other identifier: ARCoV-005
• Study Type: interventional
• Target: 28,000
• Locations: 2 countries
• Sites: 12

Brief Summary

Approximately 28,000 subjects will be enrolled in this trial. Eligible subjects will be stratified by age (\<60 years of age and ≥60 years of age, the proportion of elderly people ≥60 years old is planned to be ≥25%) and randomly assigned into the study group and the control group at a ratio of 1:1 (14,000 in each group) to be intramuscularly administered with the investigational vaccine or placebo in a 2-dose regimen at an interval of 28 days. The experimental vaccines will be cross-vaccinated after available data of the investigational vaccine show that expected efficacy and good safety have been achieved (i.e., subjects in the study group will be vaccinated with placebo and those in the control group will be vaccinated with the investigational vaccine in the same schedule as stated above ). After the completion of the second dose for crossover vaccination, subjects will be followed up for 12 months for safety observation. An immunogenicity subgroup (n≥3000) and a reactogenicity subgroup (n≥6000) will also be included in this trial to evaluate the humoral immunity induced by the investigational vaccine and the solicited adverse events observed within 7 days post immunization. All enrolled subjects will be followed up for the evaluation of protective efficacy as well, which will be primarily characterized by the incidence rate (person-year) of COVID-19 cases collected from 14 days after complete series. Adverse events will be collected over 0-28 days after each vaccination and serious adverse events will be collected from Dose 1 through 12 months post complete series.

Conditions

COVID-19; SARS-CoV-2

Keywords

SARS-CoV-2 mRNA vaccine; Efficacy; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (3)

• Primary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases

  The incidence rate (person-year) of COVID-19 cases collected from 14 days after complete series in subjects aged 18 years and above.

  From 14 days after complete series

• Primary safety endpoint as measured by the incidence rates of adverse events

  Incidence rates of adverse events observed for all subjects within 28 days post each vaccination;

  Within 28 days post each vaccination

• Primary safety endpoint as measured by the incidence rates of serious adverse events

  Incidence rates of solicited adverse events observed for subjects included in the reactogenicity subgroup within 30 minutes and at 7 days post each vaccination.

  At 7 days post each vaccination

Secondary Outcomes (4)

• Secondary efficacy endpoint as measured by the incidence rate (person-year) of severe and critical COVID-19 cases

  From 14 days after complete series

• Secondary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases resulting in deaths

  From 14 days after complete series

• Secondary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases post 1 dose of vaccination

  From 14 days after Dose 1

• Secondary safety endpoint as measured by the incidence rate of serious adverse events

  From Dose 1 through 12 months after complete series

Study Arms (2)

Study group

EXPERIMENTAL

Biological: SARS-CoV-2 mRNA Vaccine; Biological: Placebo

Control group

PLACEBO COMPARATOR

Biological: SARS-CoV-2 mRNA Vaccine; Biological: Placebo

Interventions

SARS-CoV-2 mRNA Vaccine BIOLOGICAL

The SARS-CoV-2 mRNA Vaccine is formulated by encapsulating the mRNA, which encodes the receptor-binding domain (RBD) of spike glycoprotein (S protein) of SARS-CoV-2 and is transcribed in-vitro by the corresponding DNA template, in lipid nanoparticles (LNPs). This vaccine is presented as a white to off-white dispersion for injection. Active substances: mRNA encoding the RBD of the S protein of SARS-CoV-2. The vaccine is supplied in single-dose pre-filled syringe with 0.5 mL dispersion for intramuscular injection. Each dose (0.5 mL) of the vaccine contains: 15 μg of mRNA encoding the RBD of the spike glycoprotein (S protein) of SARS-CoV-2, 0.339 mg of total lipids (including lipid 9001, cholesterol, DSPC, DMG-PEG2000).

Control group; Study group

Placebo BIOLOGICAL

0.9% sodium chloride solution, 0.5 mL/vial

Control group; Study group

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 and above (both males and females are required);
• Individuals who are able to understand the contents listed in the informed consent form and the procedure of this clinical trial; are able to sign the informed consent form voluntarily;
• Individuals who are able to communicate well with the investigator and has the ability to understand and comply with the requirements of the clinical trial;
• Individuals who are at risk of SARS-CoV-2 infection or are exposed to COVID-19 due to regional, occupational, activity and environmental factors;
• For female participants of childbearing potential, effective contraception should be used within 2 weeks prior to participation in this study and the pregnancy test results is required to be negative (those with amenorrhea of at least 1 year or surgical sterilization verified by medical records could be exempted from the pregnancy test). Participants should voluntarily agree to continue using at least one effective methods of contraception for 12 months after complete series (effective methods include oral contraceptives, injectable or implantable contraceptives, sustained-release topical contraceptives, hormonal patches, intrauterine device, sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.).
• Healthy individuals with verified medical history: individuals who are in a stable condition and whose current diseases will not worsen for at least 3 months prior to enrollment to this study.

You may not qualify if:

• Individuals with a history of SARS-CoV-2 infection or use of any preventive products for COVID-19 (e.g., a history of any SARS-CoV-2 vaccines that have or have not been marketed);
• Individuals with SARS-CoV-2 etiological testing (RT-PCR Assay) (individuals with serological testing showing positive IgG and/or IgM antibodies may be enrolled);
• Individuals with a previous history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) and other human coronavirus infections or diseases;
• Individuals who have fever within 72 hours prior to Dose 1 in this trial (oral temperature ≥38°C);
• Pregnant (e.g., positive pregnancy test) or lactating females;
• Individuals who have plan of pregnancy or interruption of effective contraceptive methods within 3 months after the second cross-vaccination in this study;
• Personnel of the study site or the sponsor;
• Individuals with prior history of allergic reaction or anaphylaxis to any vaccine or drug, e.g., hypersensitivity, urticaria, serious eczema, dyspnea, laryngeal edema, and angioedema etc.;
• Individuals who have been vaccinated with any vaccine other than the investigational vaccine used in this clinical trial from 28 days prior to Dose 1 to 28 days after Dose 2;
• Individuals who have participated in or plan to participate in other drug clinical trials form 28 days prior to Dose 1 to 12 months after Dose 4 (the second dose of cross-vaccination) in this study;
• Individuals who have hereditary hemorrhagic tendency or coagulation dysfunction (e.g., cytokine defects, coagulation disorders or platelet disorder), or a history of significant bleeding, or a history of injury caused by intramuscular injection or venipuncture;
• Individuals who are confirmed for diseases affecting immune system function, including cancer (except skin basal cell carcinoma), congenital or acquired immunodeficiency (e.g., infection with human immunodeficiency virus (HIV)), and uncontrolled autoimmune disease, based on known history or diagnosis;
• Individuals who have asplenia or functional asplenia;
• Individuals with long-term use (continuous use ≥14 days) of immunosuppressants or other immunomodulatory drugs (e.g., corticosteroids: prednisone or similar drugs) within 6 months prior to Dose 1. Drugs for topical use (e.g., ointment, eye drops, inhalants or nasal spray) are allowed in this study, and the topical medications should not exceed the recommended dose in the labels for use or induce any signs of systemic exposure;
• Individuals who have received immunoglobulin and/or blood products within 3 months prior to Dose 1;

Sponsors & Collaborators

• Walvax Biotechnology Co., Ltd.: lead
• Abogen Biosciences Co. Ltd.: collaborator
• Yuxi Walvax Biotechnology Co., Ltd.: collaborator

Study Sites (12)

Persahabatan Hospital

Jakarta, Indonesia

RECRUITING

Puskesmas Duren Sawit

Jakarta, Indonesia

RECRUITING

Puskesmas Kalideres

Jakarta, Indonesia

RECRUITING

Puskesmas Kebayoran Lama

Jakarta, Indonesia

RECRUITING

Puskesmas Pulogadung

Jakarta, Indonesia

RECRUITING

Centro de Investigación Clínica del Pacifico S.A. de C.V. (CICPA)

Acapulco, Mexico

RECRUITING

Centro de Investigación y Avances Médicos Especializados (CIAME)

Cancún, Mexico

RECRUITING

Centro de Especialidades Médicas Aplicadas

Mexico City, Mexico

RECRUITING

Instituto Nacional de Pediatría (INP)

Mexico City, Mexico

RECRUITING

Oaxaca site management organization (OSMO)

Oaxaca City, Mexico

RECRUITING

Asociación Mexicana para la investigación clínica, A.C. (AMIC)

Pachuca, Mexico

RECRUITING

Oncológico Potosino

San Luis Potosí City, Mexico

RECRUITING

Related Publications (2)

• Liu X, Li Y, Wang Z, Cao S, Huang W, Yuan L, Huang YJ, Zheng Y, Chen J, Ying B, Xiang Z, Shi J, Zhao J, Huang Z, Qin CF. Safety and superior immunogenicity of heterologous boosting with an RBD-based SARS-CoV-2 mRNA vaccine in Chinese adults. Cell Res. 2022 Aug;32(8):777-780. doi: 10.1038/s41422-022-00681-3. Epub 2022 Jun 14. No abstract available.

  PMID: 35701541 DERIVED

• Zhang NN, Zhang RR, Zhang YF, Ji K, Xiong XC, Qin QS, Gao P, Lu XS, Zhou HY, Song HF, Ying B, Qin CF. Rapid development of an updated mRNA vaccine against the SARS-CoV-2 Omicron variant. Cell Res. 2022 Apr;32(4):401-403. doi: 10.1038/s41422-022-00626-w. Epub 2022 Feb 14. No abstract available.

  PMID: 35165421 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

CVnCoV COVID-19 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

Central Study Contacts

Shuyuan Yang

CONTACT

+86 18687832269; ynwsysy@walvax.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 15, 2021
• Study Start: July 22, 2021
• Primary Completion: November 30, 2021
• Study Completion: May 30, 2023
• Last Updated: November 18, 2021

Record last verified: 2021-11

Locations

ME (7); ID (5)