Laboratory expansion to large-scale international HIV preventive vaccine trials

Current Opinion in HIV and AIDS

Volumn 2, Issue 3, 2007, Pages 201-206

  Gilmour, Jill W ^a   Stevens, Wendy S ^b   Gray, Clive ^c   De Souza, Mark ^d  

^a CHELSEA AND WESTMINSTER HOSPITAL   (United Kingdom)

^b UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^c NATIONAL INSTITUTE FOR COMMUNICABLE DISEASES   (South Africa)

^d HENRY M JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE   (United States)

Author keywords

AIDS vaccine trial; Good clinical laboratory practices; Standardization

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS VACCINE;

AFRICA; ASIA; CD4+ T LYMPHOCYTE; CENTRAL AMERICA; CLINICAL PRACTICE; CLINICAL TRIAL; DATA ANALYSIS; DRUG EFFICACY; DRUG SAFETY; ENZYME LINKED IMMUNOSPOT ASSAY; FLOW CYTOMETRY; GENITAL SYSTEM; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOGENICITY; INFECTION CONTROL; INTESTINE MUCOSA; LYMPHOCYTE COUNT; MUCOSAL IMMUNITY; PRIORITY JOURNAL; REVIEW; STATISTICAL SIGNIFICANCE; THAILAND; UNITED STATES; VIRUS LOAD; VIRUS STRAIN;

EID: 34250662272     PISSN: 1746630X     EISSN: 17466318     Source Type: Journal    
DOI: 10.1097/COH.0b013e3280eec77a     Document Type: Review

References (44)

1. Fast P. Recent trends in clinical trials of vaccines to prevent HIV/AIDS. Curr Opin HIV/AIDS 2006; 1:267-271. High-quality trials can be conducted in resource-poor settings. This article reviews the steps and current status of such trials.
2. WHO/UNAIDS/IACI Expert Group. Executive summary and recommendations from the WHO/UNAIDS/IAVI Expert Group Consultation on 'Phase II-B TOC trials as a novel strategy for evaluation of preventive HIV vaccines', 31 January-2 February 2006, IAVI, New York, USA. AIDS 2006; 21:539-546. Describes the design of TOC trials to accelerate selection of AIDS vaccine candidates.
3. Rida W, Fast P, Hoff R, Fleming T. Intermediate-size trials for the evaluation of HIV vaccine candidates: a workshop summary. J Acquir Immune Defic Syndr Hum Retrovirol 1997; 16:195-203.
4. Joint UN Programme on HIV/AIDS (UNAIDS). Report on the global AIDS epidemic 2006. Available at: http://www.unaids.org/en/HIV_data/2006GlobalReport/ default.asp.[Accessed February 2007]
5. Robinson HL, Weinhold KJ. Phase 1 clinical trials of the National Institutes of Health Vaccine Research Center HIV/AIDS candidate vaccines. J Infect Dis 2006; 194:1625-1627.
6. Excler JL. AIDS vaccine efficacy trials: expand capacity and prioritize. 'Throughout Africa, Asia and Latin America state-of-the-art clinics and laboratories. . . exist where, 4 years ago, there were none'. Expert Rev Vaccines 2006; 5:167-170. The identification of high-incidence cohorts to accelerate TOC AIDS vaccine trials.
7. Martin R, Hearn TL, Ridderhof JC, Demby A. Implementation of a quality systems approach for laboratory practice in resource-constrained countries. AIDS 2005; 19 (Suppl. 2):S59-S65.
8. Fast P, Excler J, Warren M, Ketter N. Clinical site development and preparation for AIDS vaccine efficacy trials in developing countries, Chapter 12. In: Koff W, Kahn P, Gust ID, editors. AIDS vaccine development: challenges and opportunities. Norwich, UK: Caister Academic Press; 2007. An overview describing what is needed to prepare vaccine trial sites for large-scale efficacy trials.
9. Stiles T, Grant V, Mawby N. Good Clinical Laboratory Practice (GCLP) - a quality system for laboratories that undertake the analyses of samples from clinical trials. Ipswich, UK: BARQA; 2003.
10. Stevens W. Good clinical laboratory practice (GCLP): the need for a hybrid of good laboratory practice and good clinical practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Qual Assur 2003; 10:83-89.
11. Banoo S, Bell D, Bossuyt P, et al. Evaluation of diagnostic tests for infectious diseases: general principles. Nat Rev Microbiol 2006; 4:S21-S31.
12. Khurana S, Needham J, Mathieson B, et al. Human immunodeficiency virus (HIV) vaccine trials: a novel assay for differential diagnosis of HIV infections in the face of vaccine-generated antibodies. J Virol 2006; 80:2092-2099.
13. Khurana S, Needham J, Park S, et al. Novel approach for differential diagnosis of HIV infections in the face of vaccine-generated antibodies: utility for detection of diverse HIV-1 subtypes. J Acquir Immune Defic Syndr 2006; 43:304-312.
14. Singer DE, Kiwanuka N, Serwadda D, et al. Use of stored serum from Uganda for development and evaluation of a human immunodeficiency virus type 1 testing algorithm involving multiple rapid immunoassays. J Clin Microbiol 2005; 43:5312-5315.
15. Morgan PA, de Souza MS, Chuenchitra T, et al. Phase I/II HIV Vaccine Trials in Thailand - the Armed Forces Research Institute of Medical Sciences (AFRIMS): role in HIV vaccine development, Chapter 4. In: Pitisuttithum P, Francis DP, Esparza J, Thongcharoen P, editors. HIV Vaccine Research and Development in Thailand. Bangkok, Thailand: Faculty of Tropical Medicine, Mahidol University; 2006. pp. 153-167.
16. Tsegaye A, Messele T, Tilahun T, et al. Immunohematological reference ranges for adult Ethiopians. Clin Diagn Lab Immunol 1999; 6:410-414.
17. Kassu A, Tsegaye A, Petros B, et al. Distribution of lymphocyte subsets in healthy human immunodeficiency virus-negative adult Ethiopians from two geographic locales. Clin Diagn Lab Immunol 2001; 8:1171-1176.
18. Chin SF, Cheong SK, Lim YC, Ton SH. The distribution of immunoregulatory cells in the peripheral blood of normal Malaysian adults. Malays J Pathol 1993; 15:49-52.
19. Choong ML, Ton SH, Cheong SK. Influence of race, age and sex on the lymphocyte subsets in peripheral blood of healthy Malaysian adults. Ann Clin Biochem 1995; 32:532-539.
20. Lugada ES, Mermin J, Kaharuza F, et al. Population-based hematologic and immunologic reference values for a healthy Ugandan population. Clin Diagn Lab Immunol 2004; 11:29-34.
21. Badenhorst CJ, Fourie J, Steyn K, et al. The haematological profile of urban black Africans aged 15-64 years in the Cape Peninsula. East Afr Med J 1995; 72:19-24.
22. Sahr F, Hazra PK, Grillo TA. White blood cell count in healthy Sierra Leoneans. West Afr J Med 1995; 14:105-107.
23. Bofill M, Janossy G, Lee CA, et al. Laboratory control values for CD4 and CD8 T lymphocytes. Implications for HIV-1 diagnosis. Clin Exp Immunol 1992; 88:243-252.
24. Pagana KD, Pagana TJ. Mosby's manual of diagnostic and laboratory tests. 2nd ed. St Louis: Mosby; 2002.
25. Bain BJ. Ethnic and sex differences in the total and differential white cell count and platelet count. J Clin Pathol 1996; 49:664-666.
26. Gill GV, England A, Marshal C. Low platelet counts in Zambians. Trans R Soc Trop Med Hyg 1979; 73:111-112.
27. Ezeilo GC. Nongenetic neutropenia in Africans. Lancet 1972; 2:1003-1004.
28. Maini MK, Gilson RJ, Chavda N, et al. Reference ranges and sources of variability of CD4 counts in HIV-seronegative women and men. Genitourin Med 1996; 72:27-31.
29. Tugume SB, Piwowar EM, Lutalo T, et al. Hematological reference ranges among healthy Ugandans. Clin Diagn Lab Immunol 1995; 2:233-235.
30. Urassa WK, Mbena EM, Swai AB, et al. Lymphocyte subset enumeration in HIV seronegative and HIV-1 seropositive adults in Dar es Salaam, Tanzania: determination of reference values in males and females and comparison of two flow cytometric methods. J Immunol Meth 2003; 277:65-74.
31. Menard D, Mandeng MJ, Tothy MB, et al. Immunohematological reference ranges for adults from the Central African Republic. Clin Diagn Lab Immunol 2003; 10:443-445.
32. Shaper AG, Lewis P. Genetic neutropenia in people of African origin. Lancet 1971; 2:1021-1023.
33. Kamali A, Kayitenkore K, Nanvubya A, et al. A cross sectional, observational study to establish clinical laboratory reference ranges in adults as part of a multicenter study in preparation for HIV vaccine efficacy trials. In: AIDS Vaccine Conference 06. Amsterdam, 29 August-1 September 2006.
34. Scott L, Lawrie D, Harvey J, et al. A comparison of the Guava personal cell analyser with PLG CD4 T-cell enumeration: a pilot evaluation. In: 11th Conference on Retroviruses and Opportunistic Infections. San Francisco, USA, 8th-11th February 2004. Abstract 962.
35. Cox J, deSouza M, Ratto-Kim S, et al. Cellular immune assays for evaluation of vaccine efficacy. In: Detrick B, Hamilton RG, Folds JD, editors. Manual of molecular and clinical laboratory immunology, 7th ed. Washington, DC: ASM Press; 2006. A detailed review of cellular assays for determining AIDS vaccine potency; their implementation and trouble shooting.
36. Kierstead LS, Dubey S, Meyer B, et al. Enhanced Rates and magnitude of immune responses detected against an HIV vaccine: effect of using an optimized process for isolating PBMC. AIDS Res Hum Retroviruses 2007; 23:86-92. Describes some of the parameters that need to be observed in order to optimize ELIspot responses in AIDS vaccine recipients.
37. Cox JH, Ferrari G, Kalams SA, et al. Results of an ELISPOT proficiency panel conducted in 11 laboratories participating in international human immunodeficiency virus type 1 vaccine trials. AIDS Res Hum Retroviruses 2005; 21:68-81.
38. Hayes P, Gill D, Tarragona T, et al. ELISPOT standardization for laboratories conducting immunogenicity testing in IAVI sponsored HIV vaccine trials. In: AIDS Vaccine Conference 06. Amsterdam, 29 August-1 September 2006. The first demonstration that the ELIspot assay can be standardized across multiple laboratories when standardized SOP, reagents and central training are adopted.
39. Maecker HT, Rinfret A, D'Souza P, et al. Standardization of cytokine flow cytometry assays. BMC Immunol 2005; 6:13.
40. Li B, Decker JM, Johnson RW, et al. Evidence for potent autologous neutralizing antibody titers and compact envelopes in early infection with subtype C human immunodeficiency virus type 1. J Virol 2006; 80:5211-5218.
41. Emini EA, Koff WC. AIDS/HIV. Developing an AIDS vaccine: need, uncertainty, hope. Science 2004; 304:1913-1914.
42. Lima R, Branch G, Muluubya A, et al. Information and communication technology (ICT): a critical tool for HIV vaccine clinical trials in resource-constrained settings. Rio de Janeiro: International AIDS Society; 2005.
43. Belyakov IM, Kuznetsov VA, Kelsall B, et al. Impact of vaccine-induced mucosal high-avidity CD8+ CTLs in delay of AIDS viral dissemination from mucosa. Blood 2006; 107:3258-3264.
44. Neeson P, Boyer J, Kumar S, et al. A DNA prime-oral Listeria boost vaccine in rhesus macaques induces a SIV-specific CD8 T cell mucosal response characterized by high levels of alpha4beta7 integrin and an effector memory phenotype. Virology 2006; 354:299-315.