Safety of reduced-antigen-content tetanus-diphtheria-acellular pertussis vaccine in adolescents as a sixth consecutive dose of acellular pertussis-containing vaccine

Johannes Gutenberg-Universität Mainz, Mayence, Rheinland-Pfalz, Germany
Journal of Pediatrics (Impact Factor: 3.79). 12/2006; 149(5):603-610. DOI: 10.1016/j.jpeds.2006.06.016
Source: PubMed


The safety of a booster dose of a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine was evaluated in adolescents previously vaccinated with five doses of acellular pertussis-containing vaccine.
Adolescents (n = 319) previously vaccinated with either 5 doses of diphtheria-tetanus-acellular pertussis (DTaP) (n = 193) or 4 doses of DTaP plus another acellular pertussis-containing vaccine received one dose each of Tdap and hepatitis A vaccine in a double-blinded, randomized, crossover trial. Rates of adverse events (AEs) after vaccination with Tdap versus hepatitis A and rates of local AEs among adolescents vaccinated with Tdap (sixth acellular pertussis-containing vaccine dose) versus rates in these same individuals after vaccination with their fifth DTaP dose were assessed.
After Tdap, pain (63.6%), redness (51.7%), and swelling (41.4%) were the most frequently reported AEs. Large injection site swelling (swelling > 100 mm, arm circumference increase > 50 mm or diffuse swelling interfering with daily activities) occurred in three adolescents and resolved without sequelae. After the sixth dose of acellular pertussis-containing vaccine, adolescents reported more pain and less redness and swelling compared with incidences of these AEs reported when these same individuals received their fifth DTaP dose.
These results suggest that Tdap is well tolerated as a sixth consecutive dose of acellular pertussis-containing vaccine.

54 Reads
  • Source
    • "PfAMA1-FVO[25-545] mixed with the adjuvants Alhydrogel™, Montanide and AS02 tended to be locally reactogenic, mainly causing short lasting injection site pain when administered to healthy adult volunteers. Most post immunisations adverse events were mild-to-moderate in intensity and have been seen previously with other vaccines[35]–[40]. Because this was the first time Pichia Pastoris produced FVO PfAMA1 antigen was being given to humans, the occurrence of a grade 3 adverse event was a stopping criterium, which led to withdrawal of seven subjects post dose 2 for grade 3 (>50 mm) erythema. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Plasmodium falciparum Apical Membrane Antigen 1 (PfAMA1) is a candidate vaccine antigen expressed by merozoites and sporozoites. It plays a key role in red blood cell and hepatocyte invasion that can be blocked by antibodies. We assessed the safety and immunogenicity of recombinant PfAMA1 in a dose-escalating, phase Ia trial. PfAMA1 FVO strain, produced in Pichia pastoris, was reconstituted at 10 microg and 50 microg doses with three different adjuvants, Alhydrogel, Montanide ISA720 and AS02 Adjuvant System. Six randomised groups of healthy male volunteers, 8-10 volunteers each, were scheduled to receive three immunisations at 4-week intervals. Safety and immunogenicity data were collected over one year. Transient pain was the predominant injection site reaction (80-100%). Induration occurred in the Montanide 50 microg group, resulting in a sterile abscess in two volunteers. Systemic adverse events occurred mainly in the AS02 groups lasting for 1-2 days. Erythema was observed in 22% of Montanide and 59% of AS02 group volunteers. After the second dose, six volunteers in the AS02 group and one in the Montanide group who reported grade 3 erythema (>50 mm) were withdrawn as they met the stopping criteria. All adverse events resolved. There were no vaccine-related serious adverse events. Humoral responses were highest in the AS02 groups. Antibodies showed activity in an in vitro growth inhibition assay up to 80%. Upon stimulation with the vaccine, peripheral mononuclear cells from all groups proliferated and secreted IFNgamma and IL-5 cytokines. All formulations showed distinct reactogenicity profiles. All formulations with PfAMA1 were immunogenic and induced functional antibodies. ( NCT00730782.
    Full-text · Article · Dec 2008 · PLoS ONE
  • [Show abstract] [Hide abstract]
    ABSTRACT: The results of influence of ionizing radiation (gamma-quanta with doses 10<sup>2</sup>-10<sup>9</sup> Gy, high energy electrons and fast neutrons with fluences 10<sup>12</sup>-10<sup>19</sup> cm<sup>-2</sup>) on optical properties and laser performance of YAlO<sub>3</sub>:Nd and Gd<sub>3</sub>Ga<sub>3</sub>O<sub>12</sub>:Nd crystals for solid state lasers of space based LIDAR systems are presented. The mechanisms of radiation defects formation and the origin of color centers are discussed.
    No preview · Conference Paper · Feb 2002
  • [Show abstract] [Hide abstract]
    ABSTRACT: Reduced-antigen, combined diphtheria, tetanus, and acellular pertactin-containing pertussis vaccine (dTpa; Boostrix) contains reduced quantities of the same toxoids/antigens found in a diphtheria, tetanus, and acellular pertussis vaccine (DTPa; Infanrix) used for the primary immunization series in children. A single dose of dTpa (Boostrix) is indicated for booster vaccination against diphtheria, tetanus, and pertussis in individuals aged >or=4 years in Europe and Canada, in individuals aged >or=10 years in Australia, and in adolescents aged 10-18 years in the US.A single booster dose of dTpa (Boostrix) was safe and highly immunogenic for all its component toxoids/antigens when administered to adults, adolescents (including those previously unvaccinated), and children aged >or=4 years in clinical trials conducted in various countries worldwide. It was also well tolerated, as was a second (repeat) dose administered to a small number of adolescents who had previously received the vaccine as a preschool booster. Vaccinees generally reported a low incidence of severe/grade 3, solicited, local and general adverse events during the 1-month postvaccination period.Current recommendations for dTpa usage vary from country to country; they include one dose only in adolescence or adulthood (e.g. Australia, Canada, France, Switzerland, and the US), one dose at preschool age and one in adolescence (Germany), and one dose in adolescence followed by regular (10-year) doses during adulthood (Austria). Available data support the use of dTpa (Boostrix) in place of the combined diphtheria, tetanus, whole-cell pertussis vaccine (DTwP) or DTPa booster dose in preschool children and/or the reduced-antigen, combined diphtheria, tetanus vaccine (Td) booster dose in adolescents, as well as in place of a regular Td booster dose in adults who have not previously received the vaccine.
    No preview · Article · Jan 2006 · BioDrugs
Show more