Excellent Antibody Response of North American Vaccine's Hib Vaccine In Pre-Clinical Studies Presented to FDA Advisory Panel
COLUMBIA, Md., Jan. 28 /PRNewswire/ -- North American Vaccine (Amex: NVX) reported yesterday on the excellent antibody response of its Haemophilus influenzae type b (Hib) conjugate vaccine before a United States Food and Drug Administration (FDA) advisory panel. Pre-clinical studies indicate that no significant immunologic interference between the Company's Hib and acellular pertussis (aP) vaccines in combination is anticipated in infants. The Company intends to ultimately market the stable, liquid Hib vaccine in combination with Certiva(R), its diphtheria, tetanus and acellular pertussis (DTaP) vaccine, and with injectable polio virus (IPV) vaccine.
A Certiva(R)-IPV-Hib combination vaccine is compatible with the recommended pediatric immunization schedule. The current immunization schedule for diphtheria, tetanus, pertussis, polio and Hib recommends as many as thirteen injections to protect an individual from these diseases. The proposed combination vaccine may allow for protection against all five diseases in as few as five injections.
Certiva(R) is approved in the US and Europe. Certiva(R)-IPV is approved in Europe. There has been an excellent safety and effectiveness record for both vaccines in all the clinical experience before and after their approvals. A clinical trial in Sweden of Certiva(R)-IPV combined with a commercially available Hib vaccine found no serious adverse reactions and no clinically significant immunologic interference.
Immunologic interference is an effect observed in products that combine aP and Hib vaccines that suppresses the Hib antibody response, and therefore may lower protection against Hib disease. The Company's Hib vaccine produces a high level of functional antibodies such that effective protection from Hib disease is maintained in combination with aP vaccine.
The Company believes that the ability of its Hib conjugate vaccine to produce excellent antibody response while avoiding significant immunologic interference is due primarily to the use of a novel carrier protein, known as rPorB. This protein facilitates the desired immune response to the attached Hib polysaccharide. In addition, the novel protein is expected to reduce the risk of adverse reactions that some individuals may develop to other common carrier proteins.
The Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) as well as the American Academy of Pediatrics have issued recommendations for vaccination of children against Hib infections. Vaccination against Hib consists of three primary doses at two, four and six months and a booster dose administered between 12 and 15 months of age. Children that are not properly vaccinated and are infected with Hib bacteria can develop meningitis, which may lead to blindness, deafness, acquired mental retardation or death. The peak incidence of Hib infection in the US occurs in children between six and 18 months of age. |
