Safety and immunogenicity of heterologous boosting with orally administered aerosolized bivalent adenovirus type-5 vectored COVID-19 vaccine and B.1.1.529 variant adenovirus type-5 vectored COVID-19 vaccine in adults 18 years and older: a randomized, double blinded, parallel controlled trial
ABSTRACTVaccination strategies that can induce a broad spectrum immune response are important to enhance protection against SARS-CoV-2 variants. We conducted a randomized, double-blind and parallel controlled trial to evaluate the safety and immunogenicity of the bivalent (5×1010viral particles) and...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2024-12-01
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| Series: | Emerging Microbes and Infections |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/22221751.2023.2281355 |
| _version_ | 1797271624325529600 |
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| author | Jia-Wei Xu Bu-Sen Wang Ping Gao Hai-Tao Huang Fei-Yu Wang Wei Qiu Yuan-Yuan Zhang Yu Xu Jin-Bo Gou Lin-Ling Yu Xuan Liu Rui-Jie Wang Tao Zhu Li-Hua Hou Qing- Wang |
| author_facet | Jia-Wei Xu Bu-Sen Wang Ping Gao Hai-Tao Huang Fei-Yu Wang Wei Qiu Yuan-Yuan Zhang Yu Xu Jin-Bo Gou Lin-Ling Yu Xuan Liu Rui-Jie Wang Tao Zhu Li-Hua Hou Qing- Wang |
| author_sort | Jia-Wei Xu |
| collection | DOAJ |
| description | ABSTRACTVaccination strategies that can induce a broad spectrum immune response are important to enhance protection against SARS-CoV-2 variants. We conducted a randomized, double-blind and parallel controlled trial to evaluate the safety and immunogenicity of the bivalent (5×1010viral particles) and B.1.1.529 variant (5×1010viral particles) adenovirus type-5 (Ad5) vectored COVID-19 vaccines administrated via inhalation. 451 eligible subjects aged 18 years and older who had been vaccinated with three doses inactivated COVID-19 vaccines were randomly assigned to inhale one dose of either B.1.1.529 variant Ad5 vectored COVID-19 vaccine (Ad5-nCoVO-IH group, N=150), bivalent Ad5 vectored COVID-19 vaccine (Ad5-nCoV/O-IH group, N=151), or Ad5 vectored COVID-19 vaccine (5×1010viral particles; Ad5-nCoV-IH group, N=150). Adverse reactions reported by 37 (24.67%) participants in the Ad5-nCoVO-IH group, 28 (18.54%) in the Ad5-nCoV/O-IH group, and 26 (17.33%) in the Ad5-nCoV-IH group with mainly mild to moderate dry mouth, oropharyngeal pain, headache, myalgia, cough, fever and fatigue. No serious adverse events related to the vaccine were reported. Investigational vaccines were immunogenic, with significant difference in the GMTs of neutralizing antibodies against Omicron BA.1 between Ad5-nCoV/O-IH (43.70) and Ad5-nCoV-IH (29.25) at 28 days after vaccination (P=0.0238). The seroconversion rates of neutralizing antibodies against BA.1 in Ad5-nCoVO-IH, Ad5-nCoV/O-IH, and Ad5-nCoV-IH groups were 56.00%, 59.60% and 48.67% with no significant difference among the groups. Overall, the investigational vaccines were demonstrated to be safe and well tolerated in adults, and was highly effective in inducing mucosal immunities in addition to humoral and cellular immune responses defending against SARS-CoV-2 variants.Trial registration: Chictr.org identifier: ChiCTR2200063996. |
| first_indexed | 2024-03-07T14:07:17Z |
| format | Article |
| id | doaj.art-cee3a761eea34cc3af4042b39af51639 |
| institution | Directory Open Access Journal |
| issn | 2222-1751 |
| language | English |
| last_indexed | 2024-03-07T14:07:17Z |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Emerging Microbes and Infections |
| spelling | doaj.art-cee3a761eea34cc3af4042b39af516392024-03-06T19:45:40ZengTaylor & Francis GroupEmerging Microbes and Infections2222-17512024-12-0113110.1080/22221751.2023.2281355Safety and immunogenicity of heterologous boosting with orally administered aerosolized bivalent adenovirus type-5 vectored COVID-19 vaccine and B.1.1.529 variant adenovirus type-5 vectored COVID-19 vaccine in adults 18 years and older: a randomized, double blinded, parallel controlled trialJia-Wei Xu0Bu-Sen Wang1Ping Gao2Hai-Tao Huang3Fei-Yu Wang4Wei Qiu5Yuan-Yuan Zhang6Yu Xu7Jin-Bo Gou8Lin-Ling Yu9Xuan Liu10Rui-Jie Wang11Tao Zhu12Li-Hua Hou13Qing- Wang14Expanded Program on Immunization, Chongqing Center for Disease Control and Prevention, Chongqing, People’s Republic of ChinaBeijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, People’s Republic of ChinaLogistics University of Chinese People’s Armed Police Force, Tianjin, People’s Republic of ChinaCanSino Biologics Inc., Tianjin, People’s Republic of ChinaCanSino Biologics Inc., Tianjin, People’s Republic of ChinaExpanded Program on Immunization, Chongqing Center for Disease Control and Prevention, Chongqing, People’s Republic of ChinaExpanded Program on Immunization, Chongqing Center for Disease Control and Prevention, Chongqing, People’s Republic of ChinaCanSino Biologics Inc., Tianjin, People’s Republic of ChinaCanSino Biologics Inc., Tianjin, People’s Republic of ChinaExpanded Program on Immunization, Yubei District Center for Disease Control and Prevention, Chongqing, People’s Republic of ChinaCanSino Biologics Inc., Tianjin, People’s Republic of ChinaCanSino Biologics Inc., Tianjin, People’s Republic of ChinaCanSino Biologics Inc., Tianjin, People’s Republic of ChinaBeijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, People’s Republic of ChinaExpanded Program on Immunization, Chongqing Center for Disease Control and Prevention, Chongqing, People’s Republic of ChinaABSTRACTVaccination strategies that can induce a broad spectrum immune response are important to enhance protection against SARS-CoV-2 variants. We conducted a randomized, double-blind and parallel controlled trial to evaluate the safety and immunogenicity of the bivalent (5×1010viral particles) and B.1.1.529 variant (5×1010viral particles) adenovirus type-5 (Ad5) vectored COVID-19 vaccines administrated via inhalation. 451 eligible subjects aged 18 years and older who had been vaccinated with three doses inactivated COVID-19 vaccines were randomly assigned to inhale one dose of either B.1.1.529 variant Ad5 vectored COVID-19 vaccine (Ad5-nCoVO-IH group, N=150), bivalent Ad5 vectored COVID-19 vaccine (Ad5-nCoV/O-IH group, N=151), or Ad5 vectored COVID-19 vaccine (5×1010viral particles; Ad5-nCoV-IH group, N=150). Adverse reactions reported by 37 (24.67%) participants in the Ad5-nCoVO-IH group, 28 (18.54%) in the Ad5-nCoV/O-IH group, and 26 (17.33%) in the Ad5-nCoV-IH group with mainly mild to moderate dry mouth, oropharyngeal pain, headache, myalgia, cough, fever and fatigue. No serious adverse events related to the vaccine were reported. Investigational vaccines were immunogenic, with significant difference in the GMTs of neutralizing antibodies against Omicron BA.1 between Ad5-nCoV/O-IH (43.70) and Ad5-nCoV-IH (29.25) at 28 days after vaccination (P=0.0238). The seroconversion rates of neutralizing antibodies against BA.1 in Ad5-nCoVO-IH, Ad5-nCoV/O-IH, and Ad5-nCoV-IH groups were 56.00%, 59.60% and 48.67% with no significant difference among the groups. Overall, the investigational vaccines were demonstrated to be safe and well tolerated in adults, and was highly effective in inducing mucosal immunities in addition to humoral and cellular immune responses defending against SARS-CoV-2 variants.Trial registration: Chictr.org identifier: ChiCTR2200063996.https://www.tandfonline.com/doi/10.1080/22221751.2023.2281355Bivalent adenovirus type-5 vectored COVID-19 vaccineinhalationmucosal immunitySigAsafety |
| spellingShingle | Jia-Wei Xu Bu-Sen Wang Ping Gao Hai-Tao Huang Fei-Yu Wang Wei Qiu Yuan-Yuan Zhang Yu Xu Jin-Bo Gou Lin-Ling Yu Xuan Liu Rui-Jie Wang Tao Zhu Li-Hua Hou Qing- Wang Safety and immunogenicity of heterologous boosting with orally administered aerosolized bivalent adenovirus type-5 vectored COVID-19 vaccine and B.1.1.529 variant adenovirus type-5 vectored COVID-19 vaccine in adults 18 years and older: a randomized, double blinded, parallel controlled trial Emerging Microbes and Infections Bivalent adenovirus type-5 vectored COVID-19 vaccine inhalation mucosal immunity SigA safety |
| title | Safety and immunogenicity of heterologous boosting with orally administered aerosolized bivalent adenovirus type-5 vectored COVID-19 vaccine and B.1.1.529 variant adenovirus type-5 vectored COVID-19 vaccine in adults 18 years and older: a randomized, double blinded, parallel controlled trial |
| title_full | Safety and immunogenicity of heterologous boosting with orally administered aerosolized bivalent adenovirus type-5 vectored COVID-19 vaccine and B.1.1.529 variant adenovirus type-5 vectored COVID-19 vaccine in adults 18 years and older: a randomized, double blinded, parallel controlled trial |
| title_fullStr | Safety and immunogenicity of heterologous boosting with orally administered aerosolized bivalent adenovirus type-5 vectored COVID-19 vaccine and B.1.1.529 variant adenovirus type-5 vectored COVID-19 vaccine in adults 18 years and older: a randomized, double blinded, parallel controlled trial |
| title_full_unstemmed | Safety and immunogenicity of heterologous boosting with orally administered aerosolized bivalent adenovirus type-5 vectored COVID-19 vaccine and B.1.1.529 variant adenovirus type-5 vectored COVID-19 vaccine in adults 18 years and older: a randomized, double blinded, parallel controlled trial |
| title_short | Safety and immunogenicity of heterologous boosting with orally administered aerosolized bivalent adenovirus type-5 vectored COVID-19 vaccine and B.1.1.529 variant adenovirus type-5 vectored COVID-19 vaccine in adults 18 years and older: a randomized, double blinded, parallel controlled trial |
| title_sort | safety and immunogenicity of heterologous boosting with orally administered aerosolized bivalent adenovirus type 5 vectored covid 19 vaccine and b 1 1 529 variant adenovirus type 5 vectored covid 19 vaccine in adults 18 years and older a randomized double blinded parallel controlled trial |
| topic | Bivalent adenovirus type-5 vectored COVID-19 vaccine inhalation mucosal immunity SigA safety |
| url | https://www.tandfonline.com/doi/10.1080/22221751.2023.2281355 |
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