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Safety and Viral Shedding of Live Attenuated Influenza Vaccine (LAIV) in Chinese Healthy Juveniles and Adults: A Phase Ⅰ Randomized, Double-Blind, Placebo-Controlled Study
This study was a randomized, double-blind, placebo-controlled study to evaluate the safety and viral shedding of live attenuated influenza vaccine (LAIV) in Chinese healthy juveniles and adults. A total of 80 Eligible volunteers were divided into two age groups (≥18 and 3–17 years old). Volunteers w...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9694757/ https://www.ncbi.nlm.nih.gov/pubmed/36366310 http://dx.doi.org/10.3390/vaccines10111796 |
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author | Li, Li Shi, Nianmin Xu, Na Wang, Haibin Zhao, Hui Xu, Haidong Liu, Dawei Zhang, Zheng Li, Shuping Zhang, Junnan Guo, Chunhui Huo, Jinglei Zhao, Menghan Luo, Fengji Yang, Liqing Bai, Yunhua Lu, Qiang Zhang, Yusong Zhong, Yi Gao, Wenhui |
author_facet | Li, Li Shi, Nianmin Xu, Na Wang, Haibin Zhao, Hui Xu, Haidong Liu, Dawei Zhang, Zheng Li, Shuping Zhang, Junnan Guo, Chunhui Huo, Jinglei Zhao, Menghan Luo, Fengji Yang, Liqing Bai, Yunhua Lu, Qiang Zhang, Yusong Zhong, Yi Gao, Wenhui |
author_sort | Li, Li |
collection | PubMed |
description | This study was a randomized, double-blind, placebo-controlled study to evaluate the safety and viral shedding of live attenuated influenza vaccine (LAIV) in Chinese healthy juveniles and adults. A total of 80 Eligible volunteers were divided into two age groups (≥18 and 3–17 years old). Volunteers were randomly and equally assigned to the experimental group and placebo-controlled group by ratio of 3:1 in each age group. Vaccination was carried out in steps. Totally, 34 (56.67%) adverse events and 24 (40.00%) adverse reactions of the LAIV group were reported. Most adverse reactions were grade 1 and grade 2, and the incidence of adverse reactions that grade 3 was 5%. The most common local reaction was runny nose/nasal congestion (n = 4, 6.67%). And the most common general reaction was fever (n = 10, 16.67%). There were no statistically significant differences in the incidence of total adverse reactions, different grades of adverse reactions, and symptoms between the experimental group and placebo-controlled group. No severe adverse events were reported. Three subjects (5.00%) had been detected vaccine strains on the 3rd day after LAIV vaccination; one was type B and the other two were H3N2. Four subjects (6.67%) had been detected with vaccine strains on the 7th day after LAIV vaccination, all were H3N2. There were no subjects detected carrying the influenza virus on the 15th day after vaccination. There were no statistically significant differences in the positive rate of vaccine strains of influenza virus between the experimental group and placebo-controlled group. The vaccine was well tolerated and not associated with increased rates in adverse reactions or the occurrence of severe adverse events. Pathogenicity of shed vaccine virus to surrounding people was not observed. Thus, Phase Ⅱ study can be carried out as scheduled. |
format | Online Article Text |
id | pubmed-9694757 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-96947572022-11-26 Safety and Viral Shedding of Live Attenuated Influenza Vaccine (LAIV) in Chinese Healthy Juveniles and Adults: A Phase Ⅰ Randomized, Double-Blind, Placebo-Controlled Study Li, Li Shi, Nianmin Xu, Na Wang, Haibin Zhao, Hui Xu, Haidong Liu, Dawei Zhang, Zheng Li, Shuping Zhang, Junnan Guo, Chunhui Huo, Jinglei Zhao, Menghan Luo, Fengji Yang, Liqing Bai, Yunhua Lu, Qiang Zhang, Yusong Zhong, Yi Gao, Wenhui Vaccines (Basel) Article This study was a randomized, double-blind, placebo-controlled study to evaluate the safety and viral shedding of live attenuated influenza vaccine (LAIV) in Chinese healthy juveniles and adults. A total of 80 Eligible volunteers were divided into two age groups (≥18 and 3–17 years old). Volunteers were randomly and equally assigned to the experimental group and placebo-controlled group by ratio of 3:1 in each age group. Vaccination was carried out in steps. Totally, 34 (56.67%) adverse events and 24 (40.00%) adverse reactions of the LAIV group were reported. Most adverse reactions were grade 1 and grade 2, and the incidence of adverse reactions that grade 3 was 5%. The most common local reaction was runny nose/nasal congestion (n = 4, 6.67%). And the most common general reaction was fever (n = 10, 16.67%). There were no statistically significant differences in the incidence of total adverse reactions, different grades of adverse reactions, and symptoms between the experimental group and placebo-controlled group. No severe adverse events were reported. Three subjects (5.00%) had been detected vaccine strains on the 3rd day after LAIV vaccination; one was type B and the other two were H3N2. Four subjects (6.67%) had been detected with vaccine strains on the 7th day after LAIV vaccination, all were H3N2. There were no subjects detected carrying the influenza virus on the 15th day after vaccination. There were no statistically significant differences in the positive rate of vaccine strains of influenza virus between the experimental group and placebo-controlled group. The vaccine was well tolerated and not associated with increased rates in adverse reactions or the occurrence of severe adverse events. Pathogenicity of shed vaccine virus to surrounding people was not observed. Thus, Phase Ⅱ study can be carried out as scheduled. MDPI 2022-10-26 /pmc/articles/PMC9694757/ /pubmed/36366310 http://dx.doi.org/10.3390/vaccines10111796 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Li, Li Shi, Nianmin Xu, Na Wang, Haibin Zhao, Hui Xu, Haidong Liu, Dawei Zhang, Zheng Li, Shuping Zhang, Junnan Guo, Chunhui Huo, Jinglei Zhao, Menghan Luo, Fengji Yang, Liqing Bai, Yunhua Lu, Qiang Zhang, Yusong Zhong, Yi Gao, Wenhui Safety and Viral Shedding of Live Attenuated Influenza Vaccine (LAIV) in Chinese Healthy Juveniles and Adults: A Phase Ⅰ Randomized, Double-Blind, Placebo-Controlled Study |
title | Safety and Viral Shedding of Live Attenuated Influenza Vaccine (LAIV) in Chinese Healthy Juveniles and Adults: A Phase Ⅰ Randomized, Double-Blind, Placebo-Controlled Study |
title_full | Safety and Viral Shedding of Live Attenuated Influenza Vaccine (LAIV) in Chinese Healthy Juveniles and Adults: A Phase Ⅰ Randomized, Double-Blind, Placebo-Controlled Study |
title_fullStr | Safety and Viral Shedding of Live Attenuated Influenza Vaccine (LAIV) in Chinese Healthy Juveniles and Adults: A Phase Ⅰ Randomized, Double-Blind, Placebo-Controlled Study |
title_full_unstemmed | Safety and Viral Shedding of Live Attenuated Influenza Vaccine (LAIV) in Chinese Healthy Juveniles and Adults: A Phase Ⅰ Randomized, Double-Blind, Placebo-Controlled Study |
title_short | Safety and Viral Shedding of Live Attenuated Influenza Vaccine (LAIV) in Chinese Healthy Juveniles and Adults: A Phase Ⅰ Randomized, Double-Blind, Placebo-Controlled Study |
title_sort | safety and viral shedding of live attenuated influenza vaccine (laiv) in chinese healthy juveniles and adults: a phase ⅰ randomized, double-blind, placebo-controlled study |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9694757/ https://www.ncbi.nlm.nih.gov/pubmed/36366310 http://dx.doi.org/10.3390/vaccines10111796 |
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