PMID- 6127806
OWN - NLM
STAT- MEDLINE
DA  - 19821221
DCOM- 19821221
LR  - 20061115
IS  - 0300-8878 (Print)
IS  - 0300-8878 (Linking)
VI  - 33
DP  - 1982
TI  - Reactogenicity, immunogenicity and efficacy studies of Escherichia coli type 1
      somatic pili parenteral vaccine in man.
PG  - 83-95
AB  - Purified type 1 somatic pili from enterotoxigenic Escherichia coli (ETEC) strain 
      H10407 (O78:H11) was evaluated as a parenteral immunizing agent in the hope that 
      this antigen might enhance a contemplated polyvalent pilus vaccine. Intramuscular
      inoculation with 45, 90, 900 or 1 800 mcg of pili vaccine was tolerated without
      incident in 82 volunteers. Six of 15 persons who received a 28 day booster of 1
      800 mcg developed local reactions while none of 52 persons receiving 180 or 450
      mcg boosters evinced such reactions. Pili vaccine did not significantly alter
      intestinal transit time, absorptive capacity or the prevalence of colonic E. coli
      bearing type 1 somatic pili of the H10407 antigenic variety. All vaccinees
      developed significant rises in circulating IgG antibody to type 1 somatic pili,
      the magnitude of the response being directly proportioned to the vaccine dose.
      None of the vaccinees had significant rises to CFA I or II pili nor to
      heat-labile enterotoxin. However, many had rises in O antibody, particularly
      among those inoculated with 1 800 mcg. Three challenge studies were carried out
      with E. coli H10407 to assess vaccine efficacy. In the initial study the
      vaccinees were either protected against diarrhea (2 of 6 vaccinees versus 7/7 of 
      controls) or had milder disease than the controls. In two subsequent challenges
      with H10407 significant protection was not seen. It was not clear whether
      protection exhibited by the vaccinee group in the first challenge was due to O
      antibody, pili antibody, or both acting synergistically. To clarify this, a group
      of the immunized volunteers were challenged with ETEC strain B7A which is a
      different serotype (O148:H28) lacks CFA/I or II pili, but possesses type 1
      somatic pili antigenically distantly related to those of H10407. Attack rates and
      severity of illness were similar in both vaccinee and control groups. While most 
      volunteers challenged with E. coli H10407 developed significant rises in
      circulating antibody to CFA/I, LT and O antigen, none had rises to type 1 somatic
      pili. It is unclear if this is due to immune tolerance to this antigen when
      encountered enterally or whether these pili are not present in vivo in ETEC
      initiating diarrhea in the proximal small intestine. In summary, parenterally
      inoculated type 1 somatic pili were safe and highly immunogenic in man but did
      not consistently induce protection. Further studies are planned to clarify the
      role of antibody to type 1 somatic pili in mediating protection.
FAU - Levine, M M
AU  - Levine MM
FAU - Black, R E
AU  - Black RE
FAU - Brinton, C C Jr
AU  - Brinton CC Jr
FAU - Clements, M L
AU  - Clements ML
FAU - Fusco, P
AU  - Fusco P
FAU - Hughes, T P
AU  - Hughes TP
FAU - O'Donnell, S
AU  - O'Donnell S
FAU - Robins-Browne, R
AU  - Robins-Browne R
FAU - Wood, S
AU  - Wood S
FAU - Young, C R
AU  - Young CR
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - SWEDEN
TA  - Scand J Infect Dis Suppl
JT  - Scandinavian journal of infectious diseases. Supplementum
JID - 0251025
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Bacterial Vaccines)
SB  - IM
MH  - Adult
MH  - Antibodies, Bacterial/biosynthesis
MH  - Bacterial Vaccines/*pharmacology
MH  - Colon/microbiology
MH  - Diarrhea/prevention & control
MH  - Escherichia coli/*immunology
MH  - Escherichia coli Infections/*prevention & control
MH  - Fimbriae, Bacterial/*immunology
MH  - Humans
EDAT- 1982/01/01
MHDA- 2001/03/28 10:01
CRDT- 1982/01/01 00:00
PST - ppublish
SO  - Scand J Infect Dis Suppl. 1982;33:83-95.