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"Diphtheria"
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The bravest dog ever : the true story of Balto
Recounts the life of Balto, the sled dog who braved a snowstorm to deliver medicine to Nome, Alaska, during a 1925 diphtheria epidemic.
Book
Safety and immunogenicity of SIIPL Tdap, a new tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, in healthy subjects 4–65 years of age: A Phase II/III randomized, observer-blinded, active controlled, multicenter clinical study in Germany
•To avoid a global pertussis resurgence, booster Tdap immunization is recommended.•Global shortages of acellular pertussis vaccines have been reported.•Safety and immunogenicity of SIIPL Tdap was compared to an approved Tdap vaccine.•SIIPL Tdap immune responses were non-inferior to comparator Tdap vaccine.•SIIPL Tdap was safe and well tolerated.
This study assessed the safety and immunogenicity of a new booster vaccine against tetanus, diphtheria, and pertussis manufactured by Serum Institute of India Pvt. Ltd (SIIPL Tdap).
The Phase II/III trial was randomized (2:1), observer blinded and active controlled. Healthy subjects aged 4–65 years received a single dose of either SIIPL Tdap or comparator Tdap vaccine (Boostrix®, GlaxoSmithKline, Belgium), and were followed-up for 30 days. Blood samples for safety and immunogenicity assessments were collected pre-vaccination and on day 30 post-vaccination. The study assessed safety and reactogenicity of SIIPL Tdap compared to the comparator Tdap as well as the co-primary immunogenicity outcomes: (i) seroprotection rates against diphtheria toxoid (DT) and tetanus toxoid (TT) and (ii) the booster response rates against pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) 30 days post-vaccination in all study subjects. A margin of −10 % was used for non-inferiority testing. Secondary outcomes included the booster response rates against DT and TT, seropositivity rates against pertussis antigens, and antibody geometric mean concentrations (GMCs) for all vaccine components.
At Day 30 post-vaccination, SIIPL Tdap was assessed as non-inferior to the comparator Tdap in terms of: i) seroprotection rates against DT (94.4 % vs. 94.9 %) and TT (99.9 % vs. 100 %) and ii) pertussis booster response rates (93.8 % vs. 88.4 % anti-PT, 89.7 % vs. 90.9 % anti-FHA and 86.3 % vs. 84.4 % anti-PRN), for SIIPL Tdap versus comparator Tdap, respectively. GMCs for anti-PT and anti-PRN were higher in subjects vaccinated with SIIPL Tdap compared to comparator Tdap. All other secondary outcomes were comparable. The overall frequency of local and systemic solicited AEs was comparable; no treatment related SAEs were reported.
Booster vaccination with SIIPL Tdap was non-inferior to comparator Tdap with respect to the immunogenicity of the vaccine components and was equally well tolerated.
EudraCT number: 2019-002706-46.
Journal Article
Balto and the race against time
\"When a pack of senior dogs find themselves transported back in time--and turned into puppies!--they must make their way back home, helping real-life historical dogs along the way\"-- Provided by publisher.
Book
Phase 1 trial of an investigational Tdap booster vaccine with CpG 1018 adjuvant compared with Boostrix in healthy adults and adolescents
This phase 1 trial assessed the safety and immunogenicity of an investigational tetanus/diphtheria/acellular pertussis vaccine combined with CpG 1018 adjuvant 1500 μg (Tdap-1018 1500 μg) or 3000 μg (Tdap-1018 3000 μg) in adults and adolescents. In this randomized, active-controlled, multicenter, dose-escalation trial, healthy participants aged 10 to 22 years received 1 dose of Tdap-1018 1500 μg, Tdap-1018 3000 μg, or Boostrix. Geometric mean concentrations (GMCs) and booster response rates (BRRs) for antibodies against pertussis (pertussis toxin, filamentous hemagglutinin, pertactin), tetanus, and diphtheria antigens, and neutralizing antibodies against pertussis toxin were assessed 4 weeks after vaccination. Safety and tolerability were assessed for solicited post-injection reactions within 7 days after vaccination and unsolicited adverse events up to 12 weeks after vaccination. Of 117 enrolled participants, 80 adults (92%) and 30 adolescents (100%) completed the study. Both Tdap-1018 formulations were generally well tolerated, with no vaccine-related serious adverse events. Frequency and severity in post-injection reactions after Tdap-1018 administration were similar to Boostrix except for higher proportions of moderate pain for Tdap-1018. In adults at week 4, ratio of GMCs and BRRs for all antigens in the 3000-μg group were similar to or higher than Boostrix, with significantly higher GMC ratios for anti-pertussis toxin (2.1 [1.5–3.0]) and anti-tetanus (1.8 [1.1–2.9]) and significantly higher BRRs for anti-pertussis toxin (difference [95% CI]: 34.5% [13.4–54.6]), anti-pertactin (19.2% [4.4–38.1]), and anti-tetanus (30.0% [3.6–52.7]) antibodies. For adolescents, in the 3000-μg group, ratio of GMCs and BRRs were similar to or higher than Boostrix for all antigens. Both Tdap-1018 formulations showed acceptable safety and tolerability profiles. Tdap-1018 3000 μg induced similar or higher immune responses than Boostrix.
ACTRN12620001177943 (Australian New Zealand Clinical Trials Registry; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=ACTRN12620001177943p).
•Tdap-1018 was generally well tolerated in adults and adolescents.•Tdap-1018 3000 μg induced similar or higher immune responses than Boostrix.•The results support continued development of a Tdap booster adjuvanted with CpG 1018.
Journal Article
Immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP–IPV) compared to separate administration of standalone DTaP and IPV vaccines: A randomized, controlled study in infants in the Republic of Korea
This randomized trial enrolled 442 infants in the Republic of Korea to assess the immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP–IPV; Tetraxim™) for primary vaccination at 2, 4 and 6 months of age compared with DTaP and IPV vaccines given separately. Immunogenicity was high in both groups; seroprotection and seroconversion rates of the combined vaccine (Group A) were non-inferior to the control vaccines (Group B). All subjects were seroprotected against poliovirus types 1, 2 and 3 (≥81/dil) and anti-diphtheria (≥0.01IU/mL); 99.0% were seroprotected against tetanus (≥0.1IU/mL). At least 93.6% had anti-diphtheria antibody titers ≥0.1IU/mL. Anti-pertussis toxoid (PT) and anti-filamentous haemagglutinin (FHA) seroconversion (≥4-fold increase in antibody titer) rates were 96.6% and 94.4% for Group A, 92.2% and 78.4% for Group B. Most solicited reactions occurred within 4 days of vaccination, resolved within 3 days and were mild. Severe solicited reactions occurred after ≤0.5% of doses in Group A and ≤0.9% in Group B. No withdrawals occurred because of adverse events. The DTaP–IPV combined vaccine given at 2, 4, and 6 months of age was well tolerated; immunogenicity was similar to the control vaccines.
Journal Article
The incredible life of Balto
\"Most people know the story of Balto, the world famous dog who led his dogsled team through a blizzard to deliver a lifesaving serum to the stricken people of Nome, Alaska, in 1925. Balto shot to instant stardom--a company named dog food after him, a famous sculptor erected a statue of him that stands in Central Park to this day, and the dog even starred in his own Hollywood movie. But what happened to Balto after the hoopla died down? With a lively, informative text and humorous, vibrant illustrations, Meghan McCarthy captures the extraordinary life of Balto beyond his days as a celebrity.\"--Amazon.com.
Book
A Randomized Controlled Trial of the Safety and Immunogenicity of Tetanus, Diphtheria, and Acellular Pertussis Vaccine Immunization During Pregnancy and Subsequent Infant Immune Response
In this randomized controlled trial, infants of women immunized with tetanus-diphtheria-acellular pertussis vs tetanus-diphtheria vaccine during pregnancy had higher antibody levels at birth that persisted until 2-4 months of age but lower antibody levels after the primary series at 7 months and booster dose at 12 months.
Abstract
Background
Immunization of pregnant women with tetanus-diphtheria-acellular pertussis vaccine (Tdap) provides protection against pertussis to the newborn infant.
Methods
In a randomized, controlled, observer-blind, multicenter clinical trial, we measured the safety and immunogenicity of Tdap during pregnancy and the effect on the infant's immune response to primary vaccination at 2, 4, and 6 months and booster vaccination at 12 months of age. A total of 273 women received either Tdap or tetanus-diphtheria (Td) vaccine in the third trimester and provided information for the safety analysis and samples for the immunogenicity analyses; 261 infants provided serum for the immunogenicity analyses.
Results
Rates of adverse events were similar in both groups. Infants of Tdap recipients had cord blood levels that were 21% higher than maternal levels for pertussis toxoid (PT), 13% higher for filamentous hemagglutinin (FHA), 4% higher for pertactin (PRN), and 7% higher for fimbriae (FIM). These infants had significantly higher PT antibody levels at birth and at 2 months and significantly higher FHA, PRN, and FIM antibodies at birth and 2 and 4 months, but significantly lower PT and FHA antibody levels at 6 and 7 months and significantly lower PRN and FIM antibody levels at 7 months than infants whose mothers received Td. Differences persisted prebooster at 12 months for all antigens and postbooster 1 month later for PT, FHA, and FIM.
Conclusions
This study demonstrated that Tdap during pregnancy results in higher levels of antibodies early in infancy but lower levels after the primary vaccine series.
Clinical Trials Registration
NCT00553228.
Journal Article
Balto and the great race
Recounts how the sled dog Balto saved Nome, Alaska, in 1925 from a diphtheria epidemic by delivering medicine through a raging snowstorm.
Book
Preliminarily evaluation the safety and immunogenicity of tetanus, reduced diphtheria and acellular pertussis (five components) combined vaccine, adsorbed (Tdcp) in participants aged 6 years and above: a blinded and randomised, and controlled phase I clinical trial
Pertussis remains a significant global public health challenge, particularly in China, where no licensed pertussis-containing vaccines are available for individuals aged 6 years and older. This blind, randomised, and controlled phase I clinical trial evaluated the safety and immunogenicity of the Tetanus, Reduced Diphtheria, and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp). Participants aged 6 years and above were divided into three age subgroups (6–11, 12–17, and ≥18 years) and randomised to receive Tdcp or control vaccines (PPV23 or DT). Safety endpoints included the incidence of adverse reactions within 30 days post-vaccination, while immunogenicity was assessed through seroconversion rates and geometric mean concentrations (GMCs) of anti-DT, TT, PT, FHA, PRN, and FIM 2&3 antibodies at 30 days post-vaccination. Among 178 participants, the incidence of total adverse reactions in the Tdcp group was 54.62%, primarily local reactions such as pain and itching, with no significant differences compared to controls (p > 0.05). Immunogenicity analysis revealed robust immune responses in the Tdcp groups, with seroconversion rates for pertussis-related antigens exceeding 75% in all age groups. The GMCs for anti-PT antibodies reached 125.60 IU/mL, 150.28 IU/mL, and 131.14 IU/mL in the ≥18 years, 12–17 years, and 6–11 years of Tdcp groups, respectively. Overall, the Tdcp vaccine demonstrated a good safety profile and robust immunogenicity in participants aged 6 years and above. The inclusion of five pertussis antigens, particularly PT, elicited strong immune responses, supporting its potential as an effective booster vaccine for adolescents and adults.
Journal Article