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Pichichero ME, Rennels MB, Edwards KM, et al. Combined Tetanus, Diphtheria, and 5-Component Pertussis Vaccine for Use in Adolescents and Adults. JAMA. 2005;293(24):3003–3011. doi:10.1001/jama.293.24.3003
Author Affiliations: University of Rochester
Medical Center, Rochester, NY (Dr Pichichero); University of Maryland, Baltimore
(Dr Rennels); Vanderbilt University, Nashville, Tenn (Dr Edwards); Primary
Physicians Research, Pittsburgh, Pa (Dr Blatter); University of Louisville,
Louisville, Ky (Dr Marshall); Sanofi Pasteur Limited, Toronto, Ontario (Drs
Bologa, Wang, and Mills).
Context Increasing reports of pertussis among US adolescents, adults, and their
infant contacts have stimulated vaccine development for older age groups.
Objective To assess the immunogenicity and reactogenicity of a tetanus-diphtheria
5-component (pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae
types 2 and 3) acellular pertussis vaccine (Tdap) in adolescents and adults.
Design, Setting, and Participants A prospective, randomized, modified double-blind, comparative trial
was conducted in healthy adolescents and adults aged 11 through 64 years from
August 2001 to August 2002 at 39 US clinical centers.
Interventions A single 0.5-mL intramuscular dose of either Tdap or tetanus-diphtheria
Main Outcome Measures Antibody titers to diphtheria and tetanus toxoids for Tdap and Td were
measured in sera collected from subsets of adolescents and adults, before
and 28 days after vaccination. For pertussis antigens, titers in sera from
Tdap vaccinees were assessed vs those from infants who received analogous
pediatric diphtheria-tetanus-acellular pertussis vaccine (DTaP) in a previous
efficacy trial. Safety was assessed via solicited local and systemic reactions
for 14 days and adverse events for 6 months following vaccination.
Results A total of 4480 participants were enrolled. For both Tdap and Td, more
than 94% and nearly 100% of vaccinees had protective antibody concentrations
of at least 0.1 IU/mL for diphtheria and tetanus, respectively. Geometric
mean antibody titers to pertussis toxoid, filamentous hemagglutinin, pertactin,
and fimbriae types 2 and 3 exceeded (by 2.1 to 5.4 times) levels in infants
following immunization at 2, 4, and 6 months with DTaP. The incidence of solicited
local and systemic reactions and adverse events was generally similar between
the Tdap and Td groups.
Conclusions This Tdap vaccine elicited robust immune responses in adolescents and
adults to pertussis, tetanus, and diphtheria antigens, while exhibiting an
overall safety profile similar to that of a licensed Td vaccine. These data
support the potential routine use of this Tdap vaccine in adolescents and
Conclusions Published online June 2, 2005 (doi:10.1001/jama.293.24.3003).
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