Safety and immunogenicity of REMUNE(TM) in HIV-infected Thai subjecgts

Vaccine

Volumn 16, Issue 2-3, 1998, Pages 142-149

  Limsuwan, Anuwat ^a   Churdboonchart, Vina ^a   Moss, Ronald B ^b   Sirawaraporn, Worachart ^a   Sutthent, Reungpung ^a   Smutharaks, Buranaj ^a   Glidden, David ^c   Trauger, Richard ^b   Theofan, Georgia ^b   Carlo, Dennis ^b  

^a MAHIDOL UNIVERSITY   (Thailand)

^b Orchestra Therapeutics Inc   (United States)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

Clinical trial; HIV; HIV 1 immunoen; Immunogenicity; REMUNE(TM); Safety; Thailand

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS VACCINE; IMMUNOMODULATING AGENT;

ADULT; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG SAFETY; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNIZATION; IMMUNOBLOTTING; IMMUNOGENICITY; INTRAMUSCULAR DRUG ADMINISTRATION; MALE; PRIORITY JOURNAL; THAILAND;

EID: 0031986269     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0264-410X(97)88327-2     Document Type: Article

References (24)

1. 1 Cohen, J. The Epidemic in Thailand. Science 1994, 266, 1647
2. 2 Levine, A., Groshen, S., Allen, J., Munson, K., Carlo, D.J., Daigle, A.E., Ferre, F., Jensen, F.C., Richieri, S.P., Trauger, R.J., Parker, J., Salk, P. and Salk, J. Initial studies on active immunization of HIV infected subjects using a gp-120 depleted HIV-1 immunogen: long-term follow-up. J. AIDS 1996, 11, 351-364.
3. 3 Trauger, R.J., Daigle, A.E. and Giermakowska, W. et al. Safety and immunogenicity of a gp120-depleted, inactivated HIV-1 immunogen: results of a double-blind adjuvant controlled trial. J. AIDS Hum. Retrovirol. 1995, 10, (Suppl. 2), 74-82.
4. 4 Trauger, R.J., Ferre, F., Daigle, A.E., Jensen, F.C., Moss, R.B., Mueller, S.H., Richieri, S.P., Slade, H.B. and Carlo, D.J. Effect of immunization with inactivated gp120-depleted human immunodeficiency virus type 1 (HIV-1) immunogen on HIV-1 immunity, viral DNA, and percentage of CD4 cells. J. Infect. Dis. 1994, 169, 1256-1264.
5. 5 Gaywee, J., Artenstein, A.W., VanCott, T.C., Trichavaroj, R., Suklchamnong, A., Amlee, P., de Souza, M., McCutchan, F.E., Carr, J.K., Markowitz, L.E., Michael, R. and Nittayaphan, S. Correlation of genetic and serologic approaches to HIV-1 subtyping in Thailand. J. AIDS Hum. Retrovirol. 1996, 13, 392-396.
6. 6 Turner, J.L., Trauger, R.J., Daigle, A.E. and Carlo, D.J. HIV-1 immunogen induction of HIV-1-specific delayed-type hypersensitivity: results of a double-blind, adjuvant-controlled, dose-ranging trial. AIDS 1994, 8, 1429-1435.
7. 7 Moss, R.B., Ferre, F., Trauger, R., Jensen, F., Daigle, A., Richieri, S.P. and Carlo, D.J. Inactivated HIV-1 immunogen: impact on markers of disease progression. J. AIDS 1994, 7, S21-S27.
8. 8 Prior, C., Bay, P., Ebert, B., Gore, R., Holt, J., Irish, T., Jensen, F., Leone, C., Mitschelen, J., Stiglitz, M., Tarr, C., Trauger, R., Weber, D. and Hrinda, M. Process development for the manufacture of inactivated HIV-1. BioPharm. 1995, 8, 23-35.
9. 9 Laemmli, U.K. Cleavage of structural proteins during the assembly of the head of bacteriophage T4. Nature 1970, 227, 680-685.
10. 10 Churdboonchart, V., Bhamarapravati, N., Peampramprecha, S., Sirinavin, S. Antibodies against Dengue viral proteins in primary and secondary Dengue hemorrhagic fever. Am. J. Trop. Med. Hyg., 1991, 44, 481-493.
11. 11 Pau, C-P., Lee-Thomas, S. and Auwanit, W. et al. Highly specific V-3 peptide enzyme immunoassay for serotyping HIV-1 specimens from Thailand. AIDS 1993, 7, 337-340.
12. 12 Delwart, E.L., Shaper, E.G., Loawagie, J., McCutchan, F.E., Grez, M., Rubsamen-Waigmann, H. and Mullins, J.I. Genetic relationships determined by a DNA heteroduplex mobility assay: analysis of HIV-1 env genes. Science 1993, 262, 1257-1261.
13. 13 Revets, H., Marissens, D., De Wit, S., Lacor, P., Clumeck, N., Lauwers, S. and Zissis, G. Comparative evaluation of NASBA HIV-1 RNA QT, AMPLICORE-HIV monitor, and QUANTIPLEX HIV RNA assay, three methods for quantification of human immunodeficiency virus type 1 RNA in plasma. J. Clin. Microbiol. 1996, 34, 1058-1064.
14. 14 Hughes, M.D., Johnson, V.A., Hirsch, M.S. and Bremer, J.W. et al. Monitoring plasma HIV-1 RNA levels in addition to CD4+ lymphocyte count improves assessment of antiretroviral therapeutic response. Ann. Internal Med. 1997, 126, 929-938.
15. 15 Getchell, J.P., Hicks, D.R., Srinivasan, A., Heath, J.L., York, D.A., Malonga, M., Forthal, D.N., Mann, J.M. and McCormick, J.B. Human immunodeficiency virus isolated from a serum sample collected in 1976 in Central Africa. J. Infect. Dis. 1987, 156, 833-837.
16. 16 Kalish, M.L., Chi-Cheng, L., Weniger, B.G., Khanchit, L., Young, N., Ghin-Yih, O. and Schochetman, G. Early HIV type 1 strains in Thailand were not responsible for the current epidemic. J. AIDS: Sequence Note 1994, 10, 1573-1575.
17. 17 Kalish, M.L., Baldwin, A. and Raktham, S. et al. The evolving molecular epidemiology of HIV-1 envelope subtypes in injecting drug users in Bangkok, Thailand: implications for HIV vaccine trials. AIDS 1995, 9, 851-857.
18. 18 McChutchan, F.E., Hegerich, P.A. and Brennan, T.P. et al. Genetic variants of HIV-1 in Thailand. AIDS Res. Hum. Retrovirol. 1992, 8, 1887-1895.
19. 19 Walker, C.M. and Levy, J.A. A diffusible lymphokine produced by CD8+ T lymphocytes suppresses HIV replication. Immunology 1989, 66, 628-630.
20. 20 Cocchi, F., DeVico, A.L., Garzino-Demo, A., Arya, S.K., Gallo, R.C. and Lusso, P. Identification of RANTES, MIP-1α and MIP1β as the major HIV-suppressive factors produced by CD8+ T cells. Science 1995, 270, 1811-1815.
21. 21 Moss, R.B., Trauger, R.J., Giermakowska, W.K., Turner, J.L., Wallace, M.R., Jensen, F.C., Richieri, S.P., Ferre, F., Daigle, A.E., Duffy, C., Theofan, G. and Carlo, D.J. Effect of immunization with an inactivated gp120 depleted HIV-1 immunogen (REMUNE™) on β chemokine and cytokine production in subjects with HIV-1 infection. J. AIDS Hum. Retrovirol. 1997, 14, 343-350.
22. 22 Moss, R.B., Wallace, M.R., Turner, J.L. et al. A comparison of the effect of immunization with a gp-120 depleted inactivated HIV-1 in Incomplete Freund's Adjuvant (HIV-1 Immunogen) compared with immunization with an influenza vaccine on virus specific immune function. Poster no. 119, Conference on Advances in AIDS Vaccine Development: Ninth Annual Meeting of the National Cooperative Vaccine Development Groups for AIDS, 4-7 May 1997.
23. 23 Moss, R.B., Ferre, F., Levine, A., Turner, J., Jensen, F., Daigle, A.E., Richieri, S.P., Truckenbrod, A., Trauger, R.J., Carlo, D.J. and Salk, J. Viral load, CD4 percentage, and delayed type hypersensitivity in subjects receiving the HIV-1 immunogen and anti-viral drug therapy. J. Clin. Immunol. 1996, 16, 266-271.
24. 24 Ferre, F., Moss, R.B., Daigle, A.E., Trauger, R.J., Richieri, S.P., Jensen, F. and Carlo, D.J. Combination therapies against HIV-1 infection: exploring the concept of combining anti-retroviral drug treatments with HIV-1 immune-based therapies in asymptomatic individuals. AIDS Patient Care and STDs 1996, 10, 357-361.