A pilot phase II study of the safety and immunogenicity of HIV p17/p24:VLP (p24-VLP) in asymptomatic HIV seropositive subjects

Journal of Infection

Volumn 35, Issue 3, 1997, Pages 231-235

  Peters, B S ^a,c   Cheingsong Popov, R ^a   Callow, D ^a   Foxall, R ^a   Patou, G ^d   Hodgkin, K ^b   Weber, J N ^a  

^a IMPERIAL COLLEGE LONDON   (United Kingdom)

^b British Biotech Pharmaceuticals

^c ST THOMAS HOSPITAL   (United Kingdom)

^d NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY; ANTIGEN P24; CD4 ANTIGEN; CD8 ANTIGEN; HUMAN IMMUNODEFICIENCY VIRUS ANTIGEN;

ADULT; ANTIBODY TITER; ARTICLE; CELLULAR IMMUNITY; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HUMORAL IMMUNITY; IMMUNE RESPONSE; IMMUNOGENICITY; INTRAMUSCULAR DRUG ADMINISTRATION; LYMPHOCYTE COUNT; MALE; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SERODIAGNOSIS; VACCINATION; VIRUS CULTURE;

EID: 0031468349     PISSN: 01634453     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0163-4453(97)92814-0     Document Type: Article

References (27)

1. Volberding P, Stephen W et al. Zidovudine in asymptomatic human immunodeficiency virus infection. A controlled trial in persons with fewer than 500 CD4 positive cells per cubic millimetre. N Engl J Med 1990; 322: 941-949.
2. Concorde Coordinating Committee. Concorde:MRC/ANRS randomised double-blind controlled trial of immediate and deferred zidovudine in symptom-free HIV infection. Lancet 1994; 343: 871-881.
3. Larder BA, Darby G, Richman DD. HIV reduced sensitivity to zidovudine (AZT) isolated during prolonged therapy. Science 1989; 243: 1731-1734.
4. Wainberg MA, Salomon H, Gu Z et al. Development of HIV-1 resistance to (-)2′-deoxy-3′-thiacytidine in patients with AIDS or advanced AIDS-related complex. AIDS 1995; 9: 351-357.
5. Weinberg MA, Drosopoulos WC, Salomon H et al. Enhanced fidelity of 3TC-selected mutant HIV-1 reverse transcriptase. Science 1996; 271: 1282-1285.
6. Jacobsen H, Hangii M. Ott M et al. In vivo resistance to a human immunodeficiency virus type 1 proteinase inhibitor: mutations, kinetics, and frequencies. J Inf Dis 1996; 173: 1379-1387.
7. Corey P, Holmes KK. Therapy for human immunodeficiency virus infection-what have we learned? NEJM 1996; 335: 1142-1144.
8. Salk J. Prospects for the control of AIDS by immunising sero-positive individuals. Nature 1987; 327: 473-476.
9. Levine AM, Groshen S. Allen J et al. Initial studies on active immunization of HIV-1 infected subjects using a gp120-depleted HIV-1 Immunogen: long-term follow-up. J Acquir Immunodefic Syndr Hum Retrovir 1996; 11: 351-364.
10. Solognesi DP. The immune response to HIV: implications for vaccine development. Seminars in Immunology 1993; 5: 203-214.
11. Clerlci M, Tacket CO, Via CS et al. Immunisation with subunit human immmunodeficiency virus vaccine generates stronger T-helper cell immunity than neutral infection. Eur J Immunol 1991; 21: 1345-1349.
12. Redfield RR, Birx DL, Ketter N et al. A phase I evaluation of the safety and immunogenicity of vaccination with recombinant gp160 in patients with early human immunodeficiency virus infection. N Engl J Med 1991; 324: 1677-1684.
13. Loomis LD, Deal CD, Kersey KS et al. Humoral responses to linear epitopes on the HIV-1 envelope in seropositive volunteers after vaccine therapy with rgp 160. J Acquir Immunodefic Syndr Hum Retrovir 1995; 10: 13-26.
14. Allain JP, Laurian Y, Paul DA. Serological markers in early stages of human immunodeficiency virus infection in haemophiliacs. Lancet 1986; ii: 1233-1236.
15. De Wolf F, Goudsmit J, Paul DA et al. Risk of AIDS-related complex and AIDS in homosexual men with persistent HIV antigenaemia. BMJ 1987; 295: 569-572.
16. Cheingsong-Popov R, Panagiotidi C, Bowcock S et al. Relation between humoral responses to HIV gag and env proteins at seroconversion and clinical outcome of HIV infection. BMJ 1987; 302: 23-26.
17. Sheppard HW, Asher MS. The relationship between AIDS and immunologic tolerance. J Acquir Immune Defic Syndr 1992; 5: 143-147.
18. Pedersen C, Nielsen CM, Vestergaard BF et al. Temporal relation of antigenaemia and loss of antibodies to core antigens to development of clinical disease in HIV infection. BMJ 1987: 295: 567-569.
19. Morand-Joubert L, Bludau H, Lerable J et al. Serum anti-p24 antibody concentration had a predictive value on the decrease of CD4 lymphocyte count higher than acid-dissociated p24 antigen. J Med Virol 1995; 47: 87-91.
20. Chargelegue D, Stanley CM, O'Toole CM et al. The absence of loss of antibodies of high affinity to human immunodeficiency virus (HIV) is associated with disease progression in HIV-1 infected patients. J inf Dis 1995; 172: 89-898.
21. Strathdee SA, Frank JW, McLaughlin J et al. Quantitative measures of human immununodeficiency virus-specific antibodies predict progression to AIDS, J Inf Dis 1995; 172: 1375-1379.
22. Gibbs CJ, Peters R, Gravell M et al. Observations after human immunodeficiency virus immunisation and challenge of human immunodeficiency virus seropositive and seronegative chimpanzees. Proc Natl Acad Sci USA 1991; 88: 3348-3352.
23. Adams SE, Dawson KM, Gull K et al. The expression of hybrid HIV: Ty virus-like particles in yeast. Nature 1987; 329: 68-70.
24. Adams S, Patou G. p24-VLP: immunotherapeutic vaccine for AIDS. Drugs of the future 1983; 18: 1124-1128.
25. Martin S, Vyakarnam A, Cheingsong-Popov R et al. Immunization of human HIV-seronegative volunteers with recombinant p17/p24: Ty virus-like particles elicits HIV-1 p24-specific cellular and humoral immune responses. AIDS 1993; 7: 1315-1323.
26. Weber J, Cheingsong-Popov R, Callow D et al. Immunogenicity of the yeast recombinant p17/p24: Ty virus-like particles (p-24-VLP) in health volunteers. Vaccine 1995; 13: 831-834.
27. Wahren B, Bratt G, Persson C et al. Improved cell-mediated immune responses in HIV-1 infected asymptomatic individuals after immunization with envelope glycoprotein gp160. Journal of AIDS 1994; 7: 220-229.