Safety and Immunogenicity of an mRNA-1273 Booster in Children

被引：0

作者：

Berthaud, Vladimir ^{[1
]}

Creech, C. Buddy ^{[2
]}

Rostad, Christina A. ^{[3
,4
]}

Carr, Quito ^{[5
]}

de Leon, Liberation ^{[6
]}

Dietrich, Monika ^{[7
]}

Gupta, Anil ^{[8
]}

Javita, David ^{[9
]}

Nachman, Sharon ^{[10
]}

Pinninti, Swetha ^{[11
]}

Rathore, Mobeen ^{[12
]}

Rodriguez, Carina A. ^{[13
]}

Luzuriaga, Katherine ^{[14
]}

Towner, William ^{[15
]}

Yeakey, Anne ^{[16
]}

Brown, Mollie ^{[17
]}

Zhao, Xiaoping ^{[17
]}

Deng, Weiping ^{[17
]}

Xu, Wenqin ^{[17
]}

Zhou, Honghong ^{[17
]}

Girard, Bethany ^{[17
]}

Kelly, Roxanne ^{[17
]}

Slobod, Karen ^{[18
]}

Anderson, Evan J. ^{[3
,4
,17
]}

Das, Rituparna ^{[17
]}

Miller, Jacqueline ^{[17
]}

Ghamloush, Sabine Schnyder ^{[17
]}

机构：

[1] Meharry Med Coll, Div Infect Dis, Clin & Translat Res Ctr, Nashville, TN USA

[2] Vanderbilt Univ, Med Ctr, Vanderbilt Vaccine Res Program, Nashville, TN USA

[3] Emory Univ, Sch Med, Dept Med, Atlanta, GA USA

[4] Childrens Healthcare Atlanta, Atlanta, GA USA

[5] MedPharmics LLC Albuquerque, Albuquerque, NM USA

[6] Ctr Clin Trials LLC, Paramount, CA USA

[7] Tulane Univ, Sch Med, Dept Pediat Infect Dis, 1430 Tulane Ave, New Orleans, LA 70112 USA

[8] Dr Anil K Gupta Med Profess Corp, Toronto, ON, Canada

[9] Prohlth Res Ctr, Doral, FL USA

[10] SUNY Stony Brook, Renaissance Sch Med, Stony Brook, NY 11794 USA

[11] Univ Alabama Birmingham, Childrens Alabama, Div Pediat Infect Dis, Birmingham, AL USA

[12] Univ Florida, Ctr HIV AIDS Res Educ & Serv UF CARES, Jacksonville, FL USA

[13] Univ S Florida, Morsani Coll Med, Div Pediat Infect Dis, Tampa, FL USA

[14] UMass Chan Med Sch, Program Mol Med, Worcester, MA USA

[15] Kaiser Permanente, Los Angeles Med Ctr, Dept Infect Dis, Los Angeles, CA USA

[16] BioPoint Contracting, Wake Forest, NC USA

[17] Moderna Inc, Cambridge, MA USA

[18] Cambridge ID & Immunol Consulting LLC, Somerville, MA USA

来源：

CLINICAL INFECTIOUS DISEASES | 2024年 / 79卷 / 06期

基金：

美国国家卫生研究院;

关键词：

mRNA-1273; COVID-19; booster dose; children; SARS-CoV-2; VACCINE;

D O I：

暂无

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Background. A 2-dose mRNA-1273 primary series in children aged 6 months-5 years (25 mu g) and 6-11 years (50 mu g) had an acceptable safety profile and was immunogenic in the phase 2/3 KidCOVE study. We present data from KidCOVE participants who received an mRNA-1273 booster dose. Methods. An mRNA-1273 booster dose (10 mu g for children aged 6 months-5 years; 25 mu g for children aged 6-11 years; age groups based on participant age at enrollment) was administered >= 6 months after primary series completion. The primary safety objective was the safety and reactogenicity of an mRNA-1273 booster dose. The primary immunogenicity objective was to infer efficacy of an mRNA-1273 booster dose by establishing noninferiority of neutralizing antibody (nAb) responses after a booster in children versus nAb responses observed after the mRNA-1273 primary series in young adults (18-25 years) from the pivotal efficacy study. Data were collected from March 2022 to June 2023. Results. Overall, 153 (6 months-5 years) and 2519 (6-11 years) participants received an mRNA-1273 booster dose (median age at receipt of booster: 2 and 10 years, respectively). The booster dose safety profile was generally consistent with that of the primary series in children; no new safety concerns were identified. An mRNA-1273 booster dose elicited robust nAb responses against ancestral SARS-CoV-2 among children and met prespecified noninferiority success criteria versus responses observed after the primary series in young adults. Conclusions. Safety and immunogenicity data support administration of an mRNA-1273 booster dose in children aged 6 months to 11 years. Clinical Trials Registration. NCT04796896 (Clinicaltrials.gov). A booster dose of mRNA-1273 in children aged 6 months to 11 years was well tolerated and elicited robust immune responses against SARS-CoV-2, supporting recommendations for COVID-19 vaccination in individuals aged 6 months and older.

引用

页码：1524 / 1532

页数：9

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