CASCADIA: a prospective community-based study protocol for assessing SARS-CoV-2 vaccine effectiveness in children and adults using a remote nasal swab collection and web-based survey design

被引:9
作者
Babu, Tara M. [1 ]
Feldstein, Leora R. [2 ]
Saydah, Sharon [2 ]
Acker, Zachary [3 ]
Boisvert, Cassandra L. [4 ]
Briggs-Hagen, Melissa [2 ]
Carone, Marco [5 ]
Casto, Amanda [1 ]
Cox, Sarah N. [1 ,6 ]
Ehmen, Brenna [3 ]
Englund, Janet A. [7 ]
Fortmann, Stephen P. [4 ]
Frivold, Collrane J. [1 ,6 ]
Groom, Holly [4 ]
Han, Peter D. [3 ]
Kuntz, Jennifer L. [4 ]
Lockwood, Tina [3 ,8 ]
Midgley, Claire M. [2 ]
Mularski, Richard A. [4 ]
Ogilvie, Tara [1 ]
Reich, Sacha L. [4 ]
Schmidt, Mark A. [4 ]
Smith, Ning [4 ]
Starita, Lea [3 ,9 ]
Stone, Jeremy [3 ]
Vandermeer, Meredith [4 ]
Weil, Ana A. [1 ]
Wolf, Caitlin R. [1 ]
Chu, Helen Y. [1 ]
Naleway, Allison L. [4 ]
机构
[1] Univ Washington, Dept Med, Div Allergy & Infect Dis, Seattle, WA 98195 USA
[2] CDCP, Natl Ctr Immunizat & Resp Dis, Atlanta, GA USA
[3] Univ Washington, Brotman Baty Inst Precis Med, Seattle, WA USA
[4] Kaiser Permanente Northwest, Ctr Hlth Res, Portland, OR USA
[5] Univ Washington, Dept Biostat, Seattle, WA USA
[6] Univ Washington, Dept Epidemiol, Seattle, WA USA
[7] Seattle Childrens Res Inst, Dept Pediat, Seattle, WA USA
[8] Univ Washington, Dept Pathol, Seattle, WA USA
[9] Univ Washington, Genome Sci, Seattle, WA USA
来源
BMJ OPEN | 2023年 / 13卷 / 07期
关键词
COVID-19; epidemiology; paediatric infectious disease & immunisation;
D O I
10.1136/bmjopen-2022-071446
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
IntroductionAlthough SARS-CoV-2 vaccines were first approved under Emergency Use Authorization by the Food and Drug Administration in late 2020 for adults, authorisation for young children 6 months to <5 years of age did not occur until 2022. These authorisations were based on clinical trials, understanding real-world vaccine effectiveness (VE) in the setting of emerging variants is critical. The primary goal of this study is to evaluate SARS-CoV-2 VE against infection among children aged >6 months and adults aged MethodsCASCADIA is a 4-year community-based prospective study of SARS-CoV-2 VE among 3500 adults and paediatric populations aged 6 months to 49 years in Oregon and Washington, USA. At enrolment and regular intervals, participants complete a sociodemographic questionnaire. Individuals provide a blood sample at enrolment and annually thereafter, with optional blood draws every 6 months and after infection and vaccination. Participants complete weekly self-collection of anterior nasal swabs and symptom questionnaires. Swabs are tested for SARS-CoV-2 and other respiratory pathogens by reverse transcription-PCR, with results of selected pathogens returned to participants; nasal swabs with SARS-CoV-2 detected will undergo whole genome sequencing. Participants who test positive for SARS-CoV-2 undergo serial swab collection every 3 days for 21 days. Serum samples are tested for SARS-CoV-2 antibody by binding and neutralisation assays. AnalysisThe primary outcome is SARS-CoV-2 infection. Cox regression models will be used to estimate the incidence rate ratio associated with SARS-CoV-2 vaccination among the paediatric and adult population, controlling for demographic factors and other potential confounders. Ethics and disseminationAll study materials including the protocol, consent forms, data collection instruments, participant communication and recruitment materials, were approved by the Kaiser Permanente Interregional Institutional Review Board, the IRB of record for the study. Results will be disseminated through peer-reviewed publications, presentations, participant newsletters and appropriate general news media.
引用
收藏
页数:9
相关论文
共 38 条
[1]   Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age [J].
Anderson, E. J. ;
Creech, C. B. ;
Berthaud, V ;
Piramzadian, A. ;
Johnson, K. A. ;
Zervos, M. ;
Garner, F. ;
Griffin, C. ;
Palanpurwala, K. ;
Turner, M. ;
Gerber, J. ;
Bennett, R. L. ;
Ali, K. ;
Ampajwala, M. ;
Berman, G. ;
Nayak, J. ;
Chronis, C. ;
Rizzardi, B. ;
Muller, W. J. ;
Smith, C. A. ;
Fuchs, G. ;
Hsia, D. ;
Tomassini, J. E. ;
DeLucia, D. ;
Reuter, C. ;
Kuter, B. ;
Zhao, X. ;
Deng, W. ;
Zhou, H. ;
Schrempp, D. Ramirez ;
Hautzinger, K. ;
Girard, B. ;
Slobod, K. ;
McPhee, R. ;
Pajon, R. ;
Aunins, A. ;
Das, R. ;
Miller, J. M. ;
Ghamloush, S. Schnyder .
NEW ENGLAND JOURNAL OF MEDICINE, 2022, 387 (18) :1673-1687
[2]  
[Anonymous], 2020, 2020 WD GSORATMBOC M
[3]  
[Anonymous], 2022, Coronavirus (COVID-19) dashboard
[4]  
[Anonymous], 2022, COVID data tracker
[5]  
Arnedo-Pena A., 2020, Rev Enf Emerg, V19, P64
[6]   Homologous and Heterologous Covid-19 Booster Vaccinations [J].
Atmar, R. L. ;
Lyke, K. E. ;
Deming, M. E. ;
Jackson, L. A. ;
Branche, A. R. ;
El Sahly, H. M. ;
Rostad, C. A. ;
Martin, J. M. ;
Johnston, C. ;
Rupp, R. E. ;
Mulligan, M. J. ;
Brady, R. C. ;
Frenck, R. W., Jr. ;
Backer, M. ;
Kottkamp, A. C. ;
Babu, T. M. ;
Rajakumar, K. ;
Edupuganti, S. ;
Dobrzynski, D. ;
Coler, R. N. ;
Posavad, C. M. ;
Archer, J., I ;
Crandon, S. ;
Nayak, S. U. ;
Szydlo, D. ;
Zemanek, J. A. ;
Islas, C. P. Dominguez ;
Brown, E. R. ;
Suthar, M. S. ;
McElrath, M. J. ;
McDermott, A. B. ;
Montefiori, D. C. ;
Eaton, A. ;
Neuzil, K. M. ;
Stephens, D. S. ;
Roberts, P. C. ;
Beigel, J. H. .
NEW ENGLAND JOURNAL OF MEDICINE, 2022, 386 (11) :1046-1057
[7]   Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine [J].
Baden, Lindsey R. ;
El Sahly, Hana M. ;
Essink, Brandon ;
Kotloff, Karen ;
Frey, Sharon ;
Novak, Rick ;
Diemert, David ;
Spector, Stephen A. ;
Rouphael, Nadine ;
Creech, C. Buddy ;
McGettigan, John ;
Khetan, Shishir ;
Segall, Nathan ;
Solis, Joel ;
Brosz, Adam ;
Fierro, Carlos ;
Schwartz, Howard ;
Neuzil, Kathleen ;
Corey, Larry ;
Gilbert, Peter ;
Janes, Holly ;
Follmann, Dean ;
Marovich, Mary ;
Mascola, John ;
Polakowski, Laura ;
Ledgerwood, Julie ;
Graham, Barney S. ;
Bennett, Hamilton ;
Pajon, Rolando ;
Knightly, Conor ;
Leav, Brett ;
Deng, Weiping ;
Zhou, Honghong ;
Han, Shu ;
Ivarsson, Melanie ;
Miller, Jacqueline ;
Zaks, Tal .
NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (05) :403-416
[8]   Protection of BNT162b2 Vaccine Booster against Covid-19 in Israel [J].
Bar-On, Yinon M. ;
Goldberg, Yair ;
Mandel, Micha ;
Bodenheimer, Omri ;
Freedman, Laurence ;
Kalkstein, Nir ;
Mizrahi, Barak ;
Alroy-Preis, Sharon ;
Ash, Nachman ;
Milo, Ron ;
Huppert, Amit .
NEW ENGLAND JOURNAL OF MEDICINE, 2021, 385 (15) :1393-1400
[9]   Cryptic transmission of SARS-CoV-2 in Washington state [J].
Bedford, Trevor ;
Greninger, Alexander L. ;
Roychoudhury, Pavitra ;
Starita, Lea M. ;
Famulare, Michael ;
Huang, Meei-Li ;
Nalla, Arun ;
Pepper, Gregory ;
Reinhardt, Adam ;
Xie, Hong ;
Shrestha, Lasata ;
Nguyen, Truong N. ;
Adler, Amanda ;
Brandstetter, Elisabeth ;
Cho, Shari ;
Giroux, Danielle ;
Han, Peter D. ;
Fay, Kairsten ;
Frazar, Chris D. ;
Ilcisin, Misja ;
Lacombe, Kirsten ;
Lee, Jover ;
Kiavand, Anahita ;
Richardson, Matthew ;
Sibley, Thomas R. ;
Truong, Melissa ;
Wolf, Caitlin R. ;
Nickerson, Deborah A. ;
Rieder, Mark J. ;
Englund, Janet A. ;
Hadfield, James ;
Hodcroft, Emma B. ;
Huddleston, John ;
Moncla, Louise H. ;
Mueller, Nicola F. ;
Neher, Richard A. ;
Deng, Xianding ;
Gu, Wei ;
Federman, Scot ;
Chiu, Charles ;
Duchin, Jeffrey S. ;
Gautom, Romesh ;
Melly, Geoff ;
Hiatt, Brian ;
Dykema, Philip ;
Lindquist, Scott ;
Queen, Krista ;
Tao, Ying ;
Uehara, Anna ;
Tong, Suxiang .
SCIENCE, 2020, 370 (6516) :571-+
[10]  
CDC, 2022, COVID 19 2022