Poor immune responses to a birth dose of diphtheria, tetanus, and acellular pertussis vaccine.
OBJECTIVE
To evaluate the safety and immunogenicity of an additional birth dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP).


METHODS
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.


CONCLUSIONS
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.
Halasa
Natasha B
NB
Department of Pediatrics, Division of Infectious Diseases, Vanderbilt University School of Medicine, Nashville, TN, USA.
O'Shea
Alice
A
Shi
Jian R
JR
LaFleur
Bonnie J
BJ
Edwards
Kathryn M
KM
D004165:Diphtheria / Q000517:prevention & control; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005500:Follow-Up Studies; D006192:Haemophilus Infections / Q000517:prevention & control; D018073:Haemophilus Vaccines / Q000008:administration & dosage*; D006801:Humans; D007109:Immunity / Q000187:drug effects / Q000502:physiology*; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010865:Pilot Projects; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors; D013742:Tetanus / Q000517:prevention & control; D013745:Tetanus Toxoid / Q000008:administration & dosage*; D018074:Vaccines, Conjugate; D014917:Whooping Cough / Q000517:prevention & control
D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C055753:Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate