Original articlePoor Immune Responses to a Birth Dose of Diphtheria, Tetanus, and Acellular Pertussis Vaccine
Section snippets
Study Design
This was a prospective, randomized, controlled pilot study conducted in healthy full-term infants between 2 and 14 days of age who were available for the entire study period and whose parents or guardians provided written informed consent. Subjects were randomly assigned to either the experimental group that concomitantly received DTaP in the left thigh and hepatitis B vaccine in the right thigh or to the control group that received hepatitis B vaccine in the right thigh alone. Subjects in both
Study Populations
To enroll the targeted 50 infants, a total of 270 parents/guardians were approached. The demographic and physical characteristics of the infants enrolled in the 2 groups did not differ. Overall, the mean age of the infants at enrollment was 3.2 days (range 2 to 14 days). Thirty infants were male, 20 were white, 26 were black, 1 was Asian, and 3 were Hispanic. A total of 8 infants withdrew during the entire 18-month study period (3 in the experimental group and 5 in the control group). Reasons
Discussion
Our study investigated the possibility of accelerating DTaP vaccination by administering a birth dose to infants. Because morbidity and mortality of pertussis are more severe in young infants, too young to have completed their primary DTaP series,2 we sought to determine whether neonatal vaccination increased the serologic response to the pertussis antigens. In contrast with what we anticipated, an additional birth dose of DTaP resulted in lower GMCs to 3 of the 4 pertussis antigens when
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Cited by (0)
Supported by an NIH-sponsored Mentored Institutional Clinical Research Scholar Program (K12 RR-017697); an NIH-funded K 23 award (1K23AI064246-01), and an independent investigator-initiated grant from sanofi-pasteur. Facilities for study conduct were also provided in the Vanderbilt General Clinical Research Center (M01 RR-00095), supported by the National Center for Research Resources, National Institutes of Health.