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

Safety and efficacy of MVA85A, a new tuberculosis vaccine, in infants previously vaccinated with BCG: a randomised, placebo-controlled phase 2b trial

(2013) Michele D Tameris et al.   LANCET

Designing Tomorrow's Vaccines

(2013) Gary J. Nabel   NEW ENGLAND JOURNAL OF MEDICINE

The design and evaluation of HIV-1 vaccines

(2012) Kevin O. Saunders et al.   AIDS

Safety, Immunogenicity, and Surrogate Markers of Clinical Efficacy for Modified Vaccinia Ankara as a Smallpox Vaccine in HIV-Infected Subjects

(2012) R. N. Greenberg et al.   JOURNAL OF INFECTIOUS DISEASES

The Road to an Effective HIV Vaccine

(2012) Lindsey R. Baden et al.   NEW ENGLAND JOURNAL OF MEDICINE

Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women

(2012) Jared M. Baeten et al.   NEW ENGLAND JOURNAL OF MEDICINE

Operating characteristics of a Simon two-stage phase II clinical trial design incorporating continuous toxicity monitoring

(2012) H.E. Ray et al.   PHARMACEUTICAL STATISTICS

Flexible bivariate phase II clinical trial design incorporating toxicity and response on different schedules

(2012) Herman E. Ray et al.   STATISTICS IN MEDICINE

Indicators of therapeutic effect in FIT-06, a Phase II trial of a DNA vaccine, GTU®-Multi-HIVB, in untreated HIV-1 infected subjects

(2012) Eftyhia Vardas et al.   VACCINE

Effect of vaccine dose on the safety and immunogenicity of a candidate TB vaccine, MVA85A, in BCG vaccinated UK adults

(2012) Ansar A. Pathan et al.   VACCINE

Designing phase II trials in cancer: a systematic review and guidance

(2011) S R Brown et al.   BRITISH JOURNAL OF CANCER

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

(2011) Glenda E Gray et al.   LANCET INFECTIOUS DISEASES

Prevention of HIV-1 Infection with Early Antiretroviral Therapy

(2011) Myron S. Cohen et al.   NEW ENGLAND JOURNAL OF MEDICINE

A Phase IIA Randomized Clinical Trial of a Multiclade HIV-1 DNA Prime Followed by a Multiclade rAd5 HIV-1 Vaccine Boost in Healthy Adults (HVTN204)

(2011) Gavin J. Churchyard et al.   PLoS One

An extension of the single threshold design for monitoring efficacy and safety in phase II clinical trials

(2011) P. Brutti et al.   STATISTICS IN MEDICINE

Safety and immunogenicity of a modified pox vector-based HIV/AIDS vaccine candidate expressing Env, Gag, Pol and Nef proteins of HIV-1 subtype B (MVA-B) in healthy HIV-1-uninfected volunteers: A phase I clinical trial (RISVAC02)

(2011) Felipe García et al.   VACCINE

Immunogenicity and safety of an HIV-1 lipopeptide vaccine in healthy adults: a phase 2 placebo-controlled ANRS trial

(2010) Dominique Salmon-Céron et al.   AIDS

Seamless Phase I-II Trial Design for Assessing Toxicity and Efficacy for Targeted Agents

(2010) A. Hoering et al.   CLINICAL CANCER RESEARCH

Induction of Immunity to Human Immunodeficiency Virus Type-1 by Vaccination

(2010) M. Juliana McElrath et al.   IMMUNITY

Immunology and the elusive AIDS vaccine

(2010) Herbert W. Virgin et al.   NATURE

Phase 1 Safety and Immunogenicity Evaluation of ADMVA, a Multigenic, Modified Vaccinia Ankara-HIV-1 B'/C Candidate Vaccine

(2010) Sandhya Vasan et al.   PLoS One

Phase I Safety and Immunogenicity Evaluation of MVA-CMDR, a Multigenic, Recombinant Modified Vaccinia Ankara-HIV-1 Vaccine Candidate

(2010) Jeffrey R. Currier et al.   PLoS One

Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women

(2010) Q. Abdool Karim et al.   SCIENCE

Toxicity-evaluation designs for phase I/II cancer immunotherapy trials

(2010) Karen Messer et al.   STATISTICS IN MEDICINE

A Phase 1 Study to Evaluate the Safety and Immunogenicity of a Recombinant HIV Type 1 Subtype C-Modified Vaccinia Ankara Virus Vaccine Candidate in Indian Volunteers

(2009) Vadakkuppatu Devasenapathi Ramanathan et al.   AIDS RESEARCH AND HUMAN RETROVIRUSES

Comparative Cell‐Mediated Immunogenicity of DNA/DNA, DNA/Adenovirus Type 5 (Ad5), or Ad5/Ad5 HIV‐1 Clade BgagVaccine Prime‐Boost Regimens

(2009) David M. Asmuth et al.   JOURNAL OF INFECTIOUS DISEASES

The role of IFN-γ Elispot assay in HIV vaccine research

(2009) Hendrik Streeck et al.   Nature Protocols

Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand

(2009) Supachai Rerks-Ngarm et al.   NEW ENGLAND JOURNAL OF MEDICINE

A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE®

(2009) Alfred von Krempelhuber et al.   VACCINE

A predictive probability design for phase II cancer clinical trials

(2008) J Jack Lee et al.   Clinical Trials

New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)

(2008) E.A. Eisenhauer et al.   EUROPEAN JOURNAL OF CANCER

An HIV-1 clade C DNA prime, NYVAC boost vaccine regimen induces reliable, polyfunctional, and long-lasting T cell responses

(2008) Alexandre Harari et al.   JOURNAL OF EXPERIMENTAL MEDICINE

Broad Immunogenicity of a Multigene, Multiclade HIV‐1 DNA Vaccine Boosted with Heterologous HIV‐1 Recombinant Modified Vaccinia Virus Ankara

(2008) Eric Sandström et al.   JOURNAL OF INFECTIOUS DISEASES

Early Stopping Rules in Clinical Trials Based on Sequential Monitoring of Serious Adverse Events

(2008) A. Kramar et al.   MEDICAL DECISION MAKING

Participation in two phase II prophylactic HIV vaccine trials in the UK

(2008) Kimberly Gray et al.   VACCINE

Bayesian design and conduct of phase II single-arm clinical trials with binary outcomes: A tutorial

(2007) Sarah Zohar et al.   Contemporary Clinical Trials