Aim 1. To study the impact of different sequences of combined influenza and SARS-CoV-2 vaccinations on immunological responses and sideeffects.Aim 2. To understand the immunological mechanisms that mediate the potential interference between…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Geometric mean titers of S-specific IgG in serum at 21 days after last
vaccination
Secondary outcome
- Seroconversion of IgG to the SARS-CoV-2 spike protein at day 21 after the
COVID-19 booster vaccines.
- Virus neutralization assays for the standard SARS-CoV-2 variant, as well as
for the B1.1.7 and B1.351 variants
- IgA and IgG responses against RBD- and S- and N-protein in MLF and serum at
baseline, 21 days after each vaccination
- IgG and IgA against influenza antigens in MLF and serum at baseline, 21 days
after each vaccination
- Specific anti-SARS-CoV-2 T-cell responses against standard SARS-CoV-2
variant, as well as for the B1.1.7 and B1.351 variants
- Local reactions at injection site or systemic reactions after vaccination
- Serious adverse events and other adverse events.
Background summary
The COVID-19 pandemic is the greatest public health challenge that confronted
humanity after World War II. COVID-19 has had a heavy impact on morbidity and
mortality, but also led to major economic and social disruptions in society.
Vaccination is by far the most important strategy aimed to stop the pandemic
and enable return to a normal situation, and it is crucial to ensure the
effectiveness of COVID-19 vaccines. One factor that could influence
effectiveness of vaccines is vaccine interference: as COVID-19 and influenza
vaccines will probably be administered together at the end of the year,
especially in risk groups for whom protection against these two diseases is
very important, it is urgent to study the potential interference between these
two vaccines and identify the best schedule that can ensure effectiveness.
Study objective
Aim 1. To study the impact of different sequences of combined influenza and
SARS-CoV-2 vaccinations on immunological responses and side
effects.
Aim 2. To understand the immunological mechanisms that mediate the potential
interference between influenza and COVID-19 vaccines
Study design
Single-blind placebo controlled randomized trial
Participants (N=140) will be randomly assigned to one of the following groups
(21day-intervals):
1 35 Influenza + placebo sample collection + Comirnaty
booster sample collection
2 35 Comirnaty booster + placebo sample collection +
Influenza sample collection
3 35 Influenza + Comirnaty booster sample collection +
Placebo sample collection
4 (r) 35 Comirnaty booster + placebo sample collection +
Placebo sample collection + Influenza*
Before every vaccination and 21 days after each vaccination (except for *),
venous blood and mucosal lining fluid will be obtained.
Intervention
Vaccination against SARS-CoV-2 (by Pfizer or Janssen, depending on treatment
group) & influenza
Study burden and risks
Venous blood sampling & mucosal lining fluid: minimal risk procedures (e.g.
hematoma, itchy nose)
Side-effects vaccines: as stated in the respective product characteristics.
Side effects are generally mild and self-limiting within days. The most
important ones are pain at injection site (>90%), fatigue (>60%), headeach and
myalgia (>50%).
Time-related burden for participants is minimal, visiting the study site 3
times taking 10-30 minutes per moment.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Age equal to or above 60 years
Received a COVID-19 vaccine 4-12 months prior to enrollment
Exclusion criteria
History of COVID-19 infection (confirmed by a microbiological test)
Vaccination against influenza <6months
Immunocompromised (either by co-morbidities or induced by medication)
Known allergy or history of anaphylaxis or other serious adverse reactions to
vaccines
Acute illness < 2 weeks
Participation in another drug trial
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 |
|---|---|
| EudraCT | EUCTR2021-002186-17-NL |
| CCMO | NL77590.091.21 |