Safety, potential efficacy, and pharmacokinetics of specific polyclonal immunoglobulin F(ab')2 fragments against avian influenza A (H5N1) in healthy volunteers: A single-centre, randomised, double-blind, placebo-controlled, phase 1 study

The Lancet Infectious Diseases

Volumn 15, Issue 3, 2015, Pages 285-292

  Bal, Céline ^a   Herbreteau, Cécile H ^a   Buchy, Philippe ^b   Rith, Sareth ^b   Zaid, Masliza ^c   Kristanto, William ^c   Han, Velda ^c   Reynaud, Charlotte ^a   Granjard, Patrick ^d   Lépine, Bertrand ^a   Durand, Caroline ^a   Tambyah, Paul A ^c,e  

^a Fab'Entech   (France)

^b INSTITUT PASTEUR DU CAMBODGE   (Cambodia)

^c NATIONAL UNIVERSITY HEALTH SYSTEM   (Singapore)

^d Fab'entech   (Singapore)

^e NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIVIRUS AGENT; FBF 001; IMMUNOGLOBULIN FRAGMENT; PLACEBO; POLYCLONAL ANTIBODY; UNCLASSIFIED DRUG; IMMUNOGLOBULIN F(AB) FRAGMENT; VIRUS ANTIBODY;

ADULT; AREA UNDER THE CURVE; ARTICLE; AVIAN INFLUENZA; BLEPHAROSPASM; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; ELECTROCARDIOGRAM; FEVER; HEART RATE; HEMAGGLUTINATION INHIBITION; HUMAN; HUMAN EXPERIMENT; INFLUENZA A (H5N1); INTENTION TO TREAT ANALYSIS; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SINGLE DRUG DOSE; SINUSITIS; TIME TO MAXIMUM PLASMA CONCENTRATION; BLOOD; CHEMISTRY; CLINICAL TRIAL; IMMUNOLOGY; INFLUENZA VIRUS A H5N1; INFLUENZA, HUMAN; INTRAVENOUS DRUG ADMINISTRATION; PLASMA; VIROLOGY;

ADULT; ANTIBODIES, VIRAL; DOUBLE-BLIND METHOD; HEALTHY VOLUNTEERS; HUMANS; IMMUNOGLOBULIN FAB FRAGMENTS; INFLUENZA A VIRUS, H5N1 SUBTYPE; INFLUENZA, HUMAN; INFUSIONS, INTRAVENOUS; MALE; PLACEBOS; PLASMA;

EID: 84923254084     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(14)71072-2     Document Type: Article

References (37)

1. Cumulative number of confirmed human cases of avian influenza A(H5N1) reported to WHO WHO, (accessed Nov 24, 2014). http://www.who.int/influenza/human_animal_interface/H5N1_cumulative_table_archives/en/.
2. Fonesca K, Lavoie M, Talbot J, et al. ProMED report in Canada. Avian influenza, human: Canada ex China fatal case report (accessed May 24, 2014.). http://www.promedmail.org/direct.php?id=2167282.
3. Tran TH, Nguyen TL, Nguyen TD, et al. Avian influenza A (H5N1) in 10 patients in Vietnam. N Engl J Med 2004, 350:1179-1188.
4. Beigel JH, Farrar J, Han AM, et al. Avian influenza A (H5N1) infection in humans. N Engl J Med 2005, 353:1374-1385.
5. Nguyen TH, Farrar J, Horby P Person-to-person transmission of influenza A (H5N1). Lancet 2008, 371:1392-1394.
6. Wang H, Feng Z, Shu Y, et al. Probable limited person-to-person transmission of highly pathogenic avian influenza A (H5N1) virus in China. Lancet 2008, 371:1427-1434.
7. Herfst S, Schrauwen EJ, Linster M, et al. Airborne transmission of influenza A/H5N1 virus between ferrets. Science 2012, 336:1534-1541.
8. Katz JM, Lim W, Bridges CB, et al. Antibody response in individuals infected with avian influenza A (H5N1) viruses and detection of anti-H5 antibody among household and social contacts. J Infect Dis 1999, 180:1763-1770.
9. Buchy P, Vong S, Chu S, et al. Kinetics of neutralizing antibodies in patients naturally infected by H5N1 virus. PLoS One 2010, 5:e10864.
10. McKimm-Breschkin JL, Barrett S, Pudjiatmoko, et al. I222 neuraminidase mutations further reduce oseltamivir susceptibility of Indonesian Clade 2.1 highly pathogenic avian influenza A(H5N1) viruses. PLoS One 2013, 8:e66105.
11. McKimm-Breschkin JL, Selleck PW, Usman TB, Johnson MA Reduced sensitivity of influenza A (H5N1) to oseltamivir. Emerg Infect Dis 2007, 13:1354-1357.
12. De Jong MD, Thanh TT, Khanh TH, et al. Oseltamivir resistance during treatment of influenza (H5N1) infection. N Engl J Med 2007, 353:2667-2672.
13. Kong LK, Zhou BP Successful treatment of avian influenza with convalescent plasma. Hong Kong Med J 2006, 12:489.
14. Zhou B, Zhong N, Guan Y Treatment with convalescent plasma for influenza A (H5N1) infection. N Engl J Med 2007, 357:1450-1451.
15. Prabhu N, Prabakaran M, Hongliang Q, et al. Prophylactic and therapeutic efficacy of a chimeric monoclonal antibody specific for H5 haemagglutinin against lethal H5N1 influenza. Antiviral Ther 2009, 14:911-921.
16. Sakabe S, Iwatsuki-Horimoto K, Horimoto T, et al. A cross-reactive neutralizing monoclonal antibody protects mice from H5N1 and pandemic (H1N1) 2009 virus infection. Antiviral Res 2010, 88:249-255.
17. Karliner JS, Betaval GS Incidence of reactions following administration of antirabies serum: a study of 526 cases. JAMA 1965, 193:359-362.
18. Lang J, Attanah P, Quiambao B, et al. Evaluation of the safety, immunogenicity, and pharmacokinetic profile of a new, highly purified, heat-treated equine rabies immunoglobulin, administered either alone or in association with a purified, Vero-cell rabies vaccine. Acta Tropica 1998, 70:317-333.
19. De Haro L, Lang J, Bedry R, et al. Envenimations par vipères européennes. Étude multicentrique de tolérance du Viperfav™, nouvel antivenin par voie intraveineuse. Ann Fr Anesth Réanim 1998, 17:681-687.
20. 2 are efficient in blocking highly pathogenic influenza virus (H5N1) infection with a wide coverage of circulating strains. Immunotherapy 2014, 6:699-708.
21. 2 antivenoms. An example: new polyvalent European viper antivenom (equine). Envenomings and their Treatments 1996, 161-172. Fondation Marcel Mérieux. C. Bon, M. Goyffon (Eds.).
22. Guidance for industry: Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers Food and Drug Administration, (accessed Dec 5, 2014). http://www.fda.gov/downloads/Drugs/Guidances/UCM078932.pdf.
23. Guideline on bioanalytical method validation European Medicines Agency, (accessed Dec 5, 2014). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.
24. Guidance for industry-bioanalytical method validation Food and Drug Administration, (accessed Dec 5, 2014). http://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf.
25. Hogarth PM Fc receptors are major mediators of antibody based inflammation in autoimmunity. Curr Opin Immunol 2002, 14:798-802.
26. ELISA Kit MicroVueSC5b-9 Plus. Quidel laboratory, USA.
27. Rowe T, Abernathy RA, Hu-Primmer J, et al. Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic assays. J Clin Microbiol 1999, 37:937-943.
28. Zhao Z, Yan F, Chen Z, et al. Cross clade prophylactic and therapeutic efficacy of polyvalent equine immunoglobulin F(ab')2 against highly pathogenic avian influenza H5N1 in mice. Int Immunopharmacol 2011, 11:2000-2006.
29. 2. Toxicol Appl Pharmacol 1998, 150:295-300.
30. 2, IgG and IgG(T) fragments from hyper immune equine plasma. Int Immunopharmacol 2010, 10:447-454.
31. 2 extrusion mechanism from blood to tissues. Toxicon 2004, 44:731-741.
32. 2 scorpion antivenom in healthy human volunteers. Toxicon 2005, 46:797-805.
33. Gao R, Cao B, Hu Y, et al. Human infection with a novel avian-origin influenza A (H7N9) virus. N Engl J Med 2013, 368:1888-1897.
34. 2 fragment rabies immunoglobulin (Favirab). PLoS Neglect Dis 2008, 2:e243.
35. 2 antivenom for snakebites in Thailand. Acta Trop 2008, 105:203-205.
36. Boels D, Hamel JF, Bretaudeau Deguigne M, Harry P European viper envenomings: assessment of Viperfav and other symptomatic treatments. Clin Toxicol 2012, 50:189-196.
37. 2: insights following clinical trials involving 1534 recipients of scorpion antivenom. Toxicon 2013, 76:386-393.