1389. High and Persistent Antibody Responses to Monovalent Acellular Pertussis Vaccine at Birth – a Large Randomised Controlled Trial
Session: Oral Abstract Session: Pediatric Vaccines: Measles and Pertussis
Saturday, October 10, 2015: 11:45 AM
Room: 32--ABC
Background: The first 12 weeks of life carry the highest risk of death and hospitalisation from pertussis. Current strategies to better protect young infants include vaccination of the mother in pregnancy or both parents immediately after birth (cocoon strategy). We evaluated immunogenicity and safety in a trial randomising newborns to both monovalent acellular pertussis vaccine (aP) and hepatitis B vaccine (HBV) at birth or HBV only. 

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.

Nicholas Wood, MBBS DCH MPH FRACP PhD1,2, Terry Nolan, MBBS PhD FRACP FAFPHM3,4, Helen Marshall, MBBS DCH MPH MD5, Peter Richmond, MBBS MRCP (UK) FRACP6,7,8, Emma Gibbs, BSc (Hons) MSc PhD9, Val Gebski, BA MStat Honorary FRANZCR9 and Peter Mcintyre, MB BS FRACP FAFPHM PhD1,2, (1)Discipline of Paediatrics and Child Health, University of Sydney, Sydney, Australia, (2)National Centre for Immunisation Research and Surveillance, Westmead, Australia, (3)Melbourne School of Population and Global Health, University of Melbourne & Murdoch Childrens Research Institute, Melbourne, Victoria, Australia, (4)Melbourne School of Population and Global Health, The University of Melbourne, Carlton, Victoria, Australia, (5)Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, North Adelaide, Australia, (6)Department of Paediatric and Adolescent Medicine, Princess Margaret Hospital for Children, Perth, Australia, (7)School of Paediatrics and Child Health, University of Western Australia, Perth, Australia, (8)Vaccine Trials Group, Telethon Institute of Child Health Research, Perth, Australia, (9)NHMRC Clinical Trials Centre, Camperdown, Australia

Disclosures:

N. Wood, None

T. Nolan, None

H. Marshall, None

P. Richmond, None

E. Gibbs, None

V. Gebski, None

P. Mcintyre, None

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