Elsevier

The Journal of Pediatrics

Volume 153, Issue 3, September 2008, Pages 327-332.e1
The Journal of Pediatrics

Original article
Poor Immune Responses to a Birth Dose of Diphtheria, Tetanus, and Acellular Pertussis Vaccine

https://doi.org/10.1016/j.jpeds.2008.03.011Get rights and content

Objectives

To evaluate the safety and immunogenicity of an additional birth dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP).

Study design

Fifty infants between 2 to 14 days of age were randomly assigned to receive either DTaP and hepatitis B vaccines (experimental) or hepatitis B alone (control) at birth. At 2, 4, 6, and 17 months of age, DTaP and routine vaccines were administered to both groups. Safety data were collected after each dose, and sera were obtained at birth, 6, 7, 17, and 18 months. Immune responses to pertussis toxin, filamentous hemagglutinin, pertactin, and fimbriae were measured by enzyme-linked immunosorbent assay; responses to other vaccines were assessed.

Results

No differences were seen between the 2 groups in either local or systemic reactions; all vaccines were well tolerated. Compared with the control group, infants in the experimental group demonstrated significantly lower geometric mean antibody concentrations for pertussis toxin and pertactin 6, 7, and 18 months, for fimbrae at 6, 7, 17, and 18 months, and for FHA at 18 months, and lower geometric mean antibody concentrations for diphtheria at 7 months. Immune responses to all other vaccine antigens were comparable.

Conclusion

Administration of an additional dose of DTaP at birth was safe but was associated with a significantly lower response to diphtheria and 3 of 4 pertussis antigens compared with controls.

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.

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