This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrowReprints and Permissions
Right arrow Copyright Information
Right arrow Books from ASM Press
Right arrow MicrobeWorld
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Schmitt, H.-J.
Right arrow Articles by Boutriau, D.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Schmitt, H.-J.
Right arrow Articles by Boutriau, D.

 Previous Article  |  Next Article 

Clinical and Vaccine Immunology, April 2007, p. 426-434, Vol. 14, No. 4
1071-412X/07/$08.00+0     doi:10.1128/CVI.00377-06
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Immunogenicity, Reactogenicity, and Immune Memory after Primary Vaccination with a Novel Haemophilus influenzae-Neisseria meningitidis Serogroup C Conjugate Vaccine{triangledown}

Heinz-J. Schmitt,1 Gudrun Maechler,2,{dagger} Pirmin Habermehl,1 Markus Knuf,1 Roland Saenger,3,{ddagger} Norman Begg,2 and Dominique Boutriau2*

Johannes-Gutenberg-Universität, Langenbeckstr. 1, 55101 Mainz,1 GlaxoSmithKline, Munich, Germany,3 GlaxoSmithKline Biologicals, Rixensart, Belgium2

Received 10 October 2006/ Returned for modification 16 November 2006/ Accepted 29 January 2007

We evaluated two formulations of a new combined Haemophilus influenzae type b (Hib)-meningococcal serogroup C (MenC)-tetanus toxoid (TT) conjugated vaccine and two formulations of a new MenC-TT vaccine (trials 711202/001 and 711202/008; clinical trial register numbers NCT00135486 and NCT00135564 [www.ClinicalTrials.gov]). A total of 520 healthy infants were randomized to receive primary vaccination (at 2, 3, and 4 months) with either MenC-TT plus diphtheria-tetanus-acellular pertussis (DTPa)-hepatitis B virus (HBV)-inactivated poliovirus (IPV)/Hib, Hib-MenC-TT plus DTPa-HBV-IPV, or MenC-CRM197 plus DTPa-HBV-IPV/Hib (control). At 12 to 15 months, subjects received a polysaccharide challenge with meningococcal polysaccharide C plus a DTPa-HBV-IPV/Hib booster. Immune responses were assessed 1 month after dose 2, 1 month after dose 3, and prior to and 1 month after the booster. After primary vaccination, there was no difference between groups in seroprotection rates as measured by titers of serum bactericidal antibody (SBA) to MenC (≥1:8) or concentrations of anti-polyribosyl ribitol phosphate (PRP) antibody (≥0.15 µg/ml). Prior to the booster, there was no difference between groups in SBA seroprotection rates, whereas anti-PRP seroprotection rates were significantly higher after priming with Hib-MenC-TT. Booster doses induced large increases in SBA and anti-PRP antibodies in primed groups, indicating successful priming with induction of immune memory. Reactogenicity and safety were similar in all groups during the primary and booster phases. A novel combined Hib-MenC-TT conjugate vaccine induced MenC and Hib responses comparable to those induced by licensed monovalent vaccines. A Hib-MenC-TT conjugate vaccine provides vaccination against two major pathogens in a single injection and is a suitable candidate for use in primary or booster vaccination schedules.

* Corresponding author. Mailing address: GlaxoSmithKline Biologicals, Rue du l'Institut, 89, 1330 Rixensart, Belgium. Phone: 32-2-656-9120. Fax: 32-2-656-8044. E-mail: Dominique.Boutriau{at}gskbio.com

{triangledown} Published ahead of print on 7 February 2007.

{dagger} Present address: GlaxoSmithKline, Munich, Germany.

{ddagger} Present address: GlaxoSmithKline Biologicals, Rixensart, Belgium.

Clinical and Vaccine Immunology, April 2007, p. 426-434, Vol. 14, No. 4
1071-412X/07/$08.00+0     doi:10.1128/CVI.00377-06
Copyright © 2007, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Pace, D, Snape, M, Westcar, S, Oluwalana, C, Yu, L-M, Begg, N, Wysocki, J, Czajka, H, Maechler, G, Boutriau, D, Pollard, A J (2008). A novel combined Hib-MenC-TT glycoconjugate vaccine as a booster dose for toddlers: a phase 3 open randomised controlled trial. Arch. Dis. Child. 93: 963-970 [Abstract] [Full Text]  


Copyright © 2009 by the American Society for Microbiology.   For an alternate route to Journals.ASM.org, visit: http://intl-journals.asm.org | More Info»