Field trials of tuberculosis vaccines: How could we have done them better?

doi:10.1016/0197-2456(94)90042-6

Controlled Clinical Trials

Volume 15, Issue 4, August 1994, Pages 247-276

https://doi.org/10.1016/0197-2456(94)90042-6 Get rights and content

Abstract

Nineteen controlled trials of vaccination against tuberculosis are reviewed. Most involved very large numbers of participants and represented a wide variety of geographic and socioeconomic conditions. The trials were conducted under field conditions that sometimes verged on the primitive. Length of follow-up for tuberculosis ranged from 3 to 23 years, and up to 28 years for cancer. Under these circumstances, compromises and mistakes were made along with notable successes. With the current interest in the immunology of tuberculosis and other chronic infectious diseases giving rise to renewed hope for more efficacious vaccines, lessons from the past can be useful in planning the long-term evaluations that will be needed as these hoped-for vaccines become available.

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Bacillus Calmette-Guerin (BCG) vaccine is recommended at birth in low income countries to protect against tuberculosis (TB). Estimates of the protection of the BCG vaccine against TB infections vary between 0% and 80% [1,2]. The current vaccine strains are all descendants from the original mycobacterium bovis isolate from 1921, and subsequent passages under different laboratory conditions have resulted in the different BCG strains [3].
Different Bacillus Calmette-Guerin (BCG) vaccine strains may have different non-specific effects. We assessed the effect of two BCG strains (Danish and Russian) on childhood morbidity and BCG scarification in Guinea-Bissau.
During 2011–2013, infants in the Bandim Health Project’s urban study area received the Danish or Russian BCG in a natural experiment. Health center consultations were registered at point of care and scar status and size at age 4½ months. We assessed the effect of strain on consultation rates between vaccination and age 45 days in Cox proportional hazards models. Scar prevalence and size were compared using binomial regression and ranksum tests.
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Field trials of tuberculosis vaccines: How could we have done them better?

Abstract

Br Med J

Pediatrics

Am Rev Tuberc

Bull WHO

Bull WHO

Rev Infect Dis

Ad Tuberc Res

Arch Dis Child

JNCI

Die Aetiologie der Tuberkulose

Berlin Klin Wochenschr

Am Rev Tuberc

Weitere Mitteilungen über ein Heilmittel gegen Tuberculose

Dtsch Med Wochenschr

Story of the tuberculin test from an epidemiologic viewpoint

Am Rev Respir Dis

The White Plague: Tuberculosis, Man and Society

Immunity: Principles and Application in Medicine and Public Health

Vaccination against tuberculosis with nonliving vaccines. I. The problem and its historical background

Am Rev Respir Dis

Vaccination against tuberculosis with nonliving vaccines. I. The problem and its historical background

Am Rev Respir Dis

Vaccination against tuberculosis with nonliving vaccines. I. The problem and its historical background

Am Rev Respir Dis

USA: Experimental studies of vaccination, allergy, and immunity in tuberculosis. 3. Effect of killed BCG vaccine

Bull WHO

Protective inoculation against human tuberculosis with heat-killed tubercle bacilli

Am J Hyg

Results obtained in man with the use of a vaccine of heat-killed tubercle bacilli

Am J Hyg

B.C.G. Vaccination in Theory and Practice

Medical Research Council: B.C.G. and vole bacillus vaccines in the prevention of tuberculosis in adolescents

Br Med J

Pulmonary Tuberculosis in the Adult: Its Fundamental Aspects

The history of BCG

BCG: Who were Calmette and Guérin?

Thorax

What is BCG?

Tubercle

Premiers essais de vaccination antituberculeuse de l'enfant par le bacille Calmette-Guérin (BCG)

Bull Mém Soc Med Hop Paris

La immunidad antituberculosa y la vacuanación con el B.C.G.

Rev Tuberc Habana

The case against B.C.G.

Br Med J

Present knowledge of the innocuousness of BCG

Am Rev Tuberc

The Hazards of Vaccination

The Lübeck trial

Lancet

BCG vaccination of nurses

Tubercle

The efficacy of BCG-vaccination. Tuberculosis epidemic in a state school with an observation period of 12 year

Danish Med Bull

Controversial issues in tuberculosis control

Public Health Rep

Mass Radiography of the Chest

Rationale and results

A clinical trial of sanocrysin in pulmonary tuberculosis

Am Rev Tuberc

Effect of vaccination with BCG on tuberculosis in infancy and in childhood

Am J Dis Child

Results of BCG immunization in New York City

Am Rev Tuberc

BCG vaccination of Indian infants in Saskatchewan

Tubercle

Prémunition antituberculeuse par le BCG. Campagne contrôllée poursuivie à Alger depuis 1935. Troiseème note

Arch Inst Pasteur d'Algérie

A twenty-year appraisal of BCG vaccination in the control of tuberculosis

Arch Intern Med

Protective vaccination against tuberculosis with special reference to BCG vaccination

Am Rev Tuberc

Report of a conference on BCG vaccination

Public Health Rep

Prospectus of research in mass BCG vaccination

Public Health Rep

BCG vaccination in tuberculous households

Am Rev Respir Dis