Safety and immunogenicity of heterologous boosting with orally aerosolised or intramuscular Ad5-nCoV vaccine and homologous boosting with inactivated vaccines (BBIBP-CorV or CoronaVac) in children and adolescents: a randomised, open-label, parallel-controlled, non-inferiority, single-centre study.

BACKGROUND: Heterologous booster immunisation with orally administered aerosolised Ad5-nCoV vaccine (AAd5) has been shown to be safe and highly immunogenic in adults. Here, we aimed to assess the safety and immunogenicity of heterologous booster immunisation with orally administered AAd5 in children and adolescents aged 6-17 years who had received two doses of inactivated vaccine (BBIBP-CorV or CoronaVac). METHODS: We did a randomised, open-label, parallel-controlled, non-inferiority study to assess the safety and immunogenicity of heterologous booster immunisation with AAd5 (0·1 mL) or intramuscular Ad5-nCoV vaccine (IMAd5; 0·3 mL) and homologous booster immunisation with inactivated vaccine (BBIBP-CorV or CoronaVac; 0·5 mL) in children (aged 6-12 years) and adolescents (aged 13-17 years) who had received two doses of inactivated vaccine at least 3 months earlier in Hunan, China. Children and adolescents who were previously immunised with two-dose BBIBP-CorV or CoronaVac were recruited for eligibility screening at least 3 months after the second dose. A stratified block method was used for randomisation, and participants were stratified by age and randomly assigned (3:1:1) to receive AAd5, IMAd5, or inactivated vaccine. The study staff and participants were not masked to treatment allocation. Laboratory and statistical staff were masked during the study. In this interim analysis, adverse events within 14 days and geometric mean titre (GMT) of serum neutralising antibodies on day 28 after the booster vaccination, based on the per-protocol population, were used as the primary outcomes. The analysis of non-inferiority was based on comparison using a one-sided 97·5% CI with a non-inferiority margin of 0·67. This study was registered at ClinicalTrials.gov, NCT05330871, and is ongoing. FINDINGS: Between April 17 and May 28, 2022, 436 participants were screened and 360 were enrolled: 220 received AAd5, 70 received IMAd5, and 70 received inactivated vaccine. Within 14 days after booster vaccination, vaccine-related adverse reactions were reported: 35 adverse events (in 13 [12%] of 110 children and 22 [20%] of 110 adolescents) in 220 individuals in the AAd5 group, 35 (in 18 [51%] of 35 children and 17 [49%] of 35 adolescents) in 70 individuals in the IMAd5 group, and 13 (in five [14%] of 35 children and eight [23%] of 35 adolescents) in 70 individuals in the inactivated vaccine group. Solicited adverse reactions were also reported: 34 (13 [12%] of 110 children and 21 [10%] of 110 adolescents) in 220 individuals in the AAd5 group, 34 (17 [49%] of 35 children and 17 [49%] of 35 adolescents) in 70 individuals in the IMAd5 group, and 12 (five [14%] of 35 children and seven [20%] of 35 adolescents) in 70 individuals in the inactivated vaccine group. The GMTs of neutralising antibodies against ancestral SARS-CoV-2 Wuhan-Hu-1 (Pango lineage B) in the AAd5 group were significantly higher than the GMTs in the inactivated vaccine group (adjusted GMT ratio 10·2 [95% CI 8·0-13·1]; p<0·0001). INTERPRETATION: Our study shows that a heterologous booster with AAd5 is safe and highly immunogenic against ancestral SARS-CoV-2 Wuhan-Hu-1 in children and adolescents. FUNDING: National Key R&D Program of China.

Acceptability of COVID-19 vaccination in Chinese children aged 3-7 years with bronchopulmonary dysplasia.

OBJECTIVES: To describe the status of coronavirus disease 2019 (COVID-19) vaccination with inactivated vaccines BBIBP-CorV and CoronaVac in Chinese children aged 3-7 years with bronchopulmonary dysplasia (BPD), and explore factors influencing vaccination and reasons for nonvaccination. METHODS: This cross-sectional study involving parents of 397 BPD children aged 3-7 years was conducted through WeChat or follow-up telephone interviews using a standardized questionnaire form. Factors influencing COVID-19 vaccination were explored by using modified Poisson regression models. RESULTS: The overall COVID-19 vaccination rate was 69.0% (95% confidence interval: 64.3%-73.4%). COVID-19 vaccination was less likely to be accepted in children whose mothers had a relatively high educational background (university and above), who lived in urban areas and had a low birth weight (<1 kg), a history of hospitalization for lung diseases in the past 12 months, and intellectual disability. Conversely, kindergarten students and children from families with an annual income of >300,000 CNY ( ≈ $\approx $ 41,400 USD) were more likely to accept vaccination. Adverse reactions occurred in 13/274 children (4.7%) within 10 days after vaccination. With respect to reasons of not accepting COVID-19 vaccination, 95 parents (77.2%) worried about the adverse reactions, and 17 parents (13.8%) refused vaccination on the excuse of not being convenient to go to the vaccination station or not knowing where to get the vaccines. CONCLUSIONS: The COVID-19 vaccination rate in BPD children aged 3-7 years needs to be further improved in China. Continuous efforts are required to monitor postvaccination adverse reactions in BPD children, and make vaccination more convenient and accessible.

A qualitative study about colorectal cancer patients and spousal caregivers' experience and needs during COVID-19: implications for self-efficacy intervention.

Objective: This study aims to understand the experiences of colorectal cancer (CRC) patients and their spousal caregivers during the COVID-19 pandemic and to refine a self-efficacy (SE) intervention for these couples. Methods: A descriptive phenomenological approach was used in this study. Data were collected from 11 CRC couples. All interviews were recorded, transcribed, and analyzed using the Colaizzi strategy. Results: Three themes and eight subthemes emerged: (1) Get and contribute support, (2) Life's challenges, and (3) Journey of reconstruction. The CRC couples encountered escalating challenges in coping with cancer during COVID-19. At the same time, they have received considerable support and developed confidence in rebuilding themselves in the process. Healthcare providers are advised to focus on giving appropriate support to CRC couples, so they can go further. Conclusions: This study gave insights into healthcare providers on the experiences of CRC couples and the development of SE intervention program to support these couples: (1) initially providing caregiving training for spousal caregivers and psychological support for patients, (2) encouraging self-care for CRC couples in the middle stage, (3) guiding them to view life positively in the later stage, and (4) assessing their situation in time to identify their needs and to provide support. Healthcare providers are recommended to increase flexibility in the SE intervention program delivery format to reduce the impact of COVID-19 on CRC couples.