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Investigational vaccine could offer protection for infants against Haemophilus influenzae type b and meningococcal disease.

GlaxoSmithKline (GSK) recently announced results from a Phase II vaccine clinical study presented in May at the Pediatric Academic Societies' (PAS) Annual Meeting in Toronto, Canada. The new data suggest that the investigational Hib-MenCY-TT vaccine holds potential to protect infants in the first year of life against invasive disease caused by three strains of bacteria: Neisseria meningitidis serogroups C (MenC) and Y (MenY) and Haemophilus influenzae type b (Hib). The pediatric combination vaccine is currently in Phase III clinical studies and an application for licensure in the United States has not been submitted.

"Infants 12 months of age and younger are at the greatest risk of having meningococcal infections," said Jacqueline M. Miller, MD, Director, Clinical Research and Development and Medical Affairs, GlaxoSmithKline Biologicals. "This investigational Hib-MenCY-TT vaccine was designed to be administered at the 2-, 4-, 6-, and 12-or 15-month well child visits. If ultimately approved on this dosing schedule, it would not require the addition of shots to the current CDC-recommended pediatric immunization schedule."

While the current CDC-recommended vaccination schedule calls for infants to be vaccinated against certain bacteria that cause meningitis such as Haemophilus influenzae type b and Streptococcus pneumoniae in the first year of life, there is currently no vaccine available to protect infants against any serogroup of Neisseria meningitidis.

Hib-MenCY-TT vaccine study. The Phase 11 study evaluated the immune response and safety of Hib-MenCY-TT compared to a licensed monovalent Hib conjugate vaccine (ActHib[R] Haemophilus influenza type b Conjugate Vaccine Tetanus Toxoid Conjugate) in infants and to a licensed polysaccharide meningococcal ACWY vaccine (Menomune[R] Meningococcal Polysaccharide Vaccine, Serogroups A, C, Y and W-135 Combined) in children 3-5 years of age.

In this single-blind, Phase II study, 609 infants were randomized 1:1 to receive either Hib-MenCY-TT or licensed Hib vaccine at 2, 4, and 6 months concomitantly with DTaP-Hep B-IPV (Pediarix[R] Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B [Recombinant] and Inactivated Poliovirus Vaccine Combined) and pneumococcal 7-valent conjugate vaccine (Prevnar[R] Pneumococcal 7-valent Conjugate Vaccine Diphtheria CRM Protein). A second control group of 150 children 3-5 years of age received one dose of Neisseria meningitidis serogroups A, C, W-135 and Y polysaccharide vaccine with no co-administered vaccines. Serologic follow-up was conducted 1 month after dose 3 of Hib-MenCY-TT/Hib or 1 month after ACWY, and safety follow-up was conducted from enrollment in the study until 31 days after dose 3 in the Hib-MenCY-TT/Hib groups and 31 days after vaccination in the ACWY group. The primary safety follow-up period of interest was defined as the 4 days immediately following each vaccination.

Results from the study are:

* Hib immune response induced by the Hib-MenCY-TT combination vaccine was non-inferior and statistically significantly higher than the monovalent Hib vaccine (93.5% anti-PRP 1 mcg/mL vs. 85.8% PRP 1 mcg/mL, respectively).

* The Hib-MenCY-TT combination vaccine induced antibodies nearly two times higher than the monovalent Hib vaccine produced (7.99 mcg/mL vs. 4.39 mcg/mL, respectively).

* The Hib-MenCY-TT combination vaccine demonstrated an immune response to MenC and MenY in infants that was non-inferior and statistically significantly higher for MenC and non-inferior and comparable for MenY to the immune response induced by ACWY in older children (97.7% of Hib-MenCY-TT had consolidated SBA-MenC response vs. 79.4% of ACWY and 96% of Hib-MenCY-TT had consolidated SBA-MenY response vs. 94.2% of ACWY). The data should be interpreted cautiously given the difference in age of the two treatment groups.

* Overall grade 3 solicited and unsolicited adverse events (AEs) for the combination Hib-MenCY-TT vaccine were statistically significantly lower than the monovalent Hib vaccine (local AEs were 5.2% in Hib-MenCY-TT vs. 12.9% in Hib and systemic AEs were 8.7% in Hib-MenCY-TT vs. 18.2% in Hib). The most common solicited local AE overall for both the combination Hib-MenCY-TT vaccine and the Hib control groups was pain at the Hib-containing injection site. The most common solicited systemic AE overall for both treatment groups was general irritability.

* Immunologic interference was not observed when Hib-MenCY-TT was administered with DTaP-Hep B-IPV and pneumococcal 7-valent conjugate vaccine.

Meningococcal disease. In the United States each year, there are approximately 2,500 cases of invasive meningococcal disease. Meningitis, an infection caused by Neisseria meningitidis, is a serious and devastating disease with mortality rates of approximately 10% and up to 19% of patients suffering long-term effects such as brain damage, amputation, severe skin scarring, kidney damage, mental retardation, and deafness. Infants and young children are at the greatest risk for this disease, with approximately 40% of cases occurring in children less than 24 months of age. Approximately 50% of meningococcal disease in infants in the United States is caused by serogroups C and Y. The majority of the remaining meningococcal disease is caused by serogroup B, for which there are no licensed vaccines in the United States for any age groups.

We invite your contributions to Items of Interest and Readers" Exchange. Please submit material to Judy Rollins, PhD, RN; Pediatric Nursing; East Holly Avenue Box 56; Pitman, NJ 08071-0056.
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Title Annotation:Items of Interest
Author:Rollins, Judy A.
Publication:Pediatric Nursing
Date:May 1, 2007
Words:841
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