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Specific B-cell Memory After a Single Dose or Booster MenC Conjugate Vaccination: a Pilot Study in Adults

Specific B-cell Memory After a Single Dose or Booster MenC Conjugate Vaccination: a Pilot Study in Adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27223
Enrollment
21
Registered
2008-08-25
Start date
2007-05-04
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MenC conjugate vaccination, Memory B cells, infectious diseases, meningitis

Interventions

- One group receives a primary MenC conjugate vaccination (Neisvac-C). - The other two groups receive either a conjugate MenC (Neisvac-C) or polysaccharide MenC booster vaccination (Meningovax A+C).

Sponsors

National Institute for Public Health and the Environment (RIVM) Laboratory for Vaccine Preventable Diseases (LTR) Antonie van Leeuwenhoeklaan 9 3721 MA Bilthoven
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Good general health; 2. Provision of written informed consent; 3. Adherent to protocol, and available during the study period

Exclusion criteria

Exclusion criteria: 1. Severe acute (infectious) illness of fever (>38.5°C) within 2 weeks before vaccination; 2. Present evidence of serious disease(s) demanding medical treatment that might interfere the results of the study; 3. Known or suspected allergy to any of the vaccine components (by medical history); 4. Known or suspected immune deficiency; 5. History of any neurologic disorder, including epilepsy; 6. Previous administration of plasma products (including immunoglobulins) within the last 6 months; 7. Pregnancy

Design outcomes

Primary

MeasureTime frame
- How long does B-cell memory persist after a single conjugate MenC vaccination in adults and which cells are involved?

Secondary

MeasureTime frame
- How long do serum SBA titers persist in time after a single vaccination with the conjugate MenC vaccine? - Despite decline of antibody concentrations in the years after vaccination, do memory B-cells persist? - Antibody kinetics, it is important to follow the rise of antibody titers after vaccination: o How long will it take before serum IgG antibodies are detectable and/or rise after primary- or booster vaccination? o What is the avidity of serum IgG antibodies compared to the primary and booster vaccination? - In what time period after primary vaccination with MenC are memory B-cells formed and how rapidly do memory B-cells expand after booster vaccination? - Are there differences (antibody titer levels, IgG subclass distribution and serum antibody avidity) in booster responses between a booster vaccination using the conjugate MenC vaccine or plain serogroup C capsular polysaccharide .

Contacts

Public ContactG. Berbers

RIVM, afd. LIS Postbus 1

guy.berbers@rivm.nl+31 30-2742496

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)