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1087
Immunogenicity and Safety of 3-Dose Primary Vaccination with Combined DTPa-HBV-IPV/Hib Vaccine in Canadian Aboriginal and non-Aboriginal Infants

Session: Poster Abstract Session: Vaccines: Pertussis
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Background: It has been observed that immune responses to vaccination can vary between populations, in particular that immune responses to Haemophilus influenzae type b (Hib) vaccines are lower in certain ethnic groups. This study was undertaken to assess the immune response of Canadian Aboriginals (First Nations, Inuit, Métis) to the Hib and hepatitis B virus (HBV) components of the combined hexavalent diphtheria, tetanus, acellular pertussis, HBV, inactivated poliovirus and Hib vaccine (DTPa-HBV-IPV/Hib; GlaxoSmithKline Vaccines).

Methods: Phase IV, open-label, parallel-group study conducted at 3 centers in Canada (NCT00753649). Healthy Aboriginal and non-Aboriginal infants received DTPa-HBV-IPV/Hib at 2, 4 and 6 months of age. Immune responses to Hib polyribosyl ribitol phosphate (PRP) and HBV surface antigen (HBs) were measured 1 month post-dose 3. Medically-attended and serious adverse events (MAAEs/SAEs) were recorded up to 1 month post-dose 3.

Results: Seroprotection against Hib and HBV, 1 month post-dose 3, was comparable in the 94 Aboriginal and 107 non-Aboriginal infants included in the per-protocol analysis (Table). Anti-PRP antibody geometric mean concentrations (GMCs) were 1.7 fold higher in Aboriginal infants (Table).

Seroprotection rates and GMCs for Hib and HBV, with 95% confidence intervals

 

 

Aboriginal

Non-Aboriginal

Hib PRP

% ≥0.15 µg/ml

97.9 (92.5–99.7)

99.1 (94.9–100)

 

% ≥1 µg/ml

88.3 (80.0–94.0)

85.0 (76.9–91.2)

 

GMC (µg/ml)

6.1 (4.5–8.3)

3.5 (2.7–4.5)

HBs

% ≥10 mIU/ml

100 (96.0–100)

100 (96.5–100)

 

GMC (mIU/ml)

1797.9 (1375.1–2350.7)

1544.4 (1210.4–1970.5)

23.2% Aboriginal and 17.0% non-Aboriginal infants recorded MAAEs. 7 SAEs (bronchiolitis, pyrexia, bacterial pneumonia, respiratory syncytial virus infection and 3 cases of convulsion) were recorded in 6 Aboriginal infants; only 1 case (pyrexia) was assessed as vaccine-related; all SAEs had resolved by study end.

Conclusion: 3-dose primary vaccination with DTPa-HBV-IPV/Hib elicited immune responses to the Hib and HBV antigens that were at least as high in Aboriginal as in non-Aboriginal Canadian infants. No safety concerns were identified.

David W. Scheifele, MD1, Murdo Ferguson, MBChB2, Gerald Predy, MD3, Meena Dawar, MD1,4, Deepak Assudani, MBBS, PhD5, Sherine Kuriyakose, MSc6, Olivier Van Der Meeren, MD7 and Htay Htay Han, MBBS8, (1)University of British Columbia, Vancouver, BC, Canada, (2)Colchester Research Group, Truro, NS, Canada, (3)Alberta Health Services, Edmonton, AB, Canada, (4)Vancouver Coastal Health, Vancouver, BC, Canada, (5)GlaxoSmithKline Pharmaceuticals India Ltd, Bangalore, India, (6)GlaxoSmithKline Pharmaceuticals India Ltd., Bangalore, India, (7)GlaxoSmithKline Vaccines, Wavre, Belgium, (8)GlaxoSmithKline Vaccines, King of Prussia, PA

Disclosures:

D. W. Scheifele, GlaxoSmithKline Vaccines: Grant Investigator, Research grant

M. Ferguson, GlaxoSmithKline: I am employed at the Colchester Research Group as an investigator which conducts multiple clinical trials with different pharma companies including GSK. I was PI in this study. and Investigator, My wife, Dr. Linda Ferguson is CEO/Owner of CRG which has conducted clinical trials with multiple sponsors over the last 10 years. Dr. Linda Ferguson has received renumeration as per guidelines to present papers at conferences and discussions.

G. Predy, None

M. Dawar, None

D. Assudani, GlaxoSmithKline: Employee, Salary

S. Kuriyakose, GlaxoSmithKline Pharmaceuticals: Employee, Salary

O. Van Der Meeren, GlaxoSmithKline: Employee and Shareholder, Salary

H. H. Han, GlaxoSmithKline: Employee and Shareholder, Salary

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