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Heterologous Boost Immunization with an Aerosolised Ad5-nCoV After Two-dose Priming with an Inactivated SARS-CoV-2 Vaccine

NCT05204589 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10285

Last updated 2025-02-21

No results posted yet for this study

Summary

This is a multicenter, open-label, partially radomized, parallel-controlled clinical trial to evaluate the safety and immunogenicity of heterologous prime-boost immunization with an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV-IH) after two-dose priming with an inactivated SARS-CoV-2 vaccine (ICV) in adults aged 18 years and above. 10420 healthy subjects aged over or equal to 18 years whom have received two doses of ICV before 6 months or more, will be recruited from six provinces in China in this study.Of them, 10000 eligible participants in an open cohort will receive a booster dose of Ad5-nCoV-IH to evaluate the safety profile. Another 420 participants were involved in immunogenicity cohort and randomized in a ratio of 1:1 to receive a boost of Ad5-nCoV-IH or ICV. The ICV homologous to the priming series will be supplied as the booster. The occurrence of adverse reactions within 28 days and serious adverse events within 6 months after vaccination will be observed in all participants. In addition, blood and saliva samples will be collected from all participants in immunogenicity cohort on the day 0 before and 14, 28 and month 3 and 6 after the booster vaccination. Each subject will remain in this study for approximately 6 months.

Conditions

Interventions

BIOLOGICAL

Aerosolized Ad5-nCoV

Aerosolized Ad5-nCoV is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.1 ml / dose, contains 1×10\^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, aerosol inhalation.

BIOLOGICAL

Inactivated SARS-CoV-2 vaccine

Inactivated SARS-CoV-2 vaccine is homologous to the priming series which have been administered to the subjects, produced by SinoVac Biotech Co,. Ltd, Beijing Institute of Biological Products Co,. Ltd, Wuhan Institute of Biological Products Co,. Ltd, or Biokangtai.

Sponsors & Collaborators

  • Anhui Provincial Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Shandong Province Centers for Disease Control and Prevention

    collaborator OTHER

  • Hunan Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Yunnan Center for Disease Control and Prevention

    collaborator OTHER

  • Chongqing Center for Disease Control and Prevention

    collaborator OTHER

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Principal Investigators

  • Fengcai Zhu, Prof · Jiangsu Provincial Center for Diseases Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-22
Primary Completion
2022-04-01
Completion
2022-10-27

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05204589 on ClinicalTrials.gov