Comparison of two-dose priming plus 9-month booster with a standard three-dose priming schedule for a ten-valent pneumococcal conjugate vaccine in Nepalese infants: A randomised, controlled, open-label, non-inferiority trial

The Lancet Infectious Diseases

Volumn 15, Issue 4, 2015, Pages 405-414

  Hamaluba, Mainga ^a   Kandasamy, Rama ^a   Upreti, Shyam R ^b   Subedi, Giri R ^b   Shrestha, Shrijana ^c   Bhattarai, Shiva ^c   Gurung, Meeru ^c   Pradhan, Rahul ^c   Voysey, Merryn ^d   Gurung, Santosh ^e   Pradhan, Shachi ^c   Thapa, Anushil K ^c   Maharjan, Rakesh ^c   Kiran, Usha ^c   Kerridge, Simon A ^a   Hinds, Jason ^f   van der Klis, Fiona ^g   Snape, Matthew D ^a   Murdoch, David R ^h   Kelly, Sarah ^a   Kelly, Dominic F ^a   Adhikari, Neelam ^c   Thorson, Stephen ^c   Pollard, Andrew J ^a   more..

^a NIHR OXFORD BIOMEDICAL RESEARCH CENTRE   (United Kingdom)

^b Minister for Health and Population Nepal   (Nepal)

^c Patan Academy of Health Sciences   (Nepal)

^d UNIVERSITY OF OXFORD   (United Kingdom)

^e WORLD HEALTH ORGANIZATION   (Switzerland)

^f ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^g NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^h UNIVERSITY OF OTAGO   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY; DIPHTHERIA PERTUSSIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B HEPATITIS B VACCINE; IMMUNOGLOBULIN G; PNEUMOCOCCUS VACCINE; POLIOMYELITIS VACCINE; 10-VALENT PNEUMOCOCCAL CONJUGATE VACCINE; BACTERIUM ANTIBODY; OPSONIN;

ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; BACTERIAL IMMUNITY; BACTERIAL PNEUMONIA; CHILD; CONTROLLED STUDY; DIPHTHERIA; DOSAGE SCHEDULE COMPARISON; FOLLOW UP; HEPATITIS B; HUMAN; IMMUNIZATION; IMMUNOGENICITY; INFANCY; INFANT; LABORATORY PERSONNEL; LABORATORY TEST; MAJOR CLINICAL STUDY; NASOPHARYNX; NEPAL; NEPALESE; OPEN STUDY; OPSONOPHAGOCYTOSIS; OUTCOME ASSESSMENT; PERTUSSIS; PHAGOCYTOSIS; PNEUMOCOCCAL INFECTION; POLIOMYELITIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROTYPE; SERUM; STREPTOCOCCUS PNEUMONIAE; TETANUS; WORLD HEALTH ORGANIZATION; BLOOD; COMPARATIVE STUDY; FEMALE; IMMUNOLOGY; MALE; NORMAL HUMAN; PRESCHOOL CHILD; PROCEDURES; TREATMENT OUTCOME; VACCINATION;

ANTIBODIES, BACTERIAL; CHILD, PRESCHOOL; FEMALE; HEALTHY VOLUNTEERS; HUMANS; IMMUNIZATION SCHEDULE; IMMUNOGLOBULIN G; INFANT; MALE; NEPAL; OPSONIN PROTEINS; PHAGOCYTOSIS; PNEUMOCOCCAL VACCINES; TREATMENT OUTCOME; VACCINATION;

EID: 84925352592     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(15)70007-1     Document Type: Article

References (27)

1. O'Brien KL, Wolfson LJ, Watt JP, et al. Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates. Lancet 2009, 374:893-902.
2. Flasche S, Van Hoek AJ, Sheasby E, et al. Effect of pneumococcal conjugate vaccination on serotype-specific carriage and invasive disease in England: a cross-sectional study. PLoS Med 2011, 8:e1001017.
3. Dagan R, Givon-Lavi N, Zamir O, et al. Reduction of nasopharyngeal carriage of Streptococcus pneumoniae after administration of a 9-valent pneumococcal conjugate vaccine to toddlers attending day care centers. J Infect Dis 2002, 185:927-936.
4. Direct and indirect effects of routine vaccination of children with 7-valent pneumococcal conjugate vaccine on incidence of invasive pneumococcal disease-United States, 1998-2003. MMWR Morb Mortal Wkly Rep 2005, 54:893-897. Centers for Disease Control and Prevention.
5. Kelly DF, Thorson S, Maskey M, et al. The burden of vaccine-preventable invasive bacterial infections and pneumonia in children admitted to hospital in urban Nepal. Int J Infect Dis 2011, 15:e17-e23.
6. Shah AS, Knoll MD, Sharma PR, et al. Invasive pneumococcal disease in Kanti Children's Hospital, Nepal, as observed by the South Asian Pneumococcal Alliance network. Clin Infect Dis 2009, 48(suppl 2):S123-S128.
7. Gurung M, Thorson S, Kandasamy R, et al. Enhanced surveillance of invasive pneumococcal disease in the Kathmandu Valley, Nepal, from 2005 to 2012. Pneumonia 2014, 3:110.
8. Countries approved for support GAVI Alliance, (accessed June 25, 2014). http://www.gavialliance.org/results/countries-approved-for-support/.
9. WHO vaccine preventable diseases monitoring system: immunization schedules by antigen WHO, (accessed Aug 8, 2014). http://apps.who.int/immunization_monitoring/globalsummary/schedules?sc%5Bd%5D=&sc%5Bv%5D%5B%5D=PNEUMO_CONJ&sc%5BOK%5D=OK.
10. Trotter CL, McVernon J, Ramsay ME, et al. Optimising the use of conjugate vaccines to prevent disease caused by Haemophilus influenzae type b, Neisseria meningitidis and Streptococcus pneumoniae. Vaccine 2008, 26:4434-4445.
11. Givon-Lavi N, Greenberg D, Dagan R Immunogenicity of alternative regimens of the conjugated 7-valent pneumococcal vaccine: a randomized controlled trial. Pediatr Infect Dis J 2010, 29:756-762.
12. Concepcion NF, Frasch CE Pneumococcal type 22f polysaccharide absorption improves the specificity of a pneumococcal-polysaccharide enzyme-linked immunosorbent assay. Clin Diagn Lab Immunol 2001, 8:266-272.
13. Romero-Steiner S, Libutti D, Pais LB, et al. Standardization of an opsonophagocytic assay for the measurement of functional antibody activity against Streptococcus pneumoniae using differentiated HL-60 cells. Clin Diagn Lab Immunol 1997, 4:415-422.
14. Lim FS, Koh MT, Tan KK, et al. A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia. BMC Infect Dis 2014, 14:530.
15. Elberse KE, de Greeff SC, Wattimena N, et al. Seroprevalence of IgG antibodies against 13 vaccine Streptococcus pneumoniae serotypes in the Netherlands. Vaccine 2011, 29:1029-1035.
16. Scott P, Rutjes AW, Bermetz L, et al. Comparing pneumococcal conjugate vaccine schedules based on 3 and 2 primary doses: systematic review and meta-analysis. Vaccine 2011, 29:9711-9721.
17. Ruckinger S, Dagan R, Albers L, Schonberger K, von Kries R Immunogenicity of pneumococcal conjugate vaccines in infants after two or three primary vaccinations: a systematic review and meta-analysis. Vaccine 2011, 29:9600-9606.
18. Schonberger K, Kirchgassner K, Riedel C, von Kries R Effectiveness of 2+1 PCV7 vaccination schedules in children under 2 years: a meta-analysis of impact studies. Vaccine 2013, 31:5948-5952.
19. Deloria Knoll M, Park DE, Johnson TS, et al. Systematic review of the effect of pneumococcal conjugate vaccine dosing schedules on immunogenicity. Pediatr Infect Dis J 2014, 33(suppl 2):S119-S129.
20. Spijkerman J, Veenhoven RH, Wijmenga-Monsuur AJ, et al. Immunogenicity of 13-valent pneumococcal conjugate vaccine administered according to 4 different primary immunization schedules in infants: a randomized clinical trial. JAMA 2013, 310:930-997.
21. Dagan R, Givon-Lavi N, Porat N, Greenberg D The effect of an alternative reduced-dose infant schedule and a second year catch-up schedule with 7-valent pneumococcal conjugate vaccine on pneumococcal carriage: a randomized controlled trial. Vaccine 2012, 30:5132-5140.
22. Palmu AA, Jokinen J, Borys D, et al. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet 2013, 381:214-222.
23. van den Bergh MR, Spijkerman J, Francois N, et al. Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine and DTPa-IPV-Hib when coadministered as a 3-dose primary vaccination schedule in The Netherlands: a randomized controlled trial. Pediatr Infect Dis J 2011, 30:e170-e178.
24. Bermal N, Szenborn L, Chrobot A, et al. The 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) coadministered with DTPw-HBV/Hib and poliovirus vaccines: assessment of immunogenicity. Pediatr Infect Dis J 2009, 28(4 suppl):S89-S96.
25. Hanieh S, Hamaluba M, Kelly DF, et al. Streptococcus pneumoniae carriage prevalence in Nepal: evaluation of a method for delayed transport of samples from remote regions and implications for vaccine implementation. PLoS One 2014, 9:e98739.
26. Sleeman KL, Griffiths D, Shackley F, et al. Capsular serotype-specific attack rates and duration of carriage of Streptococcus pneumoniae in a population of children. J Infect Dis 2006, 194:682-688.
27. WHO recommendations for routine immunization-summary tables WHO, (accessed Aug 8, 2014). http://www.who.int/immunization/policy/immunization_tables/en/index.html.