Trial NCT05043259
Publication Jin L, Emerg Microbes Infect, 2022
Dates: 2021-09-14 to 2021-09-16
Funding: Mixed (National Natural Science Foundation of China and Jiangsu Provincial Key Research and Development Program. CanSino Biologics Inc. provided investigational vaccines and Continuous Vapouring System)
Conflict of interest: Yes

Methods
RCT
Location : Single center / China
Follow-up duration (months): 12
CoronaVac/Boost high-dose aerosolized Ad5-nCoV (n = 140)
CoronaVac/Boost low-dose aerosolized Ad5-nCoV (n = 140)
CoronaVac/Boost CoronaVac (n = 140)
Inclusion criteria
  • Healthy participants
  • male or female
  • aged 18 years or above
  • completed two-dose priming of CoronaVac in the past 3-9 months
Exclusion criteria
  • Clinical or laboratory-confirmed COVID-19 or SARS-CoV-2 infection
  • nasal or oral diseases
  • known infection with human immunodeficiency virus
  • positive urine pregnancy test for women
Interventions
Intervention
1 inhaled booster 0.2 mL (1.0 x 10^11 vp per mL) Ad5-nCoV, 3-9 months after CoronaVac primary schedule
1 inhaled booster 0.1 mL (1.0 x 10^11 vp per mL) Ad5-nCoV, 3-9 months after CoronaVac primary schedule
Control
1 IM booster 0.5 mL CoronaVac, 3-9 months after CoronaVac primary schedule
Participants
Randomized
423 participants
Characteristics of participants
Type of participants: Healthy adults
N=423
179 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: NR
Description of participants
Healthy adults without previous SARS-CoV-2 infection who completed two-dose priming with CoronaVac in the past 3-9 months at a single center in China
Primary outcome
In the register
1) Incidence of adverse reactions within 14 days after the booster dose. [ Time Frame: Within 14 days the booster dose ]; 2) GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose. [ Time Frame: On day 14 after the booster dose ]
In the report
1) Incidence of adverse reactions within 14 days after the booster dose; 2) Geometric mean titres (GMTs) of neutralising antibodies against live SARS-CoV-2 virus at 14 days after the booster dose
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes, One month after the completion of the study
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 Prof Feng-Cai Zhu, jszfc@vip.sina.com or Prof Wei Chen, cw0226@foxmail.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 the published/pre-print article, the prospective study registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. Appendix with results referred to in the pre-print was also not available at the time of data extraction. Denominators were not available for immunogenicity outcomes in the pre-print. Local and systemic adverse events were not reported for all intervention arms. The target sample size specified in the registry was achieved.
This trial was updated on June 22nd 2022, after publication of the study report.
This trial was further updated on November 8th 2022 wih results for a longer follow up (pre-print).
This trial was updated on December 15th 2022, after publication of results at a longer follow-up.