Immunogenicity and Safety Study of Booster Vaccine With the COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain

NCT05411471 | Completed Phase 2

• 1 other identifier: PRO-nCOV-2009
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-labeled, Phase IIb clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of the booster vaccine of using one or two doses of COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain in Adults above 18 Years Old Who Have Completed Two or Three Doses of mRNA Vaccine or CoronaVac®.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Geometric mean of neutralization antibody titre (GMT)

  Geometric mean of neutralization antibody titre (GMT) on Day 14 after the last booster dose against the Omicron variant in different groups

  Day 14 after the last booster dose

• Occurrence, intensity, duration, and relationship of solicited local and systemic AEs

  Occurrence, intensity, duration, and relationship of solicited local and systemic AEs for 7 days following each booster dose vaccination and of unsolicited AEs for 28 days post booster vaccination

  28 days post booster vaccination

Secondary Outcomes (3)

• Seroconversion rate of neutralization antibody

  Day 14 after the last booster dose

• Seropositivity rate of neutralization antibody

  Day 14 after the last booster dose

• Occurrence and relationship of SAEs

  within 6 months post booster vaccination

Other Outcomes (2)

• Seropositive rate of neutralizing antibody

  At 90 days and 183 days after one or two doses of booster vaccination

• GMT of neutralizing antibody

  At 90 days and 183 days after one or two doses of booster vaccination

Study Arms (4)

Arm 1 (1 dose Omicron Vaccine arm, mRNA vaccine group)

EXPERIMENTAL

75 participants who have completed two/three doses of mRNA vaccine (prior to this study) will receive one dose COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain(1200 SOU).

Biological: COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain

Arm 2 (2 doses Omicron Vaccine arm, mRNA vaccine group)

EXPERIMENTAL

75 participants who have completed two/three doses of mRNA vaccine (prior to this study) will receive two doses COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain (0,28 days)(1200 SOU).

Biological: COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain

Arm 3 (1 dose Omicron Vaccine arm, CoronaVac® group)

EXPERIMENTAL

75 participants who have completed two/three doses of CoronaVac®(prior to this study) will receive one dose COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain (1200 SOU).

Biological: COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain

Arm 4 (2 doses Omicron Vaccine arm, CoronaVac® group)

EXPERIMENTAL

75 participants who have completed two/three doses of CoronaVac®(prior to this study) will receive two doses COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain (0,28 days)(1200 SOU).

Biological: COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain

Interventions

COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain BIOLOGICAL

The COVID-19 vaccine (Vero cell), Inactivated, Omicron Strain was developed by Sinovac Life Science Ltd.The product is a pre-filled syringe or a vial with an extractable volume of 0.5 mL. The antigen content is 1200 SOU/0.5 mL (6 µg/0.5 mL).

Also known as: COVID-19 Omicron Vaccine

Arm 1 (1 dose Omicron Vaccine arm, mRNA vaccine group); Arm 2 (2 doses Omicron Vaccine arm, mRNA vaccine group); Arm 3 (1 dose Omicron Vaccine arm, CoronaVac® group); Arm 4 (2 doses Omicron Vaccine arm, CoronaVac® group)

Eligibility Criteria

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

You may qualify if:

• Healthy adults aged 18 years and above, who have received two or three prior doses of mRNA COVID-19 vaccine (Comirnaty®, made by BioNTech/Pfizer) or CoronaVac®, with the last dose given at least 90 days prior to the day of booster vaccination in the present study;
• Evidence of a deep throat saliva (DTS) PCR negative for SARS-COV-2 within 24 hours before enrollment;
• Female participants who have a negative pregnancy test on the day of the first dose of the booster vaccine in the present study, and are not currently breastfeeding;
• The participants are able to understand and sign the informed consent voluntarily before the first dose of booster vaccine in the present study;
• The participants are willing and able to comply with all schedule visits, sample collection, vaccine plan, and other study procedures;
• The participants must be willing to provide verifiable identification (in accordance with the local regulations), has means to be contacted and to contact the investigator during the study.

You may not qualify if:

• History of confirmed or having evidence showing a current infection of SARS-CoV-2 prior to randomization or vaccination;
• Any prior administration of another investigational coronavirus vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19;
• Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
• Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc.;
• Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
• Receipt of blood/plasma products or immunoglobulins in the past three months before first vaccination in this study;
• Participation in other studies involving study intervention within 30 days prior to first vaccination in this study;
• Receipt of attenuated live vaccines in the past fourteen days prior to each vaccination in this study;
• Receipt of inactivated or subunit vaccines in the past seven days prior to each vaccination in this study;
• Acute exacerbation or presentation of stable chronic diseases (including but not limited to asthma, migraine, gastrointestinal disorder, etc.);
• Acute febrile illness with oral temperature \>37.5°C on the day of each vaccination;
• According to the investigator's judgment, the participant has any other factors that might interfere with the results of the clinical trial or pose additional risk to the participant due to participation in the study.

Sponsors & Collaborators

• Sinovac Biotech (Hong Kong) Limited: lead

Study Sites (1)

Gleneagles Hospital HongKong

Hong Kong, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines; mRNA-1273.214 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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Ivan HUNG Fan Ngai, Doctor

  Gleneagles Hospital HongKong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 9, 2022
• Study Start: June 8, 2022
• Primary Completion: June 25, 2023
• Study Completion: June 25, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

CN (1)