PMID- 18533940
OWN - NLM
STAT- MEDLINE
DCOM- 20080731
LR  - 20160511
IS  - 1442-200X (Electronic)
IS  - 1328-8067 (Linking)
VI  - 50
IP  - 3
DP  - 2008 Jun
TI  - Phase 1 trial of 13-valent pneumococcal conjugate vaccine in Japanese adults.
PG  - 295-9
LID - 10.1111/j.1442-200X.2008.02593.x [doi]
AB  - BACKGROUND: A 7-valent pneumococcal conjugate vaccine (7vPnC) has markedly 
      reduced invasive pneumococcal disease (IPD) in routine use in the USA and is in 
      clinical development in Japan. But a 13-valent pneumococcal conjugate vaccine 
      (13vPnC) would cover even more serotypes. Because vaccines are administered to 
      children by s.c. injection in Japan but by i.m. injection in the USA, a phase I 
      study of s.c. injected 13vPnC in healthy Japanese adults was appropriate before 
      commencing trials in Japanese children and older adults. METHODS: This was a 
      randomized comparison in healthy Japanese adults of s.c. administered 13-valent 
      pneumococcal conjugate vaccine and s.c. administered 23-valent plain 
      polysaccharide pneumococcal vaccine (23vPn). Local and systemic reactions were 
      recorded in a daily diary for 14 days after injection. IgG antibodies to 
      serotype-specific capsular polysaccharide were measured on enzyme-linked 
      immunosorbent assay on samples taken before and approximately 1 month after 
      immunization. RESULTS: A total of 15 subjects were evaluable for safety review in 
      each treatment group. There was a trend towards more local reactions in the 
      13vPnC group, which may be associated with s.c. administration of 
      aluminum-containing vaccines as used routinely in Japan; but the local 
      reactogenicity was mostly mild or moderate. Both 13vPnC and 23vPn were 
      immunogenic for all types, with the exception of 6A, which is not included in 
      23vPn and for which only 13vPnC was immunogenic. CONCLUSIONS: Overall, 
      immunogenicity and tolerance was adequate to lead to studies of 13vPnC in both 
      infants and older adults in Japan, using the s.c. route if appropriate.
FAU - Scott, Daniel
AU  - Scott D
AD  - Wyeth Vaccines Research, Pearl River, New York, USA.
FAU - Ruckle, Jon
AU  - Ruckle J
FAU - Dar, Marilyn
AU  - Dar M
FAU - Baker, Sherryl
AU  - Baker S
FAU - Kondoh, Hiroaki
AU  - Kondoh H
FAU - Lockhart, Stephen
AU  - Lockhart S
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Australia
TA  - Pediatr Int
JT  - Pediatrics international : official journal of the Japan Pediatric Society
JID - 100886002
RN  - 0 (Antibodies, Anti-Idiotypic)
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Pneumococcal Vaccines)
SB  - IM
MH  - Adult
MH  - Antibodies, Anti-Idiotypic/immunology
MH  - Antibodies, Bacterial/immunology
MH  - Enzyme-Linked Immunosorbent Assay
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Immunoglobulin G/immunology
MH  - Incidence
MH  - Injections, Subcutaneous
MH  - Japan/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Pneumococcal Infections/epidemiology/microbiology/*prevention & control
MH  - Pneumococcal Vaccines/*administration & dosage
MH  - Streptococcus pneumoniae/immunology
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2008/06/07 09:00
MHDA- 2008/08/01 09:00
CRDT- 2008/06/07 09:00
PHST- 2008/06/07 09:00 [pubmed]
PHST- 2008/08/01 09:00 [medline]
PHST- 2008/06/07 09:00 [entrez]
AID - PED2593 [pii]
AID - 10.1111/j.1442-200X.2008.02593.x [doi]
PST - ppublish
SO  - Pediatr Int. 2008 Jun;50(3):295-9. doi: 10.1111/j.1442-200X.2008.02593.x.