invasive meningococcal disease meningitis sepsis
Conditions
Interventions
Participants will receive a registered tetravalent MenACWY-TT conjugate vaccine
(Nimenrix) intramuscularly in the upper arm at the first visit. Blood and
saliva samples will be collected prior to (T
Sponsors
RIVM
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants eligible for this study are Dutch older persons 65-85 years of age, of moderate to good general health with regard to age, who did not receive a MenACWY-TT vaccine before.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Antibiotic use within 14 days of enrolment * Severe acute infectious illness or fever above 38.0 °C within 14 days before vaccination; * Present evidence of serious diseases either demanding regular use of oral immunosuppressive medical treatment, like corticosteroids, that might interfere with the results of the study within the last 3 months or demanding acute use of high dose oral immunosuppressive that might interfere with the results of the study within the last 2 weeks; * Known or suspected allergy to any of the vaccine components (by medical history); * Occurrence of a serious adverse event after other vaccination by medical history; * Known or suspected immune deficiency; * Known or suspected coagulation disorder; * Oral hormone use, such as postmenopausal hormones, within the last 3 months; * History of one of the following neurological disorders: multiple sclerosis, Parkinson*s disease, or epilepsy; * Previous administration of plasma-serum products including immunoglobulins within 6 months before vaccination and blood sampling; * Serious surgery within the last 3 months; * Previous vaccination with the MenC, MenC-TT or MenACWY-TT vaccine; * Previous confirmed or suspected meningococcal disease; * Any vaccination within a month before enrolment. Presence of in-and exclusion criteria will be checked by interviewing the participant during the first phone call. In addition, presence of in-and exclusion criteria will be checked at the first study visit again, prior to signing the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional antibody levels against MenA, MenC, MenW and MenY are measured using the serum bactericidal antibody (SBA) assay. | — |
Secondary
| Measure | Time frame |
|---|---|
| * To compare SBA levels of >=8 (persistence of vaccine induced protective antibody levels) at 1 month and 1 year within the two age groups and 1 month and 1 year after the booster vaccination in the booster-subcohort * To determine serum MenA-PS, MenC-PS, MenW-PS and MenY-PS specific IgG levels at 1 month and 1 year and compare between the two age groups and 1 month and 1 year after the booster vaccination in the booster-subcohort * To determine serum IgG antibody levels against tetanus, the carrier protein for both vaccines, at 1 month and 1 year and compare within the two age groups and 1 month and 1 year after the booster vaccination in the booster-subcohort * To determine serum IgA and IgM levels against MenA, MenC, MenW and MenY at 1 month and 1 year and compare between the two age groups and 1 month and 1 year after the booster vaccination in the booster-subcohort * To determine MenC-PS specific IgG subclasses (IgG1/IgG2 ratio) and avidity at 1 month and 1 year and compare between the two age groups and 1 month and 1 year after the booster vaccination in the booster-subcohort * To determine long-term persistence of functional serum antibody (IgG, IgA and IgM) titers (GMTs)/levels (GMCs) 5 years after primary vaccination * To determine salivary MenA-PS, MenC-PS, MenW-PS and MenY-PS-specific IgG, IgA and IgM levels after primary and booster vaccination. * To compare the serum MenA-Ps, MenC-PS, MenW-PS and MenY-PS specific IgG, IgA and IgM levels and SBA titers from this study to the results found in the StimulAge study (NL48510.100.14) * To compare the salivary MenA-Ps, MenC-PS, MenW-PS and MenY-PS specific IgG, IgA and IgM levels from this study to the results found in the StimulAge study (NL48510.100.14) * Explorative: to determine an immune cell profile by phenotyping white blood cells by using flow cytometry in combination with the determination of a complete blood count (CBC) pre-vaccination. * Explorative: to investigate the rel | — |
Countries
Netherlands
Outcome results
None listed