The reactogenicity and specific immune aspects of the combined pentavalent vaccine

DTPw-HepB-Hib in breastfed babies under one year of age that attended the District Hospital of Lambaré, Paraguay in 2007 and 2008

Abstract

The combined cellular pentavalent vaccine is one the greatest achievements of human kind in the 20th century and is still successful in the 21st century. It is made up of five components and protects against the following diseases: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b. The vaccine provides specific active immunization against infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, Haemophilus influenzae type B and the Hepatitis B virus in children from six weeks of age. In Paraguay, it has been used since 2002 through the Widened Program of Immunization (PAI in Spanish) of the Ministry of Public Health. The objective of this work was to determine the secondary reactoinmunogenicity to the primary combined pentavalent vaccination in children attending the District Hospital of Lambaré, Paraguay in 2007 and 2008. This is a longitudinal, prospective observational study to evaluate the secondary effects and immune-specific aspects of the Berna DTPw-HepB-Hib combined pentavalent vaccine (QUINVAXEMTM) applied to breastfed babies under one year old, of both sexes, all races, origins and nutrition statuses in the Hospital of Lambaré. The vaccination was free, according to PAI's guidelines and by consecutive sampling previous written consent of the parents, at 2 months of age. Data were collected at baseline an post-vaccination after one month and a third dose. In a total population of 40 breastfed babies, good nutrition was found in 36 (90%). Local effects were seen in 30 (75%) distributed as follows: blush in 17 (42.5%), tumefaction (less than 20 mm) in 13 (32.5%) and local heat in 11 (27.5%). General effects were distributed as follows: fever in 37 (92.5%), loud and persistent cry in 32 (80%), irritability in 23 (57.5%), hyporeactivity in 16 (40%), anorexia in 8 (20%), hypotonicity and allergy, 2 each (5%), convulsions and paralysis in none. The effects are an average after the three doses with a decreasing trend at the end. The immunogenicity basal data before the 1st dose were as follows: antitetanic IgG (+) 38/40 (95%), antidiphtheria IgG (+) 29/40 (72.5%) and anti HBs Ag (-) 0/40 (0%). Post - vaccination responses (at 7 months old) were as follows: antitetanic IgG (+) 14/14 (100%), antidiphtheria IgG (+) 12/14 (83%) and anti HBs Ag (+) 14/14 (100%). These results show a reactogenicity of variable and decreasing degree. The antibodies levels of the DT components were satisfactory and those of Hep B excellent