Fractional Dose Tetravalent A, C, Y, W135 Meningococcal Polysaccharide Vaccine
Summary
Hypothesis: Lower doses of each A/C/Y/W135 component of the meningococcal polysaccharide vaccine could confer a similar functional immunogenic response as the dose of 50 μg currently being used, and subsequently be equally protective. The purpose of this study is to evaluate the use of fractional dose tetravalent meningococcal polysaccharide vaccine to control outbreak especially caused by N. meningitidis serogroup W135 Primary Objectives: * To measure the immunogenicity of a dose corresponding to one fifth of the amount of the licensed meningococcal A/C/Y/W135 polysaccharide vaccine, i.e. 10 μg for each component; and * To measure the immunogenicity of a dose corresponding to one tenth of the licensed meningococcal A/C/Y/W135 polysaccharide vaccine, i.e. 5 μg for each component.
Timeline
- Start
- 2004-06
- Primary completion
- —
- Completion
- 2006-11
Outcome
Mixed primary results
paper Non-inferiority was demonstrated between the full dose and both fractional doses in SBA seroresponse against serogroups W135 and Y, in total population analysis. PMID 19048025 ↗
paper Non-inferiority was not shown for any of the fractionate doses for serogroup C. PMID 19048025 ↗
Publications
- Background Griffiss JM, Brandt BL, Broud DD. Human immune response to various doses of group Y and W135 meningococcal polysaccharide vaccines. Infect Immun. 1982 Jul;37(1):205-8. doi: 10.1128/iai.37.1.205-208.1982.
- Background Griffiss JM, Brandt BL, Broud DD, Altieri PL, Berman SL. Relationship of dose to the reactogenicity and immunogenicity of meningococcal polysaccharide vaccines in adults. Mil Med. 1985 Oct;150(10):529-33. No abstract available.
- Background Granoff DM, Gupta RK, Belshe RB, Anderson EL. Induction of immunologic refractoriness in adults by meningococcal C polysaccharide vaccination. J Infect Dis. 1998 Sep;178(3):870-4. doi: 10.1086/515346.
- Guerin PJ, Naess LM, Fogg C, Rosenqvist E, Pinoges L, Bajunirwe F, Nabasumba C, Borrow R, Froholm LO, Ghabri S, Batwala V, Twesigye R, Aaberge IS, Rottingen JA, Piola P, Caugant DA. Immunogenicity of fractional doses of tetravalent a/c/y/w135 meningococcal polysaccharide vaccine: results from a randomized non-inferiority controlled trial in Uganda. PLoS Negl Trop Dis. 2008;2(12):e342. doi: 10.1371/journal.pntd.0000342. Epub 2008 Dec 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ACYW135 Meningococcal Polysaccharide Vaccine | Vaccine | 5 ug | — |
| Subject | ACYW135 Meningococcal Polysaccharide Vaccine | Vaccine | 10 ug | — |
| Subject | ACYW135 Meningococcal Polysaccharide Vaccine | Vaccine | 50 ug | — |