The tetravelent MenACWY-TT vaccin administered in this study is used to prevent invasive disease caused by Meningococcal serogroup A, C, W and Y.
Conditions
Interventions
Trade Name: Nimenrix
Product Name: Nimenrix
Pharmaceutical Form: Powder and solution for solution for injection
Sponsors
National Institute for Public Health and the Environment (RIVM)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants eligible for this study are healthy Dutch elderly 65-85 years of age, who did not receive a MenACWY-TT vaccine before. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140
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 |
|---|---|
| Main Objective: The aim of this study is to investigate the immune response to a primary and a booster immunization with a tetravalent MenACWY-TT conjugate vaccine in elderly aged 65-85 years of age. Functional antibody levels against MenA, MenC, MenW and MenY are measured using the serum bactericidal antibody (SBA) assay. In addition, serum MenA-PS, MenC-PS, MenW-PS and MenY-PS specific IgG and IgA and IgM levels, subclasses and avidity are measured using fluorescent-bead-based multiplex immunoassay (MIA). ;Secondary Objective: ? To compare SBA levels of =8 (persistence of vaccine induced protective antibody levels) at 1 month and 1 year after the booster vaccination between the single vaccination cohort and the booster vaccination cohort ? 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 single vaccination cohort and booster cohort ? To determine serum IgG antibody levels against tetanus, the carrier protein for both vaccines, at 1 month and 1 year and compare between the single vaccination cohort and booster cohort at and 1 month and 1 year after the booster ? To determine serum IgA and IgM levels against MenA, MenC, MenW and MenY at 1 month and 1 year and compare between the single vaccination cohort and booster cohort ? To determine MenC-PS specific IgG subclasses (IgG1/IgG2 ratio) and avidity and compare the single vaccination cohort and booster cohort;Primary end point(s): The primary objective is to determine the level of protection in the elderly (divided into two groups: single vaccination cohort and booster vaccination cohort) to the MenACWY-TT conjugate vaccine. The primary parameter to determine the level of protection will be by measuring meningococcal specific serum bactericidal antibody (SBA) levels pre-vaccination (T0) and 1 month (T1) and 1 year (T2) after vaccination. Also, in the booster-subcohort SBA levels will be determined 1 month (T3) and 1 year (T4) after the booste | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? To compare SBA levels of =8 (persistence of vaccine induced protective antibody levels) at 1 month and 1 year after the booster vaccination between the single vaccination cohort and the booster vaccination cohort ? 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 single vaccination cohort and booster cohort at 1 month and 1 year after the booster vaccination ? To determine serum IgG antibody levels against tetanus, the carrier protein for both vaccines, at 1 month and 1 year and compare between the single vaccination cohort and booster cohort at and 1 month and 1 year after the booster ? To determine serum IgA and IgM levels against MenA, MenC, MenW and MenY at 1 month and 1 year and compare between the single vaccination cohort and booster cohort at 1 month and 1 year after the booster vaccination ? To determine MenC-PS specific IgG subclasses (IgG1/IgG2 ratio) and avidity at 1 month and 1 year and compare the single vaccination cohort and booster cohort at 1 month and 1 year after the booster vaccination ? Explorative: to explore possible differences in protective levels against at all timepoints between sub age groups (65-75 years and 75-85 years of age);Timepoint(s) of evaluation of this end point: The total duration of the study is two years and comprises three visits for the participants that receive only the primary vaccination, and five visits for the participants that receive the booster vaccination, to a study site. All participants will receive the tetravalent MenACWY-TT conjugate vaccination. Blood samples will be drawn prior to this vaccination (T0) and 1 month (T1) and 1 year (T2) after vaccination. In the booster subcohort (n=70 for each age group, total subcohort n=140), after the venipuncture at T2, the participants will receive a booster vaccination. Blood samples will be drawn 1 month (T3) and 1 year (T4) after booster vaccination. At T4, blood samp | — |
Countries
Netherlands
Contacts
Public ContactGuy Berbers
National Institute for Public Health and the Environment (RIVM)
Outcome results
None listed