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Vaccine Detail

EcSf2a-2
Vaccine Information
  • Vaccine Name: EcSf2a-2
  • Target Pathogen: Shigella
  • Target Disease: Shigellosis
  • Vaccine Ontology ID: VO_0000670
  • Type: Recombinant vector vaccine
  • Antigen: This vaccine is an aro-D mutant derivative of EcSf2a-1 (Kotloff et al., 1992).
  • Preparation: The vaccine was suspended in 20 ml of BHI broth and contained 1.5 x 10^11 CFU of bacteria (Kotloff et al., 1992).
  • Virulence: Vaccinated monkeys were protected against shigellosis after challenge with S. flexneri 2a (Kotloff et al., 1992).
Host Response

Human Response

  • Vaccination Protocol: 19 volunteers ingested three doses of either ca. 5.0 x 10^6, 5.0 x 10^7, or 2.0 x 10^9 CFU of bacteria (Kotloff et al., 1992).
  • Persistence: All 46 vaccine recipients excreted the vaccine strain on at least one occasion. Recipients of three spaced doses of ca. 2.0 x 10^9 CFU shed ca. 10^5 organisms per gram of stool for an average of 7 days. Duodenal colonization was detected in five subjects, all recipients of ca. 2.0 x 10^9 CFU (Kotloff et al., 1992).
  • Immune Response: A fourfold increase in IgA or IgG antibody titers recognizing purified LPS was detected in 61% of those tested, and a seroresponse to IPA was detected in 44% of the 38 recipients of ca. 2.0 x 10^9 CFU. The IgM response was meager. Circulating IgA ASC specific for S. flexneri 2a LPS and for IPA were each detected in 97% and 60%, respectively, of the 30 subjects tested (Kotloff et al., 1992).
  • Side Effects: Diarrhea, dysentery, and fever were observed in vaccine recipients (Kotloff et al., 1992).
  • Challenge Protocol: Challenge doses of 1.6 x 10^9 and 1.8 x 10^9 CFU of ECSf2a-2 were given to the volunteers (Kotloff et al., 1992) .
  • Efficacy: Vaccine efficacy was only 9% in the challenge study, in which 30% of recipients of three doses of ca. 2.0 x 10^9 CFU developed illness, compared 33% of 9 unvaccinated control subjects. Overall, the vaccine efficacy was 36%. Neither class-specific titers in prechallenge sera nor fourfold rises in antibody titer after vaccination could be correlated with protection against challenge (Kotloff et al., 1992).
References
Kotloff et al., 1992: Kotloff KL, Herrington DA, Hale TL, Newland JW, Van De Verg L, Cogan JP, Snoy PJ, Sadoff JC, Formal SB, Levine MM. Safety, immunogenicity, and efficacy in monkeys and humans of invasive Escherichia coli K-12 hybrid vaccine candidates expressing Shigella flexneri 2a somatic antigen. Infection and immunity. 1992; 60(6); 2218-2224. [PubMed: 1587589].