Immune Response and Risk of Side Effects After Influenza Vaccination in Athletes

Universität des Saarlandes

Status and phase: Completed; Phase 4

Conditions: Influenza Vaccine Allergy; Influenza Virus Vaccine Adverse Reaction

Treatments: Biological: Influenza Vaccination

Study type: Interventional

Funder types: Other

Identifiers

NCT03654937

Impftrain

Details and patient eligibility

About

Seasonal influenza vaccination was used to assess whether induction of immunity as well as the rate of side effects is influenced by the timing of the last training session before vaccination. Healthy athletes were vaccinated with the tetravalent influenza vaccine and blood samples were collected before, 1, 2 and 26 weeks after vaccination. The athletes were randomly assigned to vaccination within 2 hours after the last training session ("2h") vs. vaccination after a resting period of at least 26 hours ("26h"). All participants documented side effects and training restrictions. Influenza-specific T-cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. Antibodies were quantified by ELISA and neutralisation assay.

Enrollment: 45 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• performance-oriented training on at least five days a week, healthy athletes

Exclusion criteria

• current acute infection, allergy to the vaccine, immunosuppression, pregnancy, rheumatic diseases

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

2h

Active Comparator group

Description:

The participants were asked to report for their vaccination immediately after an intensive bout of training (not later than two hours after). The influenza vaccine was administered via intra-muscular injection into the deltoid muscle of the non-dominant arm in a standardized manner.

Treatment:

Biological: Influenza Vaccination

26h

Active Comparator group

Description:

The athletes of the second group were vaccinated after an entire day (between 24 and 26 hours) after their last training session.The vaccine was administered via intra-muscular injection into the deltoid muscle of the non-dominant arm in a standardized manner.

Treatment:

Biological: Influenza Vaccination