Interim safety and immunogenicity of COVID-19 omicron BA.1 variant-containing vaccine in children in the USA: an open-label non-randomised phase 3 trial - 20/06/24
, Richard Bennett, MD b, Kashif Ali, MD c, Carl Griffin, MD d, Robert A Clifford, MD e, Mark Turner, MD f, Rosanne Poston, BS a, Kelly Hautzinger, BS a, Anne Yeakey, MD a, Bethany Girard, PhD a, Wen Zhou, PhD a, Weiping Deng, PhD a, Honghong Zhou, PhD a, Sabine Schnyder Ghamloush, MD a, Barbara J Kuter, PhD a, Karen Slobod, MD a, Jacqueline M Miller, MD a, Frances Priddy, MD a, Rituparna Das, MD afor the
ROVER Study Investigators†
Bienvenue sur EM-consulte, la référence des professionnels de santé.
Article gratuit.
Connectez-vous pour en bénéficier!
Summary |
Background |
Variant-containing mRNA vaccines for COVID-19 to broaden protection against SARS-CoV-2 variants are recommended based on findings in adults. We report interim safety and immunogenicity of an omicron BA.1 variant-containing (mRNA-1273.214) primary vaccination series and booster dose in paediatric populations.
Methods |
This open-label, two-part, non-randomised phase 3 trial enrolled participants aged 6 months to 5 years at 24 US study sites. Eligible participants were generally healthy or had stable chronic conditions, without known SARS-CoV-2 infection in the previous 90 days. Individuals who were acutely ill or febrile 1 day before or at the screening visit or those who previously received other COVID-19 vaccines (except mRNA-1273 for part 2) were excluded. In part 1, SARS-CoV-2-vaccine-naive participants received two-dose mRNA-1273.214 (25 μg; omicron BA.1 and ancestral Wuhan-Hu-1 mRNA) primary series. In part 2, participants who previously completed the two-dose mRNA-1273 (25 μg) primary series in KidCOVE (NCT04796896) received a mRNA-1273.214 (10 μg) booster dose. Primary study outcomes were safety and reactogenicity of the mRNA-1273.214 primary series (part 1) or booster dose (part 2) as well as the inferred effectiveness of mRNA-1273.214 based on immune responses against ancestral SARS-CoV-2 (D614G) and omicron BA.1 variant at 28 days post-primary series (part 1) or post-booster dose (part 2). The safety set included participants who received at least one dose of the study vaccine; the immunogenicity set included those who provided immunogenicity samples. Interim safety and immunogenicity are summarised in this analysis as of the data cutoff date (Dec 5, 2022). This trial is registered with ClinicalTrials.gov, NCT05436834.
Findings |
Between June 21, 2022, and Dec 5, 2022, 179 participants received one or more doses of mRNA-1273.214 primary series (part 1) and 539 received a mRNA-1273.214 booster dose (part 2). The safety profile within 28 days after either dose of the mRNA-1273.214 primary series and the booster dose was consistent with that of the mRNA-1273 primary series in this age group, with no new safety concerns or vaccine-related serious adverse events observed. At 28 days after primary series dose 2 and the booster dose, both mRNA-1273.214 primary series (day 57, including all participants with or without evidence of prior SARS-CoV-2 infection at baseline) and booster (day 29, including participants without evidence of prior SARS-CoV-2 infection at baseline) elicited responses that were superior against omicron-BA.1 (geometric mean ratio part 1: 25·4 [95% CI 20·1–32·1] and part 2: 12·5 [11·0–14·3]) and non-inferior against D614G (part 1: 0·8 [0·7–1·0] and part 2: 3·1 [2·8–3·5]), compared with neutralising antibody responses induced by the mRNA-1273 primary series (in a historical comparator group).
Interpretation |
mRNA-1273.214 was immunogenic against BA.1 and D614G in children aged 6 months to 5 years, with a comparable safety profile to mRNA-1273, when given as a two-dose primary series or a booster dose. These results are aligned with the US Centers for Disease Control and Prevention recommendations for the use of variant-containing vaccines for continued protection against the emerging variants of SARS-CoV-2.
Funding |
Moderna.
Le texte complet de cet article est disponible en PDF.Plan
Vol 24 - N° 7
P. 687-697 - juillet 2024 Retour au numéro
Article précédent
- A measles outbreak in a school
- Sanjeet Bagcchi
- Global, regional, and national age-specific progress towards the 2020 milestones of the WHO End TB Strategy: a systematic analysis for the Global Burden of Disease Study 2021
- GBD 2021 Tuberculosis Collaborators, Jorge R Ledesma, Jianing Ma, Meixin Zhang, Ann V L Basting, Huong Thi Chu, Avina Vongpradith, Amanda Novotney, Kate E LeGrand, Yvonne Yiru Xu, Xiaochen Dai, Sneha Ingle Nicholson, Lauryn K Stafford, Austin Carter, Jennifer M Ross, Hedayat Abbastabar, Meriem Abdoun, Deldar Morad Abdulah, Richard Gyan Aboagye, Hassan Abolhassani, Woldu Aberhe Abrha, Hiwa Abubaker Ali, Eman Abu-Gharbieh, Salahdein Aburuz, Isaac Yeboah Addo, Abiola Victor Adepoju, Kishor Adhikari, Qorinah Estiningtyas Sakilah Adnani, Saryia Adra, Abel Afework, Shahin Aghamiri, Williams Agyemang-Duah, Bright Opoku Ahinkorah, Danish Ahmad, Sajjad Ahmad, Amir Mahmoud Ahmadzade, Haroon Ahmed, Mohammed Ahmed, Ayman Ahmed, Karolina Akinosoglou, Tareq Mohammed Ali AL-Ahdal, Nazmul Alam, Mohammed Albashtawy, Mohammad T AlBataineh, Adel Ali Saeed Al-Gheethi, Abid Ali, Endale Alemayehu Ali, Liaqat Ali, Zahid Ali, Syed Shujait Shujait Ali, Kasim Allel, Awais Altaf, Jaffar A Al-Tawfiq, Nelson Alvis-Guzman, Nelson J. Alvis-Zakzuk, Reza Amani, Ganiyu Adeniyi Amusa, Jimoh Amzat, Jason R Andrews, Abhishek Anil, Razique Anwer, Aleksandr Y Aravkin, Damelash Areda, Anton A Artamonov, Raphael Taiwo Aruleba, Mulusew A Asemahagn, Sachin R Atre, Avinash Aujayeb, Davood Azadi, Sina Azadnajafabad, Ahmed Y Azzam, Muhammad Badar, Ashish D Badiye, Sara Bagherieh, Saeed Bahadorikhalili, Atif Amin Baig, Maciej Banach, Biswajit Banik, Mainak Bardhan, Hiba Jawdat Barqawi, Zarrin Basharat, Pritish Baskaran, Saurav Basu, Maryam Beiranvand, Melaku Ashagrie Belete, Makda Abate Belew, Uzma Iqbal Belgaumi, Apostolos Beloukas, Paulo J G Bettencourt, Akshaya Srikanth Bhagavathula, Nikha Bhardwaj, Pankaj Bhardwaj, Ashish Bhargava, Vivek Bhat, Jasvinder Singh Bhatti, Gurjit Kaur Bhatti, Boris Bikbov, Veera R Bitra, Vesna Bjegovic-Mikanovic, Danilo Buonsenso, Katrin Burkart, Yasser Bustanji, Zahid A Butt, Paulo Camargos, Yu Cao, Sinclair Carr, Felix Carvalho, Luca Cegolon, Muthia Cenderadewi, Muge Cevik, Yaacoub Chahine, Vijay Kumar Chattu, Patrick R Ching, Hitesh Chopra, Eunice Chung, Mareli M Claassens, Kaleb Coberly, Natália Cruz-Martins, Bashir Dabo, Sriharsha Dadana, Omid Dadras, Isaac Darban, Jiregna Darega Gela, Aso Mohammad Darwesh, Mahmood Dashti, Berecha Hundessa Demessa, Biniyam Demisse, Solomon Demissie, Awoke Masrie Asrat Derese, Kebede Deribe, Hardik Dineshbhai Desai, Vinoth Gnana Chellaiyan Devanbu, Arkadeep Dhali, Kuldeep Dhama, Sameer Dhingra, Thao Huynh Phuong Do, Deepa Dongarwar, Haneil Larson Dsouza, John Dube, Arkadiusz Marian Dziedzic, Abdelaziz Ed-Dra, Ferry Efendi, Diyan Ermawan Effendi, Aziz Eftekharimehrabad, Nopryan Ekadinata, Temitope Cyrus Ekundayo, Muhammed Elhadi, Legesse Tesfaye Elilo, Theophilus I Emeto, Luchuo Engelbert Bain, Adeniyi Francis Fagbamigbe, Ayesha Fahim, Alireza Feizkhah, Getahun Fetensa, Florian Fischer, Abduzhappar Gaipov, Aravind P Gandhi, Rupesh K Gautam, Miglas W Gebregergis, Mesfin Gebrehiwot, Kahsu Gebrekirstos Gebrekidan, Kazem Ghaffari, Fariba Ghassemi, Ramy Mohamed Ghazy, Amador Goodridge, Anmol Goyal, Shi-Yang Guan, Mesay Dechasa Gudeta, Rashid Abdi Guled, Novianti Br Gultom, Veer Bala Gupta, Vivek Kumar Gupta, Sapna Gupta, Hailey Hagins, Semira Goitom Hailu, Wase Benti Hailu, Samer Hamidi, Asif Hanif, Harapan Harapan, Rumina Syeda Hasan, Shoaib Hassan, Johannes Haubold, Kamal Hezam, Sung Hwi Hong, Nobuyuki Horita, Md. Belal Hossain, Mehdi Hosseinzadeh, Mihaela Hostiuc, Sorin Hostiuc, Hong-Han Huynh, Segun Emmanuel Ibitoye, Kevin S Ikuta, Irena M. Ilic, Milena D. Ilic, Md. Rabiul Islam, Nahlah Elkudssiah Ismail, Faisal Ismail, Abdollah Jafarzadeh, Mihajlo Jakovljevic, Mahsa Jalili, Manthan Dilipkumar Janodia, Nabi Jomehzadeh, Jost B Jonas, Nitin Joseph, Charity Ehimwenma Joshua, Zubair Kabir, Bhushan Dattatray Kamble, Tanuj Kanchan, Himal Kandel, Kehinde Kazeem Kanmodi, Rami S Kantar, Ibraheem M Karaye, Arman Karimi Behnagh, Gebrehiwot G Kassa, Rimple Jeet Kaur, Navjot Kaur, Himanshu Khajuria, Faham Khamesipour, Yusra H Khan, M Nuruzzaman Khan, Mahammed Ziauddin Khan Suheb, Khaled Khatab, Fatemeh Khatami, Min Seo Kim, Soewarta Kosen, Parvaiz A Koul, Sindhura Lakshmi Koulmane Laxminarayana, Kewal Krishan, Burcu Kucuk Bicer, Md Abdul Kuddus, Mukhtar Kulimbet, Nithin Kumar, Dharmesh Kumar Lal, Iván Landires, Kamaluddin Latief, Trang Diep Thanh Le, Thao Thi Thu Le, Caterina Ledda, Munjae Lee, Seung Won Lee, Temesgen L Lerango, Stephen S Lim, Chaojie Liu, Xuefeng Liu, Platon D Lopukhov, Hong Luo, Hengliang Lv, Preetam Bhalchandra Mahajan, Amir Ali Mahboobipour, Azeem Majeed, Elaheh Malakan Rad, Kashish Malhotra, Muhammad Sajeel Ahmed Malik, Lesibana Anthony Malinga, Tauqeer Hussain Mallhi, Aseer Manilal, Bernardo Alfonso Martinez-Guerra, Francisco Rogerlândio Martins-Melo, Roy Rillera Marzo, Hossein Masoumi-Asl, Vasundhara Mathur, Richard James Maude, Ravi Mehrotra, Ziad A Memish, Walter Mendoza, Ritesh G Menezes, Muayad Aghali Merza, Tomislav Mestrovic, Laurette Mhlanga, Sanjeev Misra, Arup Kumar Misra, Prasanna Mithra, Babak Moazen, Hussen Mohammed, Ali H Mokdad, Lorenzo Monasta, Catrin E Moore, Parsa Mousavi, Francesk Mulita, Fungai Musaigwa, Raman Muthusamy, Ahamarshan Jayaraman Nagarajan, Pirouz Naghavi, Ganesh R Naik, Gurudatta Naik, Sanjeev Nair, Tapas Sadasivan Nair, Zuhair S Natto, Biswa Prakash Nayak, Hadush Negash, Dang H Nguyen, Van Thanh Nguyen, Robina Khan Niazi, Chukwudi A Nnaji, Lawrence Achilles Nnyanzi, Efaq Ali Noman, Shuhei Nomura, Bogdan Oancea, Kehinde O Obamiro, Ismail A Odetokun, Daniel Bogale Odo Odo, Oluwakemi Ololade Odukoya, In-Hwan Oh, Chukwuma O Okereke, Osaretin Christabel Okonji, Eyal Oren, Edgar Ortiz-Brizuela, Uchechukwu Levi Osuagwu, Amel Ouyahia, Mahesh Padukudru P A, Pragyan Paramita Parija, Romil R Parikh, Seoyeon Park, Ashwaghosha Parthasarathi, Shankargouda Patil, Shrikant Pawar, Minjin Peng, Veincent Christian Filipino Pepito, Prince Peprah, João Perdigão, Norberto Perico, Hoang Tran Pham, Maarten J Postma, Attur Ravindra Attur Prabhu, Manya Prasad, Akila Prashant, Elton Junio Sady Prates, Fakher Rahim, Mosiur Rahman, Muhammad Aziz Rahman, Masoud Rahmati, Sathish Rajaa, Shakthi Kumaran Ramasamy, Indu Ramachandra Rao, Sowmya J Rao, Deepthi Rapaka, Ahmed Mustafa Rashid, Zubair Ahmed Ratan, Nakul Ravikumar, Salman Rawaf, Murali Mohan Rama Krishna Reddy, Elrashdy Moustafa Mohamed Redwan, Giuseppe Remuzzi, Luis Felipe Reyes, Nazila Rezaei, Mohsen Rezaeian, Omid Rezahosseini, Mónica Rodrigues, Priyanka Roy, Guilherme de Andrade Ruela, Siamak Sabour, Basema Saddik, Umar Saeed, Sher Zaman Safi, Narjes Saheb Sharif-Askari, Fatemeh Saheb Sharif-Askari, Amirhossein Sahebkar, Biniyam Sahiledengle, Soumya Swaroop Sahoo, Nasir Salam, Afeez Abolarinwa Salami, Samreen Saleem, Mohamed A Saleh, Hossein Samadi Kafil, Sara Samadzadeh, Yoseph Leonardo Samodra, Rama Krishna Sanjeev, Aswini Saravanan, Susan M Sawyer, Siddharthan Selvaraj, Sabyasachi Senapati, Subramanian Senthilkumaran, Pritik A Shah, Samiah Shahid, Masood Ali Shaikh, Sunder Sham, Mohammad Ali Shamshirgaran, Mohd Shanawaz, Medha Sharath, Samendra P Sherchan, Ranjitha S Shetty, Hesamaddin Shirzad-Aski, Aminu Shittu, Emmanuel Edwar Siddig, João Pedro Silva, Surjit Singh, Paramdeep Singh, Harpreet Singh, Jasvinder A Singh, Md Shahjahan Siraj, Siswanto Siswanto, Ranjan Solanki, Yonatan Solomon, Joan B Soriano, Chandrashekhar T Sreeramareddy, Vijay Kumar Srivastava, Paschalis Steiropoulos, Chandan Kumar Swain, Takahiro Tabuchi, Mircea Tampa, Jacques JL Lukenze Tamuzi, Nathan Y Tat, Razieh Tavakoli Oliaee, Gebrehiwot Teklay, Edosa Geta Tesfaye, Belay Tessema, Pugazhenthan Thangaraju, Rekha Thapar, Chern Choong Chern Thum, Jansje Henny Vera Ticoalu, Imad M Tleyjeh, Ruoyan Tobe-Gai, Temesgen Mohammed Toma, Khai Hoan Tram, Aniefiok John Udoakang, Tungki Pratama Umar, Chukwuma David Umeokonkwo, Seyed Mohammad Vahabi, Asokan Govindaraj Vaithinathan, Job F M van Boven, Shoban Babu Varthya, Ziyue Wang, Muktar S A Warsame, Ronny Westerman, Tewodros Eshete Wonde, Sajad Yaghoubi, Siyan Yi, Vahit Yiğit, Dong Keon Yon, Naohiro Yonemoto, Chuanhua Yu, Fathiah Zakham, Moein Zangiabadian, Francis Zeukeng, Haijun Zhang, Yang Zhao, Peng Zheng, Magdalena Zielińska, Joshua A Salomon, Robert C Reiner Jr, Mohsen Naghavi, Theo Vos, Simon I Hay, Christopher J L Murray, Hmwe Hmwe Kyu
Bienvenue sur EM-consulte, la référence des professionnels de santé.