DOI: 10.5061/dryad.rr4xgxdgt
title: Effect of T cell vaccine in an influenza human challenge model

description: The protection afforded by inactivated influenza vaccines can
 theoretically be improved by inducing T-cell responses to conserved
 internal influenza A antigens. We hypothesized that in an
 influenza-controlled human infection challenge, susceptible individuals
 receiving a vaccine boosting T cell responses would exhibit lower viral
 load and decreased symptoms compared to placebo recipients. Healthy
 European volunteers with microneutralization titers &lt; 20 to the
 H3N2 challenge strain were randomized double-blind using a permuted-block
 list with a 3:2 allocation ratio to receive IM MVA expressing H3N2 NP and
 M1 or placebo. Over six weeks later, participants were challenged
 intranasally. Nasal swabs were collected twice daily for viral PCR, and
 symptoms of influenza were recorded through day 11. T-cell responses were
 monitored both pre- and post-vaccination (0,8, and 28 days) and challenge
 (0 and 28 days) by ELISpot and multiparameter flow cytometry. There was no
 significant effect of NVANP+M1 versus placebo on the viral area under the
 curve (vAUC), symptom scores, individual symptoms, or influenza-like
 illness in Intent to treat or Protocol Analysis. The MVA-NP+M1 vaccine was
 well-tolerated and induced three-fold increases in CD4+ and CD8+ T cell
 responses, with no change in the placebo group (p = &lt;0.001). There
 was also no correlation between vAUC or symptoms with any of the
 pre-challenge CD4+ or CD8+ T-cell phenotypes in either vaccinated or
 placebo participants. The use of an MVA vaccine to expand CD4+ and CD8+ T
 cells to conserved influenza A antigens in peripheral blood did not impact
 outcomes in an influenza H3N2 challenge model in seronegative, healthy
 adults.
description: Standard eCRFs and then put into CDISC format and exported to
 Excel for the upload. Columns with duplicate names were deleted.
description: # Effect of T cell vaccine in an influenza human challenge model
 [https://doi.org/10.5061/dryad.rr4xgxdgt](https://doi.org/10.5061/dryad.rr4xgxdgt) ## Description of the data and file structure Submitted datasets follow CDISC’s Analysis Data Model (ADaM) and include the following Excel files. All empty cells have no associated data. ### Files and Variables #### File: \`adqs1.xlsx\` **Description:** Influenza symptoms **Variables:** * Unique Subject Identifier * Pooled Subject Group 1 * Sex * Actual Treatment for Period 01 * Question Symptom Short Name * Question Name * Parameter * Parameter Category 1 (local or systemic) * Parameter Category 2 (anatomical location) * Parameter Category 3 (Description) * Category of Question (if solicited on scoring card) * Visit Name * Analysis Visit * Planned Time Point Name (morning or evening) * Phase * Analysis Relative Day * Time Point Reference * Character Results/Findings in standard grading format * Analysis Value * Baseline Value * Change from Baseline #### File: \`adqs2.xlsx\` **Description:** Reactogenicity **Unique Variables:** * Safety Population Flag * Planned Treatment for Period 01 * Question Short Name * Parameter Coding * Parameter (assigned coding number) * Standard Units * Analysis Toxicity Grade #### File: \`advs.xlsx\` **Description:** Vital signs **Unique Variables:** * Vital Signs Test Name * Vital Signs Position of Subject * Parameter (N) * Numeric Result/Finding in Standard Units * Baseline Type * Toxicity Name * Baseline Toxicity Grade * Age by decade #### File: \`adlb.xlsx\` **Description:** Safety Laboratory values **Unique Variables:** * Lab Test or Examination Short Name * Lab Test or Examination Name * Parameter Code * Parameter (assigned number) * Category for Lab Test * Epoch * Numeric Result/Finding in Standard Units * Sequence Number * Group ID * Reference Range Lower Limit-Standard Units * Reference Range Upper Limit-Standard Units * Standard Reference Range Upper Limit Qualifier * Reference Range Indicator * Reason Test Not Done * Clinically Significance #### File: \`adis.xlsx\` **Description:** Immunogenicity results **Unique Variables:** * Intent-To-Treat Population Flag * Immunogenicity Test/Exam Short Name * Immunogenicity Test or Examination Name * Parameter Code * Parameter Number * Parameter Category 1 (Antibody or cellular) * Parameter Category description * Parameter Category 2 * Parameter Category 2 (assigned number) * Parameter Category 3 (Gamma interferon or Granzyme) * Parameter Category 3 (assigned number) * Parameter Category 4 (peptides used) * Parameter Category 4 (assigned number) * Parameter Category 5 (peptide pools) * Parameter Category 5 (assigned number) * Parameter Category 6 (replicate number) * Result or Finding in Original Units * Original units * Analysis value assigned * Baseline period * Derivation type (if Below LLOQ or above ULOQ) * Replicate number * Category for Immunogenicity Test * Subcategory for Immunogenicity Test * Vendor name * Specimen type * Method of Test or Examination * Lower limit of quantitation * Reason Not Done * Number of DMSO Replicate Results #### File: \`admb.xlsx\` **Description:** Microbiology results **Unique Variables:** * Microbiology Test or Finding Short Name * Microbiology Test or Finding Name * Parameter Type * Category for Microbiology Finding (swab in transport media) * Result or Finding in Original Units * Original Units * Vendor Name * Specimen Type * Method of Test or Examination * Reference ID * Completion Status * Reason Microbiology Not Performed #### File: \`adre.xlsx\` **Description:** Respiratory data **Unique Variables:** * Test or Examination Short Name * Test or Examination Name * Actual Parameter * Parameter Code Assigned * Mean result in the treatment group * Standard error of mean result of treatment group #### File: \`adtte.xlsx\` **Description:** Time to event endpoints **Unique Variables:** * Censor * Event or Censoring Description #### File: \`adsl.xlsx\` **Description:** Participant-level demographics and disposition by column number **Unique Variables:** * Pooled Subject Group 1- number assigned * Pooled subject group 2 (challenge) * Pooled subject group 2 = number assigned * Age units * Randomized Population Flag * Per protocol population flag * Planned Arm Code * Description of planned arm * Actual Arm code * Description of actual arm * Planned Treatment for Period – number assigned * Actual Treatment for Period 01- number assigned * End of study status * Reason for Discontinuation from Study * Specific Reason for Discontinuation from Study * End of Phase 2 status * Reason for Discontinuation from Phase 2 * Specific Reason for Discontinuation from Phase 2 * End of Phase 3 status * Reason for Discontinuation from Phase 3 * Specific Reason for Discontinuation from Phase 3 * End of Phase 4 status * Reason for Discontinuation from Phase 4 * Specific Reason for Discontinuation from Phase 4 * Description of phase 1 (Screening) * Description of Phase 2 (Vaccination) * Phase 2 End Time Imputation Flag * Description of phase 3 (Challenge period) * Phase 3 End Time Imputation Flag * Description of Phase 4 (Follow-up after inpatient period for challenge) * Phase 4 End Time Imputation Flag * Body mass index at screening #### File: \`adeg.xlsx\` **Description:** ECG results **Unique Variables:** * ECG test or examination name * ECG position of the subject * Analysis category value * Analysis value assigned number * Treatment-emergent analysis flag * Analysis Reference Range Indicator * Baseline reference range indicator * Baseline reference range indicator assigned number * Analysis range lower limit * Analysis range upper limit #### File: \`adfa.xlsx\` **Description:** Mucous production **Unique Variables:** * Findings about test name * Object of the observation * Planned time point * Planned time point number * Mean result in the treatment group * Standard error of mean result of treatment group #### File: \`adae.xlsx\` **Description:** Overall adverse events **Unique Variables:** * Cohort * Intent to treat the population * Planned treatment (cohort number) * Reported term for the adverse event * Dictionary derived term * Body system or organ class * Lowest level term * High-level term * High-level group term * Analysis Start relative day * Analysis duration * Duration units * Serious adverse event (Y/N) * Standard toxicity grade * Analysis toxicity grade (Assigned number) * Action taken with the study treatment * Causality 1-Site investigator * Causality 1 (Assigned number) * Causality 2- Sponsor * Causality 2 (Assigned number) * Outcome of adverse event * Concomitant or additional treatment given * Age range by decade #### File: \`adaper.xlsx\` **Description:** Analysis periods by specific days passed **Unique Variables:** * Time between vaccination and challenge