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Human Vaccines & Immunotherapeutics Dec 2023The ongoing COVID-19 pandemic highlights that complications and mortality associated with infectious diseases increase with age. Various vaccines are recommended for... (Review)
Review
The ongoing COVID-19 pandemic highlights that complications and mortality associated with infectious diseases increase with age. Various vaccines are recommended for adults, but coverage rates remain suboptimal. Although co-administration would improve vaccine uptake and timely immunization, this is not routine practice in adults. We review key data on co-administration of vaccines in children and adults to reassure healthcare providers about its safety and advantages. In European countries and the United States, combined tetanus, diphtheria, and acellular pertussis boosters as well as meningococcal and human papillomavirus vaccines are recommended for healthy adolescents and adults of certain ages. Vaccination against influenza (annually), pneumococcal disease, and herpes zoster is recommended for older adults and specific risk groups. While co-administration is well established in children, it is less common in adults. Travelers can also receive multiple co-administered vaccines. Pediatric and travel vaccine co-administration has a well-established positive benefit-risk profile and is an efficient and cost-saving strategy to improve coverage. Healthcare providers could more often recommend and practice vaccine co-administration; this would not risk patient safety and health, would improve protection against vaccine-preventable diseases, and would help comply with national vaccination calendars. Recommending bodies may consider revising vaccination schedules to reduce the number of visits.
Topics: Adolescent; Humans; Child; United States; Aged; Vaccination Coverage; Pandemics; COVID-19; Vaccination; Tetanus Toxoid; Diphtheria-Tetanus-acellular Pertussis Vaccines
PubMed: 37039318
DOI: 10.1080/21645515.2023.2195786 -
JAMA May 2014Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine could prevent infant pertussis. (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine could prevent infant pertussis.
OBJECTIVE
To evaluate the safety and immunogenicity of Tdap immunization during pregnancy and its effect on infant responses to diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine.
DESIGN, SETTING, AND PARTICIPANTS
Phase 1-2, randomized, double-blind, placebo-controlled, clinical trial conducted from 2008 to 2012. Forty-eight pregnant women aged 18 to 45 years received Tdap (n = 33) or placebo (n = 15) at 30 to 32 weeks' gestation, with crossover immunization postpartum.
INTERVENTIONS
Tdap vaccination at 30 to 32 weeks' gestation or postpartum.
MAIN OUTCOMES AND MEASURES
Primary outcomes were maternal and infant adverse events, pertussis illness, and infant growth and development until age 13 months. Secondary outcomes were antibody concentrations in pregnant women before and 4 weeks after Tdap immunization or placebo, at delivery and 2 months' postpartum, and in infants at birth, at 2 months, and after the third and fourth doses of DTaP.
RESULTS
No Tdap-associated serious adverse events occurred in women or infants. Injection site reactions after Tdap immunization were reported in 26 (78.8% [95% CI, 61.1%-91.0%]) and 12 (80% [95% CI, 51.9%-95.7%]) pregnant and postpartum women, respectively (P > .99). Systemic symptoms were reported in 12 (36.4% [ 95% CI, 20.4%-54.9%]) and 11 (73.3% [95% CI, 44.9%-92.2%]) pregnant and postpartum women, respectively (P = .03). Growth and development were similar in both infant groups. No cases of pertussis occurred. Significantly higher concentrations of pertussis antibodies were measured at delivery in women who received Tdap during pregnancy vs postpartum (eg, pertussis toxin antibodies: 51.0 EU/mL [95% CI, 37.1-70.1] and 9.1 EU/mL [95% CI, 4.6-17.8], respectively; P < .001) and in their infants at birth (68.8 EU/mL [95% CI, 52.1-90.8] and 14.0 EU/mL [95% CI, 7.3-26.9], respectively; P < .001) and at age 2 months (20.6 EU/mL [95% CI, 14.4-29.6] and 5.3 EU/mL [95% CI, 3.0-9.4], respectively; P < .001). Antibody responses in infants born to women receiving Tdap during pregnancy were not different following the fourth dose of DTaP.
CONCLUSIONS AND RELEVANCE
This preliminary assessment did not find an increased risk of adverse events among women who received Tdap vaccine during pregnancy or their infants. For secondary outcomes, maternal immunization with Tdap resulted in high concentrations of pertussis antibodies in infants during the first 2 months of life and did not substantially alter infant responses to DTaP. Further research is needed to provide definitive evidence of the safety and efficacy of Tdap immunization during pregnancy.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00707148.
Topics: Adolescent; Adult; Antibody Formation; Child Development; Diphtheria-Tetanus-Pertussis Vaccine; Diphtheria-Tetanus-acellular Pertussis Vaccines; Double-Blind Method; Female; Humans; Immunization; Infant; Infant, Newborn; Postpartum Period; Pregnancy; Pregnancy Trimester, Third; Whooping Cough; Young Adult
PubMed: 24794369
DOI: 10.1001/jama.2014.3633 -
Archives of Razi Institute Jun 2023Validation is a Good Manufacturing Practice principle that proves any procedure, process, method, equipment, material, activity, or system actually leads to the expected...
Validation is a Good Manufacturing Practice principle that proves any procedure, process, method, equipment, material, activity, or system actually leads to the expected results. This study validates the method for the determination of free formaldehyde in biological products (including the diphtheria-tetanus vaccine and tetanus toxoid antigen). The operating procedure of this method is based on pharmacopoeial monographs. It also does not require full validation, although its suitability under the actual condition of use should be verified. Performance characterizations, such as accuracy, intra-precision (repeatability), intermediate precision (inter-precision), linearity, range, and the limit of quantitation, were investigated and calculated. Accuracy and precision were studied at different concentration levels by spiking known amounts of formaldehyde in real samples. The accuracy and precision results were expressed as the recovery and the relative standard deviation (RSD), respectively. Precision was expressed as intra-precision (repeatability) and inter-precision. Intra-precision or repeatability was performed by one operator in one day by adding three levels of concentration to the products. The inter-precision was conducted by one operator in three individual days within the same laboratory at three concentration levels. Range and linearity were assessed by investigating the correlation coefficient of the regression line between different concentrations of formaldehyde and their response. The acceptance criteria and limits were defined for these validation parameters in these biological products. The RSD for intra-day and inter-day precision studies was less than 5% in a medium concentration of linear range. At this concentration level, accuracy was 90%-110%. The method's linearity ranged between 0.0000039%-0.01% w/v of formaldehyde with a correlation coefficient of 0.9999. The results exhibited sufficient linearity, accuracy, precision, and range. Therefore, this method can be used successfully to determine free formaldehyde for biological products.
Topics: Animals; Diphtheria-Tetanus Vaccine; Tetanus Toxoid; Formaldehyde
PubMed: 38028856
DOI: 10.22092/ARI.2023.358602.2484 -
Journal of Korean Medical Science Jan 2019
Topics: Diphtheria Toxoid; Humans; Tetanus; Vaccines
PubMed: 30686954
DOI: 10.3346/jkms.2019.34.e33 -
Vaccine Mar 2023Ongoing tetanus cases and sporadic outbreaks of vaccine-preventable diseases associated with routine vaccination programmes remain problems in many low and middle-income...
BACKGROUND
Ongoing tetanus cases and sporadic outbreaks of vaccine-preventable diseases associated with routine vaccination programmes remain problems in many low and middle-income countries, including Vietnam. With no human-to-human transmission or natural immunity, tetanus antibody levels indicate both individual risk of tetanus and gaps in vaccination programmes.
METHODS
To investigate gaps in immunity to tetanus in Vietnam, a country with a historically high level of tetanus vaccination coverage, tetanus antibodies were measure by ELISA from samples selected from a long-term serum bank, established for the purposes of general-population seroepidemiological investigations in southern Vietnam. Samples were selected from 10 provinces, focussing on age-groups targeted by national vaccination programmes for infants and pregnant women (Expanded Programme on Immunization, EPI, and Maternal and Neonatal Tetanus, MNT).
RESULTS
Antibodies were measured from a total of 3864 samples. Highest tetanus antibody concentrations occurred in children under 4 years old, over 90 % of whom had protective levels. Approximately 70 % of children aged 7-12 years had protective antibody concentrations although there was variation among provinces. For infants and children, there were no significant differences in tetanus protection between males and females, but for adults aged 20-35 years, in five of the ten provinces surveyed, protection against tetanus was higher in females (p < 0.05) who are eligible for booster doses under the MNT programme. In seven of ten provinces, antibody concentrations were inversely related to age (p < 0.01) and protection of older individuals was generally low.
CONCLUSION
Widespread immunity to tetanus toxoid is seen in infants and young children consistent with the high coverage rates reported for diptheria tetanus toxoid and pertussis (DTP) in Vietnam. However, the lower antibody concentrations seen in older children and men suggest reduced immunity to tetanus in populations not targeted by EPI and MNT programmes.
Topics: Male; Infant; Child; Adult; Infant, Newborn; Humans; Female; Pregnancy; Child, Preschool; Tetanus; Vietnam; Tetanus Toxoid; Vaccination; Antibodies, Bacterial; Diphtheria-Tetanus-Pertussis Vaccine
PubMed: 36849339
DOI: 10.1016/j.vaccine.2023.02.036 -
IET Nanobiotechnology Jul 2022This paper aims to investigate the preparation and characterisation of the alginate nanoparticles (NPs) as antigen delivery system loaded by diphtheria toxoid (DT). For...
This paper aims to investigate the preparation and characterisation of the alginate nanoparticles (NPs) as antigen delivery system loaded by diphtheria toxoid (DT). For this purpose, both the loading capacity (LC) and Loading efficiency (LE) of the alginate NPs burdened by DT are evaluated. Moreover, the effects of different concentrations of sodium alginate and calcium chloride on the NPs physicochemical characteristics are surveyed in addition to other physical conditions such as homogenization time and rate. To do so, the NPs are characterised using particle size and distribution, zeta potential, scanning electron microscopy, encapsulation efficiency, in vitro release study and FT-IR spectroscopy. Subsequently, the effects of homogenization time and rate on the NPs are assessed. At the meantime, the NPs LC and efficiency in several DT concentrations are estimated. The average size of the NPs was 400.7 and 276.6 nm for unloaded and DT loaded, respectively. According to the obtained results, the zeta potential of the blank and DT loaded NPs are estimated as -23.7 mV and -21.2 mV, respectively. Whereas, the LC and LE were >80% and >90%, in that order. Furthermore, 95% of the releasing DT loaded NPs occurs at 140 h in the sustained mode without any bursting release. It can be concluded that the features of NPs such as morphology and particle size are strongly depended on the calcium chloride, sodium alginate concentrations and physicochemical conditions in the NPs formation process. In addition, appropriate concentrations of the sodium alginate and calcium ions would lead to obtaining the desirable NPs formation associated with the advantageous LE, LC (over 80%) and sustained in vitro release profile. Ultimately, the proposed NPs can be employed in vaccine formulation for the targeted delivery, controlled and slow antigen release associated with the improved antigen stability.
Topics: Alginates; Calcium Chloride; Diphtheria Toxoid; Drug Carriers; Nanoparticles; Particle Size; Spectroscopy, Fourier Transform Infrared
PubMed: 35610737
DOI: 10.1049/nbt2.12088 -
Drugs Feb 2023Agents in development for the prevention or treatment of Clostridioides difficile infection can be split into three broad categories: antibiotics, microbiome... (Review)
Review
Agents in development for the prevention or treatment of Clostridioides difficile infection can be split into three broad categories: antibiotics, microbiome restoration, and vaccines. Given the extensive list of agents currently in development, this narrative review will focus on agents that have progressed into late-stage clinical trials, defined as having a Phase III clinical trial registered on ClinicalTrials.gov. These agents include one antibiotic (ridinilazole), three live biotherapeutic products (LBPs) (CP101, RBX2660, and SER109), and two toxoid vaccines (PF06425090 and a second toxoid vaccine). As new prevention and treatment strategies enter the market, clinicians and administrators will need knowledge of these products to make rational decisions on how best to adopt them into clinical practice.
Topics: Humans; Anti-Bacterial Agents; Clostridium Infections; Toxoids
PubMed: 36645620
DOI: 10.1007/s40265-022-01832-x -
ALTEX 2015Tetanus neurotoxin (TeNT) consists of two protein chains connected by a disulfide linkage: The heavy chain mediates the toxin binding and uptake by neurons, whereas the... (Review)
Review
Tetanus neurotoxin (TeNT) consists of two protein chains connected by a disulfide linkage: The heavy chain mediates the toxin binding and uptake by neurons, whereas the light chain cleaves synaptobrevin and thus blocks neurotransmitter release.Chemically inactivated TeNT (tetanus toxoid) is utilized for the production of tetanus vaccines. For safety reasons, each toxoid bulk has to be tested for the "absence of toxin and irreversibility of toxoid". To date, these mandatory tests are performed as toxicity tests in guinea pigs. A replacement by an animal-free method for the detection of TeNT would be desirable. The BINACLE (BINding And CLEavage) assay takes into account the receptor-binding as well as the proteolytic characteristics of TeNT: The toxin is bound to immobilized receptor molecules, the light chains are then released by reduction and transferred to a microplate containing synaptobrevin, and the fragment resulting from TeNT-induced cleavage is finally detected. This assay offers a higher specificity for discriminating between toxic TeNT and inactivated toxoid molecules than other published assays. Validation studies have shown that the BINACLE assay allows the sensitive and robust detection of TeNT in toxoids, and thus may indeed represent a suitable alternative to the prescribed animal safety tests for toxoids from several European vaccine manufacturers. Product-specific validations (and possibly adaptations) of the assay protocol will be required. A European collaborative study is currently being initiated to further examine the applicability of the method for toxoid testing. The final aim is the inclusion of the method into the European Pharmacopoeia.
Topics: Animal Testing Alternatives; Animals; Biological Assay; Guinea Pigs; In Vitro Techniques; Metalloendopeptidases; R-SNARE Proteins; Reproducibility of Results; Tetanus Toxin; Tetanus Toxoid; Toxicity Tests
PubMed: 25769344
DOI: 10.14573/altex.1412181 -
Canadian Family Physician Medecin de... May 2011One of my patients is studying to become a dental hygienist. Owing to the program requirements, she received several vaccinations last week, including...
QUESTION
One of my patients is studying to become a dental hygienist. Owing to the program requirements, she received several vaccinations last week, including measles-mumps-rubella, varicella, and hepatitis B (HB) vaccines, as well as a tetanus booster. However, today a blood test confirmed that she is currently 6 weeks pregnant. What is known about the safety of these vaccines during pregnancy, and are there any general recommendations for vaccines for women who are planning to become pregnant or who are currently pregnant?
ANSWER
The combination measles-mumps-rubella vaccine and the varicella vaccine are live attenuated vaccines, and are contraindicated during pregnancy owing to theoretical concerns. However, there is no evidence that there are increased risks of malformations, congenital rubella syndrome, or varicella syndrome attributable to these vaccines. The HB and tetanus vaccines are composed of noninfectious particles or toxoids, and theoretically should cause no increased risk to the developing fetus. In addition, limited observational data also support no increased risk of any adverse pregnancy outcomes; consequently, administration of the HB and tetanus vaccines might be, if indicated, considered during pregnancy.
Topics: Chickenpox Vaccine; Contraindications; Female; Hepatitis B Vaccines; Humans; Measles-Mumps-Rubella Vaccine; Pregnancy; Tetanus Toxoid; Vaccination; Vaccines, Attenuated; Vaccines, Inactivated
PubMed: 21571717
DOI: No ID Found -
Expert Review of Vaccines 2023This study assessed safety and immunogenicity of Serum Institute of India Pvt Ltd (SIIPL)'s tetanus toxoid (TT), diphtheria toxoid (DT), and acellular pertussis booster... (Randomized Controlled Trial)
Randomized Controlled Trial
Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India.
BACKGROUND
This study assessed safety and immunogenicity of Serum Institute of India Pvt Ltd (SIIPL)'s tetanus toxoid (TT), diphtheria toxoid (DT), and acellular pertussis booster vaccine (Tdap).
RESEARCH DESIGN AND METHODS
In this Phase II/III, multicenter, randomized, active-controlled, open-label study, 1500 healthy individuals, aged 4-65 years, were randomized to receive a single dose of SIIPL Tdap or comparator Tdap vaccine (Boostrix®; GlaxoSmithKlines, India). Adverse events (AEs) during initial 30 minutes, 7-day, 30-day post-vaccination were assessed. Blood samples were taken before and 30 days post-vaccination for immunogenicity assessment.
RESULTS
No significant differences in incidence of local and systemic solicited AEs were observed between the two groups; no vaccine-related serious AEs were reported. SIIPL Tdap was non-inferior to comparator Tdap in achieving booster responses to TT and DT in 75.2% and 70.8% of the participants, respectively, and to pertussis toxoid (PT), pertactin (PRN), and filamentous hemagglutinin (FHA) in 94.3%, 92.6%, and 95.0% of the participants, respectively. Anti-PT, anti-PRN, and anti-FHA antibody geometric mean titers in both the groups, were significantly higher post-vaccination compared to pre-vaccination.
CONCLUSIONS
Booster vaccination with SIIPL Tdap was non-inferior to comparator Tdap with respect to immunogenicity against tetanus, diphtheria, and pertussis and was well tolerated.
Topics: Adult; Humans; Adolescent; Child; Tetanus Toxoid; Diphtheria-Tetanus-acellular Pertussis Vaccines; Whooping Cough; Tetanus; Diphtheria Toxoid; Pertussis Vaccine; Toxoids; Immunization, Secondary; Diphtheria; Antibodies, Bacterial
PubMed: 36883291
DOI: 10.1080/14760584.2023.2188942