The safety of immunizing with tetanus-diphtheria-acellular pertussis vaccine (Tdap) less than 2 years following previous tetanus vaccination: Experience during a mass vaccination campaign of healthcare personnel during a respiratory illness outbreak

Dartmouth Medical School, Hanover, NH, USA.
Vaccine (Impact Factor: 3.62). 09/2010; 28(50):8001-7. DOI: 10.1016/j.vaccine.2010.09.034
Source: PubMed


Tdap is recommended for health care personnel (HCP) aged <65 years who received tetanus diphtheria or tetanus toxoid immunization (Td/TT) ≥2 years earlier. During a medical center Tdap vaccination campaign, we assessed the safety of use of a Td/TT to Tdap interval <2 years in HCP. We also describe reactogenicity in HCP who were aged ≥65 years or pregnant.
HCP vaccinated with Tdap were surveyed to assess time since last Td/TT (≥2 years vs. <2 years), age, pregnancy status, and injection site adverse events (AEs) during the 2 weeks after Tdap. AE rates were calculated and compared by non-inferiority analysis using a predetermined margin of 10%. We searched clinic logbooks to assess for clinically important adverse events during the 2 months after Tdap.
Of the 4524 vaccinated HCP, 2221 (49.1%) completed a safety survey which met criteria for analysis. Non-inferiority analysis found that rates of moderate and/or severe injection site AEs were not significantly greater in those vaccinated <2 years than in those vaccinated ≥2 years after previous Td/TT. Three serious adverse events were reported during the 2 months after vaccination, none in persons who were ≥65 years, pregnant or received Td/TT <2 years before.
Our findings add to the body of evidence that a short interval between Td/TT and a single dose of Tdap is safe.

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    • "However, two recently published reports do not support this hypothesis. Even within an interval of only 1 month, adverse reactions did not occur to a higher frequency in individuals recently pre-vaccinated compared with controls [58, 59]. Thus, pertussis vaccination is recommended in athletes because the likelihood of acquiring a severe, long-lasting infection that interferes with training and competition is relevant, and the vaccine-associated side effects seem tolerable. "
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    ABSTRACT: Public health vaccination guidelines cannot be easily transferred to elite athletes. An enhanced benefit from preventing even mild diseases is obvious but stronger interference from otherwise minor side effects has to be considered as well. Thus, special vaccination guidelines for adult elite athletes are required. In most of them, protection should be strived for against tetanus, diphtheria, pertussis, influenza, hepatitis A, hepatitis B, measles, mumps and varicella. When living or traveling to endemic areas, the athletes should be immune against tick-borne encephalitis, yellow fever, Japanese encephalitis, poliomyelitis, typhoid fever, and meningococcal disease. Vaccination against pneumococci and Haemophilus influenzae type b is only relevant in athletes with certain underlying disorders. Rubella and papillomavirus vaccination might be considered after an individual risk-benefit analysis. Other vaccinations such as cholera, rabies, herpes zoster, and Bacille Calmette-Guérin (BCG) cannot be universally recommended for athletes at present. Only for a very few diseases, a determination of antibody titers is reasonable to avoid unnecessary vaccinations or to control efficacy of an individual's vaccination (especially for measles, mumps, rubella, varicella, hepatitis B and, partly, hepatitis A). Vaccinations should be scheduled in a way that possible side effects are least likely to occur in periods of competition. Typically, vaccinations are well tolerated by elite athletes, and resulting antibody titers are not different from the general population. Side effects might be reduced by an optimal selection of vaccines and an appropriate technique of administration. Very few discipline-specific considerations apply to an athlete's vaccination schedule mainly from the competition and training pattern as well as from the typical geographical distribution of competitive sites.
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    • "For all of these issues, definitive data were lacking. Because prelicensure studies of Tdap vaccine had excluded pregnant women, available information on the safety of Tdap during pregnancy was limited to unpublished data from the Vaccine Adverse Event Reporting System and pharmaceutical company-sponsored pregnancy registries along with a few small published studies (Talbot et al., 2010; CDC, 2011b; Gall et al., 2011). However, the ACIP found the available data on safety to be reassuring. "
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    • "Antibody decay rates [5,27–31] and mathematical modeling [32] [33] suggest that repeat doses of Tdap will be required to maintain protection against pertussis. Tdap has been found to be safe and immunogenic at intervals as short as 1 month–3 years following a prior diphtheria-or tetanus-containing vaccine [34] [35] [36] [37] [38]. The purpose of this study was to compare the safety and immunogenicity of a second dose of Tdap 10 years after a first Tdap compared to a first dose of Tdap in adults. "
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    ABSTRACT: Although decennial adult boosters of tetanus and diphtheria toxoids are recommended in Canada and the United States, a second dose of pertussis vaccine during adulthood is not currently recommended. This open-label, multicenter study compared the safety and immunogenicity of a first dose of an adult formulation of tetanus, diphtheria, and acelluar pertussis vaccine (Tdap) with a repeat dose of Tdap in adults who had received Tdap 10 years previously. A total of 769 participants ranging in age from 20 to 72 years took part in this study; 92.3% of naïve and 92.7% of repeat-dose participants had at least one solicited adverse event. Injection-site pain (84.4% and 87.8%), erythema (29.7% and 23.1%), and swelling (23.3% and 20.5%), and myalgia (53.5% and 60.1%), headache (37.6% and 40.6%), malaise (29.0% and 29.4%), and fever (4.9% and 4.2%) were the most common solicited adverse events reported in the naïve and repeat-dose groups, respectively. Postvaccination antibody levels ≥0.1 IU/mL were achieved by 99.7% of the naïve-group participants and all of the repeat-dose participants for tetanus and 96.1% of the naïve group and 98.5% of the repeat-dose group for diphtheria, both meeting the predefined noninferiority criteria. For pertussis antibodies, anti-PT (89.2 EU/mL vs. 116 EU/mL) was higher in the repeat-dose group, anti-FHA (249 vs. 214) and anti-PRN (216 vs. 266) were similar, and anti-FIM (1015 vs. 779) was higher in the naïve group. Noninferiority criteria were met for all antigens except for anti-FIM. A repeat dose of Tdap vaccine 10 years after the first dose was well tolerated and immunogenic in adults ( identifier: NCT00712959).
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