Immunogenicity, reactogenicity, and immune memory after primary vaccination with a novel Haemophilus influenzae-Neisseria meningitidis serogroup C conjugate vaccine.

Abstract

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-CRM(197) 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 (> or = 1:8) or concentrations of anti-polyribosyl ribitol phosphate (PRP) antibody (> or = 0.15 microg/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.

• Authors: Heinz-J Schmitt, Gudrun Maechler, Pirmin Habermehl, Markus Knuf, Roland Saenger, Norman Begg, Dominique Boutriau
• Journal: Clinical and vaccine immunology : CVI (Clin Vaccine Immunol) Vol. 14 Issue 4 Pg. 426-34 (Apr 2007) ISSN: 1556-6811 [Print] United States
• PMID: 17287313 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Bacterial
• Antigens, Bacterial
• Haemophilus Vaccines
• Meningococcal Vaccines
• Vaccines, Conjugate

Topics

• Antibodies, Bacterial (immunology, metabolism)
• Antigen-Antibody Reactions
• Antigens, Bacterial (immunology, metabolism)
• Haemophilus Vaccines (administration & dosage, immunology, metabolism)
• Haemophilus influenzae (immunology)
• Humans
• Immunologic Memory
• Infant
• Meningococcal Vaccines (administration & dosage, immunology, metabolism)
• Neisseria meningitidis, Serogroup C (immunology)
• Vaccines, Conjugate (immunology, metabolism)