Age differences in flu and shingles vaccine response

Phase 1

• Conditions: Influenza Herpes Zoster; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005682-13-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-05
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

•Healthy
•Age between 18-35 years old OR age =65 years old
•Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

•Known allergy to (components of) the influenza or herpes zoster vaccine
•Immunocompromised subjects
•Previous herpes zoster vaccination in the last year
•Receipt of any vaccination 1 month prior to the start of the study or plans to receive any other vaccination until the last study visit
•Chronic use of systemic drugs other than oral contraceptives
•Use of NSAIDS less than 4 weeks prior to the start of the study
•Acute or active illness within two weeks prior to the start of the study
•Pregnant, breastfeeding or planning to become pregnant within the study period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to identify immune senescence related pathways leading to different immunogenicity after administration of unadjuvanted influenza or AS01 adjuvanted herpes zoster vaccines;Secondary Objective: Not applicable;Primary end point(s): Functional assessment of vaccine response (including but not limited to antibody responses, cellular mediated imune responses, cross-omics, cytokine production);Timepoint(s) of evaluation of this end point: At different timepoints depending on study arm<br><br>Group 1 (young adults, HZV): D0, D1, D7, D60, D61, D67, D120, D240<br>Group 2 (older adults, HZV): D0, D1, D7, D60, D61, D67, D120, D240<br>Group 3 (young adults, QIV): D0, D1, D7, D60, D180<br>Group 4 (older adults, QIV): D0, D1, D7, D60, D180<br>Group 5 (young adults, HZV related placebo): D0, D60, D120, D240<br>Group 6 (young adults, QIV related placebo): D0, D60, D180

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety data (solicited AEs, unsolicited AEs, SAEs, MAAEs, AESIs, AEs leading to withdrawal from the study and unintentional exposure during pregnancy);Timepoint(s) of evaluation of this end point: After the last subject's last visit (6 months after last injection)