The purpose of this contract is to conduct a double-blind randomized trial to determine the efficacy of one or more acellular pertussis vaccines. Clinical trials of acellular pertussis vaccines are a top development priority for NIAID and for the PHS. NIAID has been delegated the authority to conduct efficacy trials for the National Vaccine Program (NVP), administrative locus of pertussis vaccine initiatives for the PHS, which will provide NIAID appropriated funds. A coordinated Phase I/II clinical trial (funded by NIAID) evaluating 13 candidate acellular pertussis vaccines for safety and immunogenicity was completed in June of 1991. The data collected from this trial will be used as a basis for recommending vaccine(s) to be used in the efficacy trial. The phase III trial, which has been Congressionally mandated, will be performed at a site outside the United States and will address many of the issues that were left unanswered in the efficacy trial performed in Sweden (1987-1989). Currently, sites have been developed in Canada, Italy and Sweden and final site(s) selection will be made by the US Government by September 1991. The study will involve up to two years of recruitment followed by two years of surveillance and monitoring for disease. Assuming normal circumstances, data on vaccine efficacy should be available in early 1996. Once safety and efficacy is demonstrated for one or more of these acellular vaccines, licensure for use in infants and children should follow quickly within the United States.

Project Start
1991-09-25
Project End
2003-09-30
Budget Start
1999-06-21
Budget End
2003-09-30
Support Year
Fiscal Year
1999
Total Cost
Indirect Cost
Name
National Bacteriological Laboratory
Department
Type
DUNS #
City
Stockholm
State
Country
Sweden
Zip Code
Vogt, Hartmut; Bråbäck, Lennart; Kling, Anna-Maria et al. (2014) Pertussis immunization in infancy and adolescent asthma medication. Pediatrics 134:721-8
Feng, Zhilan; Glasser, John W; Hill, Andrew N et al. (2014) Modeling rates of infection with transient maternal antibodies and waning active immunity: application to Bordetella pertussis in Sweden. J Theor Biol 356:123-32
Nilsson, Lennart; Lepp, Tiia; von Segebaden, Kerstin et al. (2012) Pertussis vaccination in infancy lowers the incidence of pertussis disease and the rate of hospitalisation after one and two doses: analyses of 10 years of pertussis surveillance. Vaccine 30:3239-47
Gustafsson, Lennart; Hessel, Luc; Storsaeter, Jann et al. (2006) Long-term follow-up of Swedish children vaccinated with acellular pertussis vaccines at 3, 5, and 12 months of age indicates the need for a booster dose at 5 to 7 years of age. Pediatrics 118:978-84
Hallander, Hans O; Gustafsson, Lennart; Ljungman, Margaretha et al. (2005) Pertussis antitoxin decay after vaccination with DTPa. Response to a first booster dose 3 1/2-6 1/2 years after the third vaccine dose. Vaccine 23:5359-64
Olin, Patrick; Gustafsson, Lennart; Barreto, Luis et al. (2003) Declining pertussis incidence in Sweden following the introduction of acellular pertussis vaccine. Vaccine 21:2015-21
Storsaeter, Jann; Hallander, Hans O; Gustafsson, Lennart et al. (2003) Low levels of antipertussis antibodies plus lack of history of pertussis correlate with susceptibility after household exposure to Bordetella pertussis. Vaccine 21:3542-9
Olin, P; Hallander, H O; Gustafsson, L et al. (2001) How to make sense of pertussis immunogenicity data. Clin Infect Dis 33 Suppl 4:S288-91
Olin, P (1999) Vaccination programmes out of pace with vaccine development: a call for national vaccination registers. Acta Paediatr 88:800-2
Storsaeter, J; Hallander, H O; Gustafsson, L et al. (1998) Levels of anti-pertussis antibodies related to protection after household exposure to Bordetella pertussis. Vaccine 16:1907-16

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