Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in adults aged 65 years and older - Advisory Committee on Immunization Practices (ACIP), 2012

Since 2005, the Advisory Committee on Immunization Practices (ACIP) has recommended a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine booster dose for all adolescents aged 11 through 18 years (preferred at 11 through 12 years) and for those adults aged 19 through 64 years who have not yet received a dose. In October 2010, despite the lack of an approved Tdap vaccine for adults aged 65 years and older, ACIP recommended that unvaccinated adults aged 65 years and older be vaccinated with Tdap if in close contact with an infant, and that other adults aged 65 years and older may receive Tdap. In July 2011, the Food and Drug Administration (FDA) approved expanding the age indication for Boostrix (GlaxoSmithKline Biologicals, Rixensart, Belgium) to aged 65 years and older. In February 2012, ACIP recommended Tdap for all adults aged 65 years and older. This recommendation supersedes previous Tdap recommendations regarding adults aged 65 years and older.     

Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine from the Advisory Committee on Immunization Practices, 2010

Despite sustained high coverage for childhood pertussis vaccination, pertussis remains poorly controlled in the United States. A total of 16,858 pertussis cases and 12 infant deaths were reported in 2009. Although 2005 recommendations by the Advisory Committee on Immunization Practices (ACIP) called for vaccination with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) for adolescents and adults to improve immunity against pertussis, Tdap coverage is 56% among adolescents and <6% among adults. In October 2010, ACIP recommended expanded use of Tdap. This report provides the updated recommendations, summarizes the safety and effectiveness data considered by ACIP, and provides guidance for implementing the recommendations.     

Physician attitudes and preferences about combined Tdap vaccines for adolescents

BACKGROUND: Combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) boosters for adolescents are a new strategy to prevent pertussis. We examined the current practices of pediatricians and family physicians regarding adolescent tetanus and diphtheria toxoids (Td) vaccine immunizations and providers' potential adherence to new Tdap recommendations for adolescents. METHODS: Using a brief survey instrument sent to a random sample of pediatricians and family physicians in January 2005, we assessed providers' patterns of administration of Td boosters, barriers to Td boosters, and agreement that pertussis vaccination of adolescents is warranted. Results of analyses in February 2005 were presented to the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (CDC) to inform its deliberations regarding adolescent Tdap vaccination. RESULTS: The overall response rate was 56% (57% pediatricians, 55% family physicians). Among 297 respondents (154 pediatricians, 143 family physicians) eligible for analysis because they provide care to adolescents, pediatricians (77%) were significantly more likely than family physicians (51%, p < 0.0001) to report that they routinely administer Td at preventive care visits for adolescents aged 11 to 12 years, but otherwise the specialties were similar in their Td practices. Forty-four percent of respondents cited infrequency of adolescent visits as a barrier to Td immunization. Slightly more than half the sample (57%) agreed or strongly agreed that pertussis is serious enough to warrant replacing Td with Tdap for adolescents; pediatricians (70%) were significantly more likely than family physicians (42%, p < 0.0001) to endorse this statement. CONCLUSIONS: This national survey indicates moderate willingness, stronger among pediatricians than among family physicians, to support recommendations for Tdap among adolescents. In February 2006, CDC released recommendations that adolescents aged 11 to 18 (preferred age 11 to 12) receive a single dose of Tdap in place of Td if they have not already received the latter. Near-term efforts regarding Tdap recommendations must address providers' concerns about infrequent routine visits for adolescents and convince more physicians of the importance of pertussis booster immunization during adolescence.     

Adolescent Tdap Vaccine Use Among Primary Care Physicians

PurposeIn 2006 the Advisory Committee on Immunization Practices (ACIP) recommended replacement of the adolescent tetanus and diphtheria toxoids (Td) booster with combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap). We examined the degree to which pediatricians and family practitioners have adopted this recommendation.MethodsNational mail-based survey of a random sample of 725 pediatricians and 725 family practitioners from January through March, 2007.ResultsOverall response rate was 60%. The majority of respondents indicated they routinely recommended Tdap to adolescents at the preferred age for vaccination, 11–12 years old (87%), and also for “catch up” vaccination among adolescents 13–18 years old (89%). In bivariate analyses, pediatrician specialty, specialty society membership, stocking Tdap in the office, and prior experience diagnosing adolescent pertussis were associated with routinely recommending Tdap to adolescents. In multivariable models adjusting for these factors simultaneously, only pediatrician specialty (OR = 4.8, 95% CI = 2.5–9.3) and stocking Tdap in the office (OR = 14.5, 95% CI = 7.5–28.5) remained significantly associated with routine recommendation. Pediatricians were significantly more likely than family practitioners to accept shorter time intervals for administering Tdap following Td vaccination, and to co-administer Tdap with MCV4. Lack of adolescent visits was the most commonly cited major barrier to adolescent Tdap administration.ConclusionsBased on self report, our results indicate the majority of physicians have adopted recent recommendations from the ACIP to administer Tdap to adolescents. However, specialty-based disparities in attitudes and practices persist, suggesting that ongoing efforts are needed to motivate physicians to recommend this vaccine to adolescents and to clarify how to integrate Tdap with other adolescent vaccinations.     

Use of mass Tdap vaccination to control an outbreak of pertussis in a high school--Cook County, Illinois, September 2006-January 2007

On September 6, 2006, the Cook County Department of Public Health (CCDPH) was notified that a local high school student aged 17 years had pertussis. During September 2006-January 2007, 36 pertussis cases directly linked to the high school were identified. Because Bordetella pertussis immunity from childhood vaccinations wanes over time, outbreaks of pertussis can periodically occur among students and staff at middle and high schools. School settings facilitate transmission of pertussis, disrupting school and community activities and putting vulnerable populations, such as unvaccinated infants, at risk. A pertussis booster vaccine suitable for adolescents and adults became available in the United States in 2005, when two new tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines were licensed for persons aged 10-18 years and 11-64 years, respectively. In 2006, the Advisory Committee on Immunization Practices (ACIP) recommended that all adolescents and adults receive a one-time Tdap booster vaccination. This report summarizes strategies used to control the pertussis outbreak in Cook County, Illinois, including efforts to increase Tdap vaccination coverage. Despite multiple communications recommending Tdap vaccination and implementation of a cough exclusion policy during the pertussis outbreak, student vaccination rates did not increase substantially until a school-based Tdap vaccination clinic was implemented. Because persons at risk for pertussis might not seek vaccination from their usual health-care provider, even during an outbreak, local health departments might consider early implementation of a cough exclusion policy and on-site Tdap vaccination clinic as control measures.     

Tetanus and pertussis vaccination coverage among adults aged ≥ 18 years --- United States, 1999 and 2008

In 2005, the Advisory Committee on Immunization Practices (ACIP) recommended that the newly licensed tetanus, diphtheria, and acellular pertussis (Tdap) vaccine replace a single decennial dose of tetanus diphtheria (Td) vaccine for persons aged 10-64 years. According to these recommendations, Tdap may be used to protect against pertussis even when <10 years have passed since the most recent tetanus vaccination. For adults with infant contact and health-care personnel (HCP) with direct patient contact (two groups at increased risk for transmitting pertussis to those who are most susceptible), the single recommended Tdap dose is suggested to be administered as soon as 2 years after the last tetanus vaccination. To assess changes in tetanus vaccination coverage and the use of Tdap among U.S. adults, CDC analyzed data from the National Health Interview Survey (NHIS) for 1999 and 2008. This report summarizes the results of that analysis, which indicated that self-reported tetanus vaccination coverage (vaccination within the preceding 10 years) was 60.4% in 1999 and 61.6% in 2008. Among adults aged 18-64 years, Tdap coverage was estimated to be 5.9% in 2008. Of those who reported receiving a tetanus vaccination during 2005-2008, 52.0% reported receiving Tdap. Tdap vaccination coverage among adults with infant contact was 5.0% and among HCP was 15.9%. Of those adults with infant contact and HCP who had received a tetanus vaccination during 2005-2008, 60.0% and 60.3% reported receiving Tdap, respectively. Health-care providers should recommend Tdap vaccination to adults aged 18-64 years whose most recent tetanus vaccination was ≥10 years prior; the interval for HCP and persons with infant contact can be as short as 2 years.     

National vaccination coverage among adolescents aged 13-17 years--United States, 2006

Before 2005, vaccines were administered during adolescence to "catch up" children with vaccinations not received at a younger age, with the exception of the tetanus and diphtheria (Td) booster. However, since 2005, three new vaccines specifically for older children have been licensed and recommended in the United States: meningococcal conjugate vaccine (MCV4) for those aged 11-12 years and 15 years; tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine for those aged 11-12 years (or at ages 13-18 years if not received at ages 11-12 years); and human papillomavirus (HPV) vaccine for girls aged 11-12 years (or at ages 13-18 years if not received at 11-12 years). Since 1996, the Advisory Committee on Immunization Practices (ACIP) and professional organizations, including the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), and the American Medical Association (AMA), have recommended a health-care visit at ages 11-12 years for receipt of recommended vaccinations. In addition, a Healthy People 2010 objective (14-27) is to achieve > or =90% vaccination coverage among adolescents aged 13-15 years for certain vaccines. In 2006, for the first time, the National Immunization Survey (NIS) collected provider-reported vaccination information for adolescents aged 13-17 years (NIS-Teen). This report describes the results of that survey, which indicated that the Healthy People 2010 target has not been met for any of the vaccines analyzed. HPV vaccination coverage is not included in this report because NIS-Teen was conducted before HPV vaccination recommendations were published in March 2007. Routine health-care visits for adolescents should be encouraged, with emphasis on a visit at ages 11-12 years, and providers should continue to assess the need for vaccinations at every opportunity. NIS-Teen will be conducted annually to monitor coverage with recommended vaccines during ages 11-17 years and to identify groups with lower coverage.     

Humoral immunity 10 years after booster immunization with an adolescent and adult formulation combined tetanus, diphtheria, and 5-component acellular pertussis vaccine

Persistence of antibodies after a single dose of Tdap vaccine (tetanus, diphtheria, and 5-component acellular pertussis vaccine) was evaluated in a follow-up study of adolescents (N=324) and adults (N=644) who had received Tdap in earlier clinical trials. Outcome measures were seroprotection (tetanus and diphtheria) or seropositivity (pertussis) and geometric mean concentrations. Humoral immune responses to all antigens were robust 1 month after initial immunization, decreased at subsequent measurements, but continued to exceed pre-immunization levels 1, 3, 5, and 10 years later. Protective levels of diphtheria and tetanus antitoxin persisted in 99.3% of adolescents 10 years after a booster dose of Tdap. Seropositivity to 1 or more pertussis antigens also persisted in most adolescents for 10 years. Although tetanus antitoxin responses were similar in adults to those observed in adolescents, diphtheria antitoxin titers were lower, reflecting the fact that a smaller proportion of adults had received diphtheria toxoid in the previous 10 years compared to adolescents. These data will contribute to the selection of the optimal interval for repeat doses of Tdap.     

Pertussis--United States, 2001-2003

Pertussis is a highly contagious, vaccine-preventable bacterial illness characterized by paroxysmal cough, posttussive vomiting, and inspiratory whoop. Pertussis also can occur as a mild or moderate cough illness in persons who are partially immune. In the United States, most hospitalizations and nearly all deaths from pertussis are reported in infants aged <6 months, but substantial morbidity does occur in other age groups. Infant/childhood vaccination has contributed to a reduction of more than 90% in pertussis-related morbidity and mortality since the early 1940s in the United States. Estimates of childhood vaccination coverage with > or =3 doses of pertussis-containing vaccine have exceeded 90% since 1994; however, reported pertussis cases increased from a historic low of 1,010 in 1976 to 11,647 cases in 2003. A substantial increase in reported cases has occurred among adolescents, who become susceptible to pertussis approximately 6-10 years after childhood vaccination. Recently, booster vaccines for adolescents and adults combining pertussis antigens with tetanus and diphtheria toxoids (Tdap) were approved by the Food and Drug Administration (FDA). On June 30, 2005, the Advisory Committee on Immunization Practices (ACIP) recommended Tdap for all persons aged 11-18 years. This report summarizes national surveillance data on pertussis reported to CDC during 2001-2003 and focuses on pertussis reported among persons aged 10-19 years before implementation of national recommendations for adolescent pertussis vaccination.     

Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) in pregnant women and persons who have or anticipate having close contact with an infant aged <12 months --- Advisory Committee on Immunization Practices (ACIP), 2011

Compared with older children and adults, infants aged <12 months have substantially higher rates of pertussis and the largest burden of pertussis-related deaths. Since 2004, a mean of 3,055 infant pertussis cases with more than 19 deaths has been reported each year through the National Notifiable Diseases Surveillance System (CDC, unpublished data, 2011). The majority of pertussis cases, hospitalizations, and deaths occur in infants aged ≤2 months, who are too young to be vaccinated; therefore, other strategies are required for prevention of pertussis in this age group. Since 2005, the Advisory Committee on Immunization Practices (ACIP) has recommended tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) booster vaccines to unvaccinated postpartum mothers and other family members of newborn infants to protect infants from pertussis, a strategy referred to as cocooning. Over the past 5 years, cocooning programs have proven difficult to implement widely. Cocooning programs might achieve moderate vaccination coverage among postpartum mothers but have had limited success in vaccinating fathers or other family members. On June 22, 2011, ACIP made recommendations for use of Tdap in unvaccinated pregnant women and updated recommendations on cocooning and special situations. This report summarizes data considered and conclusions made by ACIP and provides guidance for implementing its recommendations.     

Vaccination coverage among adolescents aged 13-17 years - United States, 2007

Three new vaccines have been recommended for adolescents by the Advisory Committee for Immunization Practices (ACIP) since 2005: meningococcal conjugate vaccine (MCV4; 1 dose), tetanus, diphtheria, acellular pertussis vaccine (Tdap; 1 dose), and quadrivalent human papillomavirus vaccine (HPV4; 3 doses). ACIP also recommends that adolescents should receive recommended vaccinations that were missed during childhood. Since 2006, CDC has conducted the National Immunization Survey-Teen (NIS-Teen) to estimate vaccination coverage from a national sample of adolescents aged 13-17 years. This report describes the findings from NIS-Teen 2007, which indicated substantial increases in receipt of new adolescent vaccinations compared with 2006, including Tdap (from 10.8% to 30.4%) and MCV4 (from 11.7% to 32.4%), and increases in coverage with childhood vaccinations, including measles, mumps, and rubella (MMR), hepatitis B (HepB), and varicella (VAR) (among those without disease history). An assessment of HPV4 coverage, which is reported for the first time, showed that 25.1% of adolescent females initiated the vaccine series (>/=1 dose) in 2007. To improve vaccination coverage among adolescents, health-care providers should take advantage of every health-care visit as an opportunity to evaluate vaccination status and administer vaccines when needed.     

FDA approval of expanded age indication for a tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine

On July 8, 2011, the Food and Drug Administration (FDA) approved an expanded age indication for the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) Boostrix (GlaxoSmithKline Biologicals, Rixensart, Belgium). Originally, Boostrix was licensed in 2005 for persons aged 10 through 18 years, but in 2008, FDA approved an expanded age indication for Boostrix to include persons aged 19 through 64 years. FDA has now expanded the age indication to include persons aged 65 years and older. Boostrix is now licensed for use in persons aged 10 years and older as a single-dose booster vaccination. This notice summarizes the indications for use of Boostrix. Recommendations of the Advisory Committee on Immunization Practices (ACIP) for Tdap vaccines have been published previously. Publication of revised Tdap recommendations within the next year is anticipated.     

The preteen visit: an opportunity for prevention

All early adolescents should visit a physician at age 11 or 12 years to receive a set of recommended vaccines. Two vaccines are recommended for boys in this age group-quadrivalent meningococcal conjugate vaccine (MCV4) and tetanus toxoid, reduced diphtheria, and acellular pertussis vaccine (Tdap). Three vaccines are recommended for girls--MCV4, Tdap, and human papilloma virus (HPV) vaccine. In addition, 2 doses of varicella vaccine are now recommended before age 5 years; both boys and girls at age 11 or 12 who have received only 1 dose should be given a second.     

Immunogenicity and reactogenicity of co-administered tetanus-diphtheria-acellular pertussis (Tdap) and tetravalent meningococcal conjugate (MCV4) vaccines compared to their separate administration

In the United States, co-administration of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine and tetravalent meningococcal conjugate vaccine (MCV4) is recommended in adolescents. In this clinical study, 1341 adolescents received Tdap (Boostrix® GlaxoSmithKline) and MCV4 (Menactra®, Sanofi-Pasteur) simultaneously or sequentially one month apart. Co-administration of Tdap + MCV4 was well tolerated and immunogenic, resulting in high levels of antibodies against diphtheria, tetanus, pertussis and meningococcal serogroup A,C,W-135 and Y antigens. The data provide support for current recommendations for co-administration of Tdap and MCV4 vaccines at the same office visit.     

Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix(®)): results of two randomized trials

Background

Pertussis can cause significant morbidity in elderly patients, who can also transmit this disease to infants and young children. There is little data available on the use of acellular pertussis vaccines in recipients ≥65 years of age.

Methods

Two studies examined the safety and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine (Boostrix^®) in healthy ≥65 year olds. In Study A subjects received single doses of Tdap and seasonal influenza vaccine either co-administered or given one month apart. In Study B subjects received either Tdap or tetanus-diphtheria (Td) vaccine. Antibodies were measured before and one month after vaccination. Reactogenicity and safety were actively assessed using diary cards.

Results

A total of 1104 subjects 65 years of age and older received a Tdap vaccination in the two studies. In study A, no differences in immune responses to Tdap or influenza vaccine were observed between co-administered or sequentially administered vaccines. In study B, Tdap was non-inferior to Td with respect to diphtheria and tetanus seroprotection, and anti-pertussis GMCs were non-inferior to those observed in infants following a 3-dose diphtheria, tetanus and acellular pertussis (DTaP) primary vaccination series, in whom efficacy against pertussis was demonstrated. Reports of adverse events were similar between Tdap and Td groups.

Conclusions

Tdap was found to be immunogenic in subjects ≥65 years, with a safety profile comparable to US-licensed Td vaccine. Tdap and influenza vaccine may be co-administered without compromise of either the reactogenicity or immunogenicity profiles of the two vaccines.     

Barriers to early uptake of tetanus, diphtheria and acellular pertussis vaccine (Tdap) among adults-United States, 2005-2007

Background

The tetanus, diphtheria and acellular pertussis vaccine (Tdap) was recommended by the Advisory Committee on Immunization Practices (ACIP) for U.S. adults in 2005. Our objective was to identify barriers to early uptake of Tdap among adult populations.

Methods

The 2007 National Immunization Survey (NIS)-Adult was a telephone survey sponsored by the Centers for Disease Control and Prevention (CDC). Immunization information was collected for persons aged ≥18 years on all ACIP-recommended vaccines. A weighted analysis accounted for the complex survey design and non-response.

Results

Overall, 3.6% of adults aged 18-64 years reported receipt of a Tdap vaccination. Of unvaccinated respondents, 18.8% had heard of Tdap, of which 9.4% reported that a healthcare provider had recommended it. A low perceived risk of contracting pertussis was the single most common reason for either not vaccinating with Tdap or being unwilling to do so (44.7%). Most unvaccinated respondents (81.8%) indicated a willingness to receive Tdap if it was recommended by a provider.

Conclusions

During the first two years of availability, Tdap uptake was likely inhibited by a low collective awareness of Tdap and a low perceived risk of contracting pertussis among U.S. adults, as well as a paucity of provider-to-patient vaccination recommendations. Significant potential exists for improved coverage, as many adults were receptive to vaccination.     

Economic impact of implementing decennial tetanus toxoid,reduced diphtheria toxoid and acellular pertussis (Tdap) vaccination in adults in the United States

BackgroundIn the United States, persons ≥11 years are recommended to receive one dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine, followed by decennial tetanus- and diphtheria-toxoid (Td) boosters. Many providers use Tdap instead of Td. We evaluated epidemiologic and economic impacts of replacing Td boosters with Tdap.MethodsWe used a static cohort model to examine replacing Td with Tdap over the lifetime of 4,386,854 adults ≥21 years. Because pertussis is underdiagnosed and true incidence is unknown, we varied incidence from 2.5 cases/100,000 person-years to 500 cases/100,000 person-years. We calculated vaccine and medical costs from claims data. We estimated cost per case prevented and per quality-adjusted life year (QALY) saved; sensitivity analyses were conducted on vaccine effectiveness (VE), protection duration, vaccine cost, disease duration, hospitalization rates, productivity loss and missed work. We did not include programmatic advantages resulting from use of a single tetanus-toxoid containing vaccine.ResultsAt lowest incidence estimates, administering Tdap resulted in high costs per averted case ($111,540) and QALY saved ($8,972,848). As incidence increased, cases averted increased and cost per QALY saved decreased rapidly. With incidence estimates of 250 cases/100,000 person-years, cost per averted case and QALY saved were $984 and $81,678 respectively; at 500 cases/100,000 person-years, these values were $427 and $35,474. In multivariate sensitivity analyses, assuming 250 cases/100,000 person-years, estimated cost per QALY saved ranged from $971 (most favorable) to $217,370 (least favorable).ConclusionsOur findings suggest that replacing Td with Tdap for the decennial booster would result in high cost per QALY saved based on reported cases. However, programmatic considerations were not accounted for, and if pertussis incidence, which is incompletely measured, is assumed to be higher than reported through national surveillance, substituting Tdap for Td may lead to moderate decreases in pertussis cases and cost per QALY.     

An adult formulation of a five-component acellular pertussis vaccine combined with diphtheria and tetanus toxoids is safe and immunogenic in adolescents and adults

Pertussis is increasingly being recognized as an important cause of cough illness in adolescents and adults. To evaluate the safety and immunogenicity of an adult formulation of a five-component (pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae 2 and 3) acellular pertussis vaccine combined with diphtheria and tetanus toxoids, we randomly allocated 749 healthy adolescents and adults from 12-54 years of age recruited from five Canadian communities to receive either tetanus-diphtheria vaccine (Td), acellular pertussis vaccine (aP) or combined diphtheria-tetanus-acellular pertussis vaccine (TdaP). Subjects and personnel were unaware of the vaccine allocation. Antibody levels were measured before and one month postimmunization; adverse events were collected at 24 and 72 h and 8 to 10 days. Adverse events were reported in similar frequency amongst the three vaccine groups. Moderate pain at the injection site was reported less frequently in the aP group than the TdaP group (10.7% compared to 19.4%; relative risk 0.6, 95% confidence interval 0.3-0.9). Chills were reported less frequently after Td (5.3%) than after TdaP (12.5%; relative risk 0.4, 95% confidence interval 0.2-0.9). There were no statistically significant differences between recipients of Td and TdaP in tetanus and diphtheria antitoxin levels achieved. Antibody response against Bordetella pertussis antigens was vigorous in all groups although recipients of aP alone had higher levels of antibody levels against pertussis toxoid, fimbriae, and agglutinins and lower antibody levels against pertactin than did TdaP recipients. We conclude that this adult formulation 5-component acellular pertussis vaccine is safe and immunogenic in adolescents and adults and is a candidate vaccine for adolescent and adult immunization programs.     

Immunogenicity and safety of a tetanus toxoid,reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19–64 years of age

Purpose

This study was conducted to assess the immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine containing three pertussis antigens (Boostrix^®, Tdap3v), currently licensed in the US for use in adolescents 10–18 years of age, in adults 19–64 years of age.

Methods

2284 healthy adults, aged 19–64 years, were randomized to receive a single dose of Tdap vaccine, either Tdap3v or a five-pertussis component Tdap vaccine (Adacel^®, Tdap5v) licensed for adult use in the US. Blood samples were taken before and 1 month after vaccination. Reactogenicity was assessed for 15 days after vaccination.

Results

Tdap3v was comparable to Tdap5v in eliciting seroprotective levels of antibodies to diphtheria and tetanus toxoids, with >98% of subjects having post-vaccination seroprotective antibody levels (≥0.1 IU/mL) against diphtheria or tetanus toxoids. The pertussis components of Tdap3v were shown to be immunogenic in adults, with booster responses to pertussis toxoid (PT), filamentous hemagglutinin (FHA), and pertactin (PRN) observed in 77.2%, 96.9%, and 93.2%, respectively, of Tdap3v recipients, and in 47.1%, 94.0%, and 91.7%, respectively, of Tdap5v recipients. Anti-pertussis antibody GMCs in Tdap3v recipients exceeded those observed in infants following primary DTaP vaccination, in whom efficacy against pertussis disease was subsequently demonstrated. Injection site reactions (pain, redness, and swelling) and fever ≥37.5 °C (99.5 °F) were reported significantly more often (p < 0.05) by Tdap5v recipients than by Tdap3v recipients. Fatigue preventing normal daily activities was reported by a small but significantly greater percentage of Tdap3v recipients (2.5%) than Tdap5v recipients (1.2%, p < 0.05).

Conclusion

In adult recipients, Tdap3v was comparable to an approved Tdap vaccine in providing seroprotection against diphtheria and tetanus, and produced immune responses to pertussis antigens consistent with protection against disease. The overall safety profile of Tdap3v was generally comparable to that of Tdap5v [NCT #106316].     

Assessment of Tdap Administration Rates from 2009 to 2012 at a Large Urban Nonteaching Hospital

Due to the significant rise in pertussis cases reported in 2012, these authors investigated the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine administration at our institution from 2009 to 2012 to determine if changes in prescribing practices reflected published updates from the Advisory Committee on Immunization Practices (ACIP). A single large, urban, private, non-teaching hospital. Documented Tdap vaccines administered from January 2009 through December 2012 were retrieved using an electronic data pull. The incidence of Tdap vaccine administration was reported as number of events per 1,000 patient visits. This data pull served to provide the longitudinal context to prescribing pattern changes at our facility, which were then compared to ACIP vaccination recommendation changes. Tdap administrations increased from 1,365 vaccinations in 2009 to 3,048 vaccinations in 2012. Tdap vaccine administration increased significantly each successive year from 2009 to 2012 from 23.96 ± 1.25 to 47.15 ± 1.63 vaccines per 1,000 patient visits to the facility. Confidence intervals did not overlap for consecutive years representing statistically significant differences between vaccination rates from year to year. Review of Tdap administrations demonstrates a clear and significant increase over consecutive years from 2009 to 2012. Over this time period there were no institutional initiatives aimed at increasing appropriate Tdap use at our institution. This study suggests a correlation between ACIP vaccination recommendations and provider prescribing of Tdap, although no definitive association can be made.