Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study)

Summary

The main goal of this study is to compare the Haemophilus influenzae type b antibody response in American Indian / Alaska Native (AI/AN) infants to two licensed vaccines: Vaxelis and PedvaxHIB.

Timeline

Start

2022-01-27

Primary completion

2023-10-26

Completion

2023-10-26

Publications

• Background Vesikari T, Becker T, Vertruyen AF, Poschet K, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, Thomas S, Ziani E, Lee AW. A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months. Pediatr Infect Dis J. 2017 Feb;36(2):209-215. doi: 10.1097/INF.0000000000001406.
• Background Bulkow LR, Wainwright RB, Letson GW, Chang SJ, Ward JI. Comparative immunogenicity of four Haemophilus influenzae type b conjugate vaccines in Alaska Native infants. Pediatr Infect Dis J. 1993 Jun;12(6):484-92. doi: 10.1097/00006454-199306000-00006.
• Background Santosham M, Wolff M, Reid R, Hohenboken M, Bateman M, Goepp J, Cortese M, Sack D, Hill J, Newcomer W, et al. The efficacy in Navajo infants of a conjugate vaccine consisting of Haemophilus influenzae type b polysaccharide and Neisseria meningitidis outer-membrane protein complex. N Engl J Med. 1991 Jun 20;324(25):1767-72. doi: 10.1056/NEJM199106203242503.
• Background Singleton R, Bulkow LR, Levine OS, Butler JC, Hennessy TW, Parkinson A. Experience with the prevention of invasive Haemophilus influenzae type b disease by vaccination in Alaska: the impact of persistent oropharyngeal carriage. J Pediatr. 2000 Sep;137(3):313-20. doi: 10.1067/mpd.2000.107843.
• Background Diaz-Mitoma F, Halperin SA, Tapiero B, Hoffenbach A, Zappacosta PS, Radley D, Bradshaw S, Martin JC, Boslego JW, Hesley TM, Bhuyan PK, Silber JL. Safety and immunogenicity of three different formulations of a liquid hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine at 2, 4, 6 and 12-14 months of age. Vaccine. 2011 Feb 1;29(6):1324-31. doi: 10.1016/j.vaccine.2010.11.053. Epub 2010 Dec 4.
• Background Silfverdal SA, Icardi G, Vesikari T, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, Thomas S, Ziani E, Lee AW. A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11-12 months. Vaccine. 2016 Jul 19;34(33):3810-6. doi: 10.1016/j.vaccine.2016.05.054. Epub 2016 Jun 18.
• Background State of Alaska Epidemiology Bulletin; Aug 11, 2009

Drugs

Indications