HIV epidemic in Asia: optimizing and expanding vaccine development

Nitayaphan, Sorachai; Ngauy, Viseth; O’Connell, Robert J.; Excler, Jean–Louis

doi:10.1586/erv.12.49

Cited by 8 publications

(10 citation statements)

References 135 publications

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“…79 vaccine clinical development have been deployed in the region since the mid-1990s. 110 The first Phase III trial in a middle-income country (Vax003) tested a bivalent recombinant gp120 B/E (MN and A244 CRF01_AE) in alum (AIDSVAX B/E) in PWID in Bangkok, Thailand. 111 The vaccine showed no efficacy against HIV acquisition or progression to disease.…”

Section: Indiamentioning

confidence: 99%

“…28,29 CRF01_AE remains predominant in southeast Asian countries and MSM populations in China and may provide a rationale for regional efficacy trials, for example, Thailand and China. 110 However, bivalent or trivalent subtype-specific vaccines targeting predominant circulating forms, such as CRF01_AE, subtype B, and, potentially, C seem more appropriate. 128 Other vaccine approaches such as prime-boost regimens using DNA and vectors (Ad26, MVA) expressing mosaic antigens 190,191 or conserved sequences must also be seriously considered as global HIV vaccine strategies.…”

Section: Implications For Hiv Prevention Trialsmentioning

confidence: 99%

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HIV Epidemic in Asia: Implications for HIV Vaccine and Other Prevention Trials

Phanuphak

Shao³

et al. 2015

AIDS Research and Human Retroviruses

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An overall decrease of HIV prevalence is now observed in several key Asian countries due to effective prevention programs. The decrease in HIV prevalence and incidence may further improve with the scale-up of combination prevention interventions. The implementation of future prevention trials then faces important challenges. The opportunity to identify heterosexual populations at high risk such as female sex workers may rapidly wane. With unabating HIV epidemics among men who have sex with men (MSM) and transgender (TG) populations, an effective vaccine would likely be the only option to turn the epidemic. It is more likely that efficacy trials will occur among MSM and TG because their higher HIV incidence permits smaller and less costly trials. The constantly evolving patterns of HIV-1 diversity in the region suggest close monitoring of the molecular HIV epidemic in potential target populations for HIV vaccine efficacy trials. CRF01_AE remains predominant in southeast Asian countries and MSM populations in China. This relatively steady pattern is conducive to regional efficacy trials, and as efficacy warrants, to regional licensure. While vaccines inducing nonneutralizing antibodies have promise against HIV acquisition, vaccines designed to induce broadly neutralizing antibodies and cell-mediated immune responses of greater breadth and depth in the mucosal compartments should be considered for testing in MSM and TG. The rationale and design of efficacy trials of combination prevention modalities such as HIV vaccine and preexposure prophylaxis (PrEP) remain hypothetical, require high adherence to PrEP, are more costly, and present new regulatory challenges. The prioritization of prevention interventions should be driven by the HIV epidemic and decided by the country-specific health and regulatory authorities. Modeling the impact and cost-benefit may help this decision process.

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Section: Indiamentioning

confidence: 99%

Section: Implications For Hiv Prevention Trialsmentioning

confidence: 99%

HIV Epidemic in Asia: Implications for HIV Vaccine and Other Prevention Trials

Phanuphak

Shao³

et al. 2015

AIDS Research and Human Retroviruses

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“…Although the greatest burden of disease is present in sub-Saharan Africa (69% of global HIV-1 infections), substantial and dynamic epidemics exist in Southeast Asia (2) and among persons in high-risk groups throughout the world. Remarkable progress has been achieved in slowing the spread of HIV-1 and preventing AIDS-related death in the setting of broad programs of prevention through effective condom use, circumcision, harm reduction in injecting drug users (IDUs), prevention of mother-to-child transmission, and availability of antiretroviral therapy (1).…”

Section: Introductionmentioning

confidence: 99%

Lessons from the RV144 Thai Phase III HIV-1 Vaccine Trial and the Search for Correlates of Protection

2015

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RV144 remains the only HIV-1 vaccine trial to demonstrate efficacy against HIV-1 acquisition. The prespecified analysis of immune correlates of risk showed that antibodies directed against the V1V2 region of gp120, in particular the IgG1 and IgG3 subclass mediating antibody-dependent cell-mediated cytotoxicity, seem to play a predominant role in protection against HIV-1 acquisition and that plasma envelope (Env)-specific IgA antibodies were directly correlated with risk. RV144 and recent nonhuman primate challenge studies suggest that Env is essential, and perhaps sufficient, to induce protective antibody responses against mucosal HIV-1 acquisition. Follow-up clinical trials are ongoing to further dissect the immune responses elicited by the RV144 ALVAC-HIV and AIDSVAX® B/E regimen. The study of gp120 Env immunogens and immune correlates of risk has resulted in the development of improved antigens. Whether the RV144 immune correlates of risk will generalize to other populations vaccinated with similar immunogens with different modes and intensity of transmission remains to be demonstrated. Efficacy trials are now planned in heterosexual populations in southern Africa and men who have sex with men in Thailand.

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“…Efficacy trials in Asia will likely target MSM and transgender women. 35,36 This generates the dilemma of a vaccine proven to be efficacious in a high-risk population and that may or may not be efficacious in other groups. Here again, a dialogue remains essential for stakeholders to understand this paradoxical situation and to analyze the possible public health and regulatory implications.…”

Section: Hiv Vaccinesmentioning

confidence: 99%

Stakeholder Engagement in HIV Cure Research: Lessons Learned from Other HIV Interventions and the Way Forward

Chu

Ananworanich

et al. 2015

AIDS Patient Care and STDs

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Clinical and basic science advances have raised considerable hope for achieving an HIV cure by accelerating research. This research is dominated primarily by issues about the nature and design of current and future clinical trials. Stakeholder engagement for HIV cure remains in its early stages. Our analysis examines timing and mechanisms of historical stakeholder engagement in other HIV research areas for HIV-uninfected individuals [vaccine development and pre-exposure prophylaxis (PrEP)], and HIV-infected individuals (treatment as prevention, prevention of mother-to-child transmission, and treatment of acute HIV infection) and articulate a plan for HIV cure stakeholder engagement. The experience from HIV vaccine development shows that early engagement of stakeholders helped manage expectations, mitigating the failure of several vaccine trials, while paving the way for subsequent trials. The relatively late engagement of HIV stakeholders in PrEP research may partly explain some of the implementation challenges. The treatment-related stakeholder engagement was strong and community-led from the onset and helped translation from research to implementation. We outline five steps to initiate and sustain stakeholder engagement in HIV cure research and conclude that stakeholder engagement represents a key investment in which stakeholders mutually agree to share knowledge, benefits, and risk of failure. Effective stakeholder engagement prevents misconceptions. As HIV cure research advances from early trials involving subjects with generally favorable prognosis to studies involving greater risk and uncertainty, success may depend on early and deliberate engagement of stakeholders.

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HIV epidemic in Asia: optimizing and expanding vaccine development

Cited by 8 publications

References 135 publications

HIV Epidemic in Asia: Implications for HIV Vaccine and Other Prevention Trials

HIV Epidemic in Asia: Implications for HIV Vaccine and Other Prevention Trials

Lessons from the RV144 Thai Phase III HIV-1 Vaccine Trial and the Search for Correlates of Protection

Stakeholder Engagement in HIV Cure Research: Lessons Learned from Other HIV Interventions and the Way Forward

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