Official Title
A Clinical Study to Evaluate the Safety and Immunogenicity of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Participants Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines
Brief Summary

A Clinical Study to Evaluate the Safety and Immunogenicity of Sequential Immunization ofRecombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Adults Aged 18 Years andOlder After the Vaccination of 2 Doses of Inactivated Vaccines

Detailed Description

This is a single arm, open-label clinical study. 34 participants aged 18 years and older
who have completed the 2 doses of administration of inactive vaccines will be enrolled in
this study to evaluate the safety and immunogenicity of V-01.

The participants will be collected blood before immunization, on day 7, day 14, day 28,
day 90 and 6 month to evaluate humoral immunity.

All adverse events (AEs) within 30 minutes and 0-7 days after booster immunization, and
unsolicited AEs from 8 to 28 days after booster immunization, as well as SAEs and AESIs
from the first vaccination to 12 months after booster immunization will be collected from
all participants.

Unknown status
COVID-19 Pandemic

Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine

The product should be a milky-white suspension for injection. For prevention of
SARS-CoV-2 infection.
Other Name: V-01

Eligibility Criteria

Inclusion Criteria:

1. Healthy participants aged 18 years and older who have completed the second dose of
2-dose regimen of SARS-CoV-2 vaccine (Vero cell) Inactivated in the past 3 months;

2. Voluntarily participate in the study and sign the informed consent form, who can
provide valid ID and follow the study protocol requirement;

3. In the past 14 days, no history of high or medium risk of the epidemic, overseas
travel history or residence history; no history of contact with confirmed,
asymptomatic or suspected COVID-19 cases; no history of contact with the persons
from high- and medium-risk epidemic areas or contact patients with fever or
respiratory symptoms; and those who are not in isolation period.

4. Males of reproductive potential and females of childbearing potential voluntarily
agree to take effective and acceptable contraceptive methods from the signing of
informed consent form to 3 months after vaccination.

Exclusion Criteria:

1. Confirmed COVID-19 cases, or positive for SARS-CoV-2 test by RT-PCR. 2. History of
previous SARS infection. 3. Fever is suspected or diagnosed within 72 hours before
enrollment, or the axillary body temperature ≥37.3℃ on the day of enrollment.

4. History of severe allergy to any vaccine or any ingredient of the vaccine including
aluminum adjuvant, e.g., anaphylactic shock, allergic laryngeal edema, allergic
purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus
reaction), dyspnea, angioedema, etc..

5. People who currently suffer from the following diseases:

1. Symptoms related to acute respiratory infections (such as: sneezing, nasal
congestion, runny nose, cough, sore throat, loss of taste, chills, shortness of
breath, etc.)

2. Patients with thrombocytopenia, any coagulation dysfunction, or receive
anticoagulant treatment, etc.

3. Patients with congenital or acquired angioedema/neuroedema;

4. A history of congenital or acquired immunodeficiency or autoimmune disease (except
for mild psoriasis, controllable autoimmune thyroid disease, vitiligo, or stable
celiac disease that does not require immunosuppressive or immunomodulatory therapy);
no spleen , or history of spleen surgery, history of trauma, or treatment with
immunomodulators within 6 months, such as: glucocorticoid with the dose causing
immunosuppressive (dose reference: equivalent to prednisone 20mg/day, more than one
week); or monoclonal antibody ; or thymosin; or interferon, etc.; but local
medication (such as ointment, eye drops, inhalation or nasal spray) is allowed.

5. Patients with active tuberculosis, viral hepatitis, human immunodeficiency virus or
syphilis infection.

6. Patients with acute diseases, or acute attacks of chronic diseases, or uncontrolled
severe chronic diseases: history of chronic respiratory diseases (including moderate
to severe asthma, COPD, pulmonary fibrosis), hypertension that cannot be controlled
by drugs (systolic blood pressure ≥150mmHg) And/or diastolic blood pressure
≥100mmHg), history of severe cardiovascular disease (including heart failure,
coronary artery disease, cardiomyopathy), history of chronic kidney disease, history
of cancer (except for basal cell carcinoma), diabetes (unsatisfied blood sugar
control or diabetes related serious complications).

6. Received attenuated live vaccine within 28 days before the vaccination or any
subunit vaccines and inactivated vaccines within 14 days before the vaccination.

7. Injection of immunoglobulin and/or other blood products within 3 months before the
administration of study vaccine; or with the plan to use such product within 6 month
after immunization.

8. Pregnant (including positive urine pregnancy test for women of childbearing age) or
breastfeeding women. Or women or their partners who have a pregnancy plan within 3
months after the trial vaccination.

9. Have participated in or are participating in other COVID-19 related clinical trials,
or are participating in other drug clinical trials; 10. Those considered by the
investigator as inappropriate to participate in the study.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

The Fifth Peoples' Hospital of Zhuhai
Zhuhai, Guangdong, China

Not Provided

Livzon Pharmaceutical Group Inc.
NCT Number
MeSH Terms
COVID-19