Effect of T cell vaccine in an influenza human challenge model

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 < 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 NVA..., Standard eCRFs and then put into CDISC format and exported to Excel for the upload. Columns with duplicate names were deleted., , # 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
* Cha...