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Maternal Influenza immunization and Birth Weights: A Randomized Trial in Bangladesh

Session VI – M.C. Steinhoff

Title of Contribution: Maternal Influenza immunization and Birth Weights:
A Randomized Trial in Bangladesh

Author(s): M. Steinhoff , K. Zaman, E. Roy, S. Omer, S. E. Arifeen, R. Raqib, 

Affiliation(s): Johns Hopkins Univ., and ICDDRB, Dhaka, Bangladesh


Abstract:
Background: Influenza immunization is recommended during pregnancy, but has been little studied. We estimated the effect of maternal flu immunization on infant birth weight in Dhaka, Bangladesh, taking into account the antigenic similarity of local flu viruses with the study flu vaccine. We used the clinical effectiveness of study flu vaccine against febrile respiratory illness as a proxy for the degree of antigenic match.

Design/Methods: We conducted a blinded RCT of 3rd trimester immunization of 340 mothers randomized to either flu vaccine or pneumococcal vaccine (control). (See NEJM 2008;359:1555) Study flu vaccine (WHO S. Hemisphere formulation, 2004) was effective against febrile respiratory illness from Feb thru Oct 2005. We compared birth weights in the 2 groups of mothers from Feb to June 2005 (matched vaccine), compared to births from Aug to Jan 2004, when local flu viruses did not match flu vaccine antigens (non-matched vaccine)

Preliminary Results: Births occurred from Aug 04 thru June 05. For infants in utero during circulation of non-matched flu viruses, mean birth weights were 3,077g in the flu vaccine group vs. 3,053g in the control vaccine group (p=0.70) . During circulation of flu viruses which matched the vaccine, the mean birth weight of 59 infants in the flu group was 3,186g vs. 2,972g in 57 control infants; a difference of +215g or +7% (p=0.018).

Conclusion: During circulation of flu viruses which matched the study vaccine, flu-immunized mothers delivered babies with statistically significantly greater birth weights, compared to mothers who received control vaccine. These unique RCT data from a limited-resource region suggest 1) prevention of influenza infection in pregnancy enhances fetal growth.  These data also 2) imply flu infection in late pregnancy may reduce birth weight.   We are planning a new RCT of maternal influenza immunization to refine these estimates.


Supported by the Bill and Melinda Gates Foundation, USAID, Wyeth Pharmaceuticals, Thrasher Research Fund, Aventis Pasteur, the International Centre for Diarrheal Disease Research, and the Johns Hopkins Bloomberg School of Public Health, USA.

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