Data for: A phase Ib/II single-blinded, randomised, controlled study to determine safety, immunogenicity and efficacy of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in adults in Kenya (doi:10.7910/DVN/L4NX9M)

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Part 1: Document Description
Part 2: Study Description
Part 3: Data Files Description
Part 4: Variable Description
Part 5: Other Study-Related Materials
Entire Codebook

Data for: A phase Ib/II single-blinded, randomised, controlled study to determine safety, immunogenicity and efficacy of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in adults in Kenya

doi:10.7910/DVN/L4NX9M

Harvard Dataverse

2023-03-10

3

Cheruiyot, Stanley; Orindi, Benedict O.; Warimwe, George M., 2023, "Data for: A phase Ib/II single-blinded, randomised, controlled study to determine safety, immunogenicity and efficacy of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in adults in Kenya", https://doi.org/10.7910/DVN/L4NX9M, Harvard Dataverse, V3, UNF:6:Hrsr33WVvMVkOXLz/cPrcA== [fileUNF]

Data for: A phase Ib/II single-blinded, randomised, controlled study to determine safety, immunogenicity and efficacy of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in adults in Kenya

doi:10.7910/DVN/L4NX9M

Cheruiyot, Stanley (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Orindi, Benedict O. (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Warimwe, George M. (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Harvard Dataverse

Cheruiyot, Stanley

Cheruiyot, Stanley

2023-03-10

https://doi.org/10.7910/DVN/L4NX9M

Medicine, Health and Life Sciences, COVID-19, SARS-COV-2, Vaccine

<p>The dataset contains information on demographics, safety and immunogenicity collected to evaluate whether the ChAdOx1 nCoV-19 vaccine is safe, elicits good immune responses and protects Kenyan adults from COVID19. The persistence of these immune responses was investigated up to 12 months following immunization with a single dose of vaccine at Day 0 and booster dose at Day 84 post first dose. A Data Management team was located at KEMRI CGMRC with data collection using eCRFs/CRFs by designated staff. Clinician/data entry clerks/trained study team members used password-protected computers. Data was entered onto an electronic database. This was done via a secure web interface with data checks used during data entry to ensure data quality. The database was activated for the study only after successfully passing a formal design and test procedure. </p> <p>The trial is registered on <a href="">ClinicalTrials.gov: NCT04324606</a></p>

Clinical Trial

Open Access

<p><strong>Data Access: </strong>Open</p> <p><strong>Citation requirement:</strong> Publications based on this data collection should acknowledge this source by means of bibliographic citation.</p>

• Number of cases: 1642

• No. of variables per record: 68

• Type of File: text/tab-separated-values

UNF:6:Xag6KaEyob4xdv9cqAEO3w==

• screen_id - screen_id
• cov_pid - cov_pid
• scr_date - scr_date
• scr_inelig_rea - scr_inelig_rea
• scr_elligible - scr_elligible
• scr_sex - scr_sex
• scr_age - scr_age
• scr_weight - scr_weight
• scr_height - scr_height
• scr_bmi - scr_bmi
• scr_spo2 - scr_spo2
• scr_pulse - scr_pulse
• scr_occupation - scr_occupation
• scr_healhcare - scr_healhcare
• arm_assigned - arm_assigned
• AE - AE
• Grade - Grade
• Description - Description
• onset_date - onset_date
• End_date - End_date
• Related - Related
• vac_date - vac_date
• days_postvac - days_postvac
• SAE_desc - SAE_desc
• SAE_reason - SAE_reason
• SAE_startdate - SAE_startdate
• SAE_end_date - SAE_end_date
• SAE_relatedness - SAE_relatedness
• StdSpikeELISAEUD0 - StdSpikeELISAEUD0
• StdSpikeELISAEUD14 - StdSpikeELISAEUD14
• StdSpikeELISAEUD28 - StdSpikeELISAEUD28
• StdSpikeELISAEUD84 - StdSpikeELISAEUD84
• StdSpikeELISAEUD112 - StdSpikeELISAEUD112
• StdSpikeELISAEUD365 - StdSpikeELISAEUD365
• od_d0 - od_d0
• negod_d0 - negod_d0
• odratio_d0 - odratio_d0
• seropos_d0 - seropos_d0
• od_d14 - od_d14
• negod_d14 - negod_d14
• odratio_d14 - odratio_d14
• seropos_d14 - seropos_d14
• od_d28 - od_d28
• negod_d28 - negod_d28
• odratio_d28 - odratio_d28
• seropos_d28 - seropos_d28
• od_d84 - od_d84
• negod_d84 - negod_d84
• odratio_d84 - odratio_d84
• seropos_d84 - seropos_d84
• od_d91 - od_d91
• negod_d91 - negod_d91
• odratio_d91 - odratio_d91
• seropos_d91 - seropos_d91
• od_d112 - od_d112
• negod_d112 - negod_d112
• odratio_d112 - odratio_d112
• seropos_d112 - seropos_d112
• od_d182 - od_d182
• negod_d182 - negod_d182
• odratio_d182 - odratio_d182
• seropos_d182 - seropos_d182
• od_d365 - od_d365
• negod_d365 - negod_d365
• odratio_d365 - odratio_d365
• seropos_d365 - seropos_d365
• dpostvac1 - dpostvac1
• censored - censored

f6976358 Location:

Variable Format: character

Notes: UNF:6:l32ACEEkxFC4KWs8hHYNxw==

f6976358 Location:

Variable Format: character

Notes: UNF:6:eGdEx8aPsDMjsG0IsxYMig==

f6976358 Location:

Variable Format: character

Notes: UNF:6:CJMCfcdTyEjjN+69051ydg==

f6976358 Location:

Variable Format: character

Notes: UNF:6:SrPjizCwYNaBsZU4f02G5g==

f6976358 Location:

Variable Format: character

Notes: UNF:6:8ikbp6t9ZpQhzDNM/xBsnA==

f6976358 Location:

Variable Format: character

Notes: UNF:6:Jn4fj9CZiucFdDwIlkw3vw==

f6976358 Location:

Summary Statistics: Valid 1354.0; StDev 8.889391609809694; Max. 72.0; Min. 18.0; Mean 31.72525849335301

Variable Format: numeric

Notes: UNF:6:XpZuy8ASuClojUw8hdrPTg==

f6976358 Location:

Summary Statistics: Max. 111.5999984741211; StDev 11.839426200329887; Valid 1354.0; Mean 65.97230434558591; Min. 38.79999923706055;

Variable Format: numeric

Notes: UNF:6:ZDP91eWoa+5hKemEbnLPmg==

f6976358 Location:

Summary Statistics: StDev 7.897546001592117; Max. 190.0; Mean 167.54977890307654; Min. 147.1999969482422; Valid 1354.0;

Variable Format: numeric

Notes: UNF:6:If6TWJ1FdmUPuTlENWIa8w==

f6976358 Location:

Summary Statistics: Mean 23.47957902961855; Min. 16.77000045776367; Max. 40.79000091552734; StDev 3.787493898257586; Valid 1354.0

Variable Format: numeric

Notes: UNF:6:GWt/rWk10aPGTzQ1ln59QQ==

f6976358 Location:

Summary Statistics: Max. 100.0; Mean 99.56868537666175; StDev 0.6247614533502759; Min. 97.0; Valid 1354.0

Variable Format: numeric

Notes: UNF:6:EwFkhLJbHmm83rPVIZDnVw==

f6976358 Location:

Summary Statistics: Mean 72.20605612998526; Min. 43.0; Valid 1354.0; StDev 12.04805327985585; Max. 134.0

Variable Format: numeric

Notes: UNF:6:qN3EwgTlKq/yrKvvjDbRGA==

f6976358 Location:

Variable Format: character

Notes: UNF:6:ntqHbG1QKuKdyFGueqrWTw==

f6976358 Location:

Variable Format: character

Notes: UNF:6:nBU2r33yz3WDr4EcSC7AZg==

f6976358 Location:

Variable Format: character

Notes: UNF:6:fKmi4hNRvS7bnB1ga1ZAPQ==

f6976358 Location:

Variable Format: character

Notes: UNF:6:LeivIJ14WbqtUx63SzK0Iw==

f6976358 Location:

Summary Statistics: StDev 0.34743172101363584; Valid 1312.0; Mean 1.1257621951219514; Min. 1.0; Max. 4.0

Variable Format: numeric

Notes: UNF:6:+2nVA3mLDozbjQXdO+pyTg==

f6976358 Location:

Variable Format: character

Notes: UNF:6:I9F4EPGbehJ6NFbAemx4zQ==

f6976358 Location:

Variable Format: character

Notes: UNF:6:3/45K3OBZjiTZlO115wo8w==

f6976358 Location:

Variable Format: character

Notes: UNF:6:MYBluVbAxNb9+f3+A94Syg==

f6976358 Location:

Summary Statistics: Valid 1312.0; Mean 2.5442073170731696; Max. 5.0; StDev 1.3840752724230196; Min. 1.0

Variable Format: numeric

Notes: UNF:6:PKrAl6u8x6eCfe9SOBDo5w==

f6976358 Location:

Variable Format: character

Notes: UNF:6:Piqu9ULfG0JZmhYgIXNOVQ==

f6976358 Location:

Summary Statistics: StDev 59.136900112550514; Max. 365.0; Mean 56.41158536585368; Min. 0.0; Valid 1312.0;

Variable Format: numeric

Notes: UNF:6:+YaBXjsR+/1LqIUdiO5wgg==

f6976358 Location:

Variable Format: character

Notes: UNF:6:LT4ujquEFmP6wvzQcdqRIg==

f6976358 Location:

Variable Format: character

Notes: UNF:6:EOX8BXOSpbHXtR8j0KcL9g==

f6976358 Location:

Variable Format: character

Notes: UNF:6:EoyS0FAInYsGII6b1pVaeQ==

f6976358 Location:

Variable Format: character

Notes: UNF:6:9fkiUH2ukOtF2sh2mpvpAw==

f6976358 Location:

Variable Format: character

Notes: UNF:6:NclU3Pba1NKe+hJAkXg+Ig==

f6976358 Location:

Summary Statistics: Max. 13505.569; Mean 166.76094903988175; StDev 798.0893821369388; Valid 1354.0; Min. 0.514;

Variable Format: numeric

Notes: UNF:6:I5qup2ii5tYEl/BA0Kpc1A==

f6976358 Location:

Summary Statistics: Max. 48813.205; Min. 0.546; Valid 1331.0; StDev 5712.377309869633; Mean 2371.9252043576284;

Variable Format: numeric

Notes: UNF:6:ftqoXNyasK9Osh2tw0Ufng==

f6976358 Location:

Summary Statistics: Mean 1795.2942412769119; Max. 32135.186; Min. 0.606; Valid 1347.0; StDev 3764.760513620516

Variable Format: numeric

Notes: UNF:6:M/IMiwIaDHGVBYARS1dwhQ==

f6976358 Location:

Summary Statistics: Valid 1346.0; Max. 22058.05; Min. 1.0; StDev 3233.5031200093285; Mean 1368.2582035661217;

Variable Format: numeric

Notes: UNF:6:oNPTWKnoJmfs9VM13YCJOw==

f6976358 Location:

Summary Statistics: Valid 1335.0; Mean 2357.4298329588014; StDev 3110.2458506788107; Min. 1.0; Max. 24471.695

Variable Format: numeric

Notes: UNF:6:weG8nJ+wY0f7VnjcNJXoAA==

f6976358 Location:

Summary Statistics: Valid 1315.0; StDev 7660.441193488493; Max. 60225.681; Mean 3099.054456273768; Min. 1.0;

Variable Format: numeric

Notes: UNF:6:NbrSClR0dIkHRm51DjvfJA==

f6976358 Location:

Summary Statistics: StDev 0.21638617549277636; Max. 1.696; Valid 1354.0; Mean 0.17468168389955682; Min. 0.032;

Variable Format: numeric

Notes: UNF:6:mOjgHaYZwNcYwMYjYASxIg==

f6976358 Location:

Summary Statistics: Min. 0.103; StDev 0.0064766827955228335; Mean 0.11401698670605614; Valid 1354.0; Max. 0.12475

Variable Format: numeric

Notes: UNF:6:nvtbUVCLaGtQzoNTmkzPdg==

f6976358 Location:

Summary Statistics: Max. 14.71304347826087; Valid 1354.0; Mean 1.5364290966731393; StDev 1.8942108409982983; Min. 0.2565130260521042

Variable Format: numeric

Notes: UNF:6:RQqErsIYPWz6U9jI2L0UZw==

f6976358 Location:

Summary Statistics: Mean 0.2341211225997057; Valid 1354.0; Min. 0.0; StDev 0.42360470854636717; Max. 1.0

Variable Format: numeric

Notes: UNF:6:3mKJU/5Acjts7OPmLq6+Fg==

f6976358 Location:

Summary Statistics: Min. 0.035; Max. 2.016; StDev 0.5870288852675816; Valid 1309.0; Mean 0.52161115355233

Variable Format: numeric

Notes: UNF:6:rLD4atfAsUmCYw7123nS4w==

f6976358 Location:

Summary Statistics: Valid 1309.0; Min. 0.11175; StDev 0.0044705149686439785; Max. 0.1225; Mean 0.11661955691367455

Variable Format: numeric

Notes: UNF:6:8ZNl0Zlc2odfxn0MEQYaIw==

f6976358 Location:

Summary Statistics: Mean 4.492535354547773; Max. 17.723077; Min. 0.2857142857142858; Valid 1309.0; StDev 5.0767707958393515

Variable Format: numeric

Notes: UNF:6:8ynN9Bz107FQd0O0bS+lIQ==

f6976358 Location:

Summary Statistics: StDev 0.4976025532844232; Mean 0.44919786096256553; Valid 1309.0; Min. 0.0; Max. 1.0;

Variable Format: numeric

Notes: UNF:6:BFZLrUY6GnnYQ2iWdq0WKw==

f6976358 Location:

Summary Statistics: StDev 0.6420838577474103; Max. 2.141; Min. 0.039; Valid 1349.0; Mean 0.6826493699036322

Variable Format: numeric

Notes: UNF:6:bLdw1VSrxYK98HrDm+I1WA==

f6976358 Location:

Summary Statistics: Max. 0.129; Mean 0.11374147516679022; StDev 0.009612644366892256; Valid 1349.0; Min. 0.1055

Variable Format: numeric

Notes: UNF:6:+X4po1iAtf09ElorAhsqlA==

f6976358 Location:

Summary Statistics: Min. 0.3145161290322581; Max. 20.0; StDev 5.586973809224137; Valid 1349.0; Mean 5.97306056383991;

Variable Format: numeric

Notes: UNF:6:QwnQ0NEkUwNv9K1zOlJ0Ow==

f6976358 Location:

Summary Statistics: StDev 0.4845170947833214; Max. 1.0; Min. 0.0; Mean 0.62416604892513; Valid 1349.0

Variable Format: numeric

Notes: UNF:6:znQWuthrITpGf01QfRnyrw==

f6976358 Location:

Summary Statistics: StDev 0.5342807766644618; Min. 0.036; Mean 0.5465604151223129; Valid 1349.0; Max. 2.071

Variable Format: numeric

Notes: UNF:6:q3UrxHrKHS0F7ui+hWejIw==

f6976358 Location:

Summary Statistics: Max. 0.114; Valid 1349.0; Mean 0.11043291326908819; Min. 0.106; StDev 0.0033707788913632983;

Variable Format: numeric

Notes: UNF:6:RMtsCwDYw+b59Y2ZGCkCnQ==

f6976358 Location:

Summary Statistics: Valid 1349.0; StDev 4.8711479518029; Max. 18.4622641509434; Mean 4.962422447111377; Min. 0.3333333333333334;

Variable Format: numeric

Notes: UNF:6:Xt/PhcV81VztsBBkhUI36A==

f6976358 Location:

Summary Statistics: Valid 1349.0; Max. 1.0; Mean 0.566345441067457; StDev 0.4957625207910726; Min. 0.0

Variable Format: numeric

Notes: UNF:6:DhmN/IYufNkQMuLR5V8HnQ==

f6976358 Location:

Summary Statistics: Max. 1.855; StDev 0.5812989385821588; Valid 1328.0; Mean 0.8302823795180723; Min. 0.037

Variable Format: numeric

Notes: UNF:6:CXatiDOlB32QbrjzntQfSA==

f6976358 Location:

Summary Statistics: Valid 1328.0; Max. 0.118; Min. 0.113; Mean 0.11545877259036146; StDev 0.0016915066210555641

Variable Format: numeric

Notes: UNF:6:WQK4uM/00QUc0UalgrEYEg==

f6976358 Location:

Summary Statistics: StDev 5.0227653450078416; Mean 7.18684328679951; Min. 0.3231441048034934; Max. 15.78723404255319; Valid 1328.0;

Variable Format: numeric

Notes: UNF:6:iE0ScucsYIOFL7YqbfWhkA==

f6976358 Location:

Summary Statistics: Mean 0.7439759036144576; Min. 0.0; Valid 1328.0; StDev 0.43659969890373634; Max. 1.0;

Variable Format: numeric

Notes: UNF:6:ZioStsl3Tnt3jrFFgAu56g==

f6976358 Location:

Summary Statistics: Mean 0.8139715568862275; Valid 1336.0; StDev 0.5679403097554044; Max. 1.861; Min. 0.042

Variable Format: numeric

Notes: UNF:6:ZahCIhWzdBtEGOnvWA7hAQ==

f6976358 Location:

Summary Statistics: StDev 0.006266238028208077; Min. 0.106; Valid 1336.0; Max. 0.1235; Mean 0.11212750748502998;

Variable Format: numeric

Notes: UNF:6:AoYQOnyUhwPnp3TrUdskRA==

f6976358 Location:

Summary Statistics: Valid 1336.0; StDev 5.055373125331902; Max. 16.9433962264151; Min. 0.3400809716599191; Mean 7.258234358726661;

Variable Format: numeric

Notes: UNF:6:LZWwrBSRLvQ26JSIe/np7w==

f6976358 Location:

Summary Statistics: Valid 1336.0; StDev 0.42603334014664085; Mean 0.7619760479041917; Max. 1.0; Min. 0.0

Variable Format: numeric

Notes: UNF:6:BzVvCO4d4olLMKzGZKuE3A==

f6976358 Location:

Summary Statistics: Mean 0.8827626224566694; Valid 1327.0; StDev 0.5922244019389448; Max. 2.214; Min. 0.043

Variable Format: numeric

Notes: UNF:6:2uwieiSgI20+vyb4aW+19A==

f6976358 Location:

Summary Statistics: Max. 0.131; Valid 1327.0; Mean 0.12262911328811858; StDev 0.0044461428282366764; Min. 0.11375

Variable Format: numeric

Notes: UNF:6:9wfS0FOxqTs3hSBB/b0jeA==

f6976358 Location:

Summary Statistics: Max. 17.90833333333333; Mean 7.177136976146001; StDev 4.769407085700561; Min. 0.3524590163934426; Valid 1327.0

Variable Format: numeric

Notes: UNF:6:CCekwL6MzWcoEXzV5n0KDQ==

f6976358 Location:

Summary Statistics: Valid 1325.0; Mean 0.803018867924528; StDev 0.39786811464704913; Max. 1.0; Min. 0.0;

Variable Format: numeric

Notes: UNF:6:bbDdhBixcrmcRA0iKX73XA==

f6976358 Location:

Summary Statistics: Mean 1.0486494296577946; Valid 1315.0; Min. 0.055; Max. 2.159; StDev 0.5421598691663311

Variable Format: numeric

Notes: UNF:6:fGlurfdH7B+1Osrh2Shs5Q==

f6976358 Location:

Summary Statistics: Min. 0.104; StDev 0.004222646190109027; Mean 0.1077528517110266; Max. 0.1146666666666667; Valid 1315.0;

Variable Format: numeric

Notes: UNF:6:Ar1+TzF+6GYwUhc57EC/0A==

f6976358 Location:

Summary Statistics: Max. 20.75961538461538; Valid 1315.0; StDev 5.12686652041628; Mean 9.76440545759459; Min. 0.4796511627906976

Variable Format: numeric

Notes: UNF:6:AAMT/kPaFmdRXMxG9v52Xw==

f6976358 Location:

Summary Statistics: Mean 0.9490494296577949; Valid 1315.0; Min. 0.0; StDev 0.21998047475807367; Max. 1.0;

Variable Format: numeric

Notes: UNF:6:aks7pTt3g//IwK4ZJx+9HQ==

f6976358 Location:

Summary Statistics: Max. 365.0; Valid 125.0; Mean 153.41600000000003; Min. 32.0; StDev 90.58699116176633;

Variable Format: numeric

Notes: UNF:6:esF2xzvlpkaYiYMe8VUzJQ==

f6976358 Location:

Summary Statistics: Min. 112.0; Mean 217.64000000000004; StDev 114.04684945656213; Valid 125.0; Max. 365.0;

Variable Format: numeric

Notes: UNF:6:sCPJ5t7DQdXv/hqueZmR8w==

Label:

COV004_analysis_codes.do

application/x-stata-syntax

Label:

COV004_Analysis_datasets_anon.dta

application/x-stata-13

Label:

COV004_CONSORT_checklist.pdf

application/pdf

Label:

COV004_Supplementary_Material.pdf

application/pdf

Label:

COV004_Trial_Dataset_Codebook.pdf

application/pdf

Label:

COV004_Trial_Dataset_readme.txt

text/plain

Label:

COV004_Trial_Protocol.pdf

application/pdf