Sequential Immunization With Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Health Adults Based on 3 Doses Inactivated COVID-19 Vaccine

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    200
  • sponsor
    Zhejiang Provincial Center for Disease Control and Prevention
Updated on 25 May 2022
Accepts healthy volunteers

Summary

COVID-19 is a novel coronavirus infection caused by respiratory droplets and contact transmission. With the spread of the epidemic, it has become a serious threat to global public health. China has launched a full range of vaccination including the third dose of homologous and sequential booster immunization. To further improve COVID-19 vaccine immunization strategy, we start the clinic research about sequential Immunization With Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Health Adults Based on 3 Doses Inactivated COVID-19 Vaccine in Zhejiang province.

Details
Condition Immunogenicity and Safety of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine Using for Sequential Immunization
Treatment Recombinant adenovirus type-5-vectored COVID-19 vaccine
Clinical Study IdentifierNCT05373030
SponsorZhejiang Provincial Center for Disease Control and Prevention
Last Modified on25 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Volunteers aged 18 and above at the time of screening
Obtain the informed consent of the volunteers and sign the informed consent
Volunteers are able and willing to comply with the requirements of the clinical trial protocol and complete the 6-month study follow-up
Have received 3 doses of Sinovac/Beijing Biological Novel Coronavirus inactivated vaccine with an interval of 6-9 months

Exclusion Criteria

Patients with history or family history of convulsion, epilepsy, encephalopathy and mental illness
Those who are allergic to any of the components of the study vaccine, have had a severe allergic reaction to the vaccine in the past, a history of allergy or asthma
Serious adverse events related to vaccination occurred after previous vaccination; 4) Positive urine pregnancy test in women during lactation or childbearing age
Acute febrile disease, infectious disease, SARS history; 6) Axillary body temperature > 37.0℃; 7) Suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrolled medication (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg when measured on site); 8) Patients with serious chronic diseases that are in the advanced stage and cannot be controlled smoothly, such as diabetes and thyroid diseases; 9) Congenital or acquired angioedema/neuroedema; 10) Urticaria 1 year before receiving the test vaccine; 11) No spleen or functional no spleen; 12) Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities; 13) History of novel coronavirus infection/illness; 14) Have traveled to medium or high risk areas or left the country in the past 21 days; have a history of novel Coronavirus 2019-epidemiological contact; 15) The researcher made a judgment based on various medical, psychological, social or other conditions that might be contrary to the test protocol or affect the subjects to sign informed consent
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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