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Poultry Vaccine Veterinary Products

Ranikhet Disease Vaccine, Live Lentogenic ‘LaSota’ Strain I.P. SUPER LaSotaTM

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Super LaSotaTM Vaccine is the latest contribution of Bio-Med to the bandbagon of currently existing Ranikhet disease vaccines. Its uniqueness lies in its characteristics of being highly immunogenic although being stress free. Hence it shall protect (broiler / layer) chicks (young chicks or birds in lay) against the potential attack of very-very virulent Ranikhet disease virus.
Super LaSotaTM has been developed in DSIR (Govt. of India) certified lab of Bio-Med by extensive research using CLONING & SELECTION procedure. Super LaSota’s I.C.P Index is 0.0125 & C.E.P Index is 115.5 hours. It causes insignificant pathogenic changes in the lung & airsacs of young chicks. The chicks vaccinated with this vaccine, resisted challenge by infectious Ranikhet disease virus(90% Survival in comparision with about 10% conferred with regular Lasota/F/B-1 Strain vaccines in a trial). All these characteristics makes Super LaSotaTM a distinct clone of R.D. virus.

[/vc_column_text][/vc_column][vc_column width=”1/3″ el_class=”block2″][vc_single_image image=”3571″ img_size=”medium” alignment=”center” el_class=”img”][/vc_column][/vc_row][vc_row el_class=”product-box” css=”.vc_custom_1512432424869{padding-top: 35px !important;}”][vc_column width=”1/3″ el_class=”block3″][vc_row_inner css=”.vc_custom_1512431727138{margin-top: 0px !important;margin-bottom: 0px !important;}”][vc_column_inner][vc_single_image image=”3346″ img_size=”24×24″ el_class=”img”][vc_column_text]PRESENTATION :

This vaccine is available in Freeze Dried from in 1000 and 5000 dose pack, Each dose of vaccine contains ≥ 106 EID50 per dose.

[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][vc_column width=”1/3″ el_class=”block4″][vc_row_inner el_class=”product-border”][vc_column_inner][vc_single_image image=”3353″ img_size=”24×24″ el_class=”img”][vc_column_text]RECOMMENDATION :

Vaccinate Chicks (Boiler/Layer) at 1-7 days, Repeat at 20-28 days. For Layers, it can be given in drinking water to birds.

[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][vc_column width=”1/3″ el_class=”block5″][vc_row_inner css=”.vc_custom_1512429922882{margin-top: 0px !important;margin-bottom: 0px !important;}”][vc_column_inner][vc_single_image image=”3346″ img_size=”24×24″ el_class=”img”][vc_column_text]METHOD OF ADMINISTRATION :

The vaccine is to be reconstituted in normal saline(0.9% Sodium Chloride Solution). Use 40 ml and 200 ml diluent for reconstitution of 1000 dose and 5000 dose vial respectively.
Administer ‘one’ drop by dropper in the mouth of each chick. Alternatively, the recontituted vaccine can be given in drinking water also. Allow birds to be thirsty for 1/2 hour to one hour depending on climate. Remove drinking & clean them. Use fresh water only. Do not use medicated or water with chlorine or any disinfectant. Add vaccine, proportionately in drinkers with enough water that should be consumed within one or two hours. Dry milk powder can be added (100gm per 20 litre) to drinking water for stabilizing vaccine.

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The vaccine must be stored in refrigerator(20 -80C) until its use.

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Poultry Vaccine Veterinary Products

Ranikhet Disease Vaccine, Live, Lentogenic ‘F’ strain, I.P. :

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Live, Attenuated, Freeze Dried

DESCRIPTION :

Ranikhet disease ‘F’ Strain is a lentogenic Strain. It is least stress causing vaccine virus strain in this class. It can be used at any age including birds in lay without any effect on laying as booster vaccine. The vaccine contains live attenuated Ranikhet disease ‘F’ strain virus propagated in SPF chicken eggs and is available in freeze dried form. The vaccine contains ≥ 106 EID50 virus per dose.

[/vc_column_text][/vc_column][vc_column width=”1/3″ el_class=”block2″][vc_single_image image=”3568″ img_size=”full” alignment=”center” el_class=”img”][/vc_column][/vc_row][vc_row el_class=”product-box” css=”.vc_custom_1512432424869{padding-top: 35px !important;}”][vc_column width=”1/3″ el_class=”block3″][vc_row_inner css=”.vc_custom_1512431727138{margin-top: 0px !important;margin-bottom: 0px !important;}”][vc_column_inner][vc_single_image image=”3346″ img_size=”24×24″ el_class=”img”][vc_column_text]VACCINATION SCHEDULE :

Primary :
. 1-7 days old chicks.
. This vaccine can be given in cold drinking water for mass vaccination to provide booster immunity.

[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][vc_column width=”1/3″ el_class=”block4″][vc_row_inner el_class=”product-border”][vc_column_inner][vc_single_image image=”3353″ img_size=”24×24″ el_class=”img”][vc_column_text]ADMINISTRATION :

Reconstitute 100 doses in 4 ml, 200 doses in 8 ml, 500 doses in 20 ml, 1000 doses in 40 ml, and 2000 doses in 80 ml using ice cooled vaccine diluents.
(a) Oral or I/ Nasal, I/Ocular method. Vaccinate chicks by putting one drop in the month of the chick or by one drop in eye or in one nose.
(b) By drinking water methods- The reconstituted vaccine is mixed in cold drinking water. Use enough water (for 1000 chicks use one litre water stabilized with 2 gm dry baby milk powder per day of age) which the chicks can drink in 1 to 2 hours.

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100, 200, 500, 1000 and 2000 dose vials.

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Store the vaccine at 20– 80C. Cool the diluent in ice one hour before start of vaccination. Always keep the reconstituted vaccine on ice during vaccination and use it within 2 hours.

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Poultry Vaccine Veterinary Products

RANIKHET DISEASE VACCINE, LIVE, LENTOGENIC LASOTA STRAIN, I.P.

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Attenuated, freeze dried

DESCRIPTION :

Ranikhet disease LaSota Strain is a Lentogenic strain. It is slightly more invassive than ‘F’ Strain. It is quite safe to 1-7 days old tender chicks including layers. It confers quite good immunity lasting for about 6 weeks.
The vaccine contains ≥ 106 EID50 units of Ranikhet disease LaSota Strain virus per dose propogated in SPF eggs.

[/vc_column_text][/vc_column][vc_column width=”1/3″ el_class=”block2″][vc_single_image image=”3565″ img_size=”full” alignment=”center” el_class=”img”][/vc_column][/vc_row][vc_row el_class=”product-box” css=”.vc_custom_1512432424869{padding-top: 35px !important;}”][vc_column width=”1/3″ el_class=”block3″][vc_row_inner css=”.vc_custom_1512431727138{margin-top: 0px !important;margin-bottom: 0px !important;}”][vc_column_inner][vc_single_image image=”3346″ img_size=”24×24″ el_class=”img”][vc_column_text]VACCINATION SCHEDULE :

Primary : Chicks should be vaccinated at 1-3 weeks age.
Booster : As per advice of doctor.

[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][vc_column width=”1/3″ el_class=”block4″][vc_row_inner el_class=”product-border”][vc_column_inner][vc_single_image image=”3353″ img_size=”24×24″ el_class=”img”][vc_column_text]ADMINISTRATION :

Reconstitute 200 doses in 8 ml, 500 doses in 20 ml, 1000 doses in 40 ml, 2000 doses in 80 ml and 5000 doses in 200 ml diluent. Give 1 drop orally or in nostril or in eye or by drinking water method ( as in case of F strain ).

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200, 500, 1000, 2000 and 5000 dose vials.

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Store the vaccine at 20– 80C. Cool the diluent in ice one hour before start of vaccination. Always keep the reconstituted vaccine on ice during vaccination and use it within 2 hours.

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Poultry Vaccine

Ranikhet Disease Vaccine, Live, Mesogenic ‘RB’strain, I.P.

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Attenuated, freeze dried
“The world’s only stress free Mesogenic strain vaccine- Bio-Med’s pride.”

DESCRIPTION :

Ranikhet Diesease ‘RB’ strain vaccine has been developed with intensive research efforts of Biomed Laboratories. This ‘RB’ strain vaccine has been proved not to cause any stress, lameness and mortality, which was usual feature of R2B strain vaccine available until recently. This vaccine can be given to layers without significant drop in egg production. Broiler can be vaccinated at 3-4 week’s age.

The vaccine contains live, attenuated Ranikhet disease ‘RB’ strain virus propogated in SPF chicken eggs, in freeze dried form. The vaccine contains ≥ 105EID50 virus per dose.

It has been shown to confer solid immunity in vaccinated chicks for 9 months under normal conditions. It has been use to control Ranikhet disease outbreak within 48 hours when given simultaneously with ‘F’ strain vaccine.

[/vc_column_text][/vc_column][vc_column width=”1/3″ el_class=”block2″][vc_single_image image=”3548″ img_size=”full” alignment=”center” el_class=”img”][/vc_column][/vc_row][vc_row el_class=”product-box” css=”.vc_custom_1512432424869{padding-top: 35px !important;}”][vc_column width=”1/3″ el_class=”block3″][vc_row_inner css=”.vc_custom_1512431727138{margin-top: 0px !important;margin-bottom: 0px !important;}”][vc_column_inner][vc_single_image image=”3346″ img_size=”24×24″ el_class=”img”][vc_column_text]VACCINATION SCHEDULE :

Primary: Ranikhet Disease Vaccine, Live, F or LaSota strain at age of 5-7 days. Booster : Ranikhet Disease ‘RB’ strain Vaccine (Live) 5-8 weeks and 16-20 weeks. In laying birds on advice of veterinary doctor.

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Inject 0.5 ml per bird by Intramuscular injection into thigh region of chicks.

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100, 1000 dose vials.

[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row el_class=”product-box” css=”.vc_custom_1512432458076{padding-top: 35px !important;}”][vc_column width=”1/3″ el_class=”block6″][vc_row_inner css=”.vc_custom_1512429922882{margin-top: 0px !important;margin-bottom: 0px !important;}”][vc_column_inner][vc_single_image image=”3353″ img_size=”24×24″][vc_column_text]FEATURES :

  • Safe for birds below 5 weeks of age.
  • No stress, lameness and mortality after vaccination.
  • Recommended for use during outbreak as booster.
  • Vaccination by ‘RB’ vaccine is recommended to control outbreak in combination with Ranikhet disease ‘F’ Strain vaccine to be given orally.

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Store the vaccine at 20– 80C. Cool the diluent in ice one hour before start of vaccination. Always keep the reconstituted vaccine on ice during vaccination and use it within 2 hours.

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REFERENCES

[vc_row css=”.vc_custom_1512547607962{margin-bottom: 0px !important;}”][vc_column width=”1/4″][vc_single_image image=”3505″ img_size=”full”][/vc_column][vc_column width=”3/4″][vc_column_text]Christie, A. B. et al. (1974),Infectious Diseases: Epidemiology and Clinical Practice,2nd Ed. Churchill Livingstone.

Crump J. A. et al. The global burden of typhoid fever. Bulletin of the World Health Organisation (2004),82: 346-353.

Felix A. and Pitt R.M. Virulence and immunogenic activities of B.Typhosus in relation to its antigenic constituents. J. Hyg. (1935), 35: 428-436.

Gupta, A .Swarnkar ,N.K. et al. Changing antibiotic sensitivity in enteric fever J. Tropical Pediadtr.(2001), 147:369-398.

Hoffman, S. et  al. Bone marrow aspirate culture superior to streptokinase clot culture and 8 ml 1:10 blood- to- broth ratio blood culture for diagnosis of Typhoid fever .Am J.Trop. Med. Hyg(1986), 35: 836-839

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Kossaczka, Z. et al. Synthesis and immunological properties of Vi and Di-O-Acetyl Pectin protein conjugates with adipic acid dihydrazide as the linker. Infect immunity (1997),65:2088-2093.

Kossaczka, Z. et al. Safety and immunogenicity  of Vi conjugate vaccine for Typhoid fever in adults, teenagers and 2 to 4 years old children in Vietnam. Infect Immunity (1999), 67:5806-5810.

Lin F. Y. et al. The efficacy of a Salmonella typhi Vi conjugate vaccine in 2 to 5 year old children.  Engl J.Med,(2001) 344: 1263-1269.

Lanh, M. N., et al. Persistent efficacy of Vi conjugate vaccine against typhoid fever in young children. N .Engl. J.Med. (2003) 349 :1390-1391.

Robbins J.D.,Robbins J.B. Reexamination of the protective role of the capsular polysaccharide (Vi antigen)of Salmonella typhi. The journal of infectious Diseases(1984),150 :436-449.

Saha ,M. R. et al. A note on incidence of Typhoid fever in diverse age groups in Kolkata, India. Jpn. J . infect. Dis.(2003),56: 121-122.

Saha, S. K., Baqui, A. H. et al. Typhoid fever in Bangladesh: Implications for vaccination policy. Pediatr. Infect. Dis. J. (2001),20: 521-524.

Sen, S. K. and Mahakur, A. C. Enteric fever in children aged less than 5 years. Lancet (1999),354:734-737.

Sinha et al. Costs of illness due to typhoid fever in an Indian Urban slum community: Implications for vaccination policy. J. Hlth. popul. Nutr. (2004), 22 : 304- 310.

Szu, S. C.,Stone, A. L. et al. Vi capsular polysaccharide-protein conjugates for prevention of typhoid fever. J. Exp. Med. (1987) 166:1510-1524.

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CONTENTS
  1. Typhiod Fever -Introduction
  2. Epidemiology
  3. Clinical picture of typhoid fever
  4. Recent advances in understanding of Typhoid fever in infants
    1. Reports on a typical clinical picture of Typhoid in infants.
    2. Reports of typhoid fever in infants & children.
  5. Typhoid vaccines
    1.  Vi Polysaccharide typhoid vaccine
    2.  Vi Conjugate typhoid vaccine (Peda Typh™)
  6. Clinical trials
    1. Introduction
    2. Methods and materials
    3. Selection of volunteers
    4. Evaluation of safety
    5. Immunological response
  7. Prescribing information of Peda Typh™
  8. References

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PRESCRIBING INFORMATION-Peda Typh TM ( Vi Conjugate typhoid vaccine )

[vc_row css=”.vc_custom_1512431460697{margin-bottom: 0px !important;}”][vc_column width=”2/3″ el_class=”block1″][vc_column_text]DESCRIPTION & INDICATION:

A clear to slightly turbid solution containing purified Vi capsular polysaccharide of Salmonella typhi (Strain Ty2) conjugated with Tetanus toxoid protein for prevention of typhoid fever. The manufacturing facilities meets the requirements as per cGMP guidelines of revised schedule ‘M’ from the Drugs & Cosmetic Act, Government of India.

[/vc_column_text][/vc_column][vc_column width=”1/3″ el_class=”block2″][/vc_column][/vc_row][vc_row el_class=”product-box” css=”.vc_custom_1512432424869{padding-top: 35px !important;}”][vc_column width=”1/3″ el_class=”block3″][vc_row_inner css=”.vc_custom_1512431727138{margin-top: 0px !important;margin-bottom: 0px !important;}”][vc_column_inner][vc_single_image image=”3346″ img_size=”24×24″ el_class=”img”][vc_column_text]COMPOSITION :

One dose (0.5 ml) contains: 5 µg of Vi polysaccharide of Salmonella typhi (Strain Ty2) conjugated to 5 µg Tetanus toxoid protein in isotonic saline 0.5 ml.

[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][vc_column width=”1/3″ el_class=”block4″][vc_row_inner el_class=”product-border”][vc_column_inner][vc_single_image image=”3353″ img_size=”24×24″ el_class=”img”][vc_column_text]INDICATIONS :

Peda TyphTM is indicated for active immunization against Salmonella typhi in infants of age ? 3 months, children and adults.

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Hypersensitivity to any constituent of the vaccine.
Pregnant & lactating women.
In the event of fever or severe infection, persistent diarrhoea and vomiting.

[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row el_class=”product-box” css=”.vc_custom_1512432458076{padding-top: 35px !important;}”][vc_column width=”1/3″ el_class=”block6″][vc_row_inner css=”.vc_custom_1512429922882{margin-top: 0px !important;margin-bottom: 0px !important;}”][vc_column_inner][vc_single_image image=”3353″ img_size=”24×24″][vc_column_text]PRECAUTIONS :

The vaccine should be shaken gently and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either of the above, being observed, discard the vaccine.
As with other vaccines, in rare cases anaphylactic shock may occur in susceptible individual. The mainstay in the treatment of severe anaphylaxis is the prompt use of adrenaline, which can be life saving. It should be used at the first suspicion of anaphylaxis. The vaccinee should remain under observation for not less than 30 minutes for possibility of occurrence of rapid allergic reactions. Hydrocortisone & antihistaminic should also be available in addition to supportive measures such as oxygen inhalation.

[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][vc_column width=”1/3″ el_class=”block7″][vc_row_inner el_class=”product-border”][vc_column_inner][vc_single_image image=”3346″ img_size=”24×24″ el_class=”img”][vc_column_text]ADMINISTRATION :

Inject 0.5ml intramuscularly. Do not inject intravenously or intradermally. Prevention becomes effective 4 weeks after immunization.

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One dose followed by booster after 2½-3 years of primary vaccination. Vaccination can be done from 3 months age onwards .

[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row el_class=”product-box” css=”.vc_custom_1512432608841{padding-top: 35px !important;}”][vc_column width=”1/3″ el_class=”block9″][vc_row_inner css=”.vc_custom_1512429922882{margin-top: 0px !important;margin-bottom: 0px !important;}”][vc_column_inner][vc_single_image image=”3352″ img_size=”24×24″][vc_column_text]POSSIBLE SIDE EFFECTS :

As for any product, there may be more or less moderate and temporary side effects like: – Pain, induration, erythema, purities at the injection site. – Rare, transient febrile reactions. – Paracetamol or Ibuprofen cover for 36 hours after vaccination shall decrease the intensity of side effects.

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Store between +2° to +8°C in the refrigerator. Do not freeze, discard if the vaccine has been frozen.

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One dose in glass vial with disposable syringe and aslo in prefilled syringe pack.

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The shelf life of the product is 36 months from the date of manufacture if stored at recommended storage conditions.

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CONTENTS
  1. Typhiod Fever -Introduction
  2. Epidemiology
  3. Clinical picture of typhoid fever
  4. Recent advances in understanding of Typhoid fever in infants
    1. Reports on a typical clinical picture of Typhoid in infants.
    2. Reports of typhoid fever in infants & children.
  5. Typhoid vaccines
    1.  Vi Polysaccharide typhoid vaccine
    2.  Vi Conjugate typhoid vaccine (Peda Typh™)
  6. Clinical trials
    1. Introduction
    2. Methods and materials
    3. Selection of volunteers
    4. Evaluation of safety
    5. Immunological response
  7. Prescribing information of Peda Typh™
  8. References

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CLINICAL TRIAL OF Vi CONJUGATE TYPHOID VACCINE (Peda TyphTM)

[vc_row css=”.vc_custom_1512546763276{margin-bottom: 0px !important;}”][vc_column width=”2/3″][vc_column_text]Introduction 
The studies were undertaken to assess the immunogenicity and safety in infants and older children of a new vaccine-Vi polysaccharide conjugated with Tetanus toxoid protein, developed by Dr. Puneet Garg & his associates at BIO MED(P) ltd, Ghaziabad, INDIA. This new technology has avoided the use of recombinant proteins for conjugation. The vaccine has passed the required safety & immunological parameters in animals. The permission to conduct clinical trial Phase III in human was cleared by the Drugs Controller General (India) after necessary evaluation.

Methods & Materials
Open , multicentric, controlled & comparative study was undertaken. The three consecutive batches of Vi conjugate typhoid vaccine (Peda TyphTM), used for conducting the clinical trial, were found to be of standard quality by Central Drugs Laboratory, Central Research Institute, Kasauli, H.P. of Government of India. The Vi polysaccharide typhoid vaccine manufactured by BIO-MED (P) LTD., was also tested for comparative assessment studies. The study protocols were approved by the ethics committee of eminent medical colleges located in three widely separated zones of India.

Details of three medical colleges where the clinical trials were conducted.[/vc_column_text][/vc_column][vc_column width=”1/3″][/vc_column][/vc_row][vc_row css=”.vc_custom_1512546782539{margin-top: 0px !important;margin-bottom: 0px !important;}”][vc_column][vc_column_text]

STUDY CENTRE CHIEF INVESTIGATOR
L.L.R.M Medical College, Meerut, UP. Dr.S.P.Goel M.D. Professor & Head Department of Pediatrics
Dr.Anil Agarwal M.D. Professor of Microbiology & Pathology
Gandhi Medical College , Secundrabad ,Andhra Pradesh Dr.P.Sudershan Reddy M.D., D.C.H. Professor & Head Department of Pediatrics
Dr.B.Balaraju M.D., Professor of Medicine & Superintendent Gandhi Medical Hospital
Medical College Bhavnagar,Bhavnagar,Gujarat Dr.M.P. Singh M.D. Professor & Head  of the Department of PSM and Superintendent Sir T. General Hospital
Dr Alpa N.Parekh M.D., Deptt. of Pediatrics Associate Professor & Head Department of Pediatrics

[/vc_column_text][/vc_column][/vc_row][vc_row css=”.vc_custom_1512549182017{margin-top: 0px !important;margin-bottom: 0px !important;}”][vc_column][vc_column_text]Selection of volunteers
The subjects were selected randomly from different economic strata of the society. All children taken in the study were normal, in good health & clinical state.

Group A-Vi conjugate typhoid vaccine (Peda TyphTM)
Peda TyphTM was administered to infants > 12 weeks of age by intramuscular route. 169 volunteers were vaccinated and observed for local and systematic side effects, paired serum samples from 145 volunteers were collected.

Group B-Vi polysaccharide typhoid vaccine
Vaccine was administered to children = 2 years of age by intramuscular route. Thirty seven volunteers were vaccinated and observed for local and systemic side effects, paired serum samples from 29 volunteers were collected.[/vc_column_text][vc_single_image image=”3512″ img_size=”full”][vc_column_text]Evaluation of safety
Local side effects (at the site of injection) : Pain, erythema and inflammation and
Systemic side effects : Fever. diarrhoea, vomiting and any other were recorded 30 minutes, 4 to 6 hours and 48 hours post vaccination. Scaling of adverse reactions was done as following :

Scaling of adverse reactions was done as following :

Excellent No local or systemic reactions
Good Local reactions (inflammation)<5 cm in diameter and axillary temperature <38.30 C.
Fair Local reaction (inflammation)>5 cm in diameter and axillary temperature < 38.30C.
Bad Local reaction (inflammation)>5 cm in diameter and axillary temperature > 38.30 C.

Of the total 169 subjects vaccinated with Peda TyphTM-147 subjects were in category “excellent”, 22 subjects in category “good”. There were no case in “fair” and “bad” categories on the scale of adverse reactions.

There were no serious adverse event leading to premature withdrawal from the study. None of the subjects had inflammation, one subject had erythema at site of injection. Local reactions were confined to mild transient pain which resolved without any sequella.

Three subjects had fever >38.30 C. The temperature rise became normal within 24 hours post vaccination without any medication.

Based on the above data, the principle investigators concluded that Peda TyphTM (Vi Conjugated Typhoid vaccine) was safe & well tolerated in all age groups including infants.

Immunological Response
Evaluation of Immunogenicity :
Blood samples(1-2ml) were collected by venipuncture before vaccination on day 0(pre-immune) and 4 weeks after vaccination (post immune). lgG anti Vi antibodies were detemined by ELISA.

ELISA test : (Assay for assessment of immune response in paired serum samples)
ELISA test kit was validated and calibrated as per the guidelines of good laboratory practice.[/vc_column_text][vc_single_image image=”3514″ img_size=”full”][vc_column_text]Serum lgG Vi antibodies were assayed by ELISA and expressed in ELISA units relative to a standard reference. The unitage of the standard reference was assigned by NICHD, NIH, USA.

Preparation of standard reference curve and calculation of lgG antibodies was done by program of ELISA version 2.0, Centers for Disease control , Atlanta(USA).

Biostatistical Analysis : Biostatistical analysis of the clinical trial of Peda TyphTM was done by Dr.R.M. Pandey Ph.D.,FRSS(U.K.),Professor and Head, Department of Bio-Statistics, All India Institute of Medical Sciences ,N.Delhi. Biostatistical analysis proved that Peda TyphTM vaccine is safe and immunogenic. The antibody titers of the sera from 100% of the subjects (from all three centers) showed a four fold or greater rise in antibody titer of each group after immunization .No statistically significant differences were found in male and female children.

Results are graphically presented in figure 2. The lgG anti-Vi antibodies of Peda TyphTM were 97.425 ELISA units in infants and children 3 months to 24 months of age. The geometric mean (95% confidence interval) of all volunteers was 70.32(62.86-78.66).

The Vi conjugate typhoid vaccine (Peda TyphTM) under clinical trial have been found to be highly immunogenic in infants and children less than 2 years of age in which unconjugated Vi polysaccharide typhoid vaccine is known to induce very low or nil immunogenic response.

The efficacy of Vi conjugate typhoid vaccine in clinical trials conducted in Vietnam have been found to be 89% over the 46 months period.

On comparing the data of clinical trial of Vi conjugate typhoid vaccine developed by N.I.H (Published in The New England Journal vol.344 no. 17, 2001 pg.No.1263-1269) with Peda TyphTM manufactured by BIO-MED(P)LTD., it was found that the geometric mean post immune lgG(25-75 percentile) are statistically equivalent.

Immunizations not only prevent mortality and morbidity. They also reduce the expenditure of public and private resources. The latest generation Vi conjugate typhoid vaccine is an effective tool to control the emerging pattern of typhoid fever in children and infants <2 years of age.

The above study has been published in :
Garg P., Garg S., Sharma M.K (2014), Clinical trial of Tetanus Toxoid Conjugated Vi Polysaccharide Typhoid Vaccine in infants and young children, Sharma et al (2014) Biotechnology International 7(4) : 90-100.

Further post licensure studies on Peda TyphTM has been done in SRM Medical college Chennai by Dr. Balaji Chinnasami et al. Dr. Monjori Mitra et.al conducted a large scale Safety Immunogenicity & Efficacy study in Municipal school children in Kolkata (highly endemic area).

The studies have been published in :

  1. Chinnasami B., Mangayarkarasi V., Prema A., Sadasivam K. & Davis M.J. (2013). Safety and immunogenicity of Salmonella typhi Vi conjugate vaccine (Peda Typh™) is children upto five years. International Journal of Scientific and Research Publication, Volume 3, issue 2, February 2013.
  2. Chinnasami B., Sadasivam K., Vivekanandhan A., Arunachalam P. & Pasupathy S. (2015). A study on Longevity of Immune Response after vaccination with Salmonella typhi Vi Conjugate Vaccine (Peda Typh™) in children. Journal of Clinical & Diagnostic Research. 2015 May, Vol-9(5).
  3. Mitra M., Shah N., Ghosh A., et al (2015). Efficacy and Safety of Vi-Tetanus Toxoid Conjugated Typhoid Vaccine (Peda TyphTM) in Indian Children: School Based Cluster Randomized study. Human Vaccine & immunotherapeutics 2016, VoI. 0,No. 0, 1-7

The highlights of the result of the studies are as under :

  • Efficacy of Peda Typh has been found to be 100% versus 33 cases of typhoid in control group over a follow up period of 1 year.
  • One dose of the vaccine was found to give protective immunity in infants & children . No significant advantage of two doses regimen over one dose was found.”as per Dr. Chinnasami in his study “ A study on Longevity of Immune Response after vaccination with Salmonella typhi Vi Conjugate Vaccine (Peda Typh™) in children.
  • Serum analysis of post licensure follow up study at SRM Medical College using Peda Typh™ showed adequate immune response 30 months post vaccination with Single dose – 14 (4.8 – 29.8) µg/ml (which is much greater than earlier seroprotective level 3.52 Elisa unit equivalent to 4.36mcg/ml or current seroprotective level 1.4 µg/ml-2µg/ml).

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CONTENTS
  1. Typhiod Fever -Introduction
  2. Epidemiology
  3. Clinical picture of typhoid fever
  4. Recent advances in understanding of Typhoid fever in infants
    1. Reports on a typical clinical picture of Typhoid in infants.
    2. Reports of typhoid fever in infants & children.
  5. Typhoid vaccines
    1.  Vi Polysaccharide typhoid vaccine
    2.  Vi Conjugate typhoid vaccine (Peda Typh™)
  6. Clinical trials
    1. Introduction
    2. Methods and materials
    3. Selection of volunteers
    4. Evaluation of safety
    5. Immunological response
  7. Prescribing information of Peda Typh™
  8. References

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TYPHOID VACCINES

[vc_row css=”.vc_custom_1512548927989{margin-bottom: 0px !important;}”][vc_column width=”2/3″][vc_column_text]Typhoid vaccines are known to the medical science for more than a century. Wright in 1896 introduced typhoid vaccine for the first time. Vi polysaccharide of S. typhi was recognized as the only important antigen involved in inducing protective antibodies Felix & Pitt(1935).The new type of typhoid vaccines were developed by reexamination of the protective role of the capsular polysaccharide (Vi antigen) Robbins J.D., Robbins J.B.(1984).

Vi Polysaccharide typhoid vaccine

Vi antigen also called as the virulence antigen of Salmonella typhi  has been described as an important antigen capable of inducing immune response in children >2 years of age. Extensive clinical trial conducted in Nepal showed that the Vi polysaccharide is immunogenic and efficacious.

This vaccine was introduced in India in 1995.It contains a very small component of the outer layer of the bacteria (Vi polysaccharide), which provides high degree of protection , with almost minimal adverse effects profile. Additionally instead of two injections with whole cell type vaccine ,Vi polysaccharide typhoid need only one injection. This vaccine provides protection which lasts for at least  2 years. Hence booster injection is recommended every 3 years.

Since Vi Polysaccharide typhoid vaccine does not induce immune response in infants and children below 2 years of age, hence they had remained unprotected against typhoid fever so far.[/vc_column_text][/vc_column][vc_column width=”1/3″][/vc_column][/vc_row][vc_row css=”.vc_custom_1512548957059{margin-top: 0px !important;margin-bottom: 0px !important;}”][vc_column][vc_column_text]Research by Szu, S.C. et al. (1987),Kossaczka Z.et al.(1997,1999) led to the development & availability of Vi conjugate typhoid vaccine in India (Peda TyphTM) for the first time in the world by Bio-Med (P) Ltd.

Vi conjugate typhoid Vaccine -Peda TyphTM

The need to find an alternative has been on for past several years. The scientists of the N.I.H.,U.S.A. & the A.I.I.M.S., New Delhi, India had been successful in developing Vi polysaccharide conjugated with recombinant protein antigens e.g.

  1. Recombinant exotoxin A of P.aeruginosa.
  2. ‘OMP’ of S.typhi produced in E.Coli.

Research by Szu, S.C. et al .(1987),Kossaczka Z.et al.(1997,1999) led to the development and availability of Vi conjugate typhoid vaccine in India (Peda TyphTM) and for the first time in the world.

BIO-MED scientists have developed a unique process of conjugation using a time tested natural protein Tetanus toxoid. This method has proved very effective and safe as tested in animal studies and in the multicentric clinical trials on infants, children and adults.

The Vi conjugated typhoid vaccines have been demonstrated to induce ‘T’ cell dependent response with much higher antibody levels providing protection in >90% Lin F.Y.et al .(2001), Lanh M.N. et al.(2003).

The Peda Typh TM availability promises control of typhoid in infants, children and adults. This vaccine is amenable to booster vaccination and is expected to confer much better grade immunity in much higher percentage of vaccinees.[/vc_column_text][/vc_column][/vc_row][vc_row css=”.vc_custom_1512548962519{margin-top: 0px !important;}”][vc_column][vc_column_text]

CONTENTS
  1. Typhiod Fever -Introduction
  2. Epidemiology
  3. Clinical picture of typhoid fever
  4. Recent advances in understanding of Typhoid fever in infants
    1. Reports on a typical clinical picture of Typhoid in infants.
    2. Reports of typhoid fever in infants & children.
  5. Typhoid vaccines
    1.  Vi Polysaccharide typhoid vaccine
    2.  Vi Conjugate typhoid vaccine (Peda Typh™)
  6. Clinical trials
    1. Introduction
    2. Methods and materials
    3. Selection of volunteers
    4. Evaluation of safety
    5. Immunological response
  7. Prescribing information of Peda Typh™
  8. References

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RECENT ADVANCES IN UNDERSTANDING OF TYPHOID FEVER IN INFANTS

[vc_row css=”.vc_custom_1512548675487{margin-bottom: 0px !important;}”][vc_column width=”1/4″][vc_single_image image=”3505″ img_size=”full”][/vc_column][vc_column width=”3/4″][vc_column_text]Until recently , typhoid was considered a disease of children above 3-5 years since it presented itself in an atypical clinical picture in infants and young children. This was further hampered due to difficulty in getting enough blood samples for appropriate culture isolation. The laboratories were not well equipped with good quality media, reagents & trained personnel. Introduction of bone marrow sampling using very sharp needles for culture identification has made detection of typhoid cases more amenable Hoffman S.et al.( 1986).

Reports on a typical clinical picture of typhoid in infants :

  • Sinha, A.et al.(2004) defined typhoid fever in infants as fever which lasted more than 5 days, with no response to antimalarial therapy, coupled with bradycardia and splenomegaly. Almost 30% of such cases suspected for typhoid fever were found to be due to para-typhoid.

  • Sen, S.K. and Mahakur, A.C.(1972) reported that continuous temperature hepato- splenomegaly and bradycardia were less frequent in children,however pulmonary signs, lymphadenopathy, hyperpyrexia and toxic tongue were more frequent. Children suffered more from complications like constipation followed by diarrhoea and tympanitis. Pulmonary complications e.g. bronchitis, bronchopneumonia, pneumonia and neurological complications like meningitis, encephalopathy, convulsions, typhoid state were more frequent in children.

Due to these atypical clinical presentation , clinicians usually resort to arrive at a diagnosis by a process of elimination of possible disease like malaria etc. to call the case as of typhoid fever.[/vc_column_text][/vc_column][/vc_row][vc_row css=”.vc_custom_1512548680612{margin-top: 0px !important;margin-bottom: 0px !important;}”][vc_column][vc_column_text]Recent reports confirm that infants and children below 2 years of age are highly susceptible to typhoid fever and constitute a high percentage of cases of typhoid fever.

Reports of typhoid fever in infants and children

A large number of studies have revealed high incidence of typhoid in infants and children below 2 years of age :

  • Sinha,A. et al.(1999) reported in their studies in Delhi area, the highest number of typhoid cases in children below 5 years (27.3%) compared to 11.7% in 5-19 years and only 1.1% in 14-40 years age group.
  • Saha ,M.R. et al.(2003) reported in their studies in Kolkata area that children between 2-3 years age group are the most susceptible(35.6%).
  • Gupta, A. et al.(2001) reported significant number of patients were below 3 years age, the youngest being an infant of 7 months in Jaipur area.
  • Saha, S.K., Baqui, A.H. et al.(2001) reported in Bangladesh that majority (54.5%) of culture positve typhoid cases were from children younger than 5 years. Out of these 27% were in first two years of life (0-5 months=0.8%, 6-12 months=8.7%, 13-24 months=17.5%)

All the above referred studies are strong pointers to the fact that typhoid causes serious disease in infants for which there was no specific vaccine available for active immunization till now.

The hygiene is very difficult to maintain for infants & toddlers, thus exposing them to more chances of getting infected. The extra cautious approach in the use of antibiotics in children makes the job of pediatrician very complicated.[/vc_column_text][/vc_column][/vc_row][vc_row css=”.vc_custom_1512548723328{margin-top: 0px !important;}”][vc_column][vc_column_text]

CONTENTS
  1. Typhiod Fever -Introduction
  2. Epidemiology
  3. Clinical picture of typhoid fever
  4. Recent advances in understanding of Typhoid fever in infants
    1. Reports on a typical clinical picture of Typhoid in infants.
    2. Reports of typhoid fever in infants & children.
  5. Typhoid vaccines
    1.  Vi Polysaccharide typhoid vaccine
    2.  Vi Conjugate typhoid vaccine (Peda Typh™)
  6. Clinical trials
    1. Introduction
    2. Methods and materials
    3. Selection of volunteers
    4. Evaluation of safety
    5. Immunological response
  7. Prescribing information of Peda Typh™
  8. References

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CLINICAL PICTURE OF TYPHOID FEVER

[vc_row css=”.vc_custom_1512548178881{margin-bottom: 0px !important;}”][vc_column width=”1/4″][vc_single_image image=”3497″ img_size=”full”][/vc_column][vc_column width=”3/4″][vc_column_text]Typhoid fever exhibits in various forms. Typically, it starts with malaise, anorexia, muscular  aches and fevers,that increases everyday by 0.25-0.50C to reach to 39 to 410 C coupled with abdominal pain & headaches. Fever rises to 410 C in 5-7 days where it stays for 10-15 days if untreated, then fever decreases slowly over several days.

During the period of rise in fever, some patients (20%) with fair skin show “rose spots” of 2-4 mm in the chest, abdomen & back areas. Constipation is typically observed.

In blood – leukocytes are below 4500/mm3 & platelets less 80,000/mm3 . Liver dysfunction may be present and can be detected by elevated serum transaminase values.

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Two of most important complications are perforations & hemorrhage as a result of intestinal lesions (See figure).

Other uncommon complications are hepatitis, empyema, osteomyelitis & psychosis. Particularly severe form of typhoid can cause cerebral dysfunction, delirium or coma and shock, case fatality in such cases can exceed 20%.

About 2% to 5% patients become chronic gallbladder carriers of the organism where it has been implicated as a cause of cancer.

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CONTENTS
  1. Typhiod Fever -Introduction
  2. Epidemiology
  3. Clinical picture of typhoid fever
  4. Recent advances in understanding of Typhoid fever in infants
    1. Reports on a typical clinical picture of Typhoid in infants.
    2. Reports of typhoid fever in infants & children.
  5. Typhoid vaccines
    1.  Vi Polysaccharide typhoid vaccine
    2.  Vi Conjugate typhoid vaccine (Peda Typh™)
  6. Clinical trials
    1. Introduction
    2. Methods and materials
    3. Selection of volunteers
    4. Evaluation of safety
    5. Immunological response
  7. Prescribing information of Peda Typh™
  8. References

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