riacon 2011- dr.patnaik
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RABIES FREE WORLD………the one who needs the most
DR. B N PATNAIK, MDHead clinical Development
INDIA
Persistence of neutralizing antibody in previously vaccinated subjects: Multiple studies showing long lasting immunity
with ABHAYRAB
“Impact on rabies immunization practice…”
In the absence of PEP vaccination it is assumed that just under 20% of victims of bites by rabid animals develop
rabies and that all clinical cases of human rabies result in death(1).
Incomplete PEP vaccination is less effective and almost 10% of human rabies cases reported from India had received incomplete PEP vaccination with CCVs (2)
1. Shim E, Hampson K, Cleaveland S, Galvani AP (2009) Evaluating the cost-effectiveness of rabies post-exposure
prophylaxis: a case study in Tanzania. Vaccine 27: 7167–7172
2. Sudarshan MK, Madhusudana SN, Mahendra BJ, Rao NSN, Ashwath Narayana DH, et al. (2007) Assessing the burden of
human rabies in India: results of a national multi-center epidemiological survey. International Journal of Infectious Diseases
11: 29–35.
Initial Abhayrab studies…
Class of Bite
No. of Subjects
Abhayrab schedule
ERIG Ab titres on
Group I Healthy volunteers
60 Days 0, 7 and 21
Not given Days 0,14,35 and 365
Group II Category II 75 Days 0, 3, 7, 14,30 and 90
Not given Days 0, 14, 30, 90 and
365
Group III Category III 67 Days 0, 3, 7, 14,30 and 90
Not given Days 0, 14, 30, 90 and
365
Group IV Category III 88 Days 0, 3, 7, 14,30 and 90
Given Days 0, 14, 30, 90 and
365
Published by Elsevier Ltd in 2004Conducted by :Institute of Preventive Medicine, Narayanguda, Hyderabad, Pasteur Institute of India, Connor, Tamilnadu, India
Persistence of Ab over time
0
12.69
18.19
12.26
00.83
13.53
15.03
7.04
4.15
00.78
15.78
8.04
9.47
7.82
0
0.61
10.34
11.66
8.42
5.8
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
0 7 14 35 90 365
GM
T
Days
GROUP I
GROUP II
GROUP III
GROUP IV
Multi-centric study on the use of intradermal administration of tissue
culture antirabies vaccines in India
Methods:
Healthy volunteers selected from five centres in the country.
The TCARVs used for intradermal administration were Purified Vero cell Rabies vaccine (PVRV Abhayrab and Coonoor), Purified chicken embryo cell vaccine (PCEC Rabipur) and Purified duck embryo vaccine ( PDEV Vaxirab) with a 2-2-2-0-1-1 regimen.
Responses to intradermal TCARVs were compared with that of French PVRV (Aventis) administered intramuscularly on 0, 3, 7,14 and 28 days.
Ten volunteers were recruited for each of the TCARV arm in each center as well as for control group receiving French PVRV.
Blood samples were collected on days 14, 28, 90 and 180 days
Study done by : Indian Council of Medical Research
Sero-protection rate, GMTs, of Anti-Rabies antibodies and its 95% CI among the volunteers receiving different TCRVs
Sero-protection rate, Geometric mean titers of anti-rabies antibodies an ICMR Study
IMMUNOGENECITY OF PURIFIED VERO CELL RABIES VACCINE USED IN THE TREATMENT OF FOX-BITE
VICTIMS IN INDIA
• 19 Patients aged 6-70 years
• Category III fox bites
• Abhayrab was administered IM to all on days 0,3,7,14 and 28
• 6 patients were treated with equine rabies antiserum (Central research institute)
• 11 patients were administered abhayrab booster on day 1020 after the first dose
• Blood was collected for antibody titre estimation on days 30,90,870,1020, and 1050
Study by Dr. I S Matha of district hospital Nasik and Dr.S R Salunke of Directorate of health services ,Mumbai,India
Response to a booster vaccination on day 1020 after the first dose of vaccine in patients who had received
either vaccine alone or vaccine + ERIG
Days after 1st dose of vaccine
No. of Patients
GMT Value, IU
Mean Range
30 12 3.16 1.00 – 8.00
90 16 25.00 8.00 – 64.00
870 11 0.77 0.26 – 2.10
1020 11 0.48 0.11 – 2.00
1050 11 30.08 2.57 – 69.18
REVIEW OF EXISTING ANTIBODIES IN TREATED POST-EXPOSURE BY CELL CULTURE VACCINES: ABHAYRAB ( IM )REGIMEN
ONE YEAR FROM THE FIRST INJECTIONS (VIETNAM)
PRINCIPAL INVESTIGATOR:
PROF ĐINH KIM XUYẾN, PhD DEPUTY DIRECTOR OF CENTER FOR SCIENTIFIC RESEARCH FOR CUMMUNITY HEALTH,HANOI,VIETNAM
Rabies Virus Neutralizing Antibody (RVNA)
Concentration by age group
Characteristics n = 101 people
≤ 15 years old > 15 years old
No. of subjects 26 75
RVNA48 to >53 Week
GMT2.06
95 % CI± 1.14
GMT1.97
95 % CI± 1.19
Antibody concentration in the age ≤ 15 years old higher than the age >15 not but not statistically significant( P>0.05)
Antibody concentrations over time from first dose to evaluation weeks
TIME
(IN WKS AFTER FIRST DOSE)
TOTAL
ANTIBODY CONCENTRATION
0.5-1 1.1-5 >5
48-50 22 5 9 5
51-53 29 10 12 6
>53 69 25 21 8
Total 120 40 42 19
Study to compare the safety and immunogenicity of Abhayrab with commercially available Rabipur vaccine, both administered as per updated Thai
Regimen (2-2-2-0-2) in healthy volunteers (simulated post-exposure study)
Antibody titers GMT (IU/mL)
(%) of Subjects Seroconverted
Abhayrab Vaccine
Rabipur Vaccine
Abhayrab Vaccine
Rabipur Vaccine
Pre vaccination Day 0 (N) Range (Min, Max)
0.12 (42) (0.00, 0.48)
0.10 (50) (0.00,0.40)
-- --
Post Vaccination Day 38 (N) Range (Min, Max)
60.39 (42) (10.81, 247.66)
56.55 (50) (70.14, 247.66)
100 100
Day 365 (N) Range (Min, Max)
0.94 (25) (0.54, 3.09)
1.15 (25) (0.56, 4.03)
100 100
SEROPROTECTION
Implications…….
• Reduced PrEP regimens would reduce the cost of protecting vulnerable populations against rabies and would promote better compliance.
• thus supporting opportunities to conduct mass PrEP rabies vaccination in children, the population most at risk of dying of this dreaded disease.
Implication……
• (PVRV) administered as a pre- or post-exposure series will provide very long lasting immune memory in normal host recipients.
• Two intradermal booster injections on days 0 and 3 will result in an accelerated anamnestic neutralizing antibody response and obliviate the need for rabies immunoglobulin in the event of a new exposure
K. Suwansrinon et al. / Vaccine 24 (2006) 3878–3880
Possible Future !!
Inclusion of Intradermal PVRV in EPI (Along with DTP vaccine schedule) of developing/Rabies Endemic countries..
Large CTs to validate the number and age for boosters
We can possibly keep Rabies related Death to a minimum…..
THANKS
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