A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China
ABSTRACTThis open-label, randomized, phase 3 study in China (V260-074; NCT04481191) evaluated the immunogenicity and safety of concomitant and staggered administration of three doses of an oral, live, pentavalent rotavirus vaccine (RV5) and three doses of an intramuscular, inactivated poliomyelitis...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2024-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2024.2324538 |
| _version_ | 1827312263496728576 |
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| author | Shaomin Chen Zhifang Ying Yan Liu Yuan Li Yebin Yu Meilian Huang Zhuhang Huang Zhiqiang Ou Yuyi Liao Yong Zhang Guixiu Liu Weiwei Zhao Rong Fu Qiong Shou Minghuan Zheng Xueyan Liao Yingmei Tu Jon Stek Jonathan Hartzel Changgui Li Jikai Zhang |
| author_facet | Shaomin Chen Zhifang Ying Yan Liu Yuan Li Yebin Yu Meilian Huang Zhuhang Huang Zhiqiang Ou Yuyi Liao Yong Zhang Guixiu Liu Weiwei Zhao Rong Fu Qiong Shou Minghuan Zheng Xueyan Liao Yingmei Tu Jon Stek Jonathan Hartzel Changgui Li Jikai Zhang |
| author_sort | Shaomin Chen |
| collection | DOAJ |
| description | ABSTRACTThis open-label, randomized, phase 3 study in China (V260-074; NCT04481191) evaluated the immunogenicity and safety of concomitant and staggered administration of three doses of an oral, live, pentavalent rotavirus vaccine (RV5) and three doses of an intramuscular, inactivated poliomyelitis vaccine (IPV) in 400 healthy infants. The primary objective was the non-inferiority of neutralizing antibody (nAb) responses in the concomitant- versus the staggered-use groups. Antibody responses were measured at baseline and 1-month post-dose 3 (PD3). Parents/legal guardians recorded adverse events for 30 or 15 d after study vaccinations in the concomitant-use or staggered-use groups, respectively. At PD3, >98% of participants seroconverted to all three poliovirus types, and the primary objective was met as lower bounds of the two-sided 95% CI for between-group difference in nAb seroconversion percentages ranged from − 4.3% to − 1.6%, for all poliovirus types, p < .001. At PD3, geometric mean titers (GMTs) of nAb responses to poliovirus types 1, 2, and 3 in the concomitant-use group and the staggered-use group were comparable; 100% of participants had nAb titers ≥1:8 and ≥1:64 for all poliovirus types. Anti-rotavirus serotype-specific IgA GMTs and participants with ≥3-fold rise in postvaccination titers from baseline were comparable between groups. Administration of RV5 and IPV was well tolerated with comparable safety profiles in both groups. The immunogenicity of IPV in the concomitant-use group was non-inferior to the staggered-use group and RV5 was immunogenic in both groups. No safety concerns were identified. These data support the concomitant use of RV5 and IPV in healthy Chinese infants. |
| first_indexed | 2024-04-24T21:40:04Z |
| format | Article |
| id | doaj.art-0433b9f021254813a1d04914c2993518 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-04-24T21:40:04Z |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-0433b9f021254813a1d04914c29935182024-03-21T06:14:44ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2024-12-0120110.1080/21645515.2024.2324538A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in ChinaShaomin Chen0Zhifang Ying1Yan Liu2Yuan Li3Yebin Yu4Meilian Huang5Zhuhang Huang6Zhiqiang Ou7Yuyi Liao8Yong Zhang9Guixiu Liu10Weiwei Zhao11Rong Fu12Qiong Shou13Minghuan Zheng14Xueyan Liao15Yingmei Tu16Jon Stek17Jonathan Hartzel18Changgui Li19Jikai Zhang20Biological Products Surveillance and Evaluation, Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong, ChinaRespiratory Virus Vaccine, National Institutes for Food and Drug Control, Beijing, ChinaDivision of Hepatitis Virus and Enterovirus Vaccines, National Institutes for Food and Drug Control, Beijing, ChinaBiological Products Surveillance and Evaluation, Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong, ChinaVaccine Clinical Research Office, Yangchun Center for Disease Control and Prevention, Yangchun, Guangdong, ChinaVaccine Clinical Research Office, Yangchun Center for Disease Control and Prevention, Yangchun, Guangdong, ChinaBiological Products Surveillance and Evaluation, Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong, ChinaBiological Products Surveillance and Evaluation, Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong, ChinaBiological Products Surveillance and Evaluation, Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong, ChinaDivision of Hepatitis Virus and Enterovirus Vaccines, National Institutes for Food and Drug Control, Beijing, ChinaClinical Research, MSD Research and Development (China) Co. Ltd., Beijing, ChinaBiostatistics and Research Decision Sciences, MSD Research and Development (China) Co. Ltd., Beijing, ChinaBiostatistics and Research Decision Sciences, MSD Research and Development (China) Co. Ltd., Beijing, ChinaBiostatistics and Research Decision Sciences, MSD Research and Development (China) Co. Ltd., Beijing, ChinaClinical Research, MSD Research and Development (China) Co. Ltd., Beijing, ChinaClinical Research, MSD Research and Development (China) Co. Ltd., Beijing, ChinaInfectious Diseases/Vaccines Clinical Research, Merck & Co. Inc., Rahway, NJ, USAInfectious Diseases/Vaccines Clinical Research, Merck & Co. Inc., Rahway, NJ, USABiostatistics and Research Decision Sciences, Merck & Co. Inc., Rahway, NJ, USAInstitute for Control of Biological Products, National Institutes for Food and Drug Control, Beijing, ChinaDirectors Office, Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong, ChinaABSTRACTThis open-label, randomized, phase 3 study in China (V260-074; NCT04481191) evaluated the immunogenicity and safety of concomitant and staggered administration of three doses of an oral, live, pentavalent rotavirus vaccine (RV5) and three doses of an intramuscular, inactivated poliomyelitis vaccine (IPV) in 400 healthy infants. The primary objective was the non-inferiority of neutralizing antibody (nAb) responses in the concomitant- versus the staggered-use groups. Antibody responses were measured at baseline and 1-month post-dose 3 (PD3). Parents/legal guardians recorded adverse events for 30 or 15 d after study vaccinations in the concomitant-use or staggered-use groups, respectively. At PD3, >98% of participants seroconverted to all three poliovirus types, and the primary objective was met as lower bounds of the two-sided 95% CI for between-group difference in nAb seroconversion percentages ranged from − 4.3% to − 1.6%, for all poliovirus types, p < .001. At PD3, geometric mean titers (GMTs) of nAb responses to poliovirus types 1, 2, and 3 in the concomitant-use group and the staggered-use group were comparable; 100% of participants had nAb titers ≥1:8 and ≥1:64 for all poliovirus types. Anti-rotavirus serotype-specific IgA GMTs and participants with ≥3-fold rise in postvaccination titers from baseline were comparable between groups. Administration of RV5 and IPV was well tolerated with comparable safety profiles in both groups. The immunogenicity of IPV in the concomitant-use group was non-inferior to the staggered-use group and RV5 was immunogenic in both groups. No safety concerns were identified. These data support the concomitant use of RV5 and IPV in healthy Chinese infants.https://www.tandfonline.com/doi/10.1080/21645515.2024.2324538Poliomyelitisgastroenteritisimmunogenicitysafetyconcomitantpentavalent rotavirus vaccine |
| spellingShingle | Shaomin Chen Zhifang Ying Yan Liu Yuan Li Yebin Yu Meilian Huang Zhuhang Huang Zhiqiang Ou Yuyi Liao Yong Zhang Guixiu Liu Weiwei Zhao Rong Fu Qiong Shou Minghuan Zheng Xueyan Liao Yingmei Tu Jon Stek Jonathan Hartzel Changgui Li Jikai Zhang A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China Human Vaccines & Immunotherapeutics Poliomyelitis gastroenteritis immunogenicity safety concomitant pentavalent rotavirus vaccine |
| title | A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China |
| title_full | A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China |
| title_fullStr | A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China |
| title_full_unstemmed | A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China |
| title_short | A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China |
| title_sort | phase 3 randomized open label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in china |
| topic | Poliomyelitis gastroenteritis immunogenicity safety concomitant pentavalent rotavirus vaccine |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2324538 |
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