Design questions for Streptococcus pneumoniae vaccine trials with a colonisation endpoint

Vaccine

Volumn 32, Issue 1, 2013, Pages 159-164

  Auranen, Kari ^a   Rinta Kokko, Hanna ^a   Goldblatt, David ^b   Nohynek, Hanna ^a   O'Brien, Katherine L ^c   Satzke, Catherine ^d,e   Simell, Birgit ^a   Tanskanen, Antti ^a   Käyhty, Helena ^a  

^a NATIONAL PUBLIC HEALTH INSTITUTE   (Finland)

^b ROYAL FREE AND UNIVERSITY COLLEGE MEDICAL SCHOOL   (United Kingdom)

^c JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^d ROYAL CHILDREN'S HOSPITAL   (Australia)

^e UNIVERSITY OF MELBOURNE   (Australia)

Author keywords

Multiple colonisation; Nasopharyngeal colonisation; Pneumococcus; Sample size; Vaccine efficacy

Indexed keywords

PNEUMOCOCCUS VACCINE;

ANTIBODY BLOOD LEVEL; ARTICLE; BACTERIAL COLONIZATION; BACTERIUM DETECTION; CONTROLLED CLINICAL TRIAL (TOPIC); DRUG EFFICACY; FEASIBILITY STUDY; HERD IMMUNITY; HUMAN; IMMUNE RESPONSE; NOSE SMEAR; PRIORITY JOURNAL; SAMPLE SIZE; SEROTYPE; SEROTYPING; STREPTOCOCCUS PNEUMONIA; STUDY DESIGN; TIME; VACCINATION;

COMBINED VACCINE EFFICACY AGAINST ACQUISITION AND DURATION OF COLONISATION; MULTIPLE COLONISATION; NASOPHARYNGEAL COLONISATION; NON-VACCINE (SERO)TYPE(S); NVT; PCV; PNEUMOCOCCAL CONJUGATE VACCINE; PNEUMOCOCCUS; SAMPLE SIZE; VACCINE (SERO)TYPE(S); VACCINE EFFICACY; VACCINE EFFICACY AGAINST ACQUISITION OF COLONISATION; VACCINE EFFICACY AGAINST COLONISATION; VE(ACQ); VE(COL); VE(T); VT;

CLINICAL TRIALS AS TOPIC; CROSS-SECTIONAL STUDIES; HUMANS; NASOPHARYNX; OUTCOME ASSESSMENT (HEALTH CARE); PNEUMOCOCCAL INFECTIONS; PNEUMOCOCCAL VACCINES; STREPTOCOCCUS PNEUMONIAE; TIME FACTORS; VACCINATION;

EID: 84891934759     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2013.06.105     Document Type: Article

References (18)

1. Auranen K., Rinta-Kokko H., Goldblatt D., Nohynek H., O'Brien K.L., Satzke C., et al. Colonisation endpoints in Streptococcus pneumoniae vaccine trials. Vaccine 2013, (in press).
2. Satzke C., Turner P., Virolainen-Julkunen A., Adrian P.V., Antonio M., Hare K.M., et al. Standard method for detecting upper respiratory carriage of Streptococcus pneumoniae: updated recommendations from the World Health Organization Pneumococcal Carriage Working Group. Vaccine 2013, (in press).
3. O'Brien K.L., Nohynek H., World Health Organization Pneumococcal Vaccine Trials Carriage Working Group Report from a WHO working group: standard method for detecting upper respiratory carriage of Streptococcus pneumoniae. Pediatr Infect Dis J 2003, 22(2):133-140.
4. Abdullahi O., Wanjiru E., Musyimi R., Glass N., Scott J.A. Validation of nasopharyngeal sampling and culture techniques for detection of Streptococcus pneumoniae in children in Kenya. J Clin Microbiol 2007, 45(10):3408-3410.
5. Gratten M., Montgomery J., Gerega G., Gratten H., Siwi H., Poli A., et al. Multiple colonization of the upper respiratory tract of Papua New Guinea children with Haemophilus influenzae and Streptococcus pneumoniae. Southeast Asian J Trop Med Public Health 1989, 20(4):501-509.
6. Turner P., Hinds J., Turner C., Jankhot A., Gould K., Bentley S.D., et al. Improved detection of nasopharyngeal colonization by multiple pneumococcal serotypes by use of latex agglutination or molecular serotyping by microarray. J Clin Microbiol 2010, 48(5):1784-1789.
7. da Gloria Carvalho M., Pimenta F.C., Jackson D., Roundtree A., Ahmad Y., Millar E.V., et al. Revisiting pneumococcal carriage by use of broth enrichment and PCR techniques for enhanced detection of carriage and serotypes. J Clin Microbiol 2010, 48(5):1611-1618.
8. Valente C., Hinds J., Pinto F., Brugger S.D., Gould K., Mühlemann K., et al. Decrease in pneumococcal co-colonization following vaccination with the seven-valent pneumococcal conjugate vaccine. PLoS One 2012, 7(1):e30235.
9. Brugger S.D., Frey P., Aebi S., Hinds J., Mühlemann K. Multiple colonization with S. pneumoniae before and after introduction of the seven-valent conjugated pneumococcal polysaccharide vaccine. PLoS One 2010, 5(7):e11638.
10. Auranen K., Rinta-Kokko H., Halloran M.E. Estimating strain-specific and overall vaccine efficacy of polyvalent vaccines against pathogens with recurrent dynamics from a cross-sectional study. Biometrics 2013, 69(1):235-244.
11. Klugman K.P. Contribution of vaccines to our understanding of pneumococcal diseases. Philos Trans R Soc Lond Biol Sci 2011, 366(1579):2790-2798.
12. Bogaert D., van Belkum A., Sluijter M., Luijendijk A., de Groot R., Rümke H.C., et al. Colonisation by Streptococcus pneumoniae and Staphylococcus aureus in healthy children. Lancet 2004, 363:1871-1872.
13. Nurhonen M., Cheng A., Auranen K. Pneumococcal transmission and disease in silico-a microsimulation model of the indirect effects of vaccination. PLoS One 2013, 8(2):e56079. doi:10.1371/journal.pone.0056079.
14. D'Agostino R.B., Massarro J.M., Sullivan L.M. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics. Stat Med 2003, 22(2):169-186.
15. Omori R., Cowling B.J., Nishiura H. How is vaccine effectiveness scaled by the transmission dynamics of interacting pathogen strains with cross-protective immunity?. PLoS One 2012, 7(11):e50751. 10.1371/journal.pone.0050751.
16. Dagan R., Givon-Lavi N., Greenberg D., Fritzell B., Siegrist C.A. Nasopharyngeal carriage of Streptococcus pneumoniae shortly before vaccination with a pneumococcal conjugate vaccine causes serotype-specific hyporesponsiveness in early infancy. J Infect Dis 2010, 201(10):1570-1579.
17. Halloran M.E., Longini I.M., Struchiner C.J. Estimability and interpretation of vaccine efficacy using frailty mixing models. Am J Epidemiol 1996, 144(1):83-97.
18. Mehtälä J., Auranen K., Kulathinal S. Optimal designs for epidemiologic longitudinal studies with binary outcomes. Stat Methods Med Res 2011, [Epub ahead of print].