Clostridium tetani is a Gram-positive, rod-shaped, anaerobic bacterium of the genus Clostridium. C. tetani is found as spores in soil or as parasites in the gastrointestinal tract of animals. C. tetani produces the toxin tetanospasmin and is the causative agent of tetanus. Tetanus can be prevented by immunization with tetanal toxoid and appropriate wound care. Specific therapy includes intramuscular administration of tetanus immunoglobulin to neutralize circulating toxin before it binds to neuronal cell membranes (Brook, 2008).
4. Microbial Pathogenesis
C. tetani typically enters a host through a wound. C. tetani produces two exotoxins, tetanolysin and tetanospasmin. Eleven strains of C. tetani have been identified, which differ primarily in flagellar antigens and in its ability to produce tetanospasmin. All toxigenic strains contain a plasmid that produces identical toxins. Tetanospasmin is a neurotoxin, one of the most potent toxins known. Tetanospasmin causes the clinical manifestations of tetanus. Tetanospasmin is distributed in the blood and lymphatic system. The toxin enters the nerve axon, transports across synaptic junctions, and finally reaches the central nervous system. It is then rapidly fixed to gangliosides at the presynaptic junctions of inhibitory motor nerve endings. The tetanus toxin blocks inhibitory impulses by interfering with the release of neurotransmitters, including glycine and gamma-aminobutyric acid. The clinical manifestations of tetanus include unopposed muscle contraction and spasm (Brook, 2008).
>pdb|1A8D|A Chain A, Tetanus Toxin C Fragment
MKNLDCWVDNEEDIDVILKKSTILNLDINNDIISDISGFNSSVITYPDAQLVPGINGKAIHLVNNESSEV
IVHKAMDIEYNDMFNNFTVSFWLRVPKVSASHLEQYGTNEYSIISSMKKHSLSIGSGWSVSLKGNNLIWT
LKDSAGEVRQITFRDLPDKFNAYLANKWVFITITNDRLSSANLYINGVLMGSAEITGLGAIREDNNITLK
LDRCNNNNQYVSIDKFRIFCKALNPKEIEKLYTSYLSITFLRDFWGNPLRYDTEYYLIPVASSSKDVQLK
NITDYMYLTNAPSYTNGKLNIYYRRLYNGLKFIIKRYTPNNEIDSFVKSGDFIKLYVSYNNNEHIVGYPK
DGNAFNNLDRILRVGYNAPGIPLYKKMEAVKLRDLKTYSVQLKLYDDKNASLGLVGTHNGQIGNDPNRDI
LIASNWYFNHLKDKILGCDWYFVPTDEGWTND
Molecule Role :
Protective antigen
Molecule Role Annotation :
The fragment C of tetanus toxin was amplified from Clostridium tetani DNA by PCR. Immunization of mice with rTTC resulted in the production of antibodies that were able to protect mice against a challenge with tetanus toxin furthermore, rTTC in vivo appeared to be able to undergo retrograde axonal transport (He et al., 2000).
Description:
It is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration.(FDA: Adacel)
l. Preparation
Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate.(FDA: Adacel)
m. Immunization Route
Intramuscular injection (i.m.)
n. Storage
Adacel vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE
o . Approved Age for Licensed Use
Adacel vaccine is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis as a single dose in persons 11 through 64 years of age.
p. Contraindication
A severe allergic reaction (e.g., anaphylaxis) after a previous dose of Adacel vaccine or any other tetanus toxoid, diphtheria toxoid or pertussis containing vaccine or any other component of this vaccine is a contraindication to vaccination with Adacel vaccine. (FDA: Adacel)
q. Description
It is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration.(FDA: Adacel)
r.
Human Response
Vaccination Protocol:
The use of Adacel vaccine as a primary series, or to complete the primary series, has not been studied. Vaccination with Adacel vaccine may not protect all of vaccinated individuals (FDA: Adacel).
Immune Response:
Strong antibody response was induced after the first immunization. The antibody response after booster immunization was also strong, esp. for young age group. The Adacel-induced immune response levels after the first immunization and booster immunization were comparable to those induced by a US licensed Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (Td) vaccine manufactured by Sanofi Pasteur Inc., Swiftwater, PA (FDA: Adacel).
Side Effects:
A severe allergic reaction (e.g., anaphylaxis) after a previous dose of Adacel vaccine. Also, headache, body ache or muscle weakness, tiredness, chills, sore and swollen joints, nausea, lymph node swelling, diarrhea, vomiting, and rash may result.(FDA: Adacel)
3. Adacel-Polio
a. Product Name:
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
b. Tradename:
Adacel-Polio
c. Manufacturer:
Sanofi Pasteur SA
d. Type:
Toxoid vaccine + Subunit vaccine + Inactivated or "killed" vaccine
e. Status:
Licensed
f. Location Licensed:
Canada
g. Host Species for Licensed Use:
Human
h. Preservative:
2-phenoxyethanol
i. Allergen:
Neomycin, Polymyxin B, Streptomycin
j. Immunization Route
Intramuscular injection (i.m.)
k. Storage
Store at 2° to 8°C (35° to 46°F), do not freeze.
l . Approved Age for Licensed Use
4 years and older.
m. Description
ADACEL®-POLIO is a sterile, uniform, cloudy, white suspension of tetanus and diphtheria toxoids and acellular pertussis vaccine adsorbed separately on aluminum phosphate and combined with inactivated poliomyelitis vaccine (vero cell origin) types 1, 2 and 3, and suspended in water for injection. Acellular pertussis vaccine is composed of five purified pertussis antigens (PT, FHA, PRN and FIM). (Product Monograph: Adacel-Polio)
4. Boostrix
a. Product Name:
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Description:
BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, vaccine for intramuscular administration. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens (FDA Boostrix).
k. Preparation
Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. Toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration (FDA Boostrix).
l. Immunization Route
Intramuscular injection (i.m.)
m. Storage
Store refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze.
n . Approved Age for Licensed Use
BOOSTRIX is approved for use in individuals 10 through 64 years of age (FDA Boostrix).
o. Contraindication
A severe allergic reaction after a previous dose of any tetanus toxoid-diphtheria toxoid or pertussis antigen containing vaccine or any component of this vaccine is a contraindication to administration of BOOSTRIX (FDA Boostrix).
p. Description
BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, vaccine for intramuscular administration. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens (FDA Boostrix).
q.
Human Response
Vaccination Protocol:
BOOSTRIX is a vaccine indicated for active booster immunization against tetanus, diphtheria, and pertussis as a single dose.
Immune Response:
In Boostrix, N=1440 to 1444, pre-vaccination levels in a 95% confidence interval were 85.2, while post-vaccination levels at a 95% confidence interval were 98.2 (FDA Boostrix).
Side Effects:
: Common solicited adverse events (≥15%) in adolescents were pain, redness, and swelling at the injection site, increase in arm circumference of injected arm, headache, fatigue, and gastrointestinal symptoms (FDA Boostrix).
5. Boostrix-Polio
a. Product Name:
Combined diphtheria, tetanus, acellular pertussis (adsorbed) and inactivated poliomyelitis vaccine
b. Tradename:
Boostrix-Polio
c. Manufacturer:
GlaxoSmithKline
d. Type:
Toxoid vaccine + Subunit vaccine + Inactivated or "killed" vaccine
e. Status:
Licensed
f. Location Licensed:
Canada
g. Host Species for Licensed Use:
Human
h. Allergen:
Neomycin, Polymyxin B
i. Immunization Route
Intramuscular injection (i.m.)
j. Storage
Store at 2° to 8°C (35° to 46°F), do not freeze.
k . Approved Age for Licensed Use
4 years of age and older.
l. Description
BOOSTRIX®-POLIO (combined diphtheria, tetanus, acellular pertussis and inactivated poliomyetitis) vaccine contains diphtheria toxoid, tetanus toxoid, three purified pertussis antigens [pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (69 kDalton outer membrane protein)] adsorbed onto aluminum salts and inactivated polio virus types 1, 2 and 3. (GSK: Boostrix-Polio)
6. C. tetani DNA vaccine pcDNA3tetC encoding fragment C
Immune Response:
Anti-Fragment C serum immunoglobulin and proliferative responses in splenocytes were observed following two immunizations with pcDNA3/tetC (Anderson et al., 1997).
Efficacy:
Immunization of mice with Fragment C protein, the non-toxic C-terminal domain of tetanus toxin, protects mice against lethal challenge with tetanus toxin. Seven out of ten immunized mice were protected (Anderson et al., 1997).
7. DAPTACEL
a. Product Name:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration (FDA: DAPTACEL).
m. Storage
should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE.
n . Approved Age for Licensed Use
DAPTACEL is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five dose series in infants and children 6 weeks through 6 years of age (prior to 7th birthday) (FDA: DAPTACEL).
o. Contraindication
Severe allergic reaction (e.g. anaphylaxis) after a previous dose of any diphtheria toxoid, tetanus toxoid, or pertussis-containing vaccine, or any component of DAPTACEL, encephalopathy within 7 days of a previous pertussis-containing vaccine with no other identifiable cause and, progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized. (FDA: DAPTACEL).
p. Description
DAPTACEL is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age.
q.
Human Response
Immune Response:
One clinical study found that among a random subset of children who received the fourth dose of DAPTACEL vaccine at 15-16 months of age, 96.5% achieved diphtheria antitoxin levels of ≥1.0 IU/mL after the fourth dose. (FDA: DAPTACEL).
Side Effects:
The most common side effects reported are: injection site reactions, fussiness/irritability, inconsolable crying, and decreased activity/lethargy, and fever (FDA: DAPTACEL).
Efficacy:
A tetanus antitoxin level ≥0.1 IU/mL as measured by the ELISA used in clinical studies of DAPTACEL vaccine is considered protective (FDA: DAPTACEL).
8. Decavac
a. Product Name:
Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
Description:
It is for intramuscular injection, and is a sterile suspension of alum (aluminum potassium sulfate)-precipitated toxoids in an isotonic sodium chloride solution (FDA Decavac).
k. Preparation
Clostridium tetani cultures are grown in a peptone-based medium containing an extract of bovine muscle tissue. The toxins are produced during the growth of the cultures are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration, and adsorbed onto alum (FDA Decavac).
l. Immunization Route
Intramuscular injection (i.m.)
m. Storage
Store at 2° to 8°C (35° to 46°F). Do not freeze. Do not use vaccine after expiration date.
n . Approved Age for Licensed Use
DECAVAC vaccine is indicated for active immunization for the prevention of tetanus and diphtheria. DECAVAC vaccine is approved for use in persons 7 years of age and older (FDA Decavac).
o. Contraindication
Do not use after anaphylaxis or other serious allergic reaction following a previous dose of this vaccine, any other tetanus or diphtheria toxoid containing vaccine, or any component of this vaccine (FDA Decavac).
p. Description
It is for intramuscular injection, and is a sterile suspension of alum (aluminum potassium sulfate)-precipitated toxoids in an isotonic sodium chloride solution (FDA Decavac).
q.
Human Response
Side Effects:
Side effects include: erythema, tenderness and induration at the injection site and 2% systemic reactions consisting of headache, malaise and temperature elevations. Boosters can accentuate side effects (FDA Decavac).
Efficacy:
The results that indicated protective levels of antibody were achieved in greater than 90% of the study population after primary immunization with both components. Booster effects were achieved in 100% of the individuals with pre-existing antibody responses (FDA Decavac).
Description:
This vaccine is for intramuscular use. It is a sterile suspension of alum-precipitated (aluminum potassium sulfate) toxoid in an isotonic sodium chloride solution (FDA: dttadLB).
l. Preparation
Clostridium tetani cultures are grown in a peptone-based medium containing bovine extract. Both toxins are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration.
m. Immunization Route
Intramuscular injection (i.m.)
n. Storage
Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE.
o . Approved Age for Licensed Use
Diphtheria and Tetanus Toxoids Adsorbed (For Pediatric Use) (DT) is indicated for active immunization of children up to age 7 years against diphtheria and tetanus. Immunization should be started at 6 weeks to 2 months of age and be completed before the seventh birthday. Immunization always should be started at once if diphtheria is present in the community. This vaccine should NOT be used for immunizing persons 7 years of age and older. For persons 7 years of age and older, the recommended vaccine is Tetanus and Diphtheria Toxoids Adsorbed for Adult Use (Td) (FDA: Tetanus Toxoid Adsorbed by Sanofi Pasteur Inc).
p. Contraindication
Hypersensitivity to any component of the vaccine is a contraindication, use of related vaccine after an immediate anaphylactic reaction associated with a previous dose, and history of systemic allergic or neurologic reactions following a previous dose (FDA: dttadLB).
q. Description
This vaccine is for intramuscular use. It is a sterile suspension of alum-precipitated (aluminum potassium sulfate) toxoid in an isotonic sodium chloride solution (FDA: dttadLB).
r.
Human Response
Immune Response:
In one clinical trial, protective levels of diphtheria and tetanus antitoxins were detected in 100% of the children following two doses of the vaccine (FDA: dttadLB).
Side Effects:
Adverse reactions may be local and include redness, warmth, edema, induration, with or without tenderness, as well as urticaria, and rash. Malaise, transient fever, pain, hypotension, nausea and arthralgia may develop as well (FDA: dttadLB).
Efficacy:
A complete vaccination series substantially reduces the risk of developing diphtheria, and vaccinated persons who develop disease have milder illness. Protection lasts at least 10 years. Vaccination does not, however, eliminate carriage of C. diphtheriae in the pharynx or nose or on the skin (FDA: dttadLB).
Description:
The vaccine is an noninfectious, sterile combination of diphtheria and tetanus toxoids and 3 pertussis antigens [inactivated pertussis toxin (PT), filamentous hemagglutinin (FHA), and pertactin (69 kiloDalton outer membrane protein)] adsorbed onto aluminum hydroxide (FDA Infanrix).
l. Preparation
Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The toxin is detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration (FDA Infanrix).
m. Storage
Store INFANRIX refrigerated between 2° and 8°C (36° and 46°F). Do not freeze.
n . Approved Age for Licensed Use
INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis (whooping cough) as a 5-dose series in infants and children 6 weeks to 7 years of age (prior to seventh birthday). INFANRIX should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older (FDA Infanrix).
o. Contraindication
Hypersensitivity to any component of the vaccine is a contraindication, the vaccine should not be administered to anyone with encephalopathy, progressive neurological disorders, or an allergic reaction to a previous dose (FDA Infanrix).
p. Description
The vaccine is an noninfectious, sterile combination of diphtheria and tetanus toxoids and 3 pertussis antigens [inactivated pertussis toxin (PT), filamentous hemagglutinin (FHA), and pertactin (69 kiloDalton outer membrane protein)] adsorbed onto aluminum hydroxide (FDA Infanrix).
q.
Human Response
Immune Response:
Ninety percent of infants who received Hib simultaneously with INFANRIX achieved anti-PRP antibodies >1 mcg/mL (N = 72), and 96% to 100% of infants who received OPV simultaneously with INFANRIX showed protective neutralizing antibody to poliovirus Types 1, 2, and 3 (N = 60-61) (FDA Infanrix).
Side Effects:
Injection site reactions, irritability, drowsiness, loss of appetite, vomiting, and crying (FDA Infanrix).
44. Infanrix -IPV/Hib
a. Product Name:
Diphtheria, tetanus, pertussis (acellular component), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)
Combined diphtheria and tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis and adsorbed conjugated Haemophilus influenzae type b vaccine
Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussin toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) (FDA: KINRIX).
The diphtheria, tetanus, and pertussis components of KINRIX are the same as those in INFANRIX and PEDIARIX and the poliovirus component is the same as that in PEDIARIX (FDA: KINRIX).
Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The toxin is then detoxified with formaldehyde, concentrated by ultrafiltration, and purified by recipitation, dialysis, and sterile filtration (FDA: KINRIX).
m. Immunization Route
Intramuscular injection (i.m.)
n. Storage
Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze.
o . Approved Age for Licensed Use
A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first three doses and INFANRIX for the fourth dose (FDA: KINRIX).
p. Contraindication
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid, tetanus toxoid, pertussis or poliovirus-containing vaccine, or to any component of KINRIX, including neomycin and polymyxin B, encephalopathy within 7 days of administration of a previous pertussis-containing vaccine, and/or progressive neurologic disorders (FDA: KINRIX).
q.
Human Response
Immune Response:
After vaccination, antibody levels in clinical trials was determined to be between 85-100% for all subjects (FDA: KINRIX).
Side Effects:
The most common side effects reported are: local injection site reactions, drowsiness, fever and loss of appetite (FDA: KINRIX).
49. Pediacel
a. Product Name:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine and Haemophilus b Conjugate Vaccine (Tetanus Protein – Conjugate)
Description:
The vaccine contains diphtheria and tetanus toxoids, 3 pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin [69 kiloDalton outer membrane protein]), hepatitis B surface antigen, plus poliovirus Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett) (FDA: Pediarix).
k. Allergen:
Polymyxin B Neomycin, Latex in plunger stopper of prefilled syringe
l. Preparation
Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The toxin is then detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration (FDA: Pediarix).
m. Immunization Route
Intramuscular injection (i.m.)
n. Storage
Store PEDIARIX refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze.
o . Approved Age for Licensed Use
PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3 as a three-dose primary series in infants born of HBsAg-negative mothers, beginning as early as 6 weeks of age. PEDIARIX should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older (FDA: Pediarix).
p. Contraindication
Hypersensitivity to any component of the vaccine, including yeast, neomycin, and polymyxin B, is a contraindication. The vaccine should not be administered to anyone with a previous alergic reaction following a dose of the vaccine, or if they have encephalopathy or a progressive neurologic disorder (FDA: Pediarix).
q. Description
The vaccine contains diphtheria and tetanus toxoids, 3 pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin [69 kiloDalton outer membrane protein]), hepatitis B surface antigen, plus poliovirus Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett) (FDA: Pediarix).
r.
Human Response
Immune Response:
In response to vaccination, all patients seem to have around 90-100% antibody response.
Side Effects:
Most common side effects reported are: local injection site reactions, fever, fussiness/irritability, and loss of appetite.
Efficacy:
Following immunization, protection persists for at least 10 years.
51. Pentacel
a. Product Name:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
Description:
It consists of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP-IPV) component and an ActHIB® vaccine component. Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel vaccine is approved for use in children 6 weeks through 4 years of age (prior to fifth birthday) (FDA: Pentacel).
k. Preservative:
2 phenoxy ethanol
l. Allergen:
Polymyxin B, Neomycin
m. Preparation
Clostridium tetani is grown in modified Mueller-Miller casamino acid medium. Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate (FDA: Pentacel).
n. Immunization Route
Intramuscular injection (i.m.)
o. Storage
Store at 2° to 8°C (35° to 46°F). Do not freeze
p . Approved Age for Licensed Use
Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel vaccine is approved for use in children 6 weeks through 4 years of age (prior to fifth birthday) (FDA: Pentacel).
q. Contraindication
A severe allergic reaction (e.g., anaphylaxis) after a previous dose of Pentacel vaccine, any ingredient of this vaccine, or any other tetanus toxoid, diphtheria toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine or H influenzae type b vaccine is a contraindication. The vaccine should also not be administered to anyone with known encephalopathy or a progressive neurologic disorder (FDA: Pentacel).
r. Description
It consists of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP-IPV) component and an ActHIB® vaccine component. Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel vaccine is approved for use in children 6 weeks through 4 years of age (prior to fifth birthday) (FDA: Pentacel).
s.
Human Response
Immune Response:
There was no evidence for interference in the immune response to the fourth dose of PCV7 (percent of participants with antibody levels ≥0.15 μg/mL and ≥0.5 μg/mL and GMCs to each serotype) administered at 15 months of age concomitantly with Pentacel vaccine (N = 155) (FDA: Pentacel).
Side Effects:
Injection site reactions include: Redness, swelling, tenderness, and an increase in arm circumference. The Systemic reactions include: fever, decreased activity, inconsolable crying, and irritability (FDA: Pentacel).
52. Quadracel
a. Product Name:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
Vaccination Protocol:
Mice were inoculated with a single intraperitoneal (i.p.) dose (5 × 10^6 pfu) of either MCMV/TetC or wild type (WT) MCMV (Δm157) control (Tierney et al., 2012).
Vaccine Immune Response Type:
VO_0003057
Efficacy:
Results show that the protective levels of anti-tetanus antibodies that are durable (lasting >13 months) in mice following only a single dose. This study demonstrates the ability of a 'single-dose' CMV-based vaccine strategy to induce durable protection, and supports the potential for a tetanus vaccine based on CMV to impact the incidence of tetanus in developing countries (Tierney et al., 2012).
Vaccination Protocol:
For each mouse strain two groups were inoculated respectively with vaccine strain GP1253 (n=26) and control strain GP1252 (n=14). Mice were inoculated twice, at 3 weeks intervals, with 10^9 CFU of bacteria in a volume of 100 μl/mouse. Two groups of 16 BALB/c mice each were inoculated intranasally with vaccine strain GP1253 or control strain GP1252.
Vaccine Immune Response Type:
VO_0000287
Challenge Protocol:
Mice immunized with vaccine strain GP1253 or control strain GP1252 were challenged with 50 or 10 LD50 of TT corresponding to 100 and 20 ng/mouse. TT was diluted in sterile PBS and administered subcutaneously in a volume of 100 μl/mouse.
Efficacy:
A total of 82% of vaccinated BALB/c mice were protected from the lethal challenge with 50 LD(50) of tetanus toxin (TT) and a direct correlation between the serum TTFC-specific IgG concentration and survival time of unprotected animals was observed. Intranasal immunization of BALB/c mice was also effective in inducing TTFC-specific serum IgG and local IgA in lung washes. Furthermore, 38% of animals immunized intranasally were protected from the lethal challenge with 10 LD(50) of TT while all control animals died within 24 h.
Description:
Td ADSORBED is a sterile, cloudy, uniform suspension of tetanus and diphtheria toxoids adsorbed on aluminum phosphate asuspended in isotonic sodium chloride solution for intramuscular injection only.
j. Immunization Route
Intramuscular injection (i.m.)
k. Storage
Store at 2º to 8ºC (35º to 46ºF).
l . Approved Age for Licensed Use
7 Years and Older
m. Description
Td ADSORBED is a sterile, cloudy, uniform suspension of tetanus and diphtheria toxoids adsorbed on aluminum phosphate asuspended in isotonic sodium chloride solution for intramuscular injection only.
56. Td Polio Adsorbed
a. Product Name:
Tetanus and Diphtheria Toxoids Adsorbed and Inactivated Poliomyelitis Vaccine
Td POLIO ADSORBED [Tetanus and Diphtheria Toxoids Adsorbed and Inactivated Poliomyelitis Vaccine] produced by Sanofi Pasteur Limited, is a sterile, cloudy, white, uniform suspension of tetanus and diphtheria toxoids adsorbed on aluminum phosphate and suspended in phosphate buffered saline solution and combined with Inactivated Poliomyelitis Vaccine for intramuscular injection only. Products: Proteins + killed virus. Other components: Bovine albumin Formaldehyde, Polysorbate 80.
57. TENIVAC
a. Product Name:
Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
Description:
TENIVAC is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older (FDA: Tenivac).
j. Preparation
Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. (FDA: Tenivac)
k. Immunization Route
Intramuscular injection (i.m.)
l. Storage
TENIVAC vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE.
m . Approved Age for Licensed Use
TENIVAC is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older (FDA: Tenivac).
n. Contraindication
Severe allergic reaction (e.g., anaphylaxis) to a previous dose of TENIVAC, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine.(FDA: Tenivac)
o. Description
Is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older(FDA: Tenivac)
p.
Human Response
Immune Response:
Among adults 65 years of age and over who received TENIVAC vaccine (N = 419), 94.5% (95% 273 confidence interval 91.9, 96.5) had a post-vaccination diphtheria antitoxoid level 275 ≥0.1 IU/mL (FDA: Tenivac).
Side Effects:
The most frequent solicited injection site reaction within 0-3 days following TENIVAC was pain, reported in 78.3% of study participants 11-59 years of age and 35.3% of participants ≥60 years of age. Contraindicatons include pain, redness, swelling, and systemic adverse effects(FDA: Tenivac)
58. Tetanus and Diphtheria Toxoids Adsorbed
a. Product Name:
Tetanus and Diphtheria Toxoids, Adsorbed
b. Tradename:
None
c. Manufacturer:
MassBiologics
d. Type:
Toxoid vaccine
e. Status:
Licensed
f. Location Licensed:
USA
g. Host Species for Licensed Use:
Human
h. Immunization Route
Intramuscular injection (i.m.)
i. Storage
Store at 2°C - 8°C (36°F - 46°F), do not freeze.
j . Approved Age for Licensed Use
7 years of age and older.
k. Description
Tetanus and Diphtheria Toxoids Adsorbed (Td) manufactured by MassBiologics is a sterile vaccine for intramuscular injection. After shaking, the vaccine appears as a homogeneous milky white suspension. Each 0.5 ml dose of MassBiologics’ Td is formulated to contain the following active ingredients: 2 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. Each 0.5 ml dose also contains aluminum adjuvant (not more than 0.53 mg aluminum by assay), < 100 mcg (0.02%) of residual formaldehyde, and a trace amount of thimerosal [mercury derivative, (< 0.3 mcg mercury/dose)] (not as a preservative) from the manufacturing process. (FDA: Tetanus and Diptheria Toxoids Adsorbed)
C. tetani culture is grown in a peptone-based medium containing an extract of bovine muscle tissue and detoxified with formaldehyde. The detoxified material is purified by serial ammonium sulfate fractionation and diafiltration, followed by sterile filtration. The toxoid is adsorbed to aluminum potassium sulfate (alum). The adsorbed toxoid is diluted with physiological saline solution (0.85%) (FDA: Tetanus Toxoid Adsorbed by Sanofi Pasteur Inc).
k. Immunization Route
Intramuscular injection (i.m.)
l. Storage
Store between 2° – 8°C (35° – 46°F). DO NOT FREEZE.
Tetanus Toxoid Adsorbed manufactured by Aventis Pasteur Inc., for intramuscular injection, is a sterile suspension of alum-precipitated (aluminum potassium sulfate) toxoid in an isotonic sodium chloride solution (FDA: Tetanus Toxoid Adsorbed).
o.
Human Response
Side Effects:
Side effects of vaccination are: injection site reactions, fever, and nausea.
Each dose contains the preservative thimerosal [(mercury derivative), 25 μg mercury/dose] (FDA: Tetanus Toxoid).
i. Allergen:
The stopper of the vial contains dry natural latex rubber, that may cause allergic reactions (FDA: Tetanus Toxoid).
j. Storage
Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE.
k . Approved Age for Licensed Use
Tetanus Toxoid is indicated for booster injection only for persons 7 years of age or older against tetanus.
l. Description
Tetanus Toxoid is interchangeable with Tetanus Toxoid Adsorbed (contains aluminum adjuvant) as a booster, and would only be preferred if aluminum was to be avoided. Although the rate of seroconversion is essentially equivalent with either form, adsorbed toxoids induce more persistent antitoxin titers.2 Tetanus Toxoid would be preferred over diphtheria-containing vaccines if there was a contraindication to the diphtheria component (FDA: Tetanus Toxoid).
Vaccination Protocol:
Mice were injected with TT preparation subcutaneously and boosted 30 days later (Gupta and Siber, 1994).
Immune Response:
Mice immunized with stearyl tyrosine TT had lower IgG responses than in mice immunized with TT adsorbed to aluminum phosphate (Gupta and Siber, 1994).
64. Tripacel
a. Product Name:
Pertussis Vaccine-Acellular, Combined with Diphtheria and Tetanus Toxoids (Adsorbed)
Description:
Tripedia vaccine combines diptheria and tetanus toxoids with purified pertussis antigens. It consists of 3 doses administered at intervals of 4-8 weeks(FDA: Tripedia)
k. Preparation
Clostridium tetani cultures are grown in a peptone-based medium containing a bovine extract. It is then detoxified with formaldehyde and seperately purified by serial ammonium sulfate fractionation and diafiltration.(FDA: Tripedia)
l. Immunization Route
Intramuscular injection (i.m.)
m. Storage
Store between 2 and 8 degrees Celsius. DO NOT FREEZE.
n . Approved Age for Licensed Use
Tripedia vaccine is indicated for active immunization against diphtheria, tetanus, and pertussis simultaneously in infants and children 6 weeks to 7 years of age (prior to seventh birthday). Due to substantial risks of complications of the disease, completion of a primary series of pertussis vaccine early in life is strongly recommended (FDA: Tripedia).
o. Contraindication
This vaccine should not be administered to anyone with a known hypersensitivity to any component of the vaccine.
p. Description
Tripedia vaccine combines diptheria and tetanus toxoids with purified pertussis antigens. It consists of 3 doses administered at intervals of 4-8 weeks(FDA: Tripedia)
q.
Human Response
Immune Response:
Overall seroconversion rates in chuldren who received ActHIB reconstituted with Tripedia vaccine were 98%, 98%, and 96% for measles, mumps, and rubella, respectively.(FDA: Tripedia)
Side Effects:
Side effects of vaccination include: injection site reactions, fevver, irritability, drowsiness, and vomiting. In some cases with infant immunization, anorexia and an unusual hig-pitched cry were reported(FDA: Tripedia)
Efficacy:
Complete immunization significantly reduces the risk of developing diptheria and protection is said to last around 10 years.(FDA: Tripedia)
V. References
1. Anderson et al., 1997: Anderson R, Gao XM, Papakonstantinopoulou A, Fairweather N, Roberts M, Dougan G. Immunization of mice with DNA encoding fragment C of tetanus toxin. Vaccine. 1997; 15(8); 827-829. [PubMed: 9234525].
2. Brook, 2008: Brook I. Current concepts in the management of Clostridium tetani infection. Expert review of anti-infective therapy. 2008; 6(3); 327-336. [PubMed: 18588497].
22. Gupta and Siber, 1994: Gupta RK, Siber GR. Comparison of adjuvant activities of aluminium phosphate, calcium phosphate and stearyl tyrosine for tetanus toxoid. Biologicals : journal of the International Association of Biological Standardization. 1994; 22(1); 53-63. [PubMed: 8068314].
23. He et al., 2000: He HJ, He ZY, Shi HJ, Zhu W, Yang GZ, Yuan QS, Wu XF. Cloning and Expression of Tetanus Toxin Fragment C in E.coli. Sheng wu hua xue yu sheng wu wu li xue bao Acta biochimica et biophysica Sinica. 2000; 32(4); 322-326. [PubMed: 12075415].
24. Medaglini et al., 2001: Medaglini D, Ciabattini A, Spinosa MR, Maggi T, Marcotte H, Oggioni MR, Pozzi G. Immunization with recombinant Streptococcus gordonii expressing tetanus toxin fragment C confers protection from lethal challenge in mice. Vaccine. 2001; 19(15-16); 1931-1939. [PubMed: 11228363].
