Therapeutic immunization with an inactivated HIV-1 Immunogen plus antiretrovirals versus antiretroviral therapy alone in asymptomatic HIV-infected subjects

Fernández‐Cruz, Eduardo; Moreno, Santiago; Navarro, J.; Clotet, Bonaventura; Bouza, Emilio; Carbone, J.; Peña, José M.; Molina, José Pérez; Podzamczer, Daniel; Rubio, Rafael; Ocaña, I; Pulido, Federico; Viciana, Pompeyo; Maradona, José A.; Blázquez, R.; Barros, Carlos; Quereda, Carmen; Rodríguez-Sáinz, Carmen; Gil, Juana; Abad, María Fernández; Díaz, Laura; Cantó, Carmen; Munoz, Maribel; Ferrer, Esther; Jou, Antoni; Sirera, Guillem; Díaz, M. Medina; López, Francisco Valverde; Gatell, Josep M.; González-Lahoz, Juan; Team, Stir

doi:10.1016/j.vaccine.2004.03.040

Cited by 20 publications

(29 citation statements)

References 28 publications

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“…To evaluate in 115 antiretroviral naïve patients with asymptomatic HIV-1 chronic infection, who had previously participated in STIR-2102 trial, 34,35 whether or not the levels of PBMC-associated HIV-1 DNA could have prognostic value beyond the current surrogate standards for the long-term virologic outcome. 1.…”

Section: Objectivesmentioning

confidence: 99%

“…IMN is an inactivated gp120 depleted HIV-1 virion in incomplete Freund's adjuvant (IFA) that was administered intramuscularly every 3 months (M) until M36. 34,35 Patients started therapy 6 weeks prior to randomisation (baseline pre-ART) on a standard fixed two antiviral drug combination (ART), including zidovudine and didanosine. Six weeks after initiation of ART (baseline post-ART) patients were randomised to receive ART plus IMN (N = 48) or ART plus IFA (N = 67) (Fig.…”

Section: Patientsmentioning

confidence: 99%

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Prognostic value of peripheral blood mononuclear cell-associated HIV-1 DNA for virological outcome in asymptomatic HIV-1 chronic infection

Rodríguez-Sáinz

Ramos

Valor

et al. 2010

Journal of Clinical Virology

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Section: Objectivesmentioning

confidence: 99%

Section: Patientsmentioning

confidence: 99%

Prognostic value of peripheral blood mononuclear cell-associated HIV-1 DNA for virological outcome in asymptomatic HIV-1 chronic infection

Rodríguez-Sáinz

Ramos

Valor

et al. 2010

Journal of Clinical Virology

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“…Along the same line, various vaccine strategies have been proposed to help restimulate HIV-specific immunity allowing HIV-infected patients to reduce time on antiretroviral therapy (ART) [7,8]. Various therapeutic vaccine candidates including peptide-, protein-, and viral vector-based vaccines have shown modest efficacy in experimental animal models [9,10] and patients [11][12][13][14][15][16][17][18]. Some candidate vaccines, such as ALVAC or Ad5, have induced potent increase in HIV-specific immune responses [19,20].…”

mentioning

confidence: 99%

NYVAC immunization induces polyfunctional HIV‐specific T‐cell responses in chronically‐infected, ART‐treated HIV patients

et al. 2012

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We report the results of the Theravac-01 phase I trial, which was conducted to evaluate the safety and immunogenicity of a poxvirus-based vector, NYVAC, expressing Gag, Pol, Nef, and Env from an HIV clade B isolate. NYVAC-B vaccine was injected intramuscularly into ten HIV-infected patients successfully treated with antiretroviral therapy, twice on day 0 and again at week 4. Safety and immunogenicity were monitored for 48 weeks. HIV-specific T-cell responses following immunization were quantitatively analyzed using an IFN-γ ELISPOT assay and qualitatively characterized for their functional profile (including multiple cytokines secretion plus cytotoxic and proliferation capacity) by polychromatic flow cytometry. Our results indicate that the NYVAC-B vaccine is safe and highly immunogenic, as indicated by increased HIV-specific T-cell responses in virtually all vaccinees. Interestingly, both an expansion of preexisting T-cell responses, and the appearance of newly detected HIV-specific CD4 + and CD8 + T-cell responses were observed. Furthermore, immunization mostly induced an increase in Gag-specific T-cell responses. In conclusion, NYVAC-B immunization induces broad, vigorous, and polyfunctional HIV-specific T-cell responses, suggesting that poxvirus-based vaccine regimens may be instrumental in the therapeutic HIV vaccine field. Eur. J. Immunol. 2012. 42: 3038-3048 Clinical immunology 3039 IntroductionThe development of antiviral therapy has dramatically changed the course and the prognosis of HIV infection. More than 30 antiviral drugs available offer many therapeutic options for the patients and some of these drugs used in combination are able to induce long-term suppression of virus replication as indicated by the persistence of levels of viremia below the limit of detection of highly sensitive PCR assays [1]. The antiviral therapy-mediated suppression of virus replication has resulted in dramatic reduction of morbidity and mortality, and HIV infection has shifted from being a life threatening to a chronic viral disease [2]. In this regard, recent studies have estimated a life expectancy of 25-30 years for subjects with HIV infection [3,4]. Despite the long-term suppression of virus replication and the normalization of a series of immunological parameters, which are not limited to the CD4 + T-cell counts but also to the recovery of a series of antigen-specific (including HIV) immunological functions, the interruption of antiviral therapy is almost invariably associated to virus rebound [1,5]. These observations indicated that the long-term suppression of virus replication does not result in the generation of an effective HIV-specific immune response [6].For these reasons, a number of immunological interventions have been investigated in the past and are currently being investigated to stimulate HIV-specific immune responses that may efficiently control HIV replication also in the absence of antiviral therapy. Among these interventions, particular attention has been given to the development of therapeutic v...

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“…Therefore, a clear demonstration of the proof of concept of the potential benefit of therapeutic immunization in HIV infection is needed. In the last years, besides studies evaluating the immunogenicity of candidate vaccines [21][22][23][24][25][26], studies were designed in order to demonstrate the immunologic efficacy and also the capability of therapeutic immunization to control virus replication either after antiviral discontinuation [27][28][29][30]31•], or during the follow up [32][33][34]. This review highlights the results of some of these recent studies conducted in patients treated early after the primary infection (PHI) or during the chronic phase of the infection.…”

Section: Rationale and Challenges Of Therapeutic Immunizationmentioning

confidence: 99%

“…In the large multicentric STIR 2102 phase II randomized double-blind, placebo-controlled study [32], 243 asymptomatic patients with CD4+ cell counts between 300 to 700 cells/mm 3 and naïve of antivirals were randomized to receive IFA placebo alone or Remune vaccine every 12 weeks over 36 months. Six weeks before randomization, patients started antiviral a combination of two nucleoside reverse transcriptase inhibitors.…”

Section: Studies Evaluating Hiv-1 Immunogen (Remune)mentioning

confidence: 99%

Therapeutic HIV vaccines: An update

Lévy

2005

Curr HIV/AIDS Rep

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The goal of therapeutic immunization in HIV infection is to induce strong and sustained immune responses against HIV. Several arguments suggest that the immune system may contain HIV replication in the long term before declining. The potency on new antiviral regimens in clinic has provided an opportunity to improve the control of the virus replication by the immune system. In clinical terms, this might allow patients to delay or to stop antiviral therapy and to minimize the duration of the exposition to antiviral drugs.

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Therapeutic immunization with an inactivated HIV-1 Immunogen plus antiretrovirals versus antiretroviral therapy alone in asymptomatic HIV-infected subjects

Cited by 20 publications

References 28 publications

Prognostic value of peripheral blood mononuclear cell-associated HIV-1 DNA for virological outcome in asymptomatic HIV-1 chronic infection

Prognostic value of peripheral blood mononuclear cell-associated HIV-1 DNA for virological outcome in asymptomatic HIV-1 chronic infection

NYVAC immunization induces polyfunctional HIV‐specific T‐cell responses in chronically‐infected, ART‐treated HIV patients

Therapeutic HIV vaccines: An update

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