A randomized phase I trial of intranasal SARS-CoV-2 vaccine dNS1-RBD in children aged 3-17 years
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Published on: May 2, 2011
Kai Chu1, Jiali Quan2,3, Xiaohui Liu2,3
1Jiangsu Provincial Centre for Disease Control and Prevention, Public Health Research Institute of Jiangsu Province, Nanjing, Jiangsu, China.
Insights
The intranasal SARS-CoV-2 vaccine dNS1-RBD is safe for children aged 3-17 years. This clinical trial found no serious adverse events, indicating good tolerability for pediatric use.
Area of Science:
- Vaccinology
- Pediatric Infectious Diseases
- Clinical Trials
Background:
- The intranasal SARS-CoV-2 vaccine dNS1-RBD (Pneucolin®), utilizing a live-attenuated influenza virus vector, has received Emergency Use Authorization in China for adults.
- Pediatric populations remain a critical focus for COVID-19 vaccine development and safety evaluation.
Purpose of the Study:
- To evaluate the safety and tolerability of the dNS1-RBD intranasal vaccine in children aged 3-17 years.
- To assess adverse events and serious adverse events (SAEs) following vaccination in this pediatric cohort.
Main Methods:
- A single-center, double-blind, placebo-controlled, age de-escalation phase 1 clinical trial was conducted.
- Sixty-three participants received two intranasal doses of dNS1-RBD vaccine or placebo on days 0 and 14.
- Safety was monitored through adverse events/reactions (30 days) and SAEs (12 months), with additional monitoring of blood indices and viral shedding.
Main Results:
- The vaccine group exhibited similar rates of adverse reactions compared to the placebo group (39.0% vs 36.4%).
- No serious adverse events (SAEs) were determined to be related to the dNS1-RBD vaccination.
- Blood indices and nasal secretion samples did not reveal significant safety concerns.
Conclusions:
- The intranasal dNS1-RBD vaccine demonstrates good tolerability in children aged 3-17 years.
- Further research into the safety, immunogenicity, and efficacy of this vaccine in pediatric populations is warranted.
Abstract:
The intranasal SARS-CoV-2 vaccine dNS1-RBD (Pneucolin®), based on a live-attenuated influenza virus vector, has obtained Emergency Use Authorization in China for individuals aged 18 years and older. Here, we conducted a single-center, double-blind, placebo-controlled, age de-escalation phase 1 clinical trial to evaluate the safety of the dNS1-RBD in children aged 3-17 years (ChiCTR2300068044). Sixty-three participants received 2 intranasal doses of the vaccine or placebo at days 0 and 14. Safety assessments included adverse events/reactions within 30 days and serious adverse events (SAEs) over 12 months. Blood and nasal secretion samples were collected to further monitor blood indices and viral shedding. The vaccine group showed similar adverse reaction rates to the placebo group (39.0% vs 36.4%), with no SAEs related to vaccination. Data suggested that the dNS1-RBD vaccine is well-tolerated in children aged 3-17 years, and warrants further studies on its safety, immunogenicity and efficacy in this population.
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