The general objective of this study is to identify immune senescence related pathways leading to different immunogenicity after administration of unadjuvanted influenza or AS01 adjuvanted herpes zoster vaccines.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functional assessment of vaccine response (including but not limited to
antibody responses, cellular mediated immune responses, cross-omics, cytokine
production)
Secondary outcome
Safety data (solicited AEs, unsolicited AEs, SAEs, MAAEs, AESIs, AEs leading to
withdrawal from the study and unintentional exposure during
pregnancy)
Background summary
Vaccines are used to prevent infectious diseases worldwide. Unfortunately, many
vaccines, like the flu vaccine, are less effective in the elderly. In this
study we would like to assess the differences in immune response between young
and older adults after vaccination with two different vaccines. One of the
vaccines is known to work well in the elderly, the other is less effective.
Exploring the underlying mechanisms can be used in future development of
vaccines.
Study objective
The general objective of this study is to identify immune senescence related
pathways leading to different immunogenicity after administration of
unadjuvanted influenza or AS01 adjuvanted herpes zoster vaccines.
Study design
Open label, randomised and partially placebo-controlled study
Intervention
There are several interventions:
The older adults will receive either the influenza vaccine or the herpes zoster
vaccine
Young adults will receive either the influenza vaccine, the herpes zoster
vaccine or a placebo
Study burden and risks
Based on previous trials and experience in the use of these vaccines in the
national vaccination programmes the risks of vaccination besides temporary
local discomfort are negligible. The largest burden for participants is the
frequency of blood collection, which is 8 visits for the herpes zoster vaccine
group, and 5 for the influenza and 3 or 4 for the placebo groups. Altogether
the time it takes for the participant is approximately 2.5 hours.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
• Healthy
• Age between 18-35 years old OR age >=65 years old
• Written informed consent
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 4 weeks prior to the start of the study or plans
to receive any other vaccination until 2 months after inclusion
• 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 during the study
period
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 2020-005682-13 |
| EudraCT | EUCTR2020-005682-13-NL |
| CCMO | NL76061.091.20 |