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Published on: November 5, 2019
Single priming dose of meningococcal group C conjugate vaccine (NeisVac-C®) in infants
Eva-Maria Poellabauer1, Borislava G Pavlova, Sandor Fritsch
1Global R&D, Baxter BioScience, Industriestrasse 67, A-1220 Vienna, Austria.
Insights
A single dose of the meningococcal C conjugate (MCC) vaccine at 4 or 6 months provides strong infant protection. This simplified schedule offers a viable alternative to the current two-dose priming for broader vaccine coverage.
Area of Science:
- Pediatric Vaccinology
- Immunology
- Public Health
Background:
- Meningococcal C conjugate (MCC) vaccines, like NeisVac-C(®), have demonstrated immunogenicity and safety since 1999.
- Previous studies suggest a single priming dose can elicit a strong immune response, boostable later.
- Optimizing infant immunization schedules with fewer doses can enhance acceptability and coverage without increasing costs.
Purpose of the Study:
- To evaluate the feasibility of a single NeisVac-C(®) vaccine priming dose at 4 or 6 months.
- To compare this single-dose strategy against the licensed two-dose priming schedule (2 and 4 months).
- To assess immune responses and seroprotection rates across different priming schedules followed by a booster.
Main Methods:
- A randomized feasibility study comparing NeisVac-C(®) vaccination schedules.
- Groups received either a single priming dose (at 4 or 6 months) or two priming doses (at 2 and 4 months).
- All groups received a booster dose at 12-13 months, with serum bactericidal antibody (rSBA) titers measured at key time points.
Main Results:
- All groups achieved high seroprotection rates (rSBA ≥ 8) one month post-priming (>99%).
- Prior to booster, seroprotection remained above 65%, with the lowest titers in the two-dose priming group.
- Following the booster, all groups showed excellent seroprotection (rSBA ≥ 128), with the single 4-month dose group exhibiting the highest GMT (2472).
Conclusions:
- A single NeisVac-C(®) priming dose at 4 or 6 months induces robust immunogenicity.
- This single-dose strategy is a feasible and valuable alternative to the current two-dose priming schedule.
- Simplified schedules may improve infant immunization coverage and acceptability.
Abstract:
Since the introduction of the meningococcal C conjugate (MCC) vaccine in the pediatric population in 1999, numerous clinical studies have confirmed the immunogenicity and safety of the NeisVac-C(®) vaccine, and several have observed a strong immune response after a single priming dose, which could be successfully boosted. Maximizing protection of infants with as few vaccine doses as possible would increase the general acceptability of the immunization strategies and support broader coverage without increasing vaccination costs. This was a randomized feasibility study of a single priming NeisVac-C(®) vaccine dose administered at 4 or 6 months of age, compared to the currently licensed two dose priming at 2 and 4 months of age, followed by a booster vaccination at 12-13 months of age. High seroprotection rates and serum bactericidal antibody (rSBA) titers were observed in all study groups, whether a single or two dose priming vaccination was administered, at all time points investigated: one month after the priming vaccination(s) (>99% of subjects rSBA≥8), prior to booster vaccination (>65% of subjects with rSBA≥8, with the lowest titers and GMTs seen in the two dose priming group), as well as after booster vaccination administration (99% with rSBA≥128 in all three study groups, with the highest GMT of 2472 seen in the 4 month single dose group). This study confirmed trends seen in previous reports that a single-dose priming vaccination at 4 or 6 months of age can be considered a valuable alternative to the currently licensed two-dose priming vaccination schedule.
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