
Methods: Term newborns received 3-component aP (GSK®) and HBV within 5 days of birth (aP vaccine) or HBV only (Control). All subsequently received routine hexavalent combination vaccine including DTaP, Haemophilus influenzae type b (Hib), HBV and polio antigens at 6 weeks, 4 and 6 months. IgG antibody responses to pertussis toxoid (PT), pertactin (PRN) and filamentous hemagglutinin (FHA) were measured in mothers at delivery and in infants at 6 and 10 weeks (W10) and 6 and 8 months (M8). Detectable PT and PRN at W10 was the a priori primary outcome variable.
Results: We recruited 440 infants (aP=221; Control=219) of 438 mothers (stratified by dTap vaccination within 5 years of delivery and prior to pregnancy (n= 96); or not (n= 344).
Table 1: Pertussis antibody results according to group and age (at W10 and M8)
|
aP vaccine |
Control |
|
|||
Antibody
|
|
GMC |
% detectable |
GMC |
% detectable |
P value |
PT |
W10 |
25.4 |
97.1 |
6.0 |
58 |
<.0001 |
M8 |
52.8 |
100 |
45.2 |
100 |
.014 |
|
PRN |
W10 |
122.2 |
100 |
27.3 |
97.9 |
<.0001 |
M8 |
260.5 |
100 |
216.7 |
100 |
.004 |
|
% both PT and PRN at W10 |
||||||
All subjects
|
93.2
|
|
50.8 |
<.0001 |
||
dTap vaccination within 5 years of delivery and prior to pregnancy |
91.5
|
|
61.4 |
<.0001 |
No vaccine-related SAEs occurred, and the reactogenicity profile was similar between aP and Control groups.
Conclusion: Monovalent aP vaccine co-administered with HBV at birth induces high antibody levels against pertussis antigens by 10 weeks of age without reducing subsequent pertussis antibody responses to routine primary immunisation. Neonatal aP vaccination was safe and well tolerated. Neonatal aP vaccination may be a safe and effective alternative to maternal immunisation.

N. Wood,
None
H. Marshall, None
P. Richmond, None
E. Gibbs, None
V. Gebski, None
P. Mcintyre, None