Evidence map›Paper›PMID 19048025›Full record

Trial reportPLoS neglected tropical diseases2008

Immunogenicity of fractional doses of tetravalent a/c/y/w135 meningococcal polysaccharide vaccine: results from a randomized non-inferiority controlled trial in Uganda.

Philippe J Guerin, Lisbeth M Naess, Carole Fogg, Einar Rosenqvist, Loretxu Pinoges, Francis Bajunirwe, Carolyn Nabasumba, Ray Borrow, Leif O Frøholm, Salah Ghabri and 6 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PLoS neglected tropical diseases, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00271479 (Assay of the Immunogenicity of Fractional Dose Tetravalent A, C, Y, W135 Meningococcal Polysaccharide Vaccine in Africa), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00271479 phase4completednot on this map

Assay of the Immunogenicity of Fractional Dose Tetravalent A, C, Y, W135 Meningococcal Polysaccharide Vaccine in Africa

TypeinterventionalSponsorEpicentreRan2004 to 2006Enrolled720ConditionsInfections, Meningococcal, Meningitis, MeningococcicArmsA, C, Y, W135 meningococcal polysaccharide vaccine
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Philippe J GuerinEpicentre, Paris, France. philippe.guerin@epicentre.msf.org
Lisbeth M Naess
Carole Fogg
Einar Rosenqvist
Loretxu Pinoges
Francis Bajunirwe
Carolyn Nabasumba
Ray Borrow
Leif O Frøholm
Salah Ghabri
Vincent Batwala
Rogers Twesigye
Ingeborg S Aaberge
John-Arne Røttingen
Patrice Piola
Dominique A Caugant

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNeisseria meningitidis serogroup A is the main causative pathogen of meningitis epidemics in sub-Saharan Africa. In recent years, serogroup W135 has also been the cause of epidemics. Mass vaccination campaigns with polysaccharide vaccines are key elements in controlling these epidemics. Facing global vaccine shortage, we explored the use of fractional doses of a licensed A/C/Y/W135 polysaccharide meningococcal vaccine. METHODS AND

findingsWe conducted a randomized, non-inferiority trial in 750 healthy volunteers 2-19 years old in Mbarara, Uganda, to compare the immune response of the full dose of the vaccine versus fractional doses (1/5 or 1/10). Safety and tolerability data were collected for all subjects during the 4 weeks following the injection. Pre- and post-vaccination sera were analyzed by measuring serum bactericidal activity (SBA) with baby rabbit complement. A responder was defined as a subject with a > or =4-fold increase in SBA against a target strain from each serogroup and SBA titer > or =128. For serogroup W135, 94% and 97% of the vaccinees in the 1/5- and 1/10-dose arms, respectively, were responders, versus 94% in the full-dose arm; for serogroup A, 92% and 88% were responders, respectively, versus 95%. Non-inferiority was demonstrated between the full dose and both fractional doses in SBA seroresponse against serogroups W135 and Y, in total population analysis. Non-inferiority was shown between the full and 1/5 doses for serogroup A in the population non-immune prior to vaccination. Non-inferiority was not shown for any of the fractionate doses for serogroup C. Safety and tolerability data were favourable, as observed in other studies.

conclusionsWhile the advent of conjugate A vaccine is anticipated to largely contribute to control serogroup A outbreaks in Africa, the scale-up of its production will not cover the entire "Meningitis Belt" target population for at least the next 3 to 5 years. In view of the current shortage of meningococcal vaccines for Africa, the use of 1/5 fractional doses should be considered as an alternative in mass vaccination campaigns.

trial registrationClinicalTrials.gov NCT00271479.

Indexed as

AdolescentAfrica South of the SaharaAnimalsBacterial VaccinesChildChild, PreschoolComplement System ProteinsDose Fractionation, RadiationDose-Response Relationship, DrugHumansMeningitis, MeningococcalNeisseria meningitidisPolysaccharides, BacterialRabbitsSafetySingle-Blind MethodBacterial VaccinesComplement System ProteinsPolysaccharides, Bacterial

Identifiers

PMID19048025
PMCPMC2584372

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.