STATISTICAL ISSUES IN THE DESIGN OF HIV VACCINE TRIALS

被引:0
作者
SCHAPER, C
FLEMING, TR
SELF, SG
RIDA, WN
机构
[1] FRED HUTCHINSON CANC RES CTR, PROGRAM BIOSTAT, SEATTLE, WA 98104 USA
[2] NIAID, DIV AIDS, BETHESDA, MD 20892 USA
关键词
HIV VACCINE; VACCINE EFFICACY; FIELD EFFICACY; SURROGATE MARKER; BEHAVIORAL INTERVENTION;
D O I
暂无
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
HIV vaccine trials present significant challenges related to trial endpoints, vaccine efficacy measurement, and the role of nonvaccine interventions. Infection is a valid endpoint for detecting sterilizing immunity. But if the vaccine prevents AIDS without preventing infection, infection may be a misleading surrogate. Appropriate endpoints must be defined for other mechanisms of vaccine action. Direct, indirect, behavioral, and biological effects all determine vaccine efficacy. False security among HIV-vaccine recipients may make negative behavioral effects an important component of vaccine performance. Both biological potency and a more comprehensive program effectiveness should be measured. These goals may require unblinded designs or community randomization. Nonvaccine interventions are currently the only HIV-prevention strategy. Support for larger scale implementation requires more rigorous evaluation that is less dependent on self-reported behavioral changes. The vaccine trial cohorts provide a unique opportunity to cost-effectively evaluate behavioral interventions.
引用
收藏
页码:1 / 22
页数:22
相关论文
共 50 条
[31]   Design and statistical considerations for studies evaluating the efficacy of a single dose of the human papillomavirus (HPV) vaccine [J].
Sampson, Joshua N. ;
Hildesheim, Allan ;
Herrero, Rolando ;
Gonzalez, Paula ;
Kreimer, Aimee R. ;
Gail, Mitchell H. .
CONTEMPORARY CLINICAL TRIALS, 2018, 68 :35-44
[32]   Participants' characteristics and motivations to screen for HIV vaccine and monoclonal antibody trials in KwaZulu-Natal, South Africa [J].
Hanass-Hancock, Jill ;
Carpenter, Bradley ;
Reddy, Tarylee ;
Nzuza, Ayanda ;
Gaffoor, Zakir ;
Goga, Ameena ;
Andrasik, Michele .
TRIALS, 2021, 22 (01)
[33]   Participants’ characteristics and motivations to screen for HIV vaccine and monoclonal antibody trials in KwaZulu-Natal, South Africa [J].
Jill Hanass-Hancock ;
Bradley Carpenter ;
Tarylee Reddy ;
Ayanda Nzuza ;
Zakir Gaffoor ;
Ameena Goga ;
Michele Andrasik .
Trials, 22
[34]   Assessing Correlates of Protection in Vaccine Trials [J].
Wittes, Janet .
JOURNAL OF INFECTIOUS DISEASES, 2014, 210 (10) :1523-1525
[35]   The global HIV vaccine enterprise [J].
Esparza, J .
INTERNATIONAL MICROBIOLOGY, 2005, 8 (02) :93-101
[36]   The path to find an HIV vaccine [J].
Gray, Glenda E. ;
Corey, Lawrence .
JOURNAL OF THE INTERNATIONAL AIDS SOCIETY, 2021, 24 (05)
[37]   Breaking the silence:: What homeless 18-to 24-year-olds say about HIV vaccine trials [J].
Koniak-Griffin, Deborah ;
Nyamathi, Adeline ;
Tallen, Louise ;
Gonzalez-Figueroa, Evelyn ;
Dominick, Ernestina .
JOURNAL OF HEALTH CARE FOR THE POOR AND UNDERSERVED, 2007, 18 (03) :687-698
[38]   Results of phase I clinical trials of a combined vaccine against HIV-1 based on synthetic polyepitope immunogens [J].
Karpenko, L. I. ;
Bazhan, S. I. ;
Bogryantseva, M. P. ;
Ryndyuk, N. N. ;
Ginko, Z. I. ;
Kuzubov, V. I. ;
Lebedev, L. R. ;
Kaplina, O. N. ;
Reguzova, A. Yu. ;
Ryzhikov, A. B. ;
Usova, S. V. ;
Oreshkova, S. F. ;
Nechaeva, E. A. ;
Danilenko, E. D. ;
Ilyichev, A. A. .
RUSSIAN JOURNAL OF BIOORGANIC CHEMISTRY, 2016, 42 (02) :170-182
[39]   Early markers of HIV-1 disease progression in a prospective cohort of seroconverters in Bangkok, Thailand - Implications for vaccine trials [J].
Buchacz, K ;
Hu, DJ ;
Vanichseni, S ;
Mock, PA ;
Chaowanachan, T ;
Srisuwanvilai, LO ;
Gvetadze, R ;
van Griensven, F ;
Tappero, JW ;
Kitayaporn, D ;
Kaewkungwal, J ;
Choopanya, K ;
Mastro, TD .
JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES, 2004, 36 (03) :853-860
[40]   Results of phase I clinical trials of a combined vaccine against HIV-1 based on synthetic polyepitope immunogens [J].
L. I. Karpenko ;
S. I. Bazhan ;
M. P. Bogryantseva ;
N. N. Ryndyuk ;
Z. I. Ginko ;
V. I. Kuzubov ;
L. R. Lebedev ;
O. N. Kaplina ;
A. Yu. Reguzova ;
A. B. Ryzhikov ;
S. V. Usova ;
S. F. Oreshkova ;
E. A. Nechaeva ;
E. D. Danilenko ;
A. A. Ilyichev .
Russian Journal of Bioorganic Chemistry, 2016, 42 :170-182