Are placebo controls necessary in controlled human infection trials for vaccines?

Bacterial Infections

Hyperimmune bovine colostral anti-CS17 antibodies protect against enterotoxigenic Escherichia coli diarrhea in a randomized, doubled-blind, placebo-controlled human infection model

J Infect Dis.

Savarino SJ, McKenzie R, Tribble DR, Porter CK, O'Dowd A, Sincock SA, Poole ST, DeNearing B, Woods CM, Kim H, Grahek SL, Brinkley C, Crabb JH, Bourgeois AL

doi: 10.1093/infdis/jiz135.

Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6-35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres

Vaccine.

Pepin S, Dupuy M, Borja-Tabora CFC, Montellano M, Bravo L, Santos J, de Castro JA, Rivera-Medina DM, Cutland C, Ariza M, Diez-Domingo J, Gonzalez CD, Martinón-Torres F, Papadopoulou-Alataki E, Theodoriadou M, Kazek-Duret MP, Gurunathan S, De Bruijn I; GQM05 Study Group

doi: 10.1016/j.vaccine.

Viral Infections, Non-HIV

Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to no vaccination or standard three and two-dose vaccination regimens: A systematic review of evidence from clinical trials

Vaccine.

Whitworth HS, Gallagher KE, Howard N, Mounier-Jack S, Mbwanji G, Kreimer AR, Basu P, Kelly H, Drolet M, Brisson M, Watson-Jones D

doi: 10.1016/j.vaccine.2019.12.017.

Bacterial Infections

Prevention of severe infectious complications after colorectal surgery using oral non-absorbable antimicrobial prophylaxis: results of a multicenter randomized placebo-controlled clinical trial

Antimicrob Resist Infect Control.

Mulder T, Kluytmans-van den Bergh M, Vlaminckx B, Roos D, de Smet AM, de Vos Tot Nederveen Cappel R, Verheijen P, Brandt A, Smits A, van der Vorm E, Bathoorn E, van Etten B, Veenemans J, Weersink A, Vos M, van 't Veer N, Nikolakopoulos S, Bonten M, Kluytmans J

doi: 10.1186/s13756-020-00745-2.

Viral Infections, Non-HIV

Immunogenicity, transplacental transfer of pertussis antibodies and safety following pertussis immunization during pregnancy: Evidence from a randomized, placebo-controlled trial

Vaccine.

Perrett KP, Halperin SA, Nolan T, Martínez Pancorbo C, Tapiero B, Martinón-Torres F, Stranak Z, Virta M, Vanderkooi OG, Kosina P, Encinas Pardilla MB, Cristobal García I, Zuccotti GV, Kostanyan L, Meyer N, Ceregido MA, Cheuvart B, Kuriyakose SO, Marcos Fernández M, Rodríguez Zambrano MÁ, Martín García A, Asenjo de la Fuente JE, Camacho Marín MD, de la Calle Fernández-Miranda M, Romero Espinar Y, Marchisio PG, Manzoni P, Mesaros N

doi: 10.1016/j.vaccine.2019.10.105.

Viral Infections, Non-HIV

Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial

Lancet Infect Dis

Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, Chen X, Hu Y, Liu X, Jiang C, Li J, Yang M, Song Y, Wang X, Gao Q, Zhu F

doi: 10.1016/S1473-3099(20)30843-4

Bacterial Infections

Cadazolid for the treatment of Clostridium difficile infection: results of two double-blind, placebo-controlled, non-inferiority, randomised phase 3 trials

Lancet Infect Dis.

Gerding DN, Cornely OA, Grill S, Kracker H, Marrast AC, Nord CE, Talbot GH, Buitrago M, Gheorghe Diaconescu I, Murta de Oliveira C, Preotescu L, Pullman J, Louie TJ, Wilcox MH

doi: 10.1016/S1473-3099(18)30614-5.

Further Publications AnesthesiologyFurther Publications PainFurther Publications Infectiology

Intravesical bacteriophages for treating urinary tract infections in patients undergoing transurethral resection of the prostate: a randomised, placebo-controlled, double-blind clinical trial

Lancet Infect Dis.

Leitner L, Ujmajuridze A, Chanishvili N, Goderdzishvili M, Chkonia I, Rigvava S, Chkhotua A, Changashvili G, McCallin S, Schneider MP, Liechti MD, Mehnert U, Bachmann LM, Sybesma W, Kessler TM

doi: 10.1016/S1473-3099(20)30330-3.

Viral Infections, Non-HIV

Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial

Lancet Respir Med.

Davey RT Jr, Fernández-Cruz E, Markowitz N, Pett S, Babiker AG, Wentworth D, Khurana S, Engen N, Gordin F, Jain MK, Kan V, Polizzotto MN, Riska P, Ruxrungtham K, Temesgen Z, Lundgren J, Beigel JH, Lane HC, Neaton JD, INSIGHT FLU-IVIG Study Group.

doi: 10.1016/S2213-2600(19)30253-X.

Related content

Hyperimmune bovine colostral anti-CS17 antibodies protect against enterotoxigenic Escherichia coli diarrhea in a randomized, doubled-blind, placebo-controlled human infection model

Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6-35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres

Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to no vaccination or standard three and two-dose vaccination regimens: A systematic review of evidence from clinical trials

Prevention of severe infectious complications after colorectal surgery using oral non-absorbable antimicrobial prophylaxis: results of a multicenter randomized placebo-controlled clinical trial

Immunogenicity, transplacental transfer of pertussis antibodies and safety following pertussis immunization during pregnancy: Evidence from a randomized, placebo-controlled trial

Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial

Cadazolid for the treatment of Clostridium difficile infection: results of two double-blind, placebo-controlled, non-inferiority, randomised phase 3 trials

Intravesical bacteriophages for treating urinary tract infections in patients undergoing transurethral resection of the prostate: a randomised, placebo-controlled, double-blind clinical trial

Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial

Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6-35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres