A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of a Heterologous Vaccine Regimen of Ad26.Mos4.HIV and Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals

The purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals.

Start Date31 Oct 2019

Sponsor / Collaborator

Janssen Vaccines & Prevention BV

CTR20190300 / RecruitingPhase 2

在HIV阴性的健康志愿者中评价不同间隔复种rTV疫苗的安全性与免疫原性的IIa期临床试验

[Translation] A phase IIa clinical trial evaluating the safety and immunogenicity of revaccination with rTV vaccine at different intervals in HIV-negative healthy volunteers

主要观察DNA疫苗接种三次后，两次rTV疫苗不同时间间隔接种的安全性和免疫原性，对比观察不同间隔复种rTV疫苗对免疫原性的影响，确定最佳免疫应答的免疫接种程序。

[Translation]

The main purpose is to observe the safety and immunogenicity of two rTV vaccines at different time intervals after three DNA vaccinations, compare the effects of revaccination of rTV vaccines at different intervals on immunogenicity, and determine the vaccination schedule for the best immune response.

Start Date28 Apr 2019

Sponsor / Collaborator

Chinese Center For Aids/Std Control And Prevention, China Cdc

[+1]

CTR20170315 / CompletedPhase 1

在健康志愿者中评价复种重组痘苗病毒（rTV）艾滋病疫苗的安全性与免疫原性的Ic期扩大临床试验

[Translation] Phase Ic expanded clinical trial evaluating the safety and immunogenicity of a revaccinated recombinant vaccinia virus (rTV) AIDS vaccine in healthy volunteers

观察复种rTV疫苗在健康志愿者中的安全性，以及rTV疫苗复种对HIV特异性免疫反应的加强作用及其持久性。

[Translation]

To observe the safety of revaccination with rTV vaccine in healthy volunteers, as well as the enhancing effect of revaccination with rTV vaccine on HIV-specific immune response and its durability.

Start Date18 May 2017

Sponsor / Collaborator

Chinese Center For Aids/Std Control And Prevention, China Cdc

[+1]

100 Clinical Results associated with gp140

100 Translational Medicine associated with gp140

0 Patents (Medical) associated with gp140

129

Literatures (Medical) associated with gp140

27 Jan 2021·Mikrobiyoloji BulteniQ4 · MEDICINE

Experience of the National HIV-AIDS Reference Center of Turkey, in the Transition to the New HIV Diagnostic Algorithm; Comparative Analysis of Line-Immunoassay Test and Bio-Rad Geenius™ HIV-1/2 Antibody Confirmatory Assay

Q4 · MEDICINE

Article

Author: Kılıç, Selçuk ; Yıldıran, Dilara ; Demir, Tülin

Shortly after the first detection of human immundeficiency virus (HIV) infection in USA in 1981, the number of cases have increased gradually from all around the world. Turkey’s high capacity for tourism and the unique geographic location extending between Europe and Asia, provides convenience for the passage of individuals across the countries and sexually transmitted infections including HIV, as well. According to the official data of the Ministry of Health; there are 25809 HIV positive and 1958 AIDS cases as of November 30, 2020, after the epidemic started in 1985 in Turkey. Despite the decrease in the number of newly detected HIV cases as a result of serious measures taken for the transmission of infection worldwide, the increase in the number of cases still continues in our country. Shortening the reporting period and starting treatment as soon as possible in the diagnosis of infection is critical for the control of the epidemic. For this purpose, Centers for Disease Control and Prevention (CDC) published a new test algorithm in 2010, which suggested the use of the Geenius™ HIV ½ supplemental assay test instead of western blot tests, which have been used for many years to verify HIV screening test positivity. In this study, we aimed to report the experience of the National HIV-Acquiner Immundeficiency Syndrome (AIDS) and Viral Hepatitis Reference Laboratories of Turkey in the first year of transition to the new HIV algorithm and to evaluate the diagnostic performance of Geenius™ HIV ½ and line immunassay (LIA) s. A total of 2090 anti-HIV positive patient sera sent to National HIV-AIDS and Viral Hepatitis Reference Laboratories of Turkey, Ankara for HIV confirmation were included in the study. All samples were retested with a fourth-generation enzyme linked immunosorbent assay (ELISA) test (VIDAS® HIV-1/2 Duo Ultra assay, BioMerieux, France) followed by the confirmatory tests; Geenius™ HIV 1/2 confirmatory assay (BioRad, Redmond, WA) and Line-immunoassay (INNO-LIA HIV ½ Score, Fujirebio, Belgium). Indeterminate/negative test results or discrepancies between the confirmatory tests were resolved with HIV-1 RNA reverse transcriptase polymerase chain reaction (RT-PCR) (artus HI Virus-1 RT-PCR, Qiagen, Germany) test and in-house HIV-2 RNA and proviral DNA PCR. The sensitivity, specificity, and the agreement of the each assay were compared. Cohen’s Kappa analysis was used for the evaluation of the agreement between the tests. According to the new algorithm which recommended Geenius™ test besides HIV-1 RNA test, 1707 (81.7%) HIV-1 positive samples were identified. Of these samples; 95.9% and 95.02% were identified as HIV-1 positive by GeeniusTM and INNO-LIA, respectively. However, 2.5% of the positive samples were negative with Geenius™ and 3.5% with INNO-LIA. One and a half percentage (1.5%) of these samples were detected with Geenius™ and 1.4% with INNO-LIA as indeterminant. When all the positive samples determined with ELISA were evaluated; it was detected that,1.3% were indeterminate by Geenius™ test and 2.4% by the INNO-LIA test. When the INNO-LIA test was regarded as the gold standard method; sensitivity, specificity, positive predictive and negative predictive values of the Geenius™ test were as follows; 99.7%, 96.1%, 98.9%, and 99.1%. The agreement between INNO-LIA and Geenius™ tests was found to be 98.95% (κ= 0.969; very good). When the Geenius™ and HIV-1 PCR tests were evaluated together for the confirmation; the sensitivities of Geenius™ and INNO-LIA tests were 99.8% and 98.3%, specificities were 89.8% and 85.3%, respectively. Slight positive bands were detected in the gp36 or gp140 bands, the HIV-2 specific envelope proteins, were detected in seven samples, However, the positivity disappeared after the dilution of the samples and it was accepted as false positivite reaction due to the absence of HIV-2 RNA and proviral DNA in these samples. In conclusion; we concluded that Geenius™ and INNO-LIA tests have a perfect agreement in HIV diagnosis and due to the rapid and reliable results provided for the HIV test protocol, Geenius™ test can be used safely as an alternative to the immunoblot tests. HIV-1 RNA testing must be performed in all HIV confirmation centers in order to detect acute HIV cases in the fast and early period which are the main reason for the updates in HIV diagnosis.

01 Dec 2020·RetrovirologyQ2 · MEDICINE

HIV-1 subtype C transmitted founders modulate dendritic cell inflammatory responses

Q2 · MEDICINE

ArticleOA

Author: Metenou, Simon ; Cicala, Claudia ; Lumngwena, Evelyn Ngwa ; Arthos, James ; Masson, Lindi ; Woodman, Zenda

AbstractBackgroundHeterosexual transmission remains the main route of HIV-1 transmission and female genital tract (FGT) inflammation increases the risk of infection. However, the mechanism(s) by which inflammation facilitates infection is not fully understood. In rhesus macaques challenged with simian immunodeficiency virus, dendritic cell (DC) mediated recruitment of CD4+ T cells to the FGT was critical for infection. The aim of this study was to delineate the mechanisms underlying DC-mediated HIV infection by comparing chemokine and pro-inflammatory cytokine production in response to transmitted founder (TF) and chronic infection (CI) Envelope (Env) pseudotyped viruses (PSV).ResultsMonocyte-derived DCs (MDDCs) were stimulated with PSV and recombinant gp140 representing matched TF and CI pairs of four individuals and cytokine secretion measured by multiplex immuno-assay. We found that 4/9 Env induced robust MDDC inflammatory responses and of those, three were cloned from TFs. Overall, TF Env induced MDDCs from healthy donors to secrete higher concentrations of inflammatory cytokines and chemokines than those from CI, suggesting TF Env were better inducers of inflammation. Assessing the signalling pathway associated with inflammatory cytokines, we found that PSV of matched TF and CI variants and a gp140 clone activated ERK and JNK to similar levels. Recombinant soluble DC-SIGN inhibited cytokine release and activation of ERK by PSV, suggesting that Env-DC-SIGN binding was partly involved in MDDC stimulation. Therefore, Env clones might differentially stimulate MDDC immune responses via alternative, yet unidentified signalling pathways.ConclusionOverall, this could suggest that the genetics of the virus itself influences inflammatory responses during HIV infection. In the absence of pre-existing infections, induction of greater inflammatory response by TFs might favour virus survival within the healthy FGT by driving an influx of target cells to sites of infection while suppressing immune responses via IL-10.

01 Sep 2020·AIDSQ2 · MEDICINE

Higher frequencies of functional HIV-envelope-specific memory B cells are associated with nonprogressive HIV infection in Indian population

Q2 · MEDICINE

Article

Author: Kulkarni, Smita S. ; Bagul, Rajani D. ; Ghate, Manisha V. ; Dhande, Jayshree R. ; Singh, Dharmendra P. ; Thakar, Madhuri R. ; Saikia, Kasturi

Objective:The HIV-1-specific antibodies are being considered for prevention and therapy in HIV infection. For effective antibody response, presence of functionally competent memory B cells (MEBs) is important; however, HIV-infection is known to alter the B-cell functionality. Very limited data are available on the HIV-specific memory B-cell population in HIV-infected Indian population.Methods:In this study, the frequencies of HIV-gp140-specific MEBs were measured in individuals with nonprogressive [long-term-nonprogressors (LTNPs), N = 20] and progressive (N = 19) HIV infection using multicolor flow cytometry. The activation and functional status of these MEBs were assessed as frequencies and mean fluorescence intensity (MFI) of the CD38 and CD40 expression, respectively.Results:The percentages of gp140 + MEBs were higher in LTNPs than seen in progressors (P = 0.0475) and associated with higher CD4+ cell count (P = 0.0312, r = 0.2833). As compared with the progressors, LTNPs also showed higher functional (CD40+) gp140 + MEBs both frequencies (P < 0.0001) and CD40 MFI (P = 0.0222), whereas the frequencies (<0.0001) and the MFI (P = 0.0047) of CD38 expression was significantly lower. Higher CD4+ cell counts and lower plasma viral load values were associated with higher frequencies of CD40+ gp140 + MEBs (P < 0.0001, r = 0.4962) (P = 0.0036, r = −0.4202) and lower frequencies (P = 0.0008, r = −0.4231) and CD38 expression (MFI) (P = 0.004, r = −0.3719) (P = 0.0066, r = 0.4033).Conclusion:Our study suggests that LTNPs have functional HIV-specific memory B-cell compartment with reduced activation that may lead to effective HIV-specific humoral immune responses contributing to their nondisease progression status. These findings would help in better understanding of the characteristics of the HIV-specific memory B-cell population in nonprogressive HIV infection.

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