Oral vaccine treatment for Allergic disease

Treatment of Allergy  by Oral Vaccine

(Oral Allergen Mixture for Sublingual Immunotherapy (SLIT))

 

These are mixtures of glycerinated aqueous allergen extracts for specific de sensitisation of allergic diseases.

The raw material is extracted with glycerinated buffer saline. Sub lingual Immunotherapy is used for treatment of a wide variety of common allergic conditions – respiratory tract allergies such as asthma, rhinitis, skin allergies, migraine, food allergies etc.

The oral allergens stimulate the body to develop antibodies against the specific allergens such as pollen, animal hair, fungal spores, mites, dusts and foods.

Each course of the Allergen mixture therapy is specially dispensed for an individual patient in accordance with the information obtained from the patient’s allergy skin test reactions.

They are dispensed from standard bulk extracts from Creative Drug Industries, New Mumbai, and have undergone stringent quality control tests such as determination of pH, glycerol limit test, phenol limit test and sodium chloride test. They have also undergone toxicity and sterility tests as per I.P. At no stage is human or animal serum used.

Side effects from immunotherapy with Oral Allergens are practically unknown. They are safe, effective and acceptable even to pediatric patients.  However, it should be avoided during pregnancy.

Administration

It is taken orally, half an hour before or two hours after any meal, according to the recommended dosage scheme. The extract is kept under the tongue for 1 to 2 minutes. It is then swallowed. (SLIT – Sub Lingual Immuno Therapy)

Dosage: Each course consists of an Initial treatment course of 3 multi dose Vials of allergen extracts in graded concentrations and a Maintenance course of multi dose vials in strength 3.

Initial treatment course Commenced with the No. 1 Vial, proceeding next to the No. 2 Vial and finally the No. 3 Vial as indicated in the dosage scheme enclosed along with.

Maintenance course should immediately follow the Initial course without interruption. If for any reason, there is any interruption of treatment of more than 4 weeks maintenance treatment should NOT be attempted, but the Initial course of Vials No. 1, 2 and 3 should be taken again.

To prevent lapse in continuity, Fresh No. 3 Vials should be obtained well in advance, much before the No. 3 Vial in use is about to finish.

ALLERGEN MIXTURE DOSAGE GUIDE

Oral mixture of allergens (Creative Drug Industries)

For ORAL use only     (Not to be injected)

Patient’s Name :

Date -

Dose No.
Day
Date, Month, Year No. of drops Progress relating to severity& frequency of symptoms
VialNo.1(1+9999)(0.01% w/v) 1 Monday 1
2 Wednesday 2
3 Friday 3
4 Monday 4
5 Wednesday 5
6 Friday 6
7 Monday 7
8 Wednesday 8
9 Friday 9
10 Sunday 10
VialNo.2(1+999)(0.1% w/v) 11 Monday 1
12 Wednesday 2
13 Friday 3
14 Monday 4
15 Wednesday 5
16 Friday 6
17 Monday 7
18 Wednesday 8
19 Friday 9
20 Sunday 10
VialNo.3(1+99)(1% w/v) 21 Monday 1
22 Wednesday 2
23 Friday 3 Inform for further No. 3 Vial
24 Monday 4
25 Wednesday 5
26 Friday 6
27 Monday 7
28 Wednesday 8
29 Friday 9
30 Sunday 10

ALLERGEN MIXTURE DOSAGE GUIDE

Oral mixture of allergens (Creative Drug Industries)

For ORAL use only     (Not to be injected)

Patient’s Name :

Date -

Dose No.
Day
Date, Month, Year No. of drops Progress relating to severity& frequency of symptoms
VialNo.3(1+99)(1% w/v) Twice in a week 31 Monday 10
32 Thursday 10
33 Monday 10
34 Thursday 10
Twice in a week 35 Monday 10
36 Thursday 10
37 Monday 10 Inform for further No. 3 Vial
38 Thursday 10
39 Monday 10
40 Thursday 10
VialNo.3(1+99)(1% w/v) Once in a week 41 Monday 10
42 Monday 10
43 Monday 10
44 Monday 10
45 Monday 10
46 Monday 10
47 Monday 10 Inform for further No. 3 Vial
48 Monday 10
49 Monday 10
50 Monday 10

Note –

The final dose of 10 drops once a week should be continued without interruption for 2 to 3 years for lasting benefit.
There should be no interruption in taking the allergen mixture. Care should be taken to order fresh No. 3 vials well in  advance to avoid break in continuity of administration of the mixture.
Since extra solution has been added to each vial, some amount may remain in the vials. The extra solution in vials No 1 and No. 2 should not be used, but preserved till expiry in the refrigerator. Vial No. 3 is the main vial and  its contents should be utilised till the bottle is empty.
If there is an interruption in the continuity of administration of over 2 months, it is advisable to start all over again from Vial No. 1, No. 2 and then No. 3 for maximum therapeutic benefit.
Contents of Vial Nos 1, 2, and 3 (Initial course) should last approximately 9 weeks. The next Vial No 3 should last approximately 12 weeks (3 months). The subsequent No. 3 vials should last  approximately 16  weeks each ( 4 months).

Sublingual Immunotherapy  (SLIT)

Allergen specific immunotherapy, together with drugs and allergen avoidance, is the corner stone of management of res­piratory and other allergies. Allergen-specific immunotherapy is the practice of administering to subjects with aller­gy, increasing amounts of allergens to achieve a hypo sensitization and to reduce the symptoms occurring during the natural exposure to the allergen. Immunotherapy is an allergen-oriented immuno mod­ulator that modifies the body’s immune response to allergens.  The action is seen to develop slowly, but surely, over  many months.

In SLIT, on an empty stomach, the extract is kept under the tongue for 1 to 2 minutes. It is then swallowed. Contact of the allergen with the oral mucosa leads the allergen into the regional cervical lymph nodes. Also, once swallowed, the allergen enters the abundant gastrointestinal tract mucosal – immune – sys­tem, the so-called gut-associated lymphoid tissue [GALT]. Therefore an effective antigen presentation is achieved. Objectively, increase in allergen-specific IgE and IgG4 have been noted,  which confirm that SLIT has a significant potential to induce immunologic changes.

SLIT modifies the natur­al history of the disease (i.e, the onset of asthma in patients with rhinitis) and it prevents the onset of new sensitizations. Moreover it has a long-lasting effect after discontinuation. This reduces the days with clin­ical symptoms, the intake of medication and intake of systemic and local steroids and improves the patient’s quality of life. SLIT also significantly reduces non specific (as well as specific) bronchial hyper responsiveness preventing the development of asthma in patients with allergic rhinitis.

Preventive effect and long-lasting efficacy

A  SLIT course involves a buildup phase (extract adminis­tered at increasing doses) and a maintenance phase (extract adminis­tered at a final optimum dose), in which the maximum dose is administered 2 or 3 times a week usually for 3 years -long~term immunomodulation. SLIT can be given preseason­ally or pre-coseasonally, (for pollen allergies) or continuously for perennial allergens.

Efficacy

Conventional SLIT confers positive clinical benefit in patients whose allergic rhinitis and bronchitis are resistant to conventional drug treatment. Symptom benefits last for at least 4 to 5 years thereafter. Young pediatric patients are started early in AR to prevent asthma. Accelerated build up schedules (“Rush Therapy”) by high dose SLIT are possible due to its good safety pro­file, tolerability and effectiveness.

SLIT has a similar efficacy as compared with the conventional SCIT (SubCutaneous ImmunoTherapy). Both treatments are  significantly more effective than pharmacologic treatment alone. As with SCIT, SLIT is not an alternative to drugs for controlling symptoms, but it must be used in combination with them.

Safety

An ideal allergy de sensitization scheme should offer safe and effective therapy for those with allergic disease even without the presence of an allergist, which can be taken by the patient on his own in community settings. Safety would also ensure  better patient compliance.

 

Side effects

Side effects are extremely rare. Occasionally noted are oral/sublingual itching or lip swelling after taking the dose. Rarely headache, rhinorrhea, conjunctivitis, gastrointestinal upset and urticaria. Not a single severe systemic adverse reaction has been reported in the literature in 15 years.  In none of the patients was the discontin­uation of treatment required. Side effects are ususally mild and self-resolv­ing, not requiring any treatment and controlled by a temporary dose adjustment.

CONCLUSIONS

The clinical efficacy of SLIT in both asthma and rhinitis is now supported by a large number of controlled trials, and it appears particularly suit­able also in pediatric allergies.

In 1998 the World Health Organ­ization, and the ARIA (Allergic Rhinitis and its Impact on Asthma) document on the basis of an extensive review of the litera­ture, concluded that sublingual (SLIT) immunotherapy is a viable & valid alternative to injection immunotherapy SCIT) and that its use in clinical practice in adults and children is safe, effective and justified. Cur­rently, SLIT is used in many European countries. Oral immunotherapy has been successfully used since over 15 years now.