NCT05373485

Brief Summary

To evaluate the safety and immunogenicity of the COVID-19 mRNA vaccine in people aged 18 years and older, 80 participants will be enrolled and divided into two groups: low- and high-dose groups. Each dose group will be divided into 2 age groups (20 people each):18 to 59 years old and ≥ 60 years old. Subjects will be randomized into vaccine group or placebo group in a ratio of 3:1. Subjects will receive 2 doses of either vaccine or placebo on Day 0 and Day 21, in which the low-dose group will received 0.3 ml of the study vaccine or placebo, and the high dose group will receive 0.5 ml of the study vaccine or placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_1 covid19

Timeline
Completed

Started May 2022

Shorter than P25 for phase_1 covid19

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 17, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2022

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

May 12, 2022

Last Update Submit

December 2, 2024

Conditions

COVID-19

Keywords

COVIDmRNAVaccinePlaceboSafetyImmunogenicity

Outcome Measures

Primary Outcomes (1)

  • The incidence of adverse reactions (AR)

    To evaluate the incidence of adverse reactions (AR) within 14 days of immunization in all subjects

    within 14 days of immunization

Secondary Outcomes (17)

  • The incidence of adverse reactions (AR)

    within 28 days of immunization

  • The incidence of SAE, MAE and AESI

    From vaccination to post of 12 months vaccination

  • The incidence of adverse reactions (AR)

    Within 60 minutes of each vaccination

  • Changes in laboratory indicators

    Day 4 and Day 7 post each vaccination

  • Changes in laboratory indicators

    Day 4 and Day 7 post each vaccination

  • +12 more secondary outcomes

Study Arms (8)

Vaccine Group, low dose, 18-59 year-old

EXPERIMENTAL

2 doses of COVID-19 mRNA vaccine (30µg, 0.3 ml) on Day 0 and Day 21

Biological: COVID-19 mRNA vaccine

Vaccine Group, low dose, 60 year-old and above

EXPERIMENTAL

2 doses of COVID-19 mRNA vaccine (30µg, 0.3 ml) on Day 0 and Day 21

Biological: COVID-19 mRNA vaccine

Vaccine Group, high dose, 18-59 year-old

EXPERIMENTAL

2 doses of COVID-19 mRNA vaccine (50µg, 0.5 ml) on Day 0 and Day 21

Biological: COVID-19 mRNA vaccine

Vaccine Group, high dose, 60 year-old and above

EXPERIMENTAL

2 doses of COVID-19 mRNA vaccine (50µg, 0.5 ml) on Day 0 and Day 21

Biological: COVID-19 mRNA vaccine

Placebo Group, low dose, 18-59 year-old

PLACEBO COMPARATOR

2 doses of placebo (0µg, 0.3 ml) on Day 0 and Day 21

Biological: Placebo

Placebo Group, low dose, 60 year-old and above

PLACEBO COMPARATOR

2 doses of placebo (0µg, 0.3 ml) on Day 0 and Day 21

Biological: Placebo

Placebo Group, high dose, 18-59 year-old

PLACEBO COMPARATOR

2 doses of placebo (0µg, 0.5 ml) on Day 0 and Day 21

Biological: Placebo

Placebo Group, high dose, 60 year-old and above

PLACEBO COMPARATOR

2 doses of placebo (0µg, 0.5 ml) on Day 0 and Day 21

Biological: Placebo

Interventions

COVID-19 mRNA vaccineBIOLOGICAL

2 doses of vaccine on Day 0 and Day 21

Vaccine Group, high dose, 18-59 year-oldVaccine Group, high dose, 60 year-old and aboveVaccine Group, low dose, 18-59 year-oldVaccine Group, low dose, 60 year-old and above
PlaceboBIOLOGICAL

2 doses of placebo on Day 0 and Day 21

Placebo Group, high dose, 18-59 year-oldPlacebo Group, high dose, 60 year-old and abovePlacebo Group, low dose, 18-59 year-oldPlacebo Group, low dose, 60 year-old and above

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years and above with BMI of 18 to 30 (including boundary values);
  • Volunteers are able and willing to comply with the requirements of the clinical trial protocol, and volunteers or witnesses can sign informed consent forms;
  • Willing to discuss the medical history with the investigator or doctor and allow access to all medical records related to this trial;
  • Provide 48-hour PCR negative report;
  • Have not received any other COVID-19 vaccines.

You may not qualify if:

  • Other medical or psychiatric conditions, including recent (within the past year) or current presence of suicidal ideation/behavior, or laboratory abnormalities that may increase the risk of participating in the study, or subjects who are not suitable to participate in the study according to the investigator's judgment;
  • Positive for human immunodeficiency virus (HIV);
  • History of infection or disease of Middle East Respiratory Syndrome (MERS), SARS or other coronaviruses or related immunizations;
  • History of serious adverse reactions associated with the vaccine and/or a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine under study;
  • Immunocompromised patients with known or suspected immunodeficiency identified by medical history and/or physical examination;
  • Bleeding constitution or condition associated with prolonged bleeding which investigators believe that intramuscular injection is contraindicated;
  • Women who test positive for blood pregnancy or are breastfeeding, volunteers or their partners have a pregnancy plan within 12 months;
  • Severe hypertension and uncontrollable medication (on-site measurement: systolic blood pressure ≥ 160mmHg, diastolic blood pressure ≥ 100mmHg);
  • Have a serious chronic disease or the condition is in the progression period can not be smoothly controlled, such as diabetes, thyroid disease, etc.;
  • History of severe myocarditis, pericarditis and other heart diseases;
  • Abnormal laboratory tests during the screening window and judged by researchers to be of clinical significance;
  • Plans to receive other vaccines within 28 days before and after receiving the test vaccine;
  • Those receiving immunosuppressive therapy, including cytotoxic drugs or systemic corticosteroids, such as for cancer or autoimmune diseases, or who were scheduled to receive treatment throughout the study period. If systemic corticosteroids are used in a short period of time (\< 14 days) for the treatment of acute illness, subjects should not enter this study until at least 28 days after corticosteroid therapy has been discontinued prior to study vaccination. Inhalation/spraying, intra-articular, intraskeletal, or topical (skin or eyes) use of corticosteroids is permitted;
  • Receiving blood/plasma products or immunoglobulins 60 days prior to study vaccination or plan to receive for the entire study duration;
  • Engage in other interventional studies within 28 days prior to entering the study and/or during the study's participation;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Location

Hebei Petro China Center Hospital

Langfang, Hebei, China

Location

Hunan Provincial Center for Disease Control and Prevention

Changsha, Hunan, China

Location

Related Publications (1)

  • Jin Z, Wu J, Wang Y, Huang T, Zhao K, Liu J, Wang H, Zhu T, Gou J, Huang H, Wu X, Yin H, Song J, Li R, Zhang J, Li L, Chen J, Li X, Zhang M, Li J, Hou M, Song Y, Wang B, Gao Q, Wu L, Kong Y, Dong R. Safety and immunogenicity of the COVID-19 mRNA vaccine CS-2034: A randomized, double-blind, dose-exploration, placebo-controlled multicenter Phase I clinical trial in healthy Chinese adults. J Infect. 2023 Dec;87(6):556-570. doi: 10.1016/j.jinf.2023.10.012. Epub 2023 Oct 28.

    PMID: 37898410DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

CVnCoV COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ruihua Dong

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

  • Kexin Zhao

    Hebei Petro China Center Hospital

    PRINCIPAL INVESTIGATOR

  • Tao Huang

    Hunan Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 13, 2022

Study Start

May 17, 2022

Primary Completion

August 8, 2022

Study Completion

August 8, 2022

Last Updated

December 4, 2024

Record last verified: 2024-12

Locations

CN(3)