The HIV field is in a critical period to develop rapidly and evaluate immunogens that build upon findings from the RV144 regimen and to put forth rational new paradigms for protection. Over the past seven years, the HVTN Laboratory Program was a major leader and substantial contributor to understanding vaccine effects and immune correlates in the VaxGen, Step and RV144 efficacy trials. We raised the standards of immune monitoring in clinical trials, consistently providing high quality data in a GCLP setting using validated or standardized assays. When indicated, we rapidly shifted priorities, broadened collaborations and improved assays. Our Laboratory Center proposes to continue the performance of high quality, state-of-the-art laboratory research, which will accelerate the development of a safe and efficacious HIV vaccine. To accomplish this, we will execute protocol-related, validated endpoint laboratory assays and more comprehensive immunologic investigations to provide unambiguous measurements of vaccine immunogenicity (Aim 1). We will improve existing and adopt novel technologies that can enhance our knowledge of ways vaccines prime the immune system (Aim 2). In phase 2b-3 trials, we will determine vaccine efficacy and investigate potential immune correlates and mechanisms of protection through vaccination (Aim 3). We will optimize strategies to assess vaccine-induced mucosal defense against HIV-1 invasion (Aim 4). Combination strategies with vaccines to prevent HIV will be an important direction for the HVTN, and we will investigate how these may alter and improve immune responses (Aim 5). Finally, we will apply our expertise to fill gaps in development of vaccines for other major global health concerns (Aim 6). Headquartered at FHCRC, the Laboratory Center will integrate its activities seamlessly with the HVTN Leadership and Operations Center and the Statistical and Data Management Center, and cooperatively with the DAIDS Vaccine Clinical Branch. Our core laboratories will continue to be based at FHCRC and Duke University, and we will expand laboratory capacity in South Africa as needed to support efficacy studies.

Public Health Relevance

A safe and effective HIV vaccine is needed to halt the HIV epidemic. We will conduct high quality laboratory studies in support of HVTN HIV vaccine trials that can inform the field about what a candidate HIV vaccine can and cannot do in the populations who would benefit most. Our efforts will provide a rich database that will help advance vaccine development for HIV and other globally important pathogens.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZAI1-EB-A (S1))
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D'Souza, Patricia D
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Fred Hutchinson Cancer Research Center
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Li, Shuying S; Kochar, Nidhi K; Elizaga, Marnie et al. (2017) DNA Priming Increases Frequency of T-Cell Responses to a Vesicular Stomatitis Virus HIV Vaccine with Specific Enhancement of CD8+ T-Cell Responses by Interleukin-12 Plasmid DNA. Clin Vaccine Immunol 24:
Janes, Holly E; Cohen, Kristen W; Frahm, Nicole et al. (2017) Higher T-Cell Responses Induced by DNA/rAd5 HIV-1 Preventive Vaccine Are Associated With Lower HIV-1 Infection Risk in an Efficacy Trial. J Infect Dis 215:1376-1385
Moncunill, Gemma; De Rosa, Stephen C; Ayestaran, Aintzane et al. (2017) RTS,S/AS01E Malaria Vaccine Induces Memory and Polyfunctional T Cell Responses in a Pediatric African Phase III Trial. Front Immunol 8:1008
Hensel, Michael T; Peng, Tao; Cheng, Anqi et al. (2017) Selective Expression of CCR10 and CXCR3 by Circulating Human Herpes Simplex Virus-Specific CD8 T Cells. J Virol 91:
Chang, Ming; Wong, Audrey J S; Raugi, Dana N et al. (2017) Clinical validation of a novel diagnostic HIV-2 total nucleic acid qualitative assay using the Abbott m2000 platform: Implications for complementary HIV-2 nucleic acid testing for the CDC 4th generation HIV diagnostic testing algorithm. J Clin Virol 86:56-61
Cohen, Kristen W; Frahm, Nicole (2017) Current views on the potential for development of a HIV vaccine. Expert Opin Biol Ther 17:295-303
Huang, Yunda; Zhang, Lily; Janes, Holly et al. (2017) Predictors of durable immune responses six months after the last vaccination in preventive HIV vaccine trials. Vaccine 35:1184-1193
Rahmberg, Andrew R; Rajakumar, Premeela A; Billingsley, James M et al. (2017) Dynamic Modulation of Expression of Lentiviral Restriction Factors in Primary CD4+ T Cells following Simian Immunodeficiency Virus Infection. J Virol 91:
Buchbinder, Susan P; Grunenberg, Nicole A; Sanchez, Brittany J et al. (2017) Immunogenicity of a novel Clade B HIV-1 vaccine combination: Results of phase 1 randomized placebo controlled trial of an HIV-1 GM-CSF-expressing DNA prime with a modified vaccinia Ankara vaccine boost in healthy HIV-1 uninfected adults. PLoS One 12:e0179597
McElrath, M Juliana (2017) Adjuvants: tailoring humoral immune responses. Curr Opin HIV AIDS 12:278-284

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