Immunogenicity and safety of tixagevimab-cilgavimab for COVID-19 pre-exposure prophylaxis in immunocompromised 20 to <40 kg children and adolescents: A pilot, prospective, open-labeled study
We evaluated the immunogenicity of 300 mg Tixagevimab-Cilgavimab in immunocompromised children and adolescents who weighed 20 to >40 kg. Six to 18-year-old participants were divided into two groups by body weight and received 300 mg (20 to <40 kg) and 600 mg (≥40 kg) Tixagevimab-Cilgavimab, re...
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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/10.1080/21645515.2024.2428011 |
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| author | Jassada Buaboonnam Supattra Rungmaitree Nuntawan Piyaphanee Sirirat Charuvanij Onsiri Pitisuttithum Katherine Copeland Chatkamol Pheerapanyawaranun Laddawan Jansarikit Suvimol Niyomnaitham Kulkanya Chokephaibulkit |
| author_facet | Jassada Buaboonnam Supattra Rungmaitree Nuntawan Piyaphanee Sirirat Charuvanij Onsiri Pitisuttithum Katherine Copeland Chatkamol Pheerapanyawaranun Laddawan Jansarikit Suvimol Niyomnaitham Kulkanya Chokephaibulkit |
| author_sort | Jassada Buaboonnam |
| collection | DOAJ |
| description | We evaluated the immunogenicity of 300 mg Tixagevimab-Cilgavimab in immunocompromised children and adolescents who weighed 20 to >40 kg. Six to 18-year-old participants were divided into two groups by body weight and received 300 mg (20 to <40 kg) and 600 mg (≥40 kg) Tixagevimab-Cilgavimab, respectively. Anti-SARS-CoV-2 receptor-binding domain IgG concentrations and pseudovirus neutralizing antibody (NAb) titers were measured at 4, 12, and 24 weeks after administration and compared with reference data from healthy Thai children at 2 weeks after three BNT162b2 vaccinations. Of 59 participants, 49.2% were female, with a median (IQR) age of 12 (9, 15) years; 16 (27.1%) had cancer. NAb titers (95% CI) for the ancestral Wuhan strain were comparatively high for both dosing regimens (16363.2 [13765.9, 19450.5] vs 17768.3 [15539.5, 20316.9] in 20 to <40 kg and ≥40 kg participants, respectively) and significantly higher than reference titers (P < 0.001 for both). NAb titers for Omicron BA.4/5 were on par with the reference for both dosing regimens. Adverse events were mild, well tolerated, and slightly more prevalent in ≥40 kg participants who received full-dose Tixagevimab–Cilgavimab. Minimal waning in anti-RBD IgG concentrations, comparable to the reference, was observed at 12 and 24 weeks after Tixagevimab-Cilgavimab administration for both regimens. We concluded that half-dose Tixagevimab-Cilgavimab in 20 to <40 kg participants generated equivalent antibodies to standard doses in ≥40 kg participants and significantly higher antibodies than three-dose BNT162b2 vaccination. Further study of monoclonal long-acting antibodies in larger cohorts and <6-year-old children are warranted. |
| format | Article |
| id | doaj-art-e4bf0bcbdc0646d4bfc08de6a05b8897 |
| institution | OA Journals |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
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| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-e4bf0bcbdc0646d4bfc08de6a05b88972025-08-20T02:34:25ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2024-12-0120110.1080/21645515.2024.2428011Immunogenicity and safety of tixagevimab-cilgavimab for COVID-19 pre-exposure prophylaxis in immunocompromised 20 to <40 kg children and adolescents: A pilot, prospective, open-labeled studyJassada Buaboonnam0Supattra Rungmaitree1Nuntawan Piyaphanee2Sirirat Charuvanij3Onsiri Pitisuttithum4Katherine Copeland5Chatkamol Pheerapanyawaranun6Laddawan Jansarikit7Suvimol Niyomnaitham8Kulkanya Chokephaibulkit9Division of Hematology and Oncology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, ThailandDivision of Infectious Diseases, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, ThailandDivision of Nephrology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, ThailandDivision of Rheumatology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, ThailandTherapeutic Area Medical Lead, AstraZeneca (Thailand) Ltd, Bangkok, ThailandSiriraj Institute of Clinical Research (SICRES), Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, ThailandSiriraj Institute of Clinical Research (SICRES), Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, ThailandDepartment of Pharmacology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, ThailandSiriraj Institute of Clinical Research (SICRES), Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, ThailandDivision of Infectious Diseases, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, ThailandWe evaluated the immunogenicity of 300 mg Tixagevimab-Cilgavimab in immunocompromised children and adolescents who weighed 20 to >40 kg. Six to 18-year-old participants were divided into two groups by body weight and received 300 mg (20 to <40 kg) and 600 mg (≥40 kg) Tixagevimab-Cilgavimab, respectively. Anti-SARS-CoV-2 receptor-binding domain IgG concentrations and pseudovirus neutralizing antibody (NAb) titers were measured at 4, 12, and 24 weeks after administration and compared with reference data from healthy Thai children at 2 weeks after three BNT162b2 vaccinations. Of 59 participants, 49.2% were female, with a median (IQR) age of 12 (9, 15) years; 16 (27.1%) had cancer. NAb titers (95% CI) for the ancestral Wuhan strain were comparatively high for both dosing regimens (16363.2 [13765.9, 19450.5] vs 17768.3 [15539.5, 20316.9] in 20 to <40 kg and ≥40 kg participants, respectively) and significantly higher than reference titers (P < 0.001 for both). NAb titers for Omicron BA.4/5 were on par with the reference for both dosing regimens. Adverse events were mild, well tolerated, and slightly more prevalent in ≥40 kg participants who received full-dose Tixagevimab–Cilgavimab. Minimal waning in anti-RBD IgG concentrations, comparable to the reference, was observed at 12 and 24 weeks after Tixagevimab-Cilgavimab administration for both regimens. We concluded that half-dose Tixagevimab-Cilgavimab in 20 to <40 kg participants generated equivalent antibodies to standard doses in ≥40 kg participants and significantly higher antibodies than three-dose BNT162b2 vaccination. Further study of monoclonal long-acting antibodies in larger cohorts and <6-year-old children are warranted.https://www.tandfonline.com/doi/10.1080/21645515.2024.2428011Tixagevimab-cilgavimabpre-exposure prophylaxisimmunocompromisedchildrenadolescentsThailand |
| spellingShingle | Jassada Buaboonnam Supattra Rungmaitree Nuntawan Piyaphanee Sirirat Charuvanij Onsiri Pitisuttithum Katherine Copeland Chatkamol Pheerapanyawaranun Laddawan Jansarikit Suvimol Niyomnaitham Kulkanya Chokephaibulkit Immunogenicity and safety of tixagevimab-cilgavimab for COVID-19 pre-exposure prophylaxis in immunocompromised 20 to <40 kg children and adolescents: A pilot, prospective, open-labeled study Human Vaccines & Immunotherapeutics Tixagevimab-cilgavimab pre-exposure prophylaxis immunocompromised children adolescents Thailand |
| title | Immunogenicity and safety of tixagevimab-cilgavimab for COVID-19 pre-exposure prophylaxis in immunocompromised 20 to <40 kg children and adolescents: A pilot, prospective, open-labeled study |
| title_full | Immunogenicity and safety of tixagevimab-cilgavimab for COVID-19 pre-exposure prophylaxis in immunocompromised 20 to <40 kg children and adolescents: A pilot, prospective, open-labeled study |
| title_fullStr | Immunogenicity and safety of tixagevimab-cilgavimab for COVID-19 pre-exposure prophylaxis in immunocompromised 20 to <40 kg children and adolescents: A pilot, prospective, open-labeled study |
| title_full_unstemmed | Immunogenicity and safety of tixagevimab-cilgavimab for COVID-19 pre-exposure prophylaxis in immunocompromised 20 to <40 kg children and adolescents: A pilot, prospective, open-labeled study |
| title_short | Immunogenicity and safety of tixagevimab-cilgavimab for COVID-19 pre-exposure prophylaxis in immunocompromised 20 to <40 kg children and adolescents: A pilot, prospective, open-labeled study |
| title_sort | immunogenicity and safety of tixagevimab cilgavimab for covid 19 pre exposure prophylaxis in immunocompromised 20 to 40 kg children and adolescents a pilot prospective open labeled study |
| topic | Tixagevimab-cilgavimab pre-exposure prophylaxis immunocompromised children adolescents Thailand |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2428011 |
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