V-1 Immunitor: oral therapeutic AIDS vaccine with prophylactic potential

Jirathitikal, Vichai; Sooksathan, Penpit; Metadilogkul, Orapun; Bourinbaiar, Aldar S.

doi:10.1016/s0264-410x(02)00570-4

Cited by 13 publications

(11 citation statements)

References 9 publications

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“…Regardless of whether V1 is superior or inferior to HAART by a few percentage points there is little doubt that the therapeutic vaccination represents much safer alternative. None of the patients on V1 have experienced any adverse reaction to the therapy-an observation which supports our phase I safety study (Jirathitikal et al, 2003a(Jirathitikal et al, , 2003b. In contrast, the toxicity of HAART, including a high incidence of life-threatening reactions, is a serious concern that is now voiced with increased frequency in the medical literature (Reisler et al, 2003).…”

Section: Discussionsupporting

confidence: 75%

“…Since the introduction of V1 in June 2001, about 68,000 patients in 65 countries around the world have used it. Open-label studies carried out during the past 2 years in over 1000 patients have indicated that V1 provides clinical benefit to AIDS patients Jirathitikal et al, 2003aJirathitikal et al, , 2003bJirathitikal et al, , 2004Metadilogkul et al, 2002). V1-treated individuals experienced improved quality of life, normalization of liver function, reduced incidence of opportunistic infection, body weight gain, increase in CD4 and CD8 cells, decrease in viral load, and prolonged survival rate.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Phase II placebo-controlled study of V-1 Immunitor as a therapeutic modality for treatment of HIV

Bourinbaiar¹,

Jirathitikal²,

Metadilogkul

et al. 2004

Journal of Clinical Virology

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Section: Discussionsupporting

confidence: 75%

Section: Introductionmentioning

confidence: 99%

Phase II placebo-controlled study of V-1 Immunitor as a therapeutic modality for treatment of HIV

Bourinbaiar¹,

Jirathitikal²,

Metadilogkul

et al. 2004

Journal of Clinical Virology

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“…Our earlier open-label and subsequent placebo-controlled clinical study have shown that V1 administration results in an increase of absolute CD4 and CD8 cell counts in both HIV-positive and HIV-negative subjects (72,73). Viral load measurements performed in V1-treated AIDS patients have shown a statistically significant trend in decrease indicating that changes due to V1 administration cannot be attributed to MUCOSAL AIDS VACCINES a simple coincidence (72).…”

Section: V-1 Immunitor (V1)mentioning

confidence: 97%

“…None of the HIV-negative volunteers developed HIV-specific systemic antibodies. However, when the matched blood of immunized volunteers was transferred to terminally ill HIV-positive relatives, the recipients experienced a significant improvement in their health status (73). A similar strategy has been successfully used in hepatitis patients where the transfer of Hep B core antigen-reactive T cells derived from bone marrow of donors immunized with prophylactic Hep B vaccine resulted in resolution of chronic HBV infection (92).…”

Section: V-1 Immunitor (V1)mentioning

confidence: 99%

Mucosal AIDS Vaccines

Bourinbaiar¹,

Metadilogkul

Jirathitikal³

2003

Viral Immunology

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Debates are still being waged over what is the best strategy for developing a potent AIDS vaccine. All the obvious approaches to making AIDS vaccines have been tried in the past two decades without much success. It is clear that new thinking and a revision of prevailing dogmas needs to be in place if we really want a vaccine. Conventional envelope-based antibody-inducing vaccines do not appear to hold promise, and broadly-neutralizing antibodies are now being searched as an alternative to the failed approach with subunit vaccines. The current consensus is that cellular immune responses, especially those mediated by CD8 cytotoxic/suppressor (CTL) and CD4 helper T lymphocytes, are needed to control HIV. Vaccines capable of inducing cell-mediated responses are, therefore, considered critical for controlling the spread of HIV. DNA-based vaccines triggering CTL reaction are currently thought to be an answer, but will they fulfill the promise? In the following paragraphs, a critical assessment of the state of the art will be provided in an attempt to analyze what we know and still don't know. The focus of this review is primarily on mucosal vaccines-a relatively new area in AIDS research. The update on V-1 Immunitor, the first mucosal AIDS vaccine available commercially, is provided within this context. Some of the reviewed concepts may be disputable, but without departure from the uninspiring consensus no substantial progress in the AIDS vaccine field can be envisioned.

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“…Vaccine V-1 Immunitor is a polyvalent oral vaccine containing heatinactivated, pooled HIV antigens derived from primary clinical isolates (Jirathitikal et al, 2003 Thus, V1 also has a status as an experimental medicine, which will eventually lead to licensure of V1 as an immunomodulating drug or therapeutic vaccine. V-1 Immunitor is provided as an 850 mg coated pill, 10 of which are sealed in a 'blister' package.…”

Section: Patientsmentioning

confidence: 99%

Increased body weight and improved quality of life in AIDS patients following V-1 Immunitor administration

Jirathitikal¹,

Metadilogkul

Bourinbaiar³

2003

Eur J Clin Nutr

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Objectives: Development of affordable and safe therapy to reverse the loss of body mass is of critical importance since AIDSrelated wasting is associated with increased mortality. Method: We have demonstrated earlier that oral therapeutic HIV vaccine, V-1 Immunitor (V1), tested in a small group of AIDS patients in Thailand not only increases T-cell counts and decreases the viral load but also results in weight gain and prolonged survival. To further expand this observation, we retrospectively analyzed 650 HIV-positive patients who were followed for an average of 23 weeks.Results: The treatment with V1 resulted in a sustained and statistically significant increase in body mass across the whole population (mean7s.e.; 1.570.4 kg; P ¼ 6.5EÀ015). Among them, 384 (59%) patients gained an average of 4.270.2 kg; 107 (17%) had unchanged weight; and 159 (24%) had lost 3.870.3 kg. Thus, the prevailing majority of patients (76%) were able to gain or maintain weight. Treatment was well tolerated; in a survey of health status in a comparable but separate group of 382 patients, about 85% reported subjective improvement after V1 treatment, 6% reported no difference, and 9% of the patients reported minor adverse reactions, which did not last more than 1 week. Subjective improvement coincides with the reduction or clearance of oral thrush or mucocutaneous candidiasis in 87.5% of the patients. Conclusions:In an open label setting, V1 increases body weight, subjective assessment of quality of life, and is safe and effective for HIV patients with weight loss. These data provide the impetus of using V-1 Immunitor as an affordable and easy-toadminister means of treating AIDS-associated wasting and opportunistic infections.

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V-1 Immunitor: oral therapeutic AIDS vaccine with prophylactic potential

Cited by 13 publications

References 9 publications

Phase II placebo-controlled study of V-1 Immunitor as a therapeutic modality for treatment of HIV

Phase II placebo-controlled study of V-1 Immunitor as a therapeutic modality for treatment of HIV

Mucosal AIDS Vaccines

Increased body weight and improved quality of life in AIDS patients following V-1 Immunitor administration

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