Accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimised multi-arm phase I/II trial design

Abdool Karim Q(2010)Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women Science 329 1168-1174

Abdool Karim SS(2011)Prevention of HIV-1 infection with early antiretroviral therapy N Engl J Med 365 493-505

Frohlich JA(2007)Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial Lancet 369 657-666

Grobler AC(2012)Antiretroviral prophylaxis for HIV prevention in heterosexual men and women N Engl J Med 367 399-410

Baxter C(2009)Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand N Engl J Med 361 2209-2220

Mansoor LE(2006)HIV/AIDS preventive vaccine ‘prime-boost’ phase III trial: foundations and initial lessons learned from Thailand AIDS 20 1471-1479

Kharsany AB(2012)The road to an effective HIV vaccine N Engl J Med 366 1343-1344

Sibeko S(2011)Safety and efficacy of the HVTN 503/Phambili study of a clade-B-based HIV-1 vaccine in South Africa: a double-blind, randomised, placebo-controlled test-of-concept phase 2b study Lancet Infect Dis 11 507-515

Mlisana KP(2083–2092)Efficacy Trial of a DNA/rAd5 HIV-1 preventive vaccine N Engl J Med 2013 369-1302

Omar Z(2012)The design and evaluation of HIV-1 vaccines AIDS 26 1293-560

Abdool Karim Q(2010)Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women Science 329 1168-1174

Abdool Karim SS(2011)Prevention of HIV-1 infection with early antiretroviral therapy N Engl J Med 365 493-505

Frohlich JA(2007)Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial Lancet 369 657-666

Grobler AC(2012)Antiretroviral prophylaxis for HIV prevention in heterosexual men and women N Engl J Med 367 399-410

Baxter C(2009)Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand N Engl J Med 361 2209-2220

Mansoor LE(2006)HIV/AIDS preventive vaccine ‘prime-boost’ phase III trial: foundations and initial lessons learned from Thailand AIDS 20 1471-1479

Kharsany AB(2012)The road to an effective HIV vaccine N Engl J Med 366 1343-1344

Sibeko S(2011)Safety and efficacy of the HVTN 503/Phambili study of a clade-B-based HIV-1 vaccine in South Africa: a double-blind, randomised, placebo-controlled test-of-concept phase 2b study Lancet Infect Dis 11 507-515

Mlisana KP(2083–2092)Efficacy Trial of a DNA/rAd5 HIV-1 preventive vaccine N Engl J Med 2013 369-1302

Omar Z(2012)The design and evaluation of HIV-1 vaccines AIDS 26 1293-560