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Author Notes:

Address correspondence to Mark J. Mulligan, The Hope Clinic of the Emory Vaccine Center, 603 Church Street, Decatur, GA 30030. Email: mark.mulligan@emory.edu.

Srilatha Edupuganti and Rachel B. Eidex contributed equally.

Harvey Lipman is deceased.

The authors wish to dedicate the manuscript in memory of Harvey Lipman, PhD, Centers for Disease Control and Prevention biostatistician and coinvestigator on this study, who passed away during manuscript preparation.

The authors thank the study volunteers for their time and commitment to this trial.

The other members of the YF-Ig Study Team are Bali Pulendran, Angela Caliendo, Joseph Miller, Kirk Easley, Seema Garg, Benton Lawson, and Paula M. Frew.

We wish to acknowledge the following members of the YFV Vaccine Study Team who assisted with the conduct of the study (Jane Skvarich, Susan Lalor, Kenya Kirkendoll, Zabrina Furlow, Mersiha Hotic, Renata Dennis, Alexis Daugherty, Mary Bower, Wendy Nesheim, Summer Nijem, Pat Anderson, Joseph Hilinski, Heather Coote, and Eileen Osinski) and John Connolly at the Luminex Core at Baylor Institute for Immunology Research.

D.T. was employed by the study sponsor, Sanofi Pasteur, at the time that the study was conducted. Seema Garg moved to Sanofi Pasteur after the study was completed. These statements are made in the interest of full disclosure and not because the authors consider their employment to be a conflict of interest.

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Research Funding:

This work was supported by a grant from Sanofi Pasteur.

This work was facilitated by the Center for AIDS Research (CFAR) at Emory University (P30 AI050409).

A Randomized, Double-Blind, Controlled Trial of the 17D Yellow Fever Virus Vaccine Given in Combination with Immune Globulin or Placebo: Comparative Viremia and Immunogenicity

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Journal Title:

American Journal of Tropical Medicine and Hygiene

Volume:

Volume 88, Number 1

Publisher:

, Pages 172-177

Type of Work:

Article | Final Publisher PDF

Abstract:

We evaluated whether coadministration of the yellow fever (YF) virus vaccine with human immunoglobulin (Ig) that contained YF virus-neutralizing antibodies would reduce post-vaccination viremia without compromising immunogenicity and thus, potentially mitigate YF vaccine-associated adverse events. We randomized 80 participants to receive either YF vaccine and Ig or YF vaccine and saline placebo. Participants were followed for 91 days for safety and assessments of viremia and immunogenicity. There were no differences found between the two groups in the proportion of vaccinated participants who developed viremia, seroconversion, cluster of differentiation (CD)-8+ and CD4+ T-cell responses, and cytokine responses. These results argue against one putative explanation for the increased reporting of YF vaccine side effects in recent years (i.e., a change in travel clinic practice after 1996 when hepatitis A prophylaxis with vaccine replaced routine use of pre-travel Ig, thus potentially removing an incidental YF vaccine-attenuating effect of anti-YF virus antibodies present in Ig) (ClinicalTrials.gov identifier: NCT00254826).

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© The American Society of Tropical Medicine and Hygiene

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