Vaccine trials in the developing world: Operational lessons learnt from a phase IV poliomyelitis vaccine trial in South Africa

Vaccine

Volumn 30, Issue 40, 2012, Pages 5839-5843

  Geldenhuys, H ^a,b   Waggie, Z ^a,b   Jacks, M ^a,b   Geldenhuys, M ^a,b   Traut, L ^a,b   Tameris, M ^a,b   Hatherill, M ^a,b   Hanekom, W A ^a,b   Sutter, R ^c   Hussey, G ^a,b   Mahomed, H ^a,b  

^a UNIVERSITY OF CAPE TOWN   (South Africa)

^b UNIVERSITY OF CAPE TOWN   (South Africa)

^c WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

Clinical trial operations; Developing world clinical trials; Poliomyelitis vaccines; Vaccine trial operations

Indexed keywords

POLIOMYELITIS VACCINE;

ARTICLE; CLINICAL TRIAL (TOPIC); COMMUNITY CARE; COST CONTROL; DRUG STORAGE; FORECASTING; HEALTH CARE PERSONNEL; HEALTH CARE SYSTEM; HUMAN; MEDICAL EDUCATION; PHASE 4 CLINICAL TRIAL; POLIOMYELITIS; PRIORITY JOURNAL; PROBLEM SOLVING; REFRIGERATOR; RURAL AREA; SOUTH AFRICA;

CLINICAL TRIALS, PHASE IV AS TOPIC; FORECASTING; HEALTH PERSONNEL; HEALTH SERVICES NEEDS AND DEMAND; HUMANS; PATIENT SELECTION; POLIOMYELITIS; POLIOVIRUS VACCINES; RESEARCH DESIGN; SOUTH AFRICA; WORLD HEALTH ORGANIZATION;

EID: 84864806643     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.07.026     Document Type: Article

References (14)

1. Clemens J., Jodar L. Introducing new vaccines into developing countries: obstacles, opportunities and complexities. Nat Med 2005, 11(4 Suppl.):S12-S15.
2. Cutts F.T., Enwere G., Zaman S.M., Yallop F.G. Operational challenges in large clinical trials: examples and lessons learned from the gambia pneumococcal vaccine trial. PLoS Clin Trials 2006, 1(3):e16.
3. Waggie Z., Geldenhuys H., Sutter R.W., Jacks M., Mulenga H., Mahomed H., et al. Randomized trial of type 1 and type 3 oral monovalent poliovirus vaccines in newborns in Africa. J Infect Dis 2012, 205(2):228-236.
4. Abel B., Tameris M., Mansoor N., Gelderbloem S., Hughes J., Abrahams D., et al. The novel TB vaccine, AERAS-402, induces robust and polyfunctional CD4 and CD8 T cells in adults. Am J Respir Crit Care Med 2009, 2010:10-1484.
5. Hawkridge T., Scriba T.J., Gelderbloem S., Smit E., Tameris M., Moyo S., et al. Safety and immunogenicity of a new tuberculosis vaccine, MVA85A, in healthy adults in South Africa. J Infect Dis 2008, 198(4):544-552.
6. Scriba T.J., Tameris M., Mansoor N., Smit E., van der Merwe L., Isaacs F., et al. Modified vaccinia Ankara-expressing Ag85A, a novel tuberculosis vaccine, is safe in adolescents and children, and induces polyfunctional CD4+ T cells. Eur J Immunol 2009, 40(1):279-290.
7. Hawkridge A., Hatherill M., Little F., Goetz M.A., Barker L., Mahomed H., et al. Efficacy of percutaneous versus intradermal BCG in the prevention of tuberculosis in South African infants: randomised trial. BMJ 2008, 337:a2052.
8. English R. Annual health status report 2008, Department of Health: Boland/Overberg Region, Worcester.
9. Barron P., Day C., Monticelli F., Sello E. The district health barometer 2007/8 2008, Health Systems Trust, Durban.
10. SA Department of Health Guidelines for good clinical practice in the conduct of clinical trials with human participants in South Africa 2006, Department of Health, Pretoria, South Africa.
11. Silver S., Page J., Geldenhuys M., Hussey G., Hawkridge A., Mazod D., et al. A professional development model in clinical research for developing countries. Monitor 2008, 22.
12. Geldenhuys M., Page J., Silver S., Geiter L., Hussey G. Teaching clinical research to all: the Aeras-SATVI/UCT Professional Development Programme. Prof Nurs Today 2005, 9(55).
13. Hunninghake D.B., Darby C.A., Probstfield J.L. Recruitment experience in clinical trials: literature summary and annotated bibliography. Control Clin Trials 1987, 8(4 Suppl.):6S-30S.
14. World Health Organization Product information sheets 2000, World Health Organization, Geneva, Retrieved from: http://www.who.int/vaccines-documents/DocsPDF00/www518.pdf.