Immunogenicity, Safety, and Antibody Persistence at 3, 5, and 10 Years Postvaccination in Adolescents Randomized to Booster Immunization with a Combined Tetanus, Diphtheria, 5-Component Acellular Pertussis, and Inactivated Poliomyelitis Vaccine Administered with a Hepatitis B Virus Vaccine Concurrently or 1 Month Apart

Abstract

An understanding of the antibody persistence elicited by a combined tetanus, diphtheria, 5-component acellular pertussis, and inactivated poliovirus vaccine (Tdap-IPV) after adolescent vaccination is important to optimize booster dosing intervals. Our objectives were to compare the safety and immunogenicity of Tdap-IPV coadministered with hepatitis B vaccine (HepB) and sequential administration and evaluate humoral immunity at 3, 5, and 10 years after Tdap-IPV vaccination in adolescents. This phase II randomized, controlled, and open-label study enrolled 280 11-to 14-year-old adolescents with up to 10 years postvaccination follow-up. Group 1 (n ‫؍‬ 145) received Tdap-IPV, followed by a HepB dose 1 month later, and group 2 (n ‫؍‬ 135) received both vaccines simultaneously. No consistent increases in solicited reactions or unsolicited adverse events occurred with coadministration. All vaccinees attained seroprotective antibody levels at >0.01 IU/ml for diphtheria and tetanus, at a >1:8 dilution for poliovirus (serotypes 1, 2, and 3), and >10 mIU/ml for hepatitis B at 1 month postvaccination. Clinically relevant immunologic interactions did not occur with coadministration. For pertussis, all participants achieved seropositivity levels (at or above the lower limit of quantitation), and 72.7% to 95.8% had 4-fold increases in pertussis antibodies at 1 month postvaccination. At 10 years postvaccination, the remaining participants (62.8% of the original cohort) maintained seroprotective levels of >0.01 IU/ml for diphtheria and tetanus, a >1:8 dilution for all 3 poliovirus serotypes, and 74.1% to 98.2% maintained pertussis seropositivity levels depending on the antigen tested. There were no differences between the groups. These results support the coadministration of Tdap-IPV and HepB to adolescents and suggest that vaccination with Tdap-IPV can offer protection for 10 years after an adolescent booster vaccination. Despite widespread childhood immunization with pertussis vaccines, the recurrence of pertussis has been reported among adolescents and young adults, with periodic outbreaks in several countries, suggesting early waning of immunity (1-8). In these outbreaks, high rates of pertussis infection were observed among infants age Ͻ1 year, and the incidence in adolescents age 10 to 14 years also increased.In addition to pertussis morbidity in infected adolescents and adults, these patients constitute a major source of transmission to infants, especially those Ͻ6 months of age, who are at highest risk for serious disease and death (3, 9). Thus, pertussis immunization of adults and adolescents is recommended for both personal protection and to reduce exposure in vulnerable infants (10, 11). The current recommendations for adolescent vaccination in some European countries and most Canadian provinces include combined tetanus, diphtheria, and acellular pertussis (Tdap) and hepatitis B (HepB) vaccines (12). In Canada, the incidence of reported pertussis decreased in all age groups after the National Advisory Committee on Imm...

Does vaccination ensure protection? Assessing diphtheria and tetanus antibody levels in a population of healthy children

“…After the booster injection, all patients developed a protective antibody titer, which persisted for the following 10 years. In a Canadian study by Embree et al, [5] protective concentrations of antibodies against diphtheria and tetanus were found in 82% and 99% of 11-year-olds (5 years following their last tetanus–diphtheria vaccination), respectively. One month following a booster injection, these percentages reached 100% and remained at that level for 10 years.…”

“…The boosters are necessary, as antibody levels decrease as time from the last dose increases. [5] The decrease in vaccine-induced antibody levels with age is a significant issue, as women tend to give birth later in their lives. A newborn's tetanus antibody level is essentially the same as the mother's.…”

Safety of human papillomavirus vaccines in healthy young women: a meta-analysis of 24 controlled studies

“…We defined these symptoms as follows [18–20]: Solicited local symptoms were defined as pain, redness and/or swelling at the injection site observed within 15 days after vaccination. Solicited systemic symptoms were defined as arthralgia, fatigue, fever, gastrointestinal symptoms, headache, rash, urticaria, and/or myalgia observed within 15 days after vaccination.…”

Immune persistence after pertussis vaccination

“…64,65 According to these studies conducted during the follow-up of 1-10 y after a Tdap vaccination, the majority of subjects were still seropositive for one or more pertussisspecific antibodies, of which the concentration remained higher than pre-vaccination levels. [64][65][66][67][68][69] Therefore, it has been suggested that 10 y could be an optimal interval for Tdap vaccine booster doses to reduce the reservoir of pertussis, which could help protect young infants. 64,68,69 A second Tdap booster has been found highly immunogenic and well tolerated in adults who have received one Tdap dose 10 y previously.…”

“…[64][65][66][67][68][69] Therefore, it has been suggested that 10 y could be an optimal interval for Tdap vaccine booster doses to reduce the reservoir of pertussis, which could help protect young infants. 64,68,69 A second Tdap booster has been found highly immunogenic and well tolerated in adults who have received one Tdap dose 10 y previously. 70,71 Field evaluations conducted shortly after the introduction of the Tdap vaccine among adolescents revealed 66% to 78% effectiveness.…”