Local tolerance and systemic toxicity of single and repeated intramuscular administrations of two different formulations of the RTS,S malaria candidate vaccine in rabbits

Regulatory Toxicology and Pharmacology

Volumn 71, Issue 2, 2015, Pages 269-278

  Segal, Lawrence ^a   Morelle, Danielle ^a   Blee, Mark ^b   Moore, Emma ^b   Damsten, Micaela ^a   Liu, Kai Chiu ^b   Destexhe, Eric ^a   Garçon, Nathalie ^a  

^a GSK   (Belgium)

^b HUNTINGDON LIFE SCIENCES   (United Kingdom)

Author keywords

Adjuvant; AS01; AS02; Malaria; Rabbit; RTS,S; Toxicity study

Indexed keywords

ARSENIC DIOXIDE; ARSENIC OXIDE; IMMUNOLOGICAL ADJUVANT; MALARIA VACCINE; RTS S VACCINE; UNCLASSIFIED DRUG; RECOMBINANT VACCINE; RTS,S-AS01 VACCINE; RTS,S-AS02A VACCINE;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BLOOD CHEMISTRY; CONTROLLED STUDY; DOSAGE SCHEDULE COMPARISON; DRUG FORMULATION; DRUG TOLERABILITY; FEMALE; HEALTH STATUS; IMMUNE RESPONSE; MALARIA; MALE; NEW ZEALAND WHITE (RABBIT); NONHUMAN; TOXICITY; TOXICITY TESTING; ANIMAL; BLOOD ANALYSIS; DRUG EFFECTS; INTRAMUSCULAR DRUG ADMINISTRATION; MEDICINAL CHEMISTRY; METABOLISM; NEUTROPHIL; PROCEDURES; RABBIT;

ORYCTOLAGUS CUNICULUS;

ANIMALS; BLOOD CHEMICAL ANALYSIS; CHEMISTRY, PHARMACEUTICAL; FEMALE; INJECTIONS, INTRAMUSCULAR; MALARIA VACCINES; MALE; NEUTROPHILS; RABBITS; VACCINES, SYNTHETIC;

EID: 84921415809     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2014.12.017     Document Type: Article

References (40)

1. D malaria vaccine in infants living in a malaria-endemic region. Malar. J. 2013, 12:11.
2. A malaria vaccine in Mozambican children during a phase IIb trial. Vaccine 2011, 29:6059-6067.
3. A malaria vaccine in prevention of Plasmodium falciparum disease in Mozambican children: single-blind extended follow-up of a randomised controlled trial. Lancet 2005, 366:2012-2018.
4. A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial. Lancet 2004, 364:1411-1420.
5. D malaria candidate vaccines administered according to different schedules to Ghanaian children. PLoS ONE 2011, 6:e18891.
6. D candidate malaria vaccine in infants living in a highly endemic area of Mozambique: a double blind randomised controlled phase I/IIb trial. Lancet 2007, 370:1543-1551.
7. Bojang K., Milligan P., Pinder M., Doherty T., Leach A., Ofori-Anyinam O., Lievens M., Kester K., Schaecher K., Ballou W.R., Cohen J. Five year safety and immunogenicity of GlaxoSmithKline's candidate malaria vaccine RTS,S/AS02 following administration to semi-immune adult men living in a malaria-endemic region of The Gambia. Hum. Vaccin. 2009, 5:242-247.
8. Bojang K.A., Milligan P.J.M., Pinder M., Vigneron L., Alloueche A., Kester K.E., Ballou W.R., Conway D.J., Reece W.H.H., Gothard P., Yamuah L., Delchambre M., Voss G., Greenwood B.M., Hill A., McAdam K.P.W.J., Tornieporth N., Cohen J.D., Doherty T. Efficacy of RTS,S/AS02 malaria vaccine against Plasmodium falciparum infection in semi-immune adult men in The Gambia: a randomised trial. Lancet 2001, 358:1927-1934. for the RTS,S Malaria Vaccine Trials Team.
9. A candidate malaria vaccine in Gambian children. Vaccine 2005, 23:4148-4157.
10. Cohen J., Nussenzweig V., Nussenzweig R., Vekemans J., Leach A. From the circumsporozoite protein to the RTS,S/AS candidate vaccine. Hum. Vaccin. 2010, 6:90-96.
11. DeCubellis J., Graham J. Gastrointestinal disease in guinea pigs and rabbits. Vet. Clin. North Am. Exot. Anim Pract. 2013, 16:421-435.
12. Didierlaurent A.M., Collignon C., Bourguignon P., Wouters S., Fierens K., Fochesato M., Dendouga N., Langlet C., Malissen B., Lambrecht B., Garçon N., Van Mechelen M., Morel S. Enhancement of adaptive immunity by the human vaccine adjuvant AS01 depends on activated dendritic cells. J. Immunol. 2014, 193:1920-1930.
13. Diehl K.-H., Hull R., Morton D., Pfister R., Rabemampianina Y., Smith D., Vidal J.-M., van de Vorstenbosch C. A good practice guide to the administration of substances and removal of blood, including routes and volumes. J. Appl. Toxicol. 2001, 21:15-23.
14. Doherty J.F., Pinder M., Tornieporth N., Carton C., Vigneron L., Milligan P., Ballou W.R., Holland C.A., Kester K.E., Voss G., Momin P., Greenwood B.M., McAdam K.P.W.J., Cohen J. A phase I safety and immunogenicity trial with the candidate malaria vaccine RTS,S/SBAS2 in semi-immune adults in The Gambia. Am. J. Trop. Med. Hyg. 1999, 61:865-868.
15. European Medicines Agency. Note for Guidance on Preclinical Pharmacological and Toxicological Testing of Vaccines. (1997) . http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004004.pdf.
16. European Medicines Agency. Guideline on adjuvants in vaccines for human use. (2005) . http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003809.pdf.
17. Gabay C., Kushner I. Acute-phase proteins and other systemic responses to inflammation. N. Engl. J. Med. 1999, 340:448-454.
18. Garçon N., Heppner D.G., Cohen J. Development of RTS,S/AS02: a purified subunit-based malaria vaccine candidate formulated with a novel adjuvant. Expert Rev. Vaccines 2003, 2:231-238.
19. A malaria vaccine: further results from a phase IIb trial in Mozambican children. PLoS ONE 2009, 4:e5165.
20. Huynh M., Vilmouth S., Gonzalez M.S., Calvo Carrasco D., Di Girolamo N., Forbes N.A. Retrospective cohort study of gastrointestinal stasis in pet rabbits. Vet. Rec. 2014, 175:225.
21. Kester K.E., Cummings J.F., Ockenhouse C.F., Nielsen R., Hall B.T., Gordon D.M., Schwenk R.J., Krzych U., Holland C.A., Richmond G., Dowler M.G., Williams J., Wirtz R.A., Tornieporth N., Vigneron L., Delchambre M., Demoitié M.A., Ballou W.R., Cohen J., Heppner D.G. Phase 2a trial of 0, 1, and 3 month and 0, 7, and 28 day immunization schedules of malaria vaccine RTS,S/AS02 in malaria-naive adults at the Walter Reed Army Institute of Research. Vaccine 2008, 26:2191-2202.
22. A in malaria-naive adults: safety, efficacy, and immunologic associates of protection. J. Infect. Dis. 2009, 200:337-346.
23. A in malaria-naive adults. Vaccine 2007, 25:5359-5366.
24. Lalvani A., Moris P., Voss G., Pathan A.A., Kester K.E., Brookes R., Lee E., Koutsoukos M., Plebanski M., Delchambre M., Flanagan K.L., Carton C., Slaoui M., Van Hoecke C., Ballou W.R., Hill A.V.S., Cohen J. Potent induction of focused Th1-type cellular and humoral immune responses by RTS,S/SBAS2, a recombinant Plasmodium falciparum malaria vaccine. J. Infect. Dis. 1999, 180:1656-1664.
25. Leach A., Vekemans J., Lievens M., Ofori-Anyinam O., Cahill C., Owusu-Agyei S., Abdulla S., Macete E., Njuguna P., Savarese B., Loucq C., Ballou W.R. Design of a phase III multicenter trial to evaluate the efficacy of the RTS,S/AS01 malaria vaccine in children across diverse transmission settings in Africa. Malar. J. 2011, 10:224. Clinical Trials Partnership Committee.
26. Lell B., Agnandji S., von Glasenapp I., Haertle S., Oyakhiromen S., Issifou S., Vekemans J., Leach A., Lievens M., Dubois M.-C., Demoitié M.-A., Carter T., Villafana T., Ballou W.R., Cohen J., Kremsner P.G. A randomized trial assessing the safety and immunogenicity of AS01 and AS02 adjuvanted RTS,S malaria vaccine candidates in children in Gabon. PLoS ONE 2009, 4:e7611.
27. A candidate malaria vaccine in children aged 1-4 in Mozambique. Trop. Med. Int. Health 2007, 12:37-46.
28. Macete E.V., Sacarlal J., Aponte J.J., Leach A., Navia M.M., Milman J., Guinovart C., Mandomando I., López-Púa Y., Lievens M., Owusu-Ofori A., Dubois M.C., Cahill C.P., Koutsoukos M., Sillman M., Thompson R., Dubovsky F., Ballou W.R., Cohen J., Alonso P.L. Evaluation of two formulations of adjuvanted RTS,S malaria vaccine in children aged 3 to 5 years living in a malaria-endemic region of Mozambique: a Phase I/IIb randomized double-blind bridging trial. Trials 2007, 8:11.
29. Mettens P., Dubois P.M., Demoitié M.-A., Bayat B., Donner M.-N., Bourguignon P., Stewart V.A., Heppner D.G., Garcon N., Cohen J. Improved T cell responses to Plasmodium falciparum circumsporozoite protein in mice and monkeys induced by a novel formulation of RTS,S vaccine antigen. Vaccine 2008, 26:1072-1082.
30. E malaria candidate vaccines given according to different schedules in Ghanaian children. PLoS ONE 2009, 4:e7302.
31. B in adults in a high malaria transmission area. PLoS ONE 2009, 4:e6465.
32. Roll Back Malaria. The global malaria action plan. (2008) . http://www.rbm.who.int/gmap/gmap.pdf.
33. Sacarlal J., Aide P., Aponte J.J., Renom M., Leach A., Mandomando I., Lievens M., Bassat Q., Lafuente S., Macete E., Vekemans J., Guinovart C., Sigaúque B., Sillman M., Milman J., Dubois M.C., Demoitié M.A., Thonnard J., Menéndez C., Ballou W.R., Cohen J., Alonso P.L. Long-term safety and efficacy of the RTS,S/AS02A malaria vaccine in Mozambican children. J. Infect. Dis. 2009, 200:329-336.
34. A. Vaccine 2006, 24:6483-6492.
35. Stewart V.A., Walsh D.S., McGrath S.M., Kester K.E., Cummings J.F., Voss G., Delchambre M., Garçon N., Cohen J.D., Heppner D.G. Cutaneous delayed-type hypersensitivity (DTH) in a multi-formulation comparator trial of the anti-falciparum malaria vaccine candidate RTS,S in rhesus macaques. Vaccine 2006, 24:6493-6502.
36. A in adults in a hyperendemic region of western Kenya. Am. J. Trop. Med. Hyg. 2006, 75:166-170.
37. Stoute J.A., Slaoui M., Heppner D.G., Momin P., Kester K.E., Desmons P., Wellde B.T., Garçon N., Krzych U., Marchand M., Ballou W.R., Cohen J.D. A preliminary evaluation of a recombinant circumsporozoite protein vaccine against Plasmodium falciparum malaria. N. Engl. J. Med. 1997, 336:86-91. for the RTS,SMalaria Vaccine Evaluation Group.
38. A phase 3 trial of RTS, S/AS01 malaria vaccine in African infants. N. Engl. J. Med. 2012, 367:2284-2295. The RTS,SClinical Trials Partnership.
39. Thuilliez C., Dorso L., Howroyd P., Gould S., Chanut F., Burnett R. Histopathological lesions following intramuscular administration of saline in laboratory rodents and rabbits. Exp. Toxicol. Pathol. 2009, 61:13-21.
40. World Health Organisation. WHO guidelines on nonclinical evaluation of vaccines - Technical Report Series, No 927. (2005) . http://www.who.int/biologicals/publications/trs/areas/vaccines/nonclinical_evaluation/ANNEX%201Nonclinical.P31-63.pdf?ua=1.