Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial
<b>Background</b>: SCTV01E is a tetravalent recombinant COVID-19 vaccine authorized for emergency use in China for adults 18 years and older but not for those under 18. <b>Objective</b>: This Phase 2 trial assessed the safety and immunogenicity of SCTV01E in healthy children...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-01-01
|
| Series: | Vaccines |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-393X/13/1/43 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Summary: | <b>Background</b>: SCTV01E is a tetravalent recombinant COVID-19 vaccine authorized for emergency use in China for adults 18 years and older but not for those under 18. <b>Objective</b>: This Phase 2 trial assessed the safety and immunogenicity of SCTV01E in healthy children and adolescents aged 3 to 17 years, to establish immunobridging with that observed in adults from the efficacy pivotal trial (NCT05308576). <b>Methods</b>: Participants were randomly assigned to receive either 30 µg of SCTV01E or a placebo. Primary endpoints were safety and immunogenicity focused on the geometric mean titer (GMT) and seroresponse rate (SRR) of neutralizing antibodies (nAb) against Omicron BA.5. <b>Results</b>: In total, 268 participants (214 SCTV01E vs. 54 placebo) were included in the safety analysis, with 241 participants (191 vs. 50) in the immunogenicity analysis. Overall, 127 (59.3%) participants receiving SCTV01E and 9 (16.7%) receiving a placebo reported adverse events (AEs), most of which were Grade 1 or 2. No serious adverse events (SAEs) or adverse events of special interest (AESIs) were reported. In the immunogenicity bridging analysis, data from 95 youths were compared with data from 188 adults; the geometric mean ratio (GMR) of the titers was 8.78 (95% CI: 6.05–12.74, <i>p</i> < 0.001), with the lower bound of the 95% CI exceeding 0.67. The difference in the SRR was 6.34% (95% CI: 0.93–11.22%) (<i>p</i> = 0.029), and the lower bound of the 95%CI was >−5%, indicating superiority. <b>Conclusions</b>: SCTV01E was found to be safe and well tolerated in children and adolescents, generating a robust immune response against Omicron BA.5. This supports its potential use in younger populations. |
|---|---|
| ISSN: | 2076-393X |