Immunogenicity and Safety after Booster Vaccination of Diphtheria, Tetanus, and Acellular Pertussis in Young Adults: an Open Randomized Controlled Trial in Japan

Abstract

The recent increase of pertussis in young adults in Japan is hypothesized to be due in part to waning protection from the acellular pertussis vaccine. While a booster immunization may prevent an epidemic of pertussis among these young adults, little is known about the safety and immunogenicity of such a booster with the diphtheria, tetanus, and acellular pertussis vaccine (DTaP), which is currently available in Japan. One hundred and eleven medical students with a mean age of 19.4 years were randomly divided into 2 groups of 55 and 56 subjects and received, respectively, 0.2 or 0.5 ml of DTaP. Immunogenicity was assessed by performing the immunoassay using serum, and the geometric mean concentration (GMC), GMC ratio (GMCR), seropositive rate, and booster response rate were calculated. Adverse reactions and adverse events were monitored for 7 days after vaccination. After booster vaccination in the two groups, significant increases were found in the antibodies against pertussis toxin, filamentous hemagglutinin, diphtheria toxoid, and tetanus toxoid, and the booster response rates for all subjects reached 100%. The GMCs and GMCRs against all antigens were significantly higher in the 0.5-ml group than in the 0.2-ml group. No serious adverse events were observed. Frequencies of local reactions were similar in the 2 groups, although the frequency of severe local swelling was significantly higher in the 0.5-ml group. These data support the acceptability of booster immunization using both 0.2 and 0.5 ml of DTaP for young adults for controlling pertussis. (This study was registered at UMIN-CTR under registration number UMIN000010672.)

Safety of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccine in Adults in Japan

“…In our study, although the frequency of local AEs with the DTaP vaccine was higher than that with other vaccines, no serious AEs were observed, and the vaccine was well tolerated. that the immune response induced by the increased antigen dose is also generally high (8,9), booster vaccination with DTaP might be a reasonable strategy for adolescents and adults instead of Tdap vaccination, which demonstrates issues regarding the duration of efficacy (17).…”

“…Vaccine in Adults in Japan the antigen could be a novel strategy to achieve high immunogenicity (8,9). However, there is limited information on the safety profile of a booster dose of DTaP vaccine in adults (8)(9)(10).…”

“…Vaccine in Adults in Japan the antigen could be a novel strategy to achieve high immunogenicity (8,9). However, there is limited information on the safety profile of a booster dose of DTaP vaccine in adults (8)(9)(10). Therefore, in this study, we investigated the safety of booster immunization with the DTaP vaccine in adults and adolescents and the reporting rate of adverse events (AEs), including serious AEs, after immunization.…”

Pertussis-Specific Memory B-Cell and Humoral IgG Responses in Adolescents after a Fifth Consecutive Dose of Acellular Pertussis Vaccine

“…This has led to the evaluation of an adolescent booster in many countries (19)(20)(21)(22)(23). In Sweden, a school-leaving booster at 14 to 16 years of age will be introduced in 2016.…”

Pertussis outbreak in university students and evaluation of acellular pertussis vaccine effectiveness in Japan

“…Other reasons may include a higher rate of completed vaccine courses: in our study population, the vaccination coverage, or the percentage of the study population that had received 4 vaccine doses, was 94%. Differences in vaccine components [ 24 , 25 ] and vaccination methods (subcutaneous injection in Japan vs. intramuscular injection in the US) may also have contributed to differences in reported results.…”