A randomized non-inferiority clinical study to assess post-exposure prophylaxis by a new purified vero cell rabies vaccine (Rabivax-S) administered by intramuscular and intradermal routes

Vaccine

Volumn 34, Issue 40, 2016, Pages 4820-4826

  Bose, Anuradha ^a   Munshi, Renuka ^b   Tripathy, Radha Madhab ^c   Madhusudana, Shampur N ^d   Harish, B R ^e   Thaker, Saket ^f   Mahendra, B J ^e   Gunale, Bhagwat ^g   Gogtay, Nithya J ^f   Thatte, Urmila M ^f   Mani, Reeta Subramaniam ^d   Manjunath, K ^a   George, Kuryan ^a   Yajaman, Ashwin Belludi ^d   Sahai, Ashish ^g   Dhere, Rajeev M ^g   Alex, Reginald G ^a   Adhikari, Debasis Das ^a   Abhilash, ^a   Raghava, Venkata ^a   Kumbhar, Dipti ^b   Behera, Tapas Ranjan ^c   Kulkarni, Prasad S ^g   more..

^a CHRISTIAN MEDICAL COLLEGE   (India)

^b BYL NAIR CHARITABLE HOSPITAL   (India)

^c MKCG MEDICAL COLLEGE   (India)

^d NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES   (India)

^e Mandya Rajiv Gandhi University of Medical Sciences   (India)

^f KEM HOSPITAL   (India)

^g Serum Institute of India Ltd   (India)

Author keywords

Immunogenicity; Purified vero cell rabies vaccine; Rabies; Safety

Indexed keywords

NEUTRALIZING ANTIBODY; RABIES IMMUNOGLOBULIN; RABIES VACCINE; VIRUS ANTIBODY;

ABDOMINAL PAIN; ADULT; ARTHRALGIA; ARTICLE; ASTHENIA; CHICK EMBRYO; CHILD; CHILL; CONTROLLED STUDY; COUGHING; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EDEMA; ERYTHEMA; FAINTNESS; FEMALE; FEVER; HEADACHE; HUMAN; IMMUNE RESPONSE; INTENTION TO TREAT ANALYSIS; MAJOR CLINICAL STUDY; MALE; MYALGIA; NAUSEA; PAIN; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; POST EXPOSURE PROPHYLAXIS; PRIORITY JOURNAL; PRURITUS; RABIES; RANDOMIZED CONTROLLED TRIAL; RASH; RHINOPHARYNGITIS; SHIVERING; SWELLING; UPPER RESPIRATORY TRACT INFECTION; VACCINATION; VACCINE IMMUNOGENICITY; VERO CELL LINE; WOUND COMPLICATION; ADOLESCENT; AGED; ANIMAL; BLOOD; CHLOROCEBUS AETHIOPS; CLINICAL TRIAL; INDIA; INTRADERMAL DRUG ADMINISTRATION; INTRAMUSCULAR DRUG ADMINISTRATION; MIDDLE AGED; MULTICENTER STUDY; PRESCHOOL CHILD; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANIMALS; ANTIBODIES, NEUTRALIZING; ANTIBODIES, VIRAL; CERCOPITHECUS AETHIOPS; CHILD; CHILD, PRESCHOOL; FEMALE; HUMANS; INDIA; INJECTIONS, INTRADERMAL; INJECTIONS, INTRAMUSCULAR; MALE; MIDDLE AGED; POST-EXPOSURE PROPHYLAXIS; RABIES; RABIES VACCINES; VERO CELLS; YOUNG ADULT;

EID: 85003680977     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2016.08.005     Document Type: Article

References (19)

1. [1] Rabies vaccines, WHO position paper. Wkly Epidemiol Rec 85:32 (2010), 309–320 Aug 6.
2. [2] Sudarshan, M.K., Madhusudana, S.N., Mahendra, B.J., et al. Assessing the burden of human rabies in India: results of a national multi-center epidemiological survey. Int J Infect Dis 11:1 (2007), 29–35 Jan.
3. [3] Hampson, K., Coudeville, L., Lembo, T., et al. PLoS Negl Trop Dis, 9(4), 2015, e0003709 Apr 16.
4. [4] Kulkarni, P.S., Sapru, A., D'costa, P.M., Pandit, A., Madhusudana, S.N., Yajaman, A.B., et al. Safety and immunogenicity of a new purified vero cell rabies vaccine (PVRV) administered by intramuscular and intradermal routes in healthy volunteers. Vaccine 31:24 (2013), 2719–2722 May 31.
5. [5] Verma, R., Khanna, P., Prinja, S., Rajput, M., Intra-dermal administration of rabies vaccines in developing countries: at an affordable cost. Hum Vaccine 7:7 (2011), 792–794 Jul.
6. [6] Hampson, K., Cleaveland, S., Briggs, D., Evaluation of cost-effective strategies for rabies post-exposure vaccination in low-income countries. PLoS Negl Trop Dis, 5(3), 2011, e982 Mar 8.
7. [7] Briggs, D.J., Banzhoff, A., Nicolay, U., Sirikwin, S., Dumavibhat, B., Tongswas, S., et al. Antibody response of patients after postexposure rabies vaccination with small intradermal doses of purified chick embryo cell vaccine or purified vero cell rabies vaccine. Bull World Health Organ 78 (2000), 693–698.
8. [8] Quiambao, B.P., Dimaano, E.M., Ambas, C., Davis, R., Banzhoff, A., Malerczyk, C., Reducing the cost of post-exposure rabies prophylaxis: efficacy of 0.1 mL PCEC rabies vaccine administered intradermally using the Thai Red Cross post-exposure regimen in patients severely exposed to laboratory-confirmed rabid animals. Vaccine 23 (2005), 1709–1714.
9. [9] TM, J., Mathew, T., AT, S., SC, M., Philip, R.R., Post-exposure prophylaxis against rabies at two newly designated intradermal rabies vaccination clinics in Kerala, India. Natl Med J India 25:5 (2012), 268–270 Sep–Oct.
10. [10] Sudarshan, M.K., Bhardwaj, S., Mahendra, B.J., Sharma, H., Sanjay, T.V., Ashwathnarayana, D.H., et al. An immunogenicity, safety and post-marketing surveillance of a novel adsorbed human diploid cell rabies vaccine (Rabivax) in Indian participants. Hum Vaccine 4:4 (2008), 275–279 Jul-Aug.
11. [11] Kulkarni, P.S., Raut, S.K., Jadhav, S.S., Kapre, S.V., Deuskar, N., Immunogenicity of two modern tissue culture rabies vaccines in pre-exposure prophylaxis. Hum Vaccine 3:5 (2007), 183–186 Sep–Oct.
12. [12] Khawplod, P., Wilde, H., Sirikwin, S., Benjawongkulchai, M., Limusanno, S., Jaijaroensab, W., et al. Revision of the Thai Red Cross intradermal rabies post-exposure regimen by eliminating the 90-day booster injection. Vaccine 24:16 (2006), 3084–3086 Apr 12.
13. [13] Tantawichien, T., Sibunruang, S., Tantawichien, T., Angsanakul, J., Benjavongkulchai, M., Limsuwan, K., et al. Safety and immunogenicity of chromatographically purified vero cell rabies vaccine for intradermal pre-and post-exposure rabies prophylaxis. Expert Rev Vaccines 13:12 (2014), 1593–1601 Dec.
14. [14] Tanisaro, T., Tantawichien, T., Tiranathanagul, K., Susantitaphong, P., Chirananthavat, T., Praditpornsilpa, K., et al. Neutralizing antibody response after intradermal rabies vaccination in hemodialysis patients. Vaccine 28:12 (2010), 2385–2387 Mar 11.
15. [15] Ashwath Narayana, D.H., Madhusudana, S.N., Sampath, G., Tripathy, R.M., Sudarshan, M.K., Gangaboraiah, et al. Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman-Moore strain) manufactured in India. Hum Vaccine Immunother 10:1 (2014), 20–25.
16. [16] Ravish, H.S., Vijayashankar, V., Madhusudana, S.N., Sudarshan, M.K., Narayana, D.H., Andanaiah, G., et al. Safety and immunogenicity of purified chick embryo cell rabies vaccine (VaxiRab N) administered intradermally as post exposure prophylaxis. Hum Vaccine Immunother 10:8 (2014), 2433–2437.
17. [17] Giesen, A., Gniel, D., Malerczyk, C., 30 Years of rabies vaccination with Rabipur: a summary of clinical data and global experience. Expert Rev Vaccines 14:3 (2015), 351–367 Mar.
18. [18] Toovey, S., Preventing rabies with the Verorab vaccine: 1985–2005 twenty years of clinical experience. Travel Med Infect Dis 5:6 (2007), 327–348 Nov.
19. [19] Rupprecht, C.E.L., Briggs, D., Brown, C.M., Franka, R., Katz, S.L., Kerr, H.D., et al. Centers for disease control and prevention (CDC). Use of a reduced (4-dose) vaccine schedule for postexposure prophylaxis to prevent human rabies: recommendations of the advisory committee on immunization practices. MMWR Recomm Rep 59:RR-2 (2010), 1–9 Mar 19.