This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Purpose: To determine among children with a prior history of extensive swelling reactions (ESR) whether there is a difference between licensed vaccines in the proportion children experiencing > 5 cm of swelling or entire upper limb swelling. To compare seroresponse rates and GMC of IgG to diphtheria toxin, tetanus toxin, and common pertussis antigens (pertussis toxin, pertactin and filamentous hemagglutinin) between children who experience post-dose 5 ESR and children with no, or mild (<2 cm) swelling reaction post-dose 5. To determine the rate of and severity of ESR post-dose 5 DTaP in children who have a history of extensive local reaction post-dose 4. To compare between vaccines rates of other reactions (Fever: T>38C, T>39C, T>40C; erythema (any, mild, moderate, severe): pain (any, mild, moderate, severe); swelling (any, mild, moderate, severe); induration (present, absent). To explore the association of rate of ESR with body mass index (BMI). Volunteers: Three hundred children (50 at Stanford) who have experienced a severe local reaction after their toddler dose of DTaP will be enrolled into the study at one of the 7 Clinical Immunization Safety Assessment (CISA) Centers. They will be equally randomized to receive one of two licensed DTaP vaccines (Infanrix or DAPTACEL) and followed for 4 days after vaccination for the occurrence and grading of local and systemic reactions. Venous blood will be drawn immediately before and one month after vaccination for measurement of IgG to diphtheria toxin, tetanus toxin, and common pertussis antigens (pertussis toxin, pertactin, and filamentous hemagglutinin). Volunteer Participation: Volunteers will be receive one of two vaccines of DTaP in the left deltoid using a 23 gauge 1 inch needle. Parents will be given a digital thermometer and tuaght how to use it. They will also be provided with a special ruler device for measuring limb circumference. For 4 days following vaccination, parents will be asked to record on a diary card an evening oral temperature and grade general activity. Each evening, for 14 days, the parent will examine the site of injection of the experimental vaccine and record the presence of severity of the following local reactions for each injection site: pain, functional assessment of the arm, redness, local swelling, pruritis, warmth, induration, and limb circumference. The study nurse will phone the family on days 2, 5, and 15 post-vaccination to collect the safety data. Volunteers will return to clinic four to six weeks after vaccination for a blood draw that will compare IgG seroresponses. Variables to be Investigated: 1) To determine rates and severity of swelling reactions post-dose 5 DTaP in children who have a prior history of extensive local reaction. 2) To determine if there are significant differences in rates and severity of swelling reactions following the 5th dose of different licensed DTaP vaccines in children who experienced an extensive swelling reaction after the 4th toddler dose. 3) To compare IgG seroresponses to vaccine components in children who do and do not have extensive swelling reactions post-dose 5. Risks/Benefits: The risk of participating in this study are those known to exist for vaccination with DTaP and those of blood draw. The benefit to the volunteer is potential protection against diphtheria, tetanus, and pertussis. The benefit to society is to determine if one vaccine produces fewer extensive swelling reactions than the other.
Showing the most recent 10 out of 589 publications
