Trial NCT05204589
Publication Li X, SSRN, 2023
Dates: 2022-01-22 to 2022-03-12
Funding: Mixed (National Natural Science Foundation of China, Jiangsu Provincial Science Fund for Distinguished Young Scholars , and Jiangsu Provincial Key Project of Science and Technology Plan. CanSino Biologics Inc. contributed in providing investigational vaccines and the vapouring unit.)
Conflict of interest: no COI

Methods
RCT
Location : Multicenter / China
Follow-up duration (months): 6
Aerosolized Ad5-nCoV = (n=210)
CoronaVac = (n=210)
Inclusion criteria
  • Healthy subjects aged ≥18 years.
  • Have received two-dose inactivated SARS-CoV-2 vaccine before 6 months or more.
  • The subject can provide with informed consent and sign informed consent form (ICF).
  • The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 6-month follow-up of the study.
Exclusion criteria
  • Have the medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
  • Be allergic to any component of the research vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination.
  • Women with positive urine pregnancy test.
  • Have acute febrile diseases and infectious diseases.
  • Axillary temperature>37.0℃.
  • Have serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg when measured in the field).
  • Have severe chronic diseases or condition in progress cannot be smoothly controlled, such as asthma, diabetes, thyroid disease.
  • Congenital or acquired angioedema / neuroedema.
  • Have the history of urticaria 1 year before receiving the investigational vaccine.
  • Have asplenia or functional asplenia.
  • Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities.
  • Have history of SARS-CoV-2 infection or COVID-19.
  • Have symptoms of upper respiratory tract infection. Have traveled to medium or high risk areas or traveled abroad in the past 21 days, and epidemiologically contacted with SARS-CoV-2.
  • Any medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's informed consent
Interventions
Intervention
1 IN dose of aerosolized Ad5-nCoV at least 6 months after prime vaccination with an inactivated virus COVID-19 vaccine
Control
1 IM dose of CoronaVac at least 6 months after prime vaccination with an inactivated virus COVID-19 vaccine
Participants
Randomized
420 participants
Characteristics of participants
Type of participants: Healthy volunteers
N=420
218 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: NR
Description of participants
Healthy adults with no history of COVID-19 in multiple centres in China.
Primary outcome
In the register
Incidence of adverse reactions within 28 days after the booster dose. [ Time Frame: Within 28 days the booster dose ] Incidence of adverse reactions within 28 days after the booster dose. GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort. [ Time Frame: On day 28 after the booster dose ] GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.
In the report
Incidence of adverse reactions within 28 days after the boost immunization. The primary endpoint for immunogenicity was the serum geometric mean titer (GMT) of SARS- CoV-2 neutralizing antibodies against omicron BA.4/5 at 28 days after the booster dose, using a pseudovirus neutralization test (a vesicular stomatitis virus pseudovirus system expressing the omicron BA.4/5 spike glycoprotein), with a cutoff titer of 1:30
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes, After de-identification
Data accessibility: Researchers who provide a scientifically sound proposal will be allowed to access to the de-identified individual participant data. Proposals should be directed to jszfc@vip.sina.com.
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to all available versions of the pre-print, the study registry was used in data extraction and risk of bias assessment. The efficacy and immunologic outcomes were assessed in a randomized sub-set of participants, the efficacy analysis was post-hoc and results were self-repoted. The target sample size specified in the registry was achieved (n=420). There were no important differences between registry and pre-print in population, procedures or interventions.