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Greater viral rebound and reduced time to resume antiretroviral therapy after therapeutic immunization with the ALVAC-HIV vaccine (vCP1452).
AIDS. 2008 Jul 11; 22(11):1313-22.AIDS

Abstract

OBJECTIVE

Evaluate immunogenicity and clinical efficacy of two immunization strategies with the ALVAC-HIV-recombinant canarypox vaccine (vCP1452) in treated HIV-infected patients.

DESIGN

Randomized, double-blind, placebo-controlled, phase II study of vCP1452 immunization in chronically HIV-infected patients on therapy with CD4 T-cell count more than 350 cells/microl, CD4 nadir less than 400 cells/microl and pHIV-RNA less than 400 copies/ml. Patients were equally randomized to four injections at weeks 0, 4, 8, 20; three injections at weeks 4, 8, 20; and placebo. The primary endpoint was vaccine immunogenicity at week 24 measured by enzyme-linked immunospot-interferon-gamma against the HIV-gag-reverse transcriptase-nef vaccine sequences. Secondary endpoints included time to treatment resumption and viral quantitation following treatment interruption at week 24. Criteria to resume therapy included CD4 T-cell count decline less than 250 cells/microl or 50% decrease from baseline or pHIV-RNA more than 50,000 copies/ml.

RESULTS

Sixty-five patients enrolled. Changes from baseline in HIV-specific T cells in the four injection arms (+480 spot-forming cells/M-peripheral blood mononuclear cell) were significant compared to placebo (+8; P = 0.014), but not in the three injection arms (+322). The week 36 pHIV-RNA (log10 copies/ml) after treatment interruption was higher in the four (4.71; P = 0.023) and three (4.82; P = 0.009) injection arms compared to placebo (4.40). Percentages of patients reaching treatment resumption criteria by week 48 were 74, 55 and 23% in the three respective arms (P = 0.013). Two independent factors influenced time to therapy resumption: immunization (hazards ratio = 2.7, P = 0.048 for three injections; hazards ratio = 4.1, P = 0.003 for four injections) and CD4 nadir (hazards ratio = 0.4, P = 0.002).

CONCLUSIONS

Significant immunogenicity was induced by vCP1452; however, this strategy was independently associated with a shorter time to resume therapy and higher viral rebound.

Authors+Show Affiliations

UPMC Univ Paris 06, UMR_543, France. brigitte.autran@psl.aphp.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18580611

Citation

Autran, Brigitte, et al. "Greater Viral Rebound and Reduced Time to Resume Antiretroviral Therapy After Therapeutic Immunization With the ALVAC-HIV Vaccine (vCP1452)." AIDS (London, England), vol. 22, no. 11, 2008, pp. 1313-22.
Autran B, Murphy RL, Costagliola D, et al. Greater viral rebound and reduced time to resume antiretroviral therapy after therapeutic immunization with the ALVAC-HIV vaccine (vCP1452). AIDS. 2008;22(11):1313-22.
Autran, B., Murphy, R. L., Costagliola, D., Tubiana, R., Clotet, B., Gatell, J., Staszewski, S., Wincker, N., Assoumou, L., El-Habib, R., Calvez, V., Walker, B., & Katlama, C. (2008). Greater viral rebound and reduced time to resume antiretroviral therapy after therapeutic immunization with the ALVAC-HIV vaccine (vCP1452). AIDS (London, England), 22(11), 1313-22. https://doi.org/10.1097/QAD.0b013e3282fdce94
Autran B, et al. Greater Viral Rebound and Reduced Time to Resume Antiretroviral Therapy After Therapeutic Immunization With the ALVAC-HIV Vaccine (vCP1452). AIDS. 2008 Jul 11;22(11):1313-22. PubMed PMID: 18580611.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Greater viral rebound and reduced time to resume antiretroviral therapy after therapeutic immunization with the ALVAC-HIV vaccine (vCP1452). AU - Autran,Brigitte, AU - Murphy,Robert L, AU - Costagliola,Dominique, AU - Tubiana,Roland, AU - Clotet,Bonaventura, AU - Gatell,Jose, AU - Staszewski,Schlomo, AU - Wincker,Norma, AU - Assoumou,Lambert, AU - El-Habib,Raphaelle, AU - Calvez,Vincent, AU - Walker,Bruce, AU - Katlama,Christine, AU - ,, PY - 2008/6/27/pubmed PY - 2008/8/22/medline PY - 2008/6/27/entrez SP - 1313 EP - 22 JF - AIDS (London, England) JO - AIDS VL - 22 IS - 11 N2 - OBJECTIVE: Evaluate immunogenicity and clinical efficacy of two immunization strategies with the ALVAC-HIV-recombinant canarypox vaccine (vCP1452) in treated HIV-infected patients. DESIGN: Randomized, double-blind, placebo-controlled, phase II study of vCP1452 immunization in chronically HIV-infected patients on therapy with CD4 T-cell count more than 350 cells/microl, CD4 nadir less than 400 cells/microl and pHIV-RNA less than 400 copies/ml. Patients were equally randomized to four injections at weeks 0, 4, 8, 20; three injections at weeks 4, 8, 20; and placebo. The primary endpoint was vaccine immunogenicity at week 24 measured by enzyme-linked immunospot-interferon-gamma against the HIV-gag-reverse transcriptase-nef vaccine sequences. Secondary endpoints included time to treatment resumption and viral quantitation following treatment interruption at week 24. Criteria to resume therapy included CD4 T-cell count decline less than 250 cells/microl or 50% decrease from baseline or pHIV-RNA more than 50,000 copies/ml. RESULTS: Sixty-five patients enrolled. Changes from baseline in HIV-specific T cells in the four injection arms (+480 spot-forming cells/M-peripheral blood mononuclear cell) were significant compared to placebo (+8; P = 0.014), but not in the three injection arms (+322). The week 36 pHIV-RNA (log10 copies/ml) after treatment interruption was higher in the four (4.71; P = 0.023) and three (4.82; P = 0.009) injection arms compared to placebo (4.40). Percentages of patients reaching treatment resumption criteria by week 48 were 74, 55 and 23% in the three respective arms (P = 0.013). Two independent factors influenced time to therapy resumption: immunization (hazards ratio = 2.7, P = 0.048 for three injections; hazards ratio = 4.1, P = 0.003 for four injections) and CD4 nadir (hazards ratio = 0.4, P = 0.002). CONCLUSIONS: Significant immunogenicity was induced by vCP1452; however, this strategy was independently associated with a shorter time to resume therapy and higher viral rebound. SN - 1473-5571 UR - https://www.unboundmedicine.com/medline/citation/18580611/Greater_viral_rebound_and_reduced_time_to_resume_antiretroviral_therapy_after_therapeutic_immunization_with_the_ALVAC_HIV_vaccine__vCP1452__ L2 - http://Insights.ovid.com/pubmed?pmid=18580611 DB - PRIME DP - Unbound Medicine ER -