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

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.

Abbreviations: DTaP, Diphtheria and tetanus toxoids and acellular pertussis vaccine, DTP, Diphtheria and tetanus toxoids, ELISA, Enzyme-linked immunosorbent assay, FDA, Food and Drug Administration, FHA, Filamentous hemagglutinin, FIM, Fimbriae 2 and 3, GMC, Geometric mean concentration, HBS, Hepatitis B surface, HepB, Hepatitis B vaccine, Hib, Haemophilus influenzae type b conjugate vaccine, IgG, Immunoglobulin G, IPV, Inactivated trivalent poliovirus vaccine, MMR, Measles mumps rubella, PCV7, Pneumococcal conjugate vaccine 7-valent, PRN, Pertactin, PRP, Polyribosylribitol phosphate, PT, Pertussis toxoid, V, Varicella virus vaccine live