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Anti-O-specific polysaccharide (OSP) immune responses following vaccination with oral cholera vaccine CVD 103-HgR correlate with protection against cholera after infection with wild-type Vibrio cholerae O1 El Tor Inaba in North American volunteers.
PLoS Negl Trop Dis. 2018 04; 12(4):e0006376.PN

Abstract

BACKGROUND

Cholera is an acute voluminous dehydrating diarrheal disease caused by toxigenic strains of Vibrio cholerae O1 and occasionally O139. A growing body of evidence indicates that immune responses targeting the O-specific polysaccharide (OSP) of V. cholerae are involved in mediating protection against cholera. We therefore assessed whether antibody responses against OSP occur after vaccination with live attenuated oral cholera vaccine CVD 103-HgR, and whether such responses correlate with protection against cholera.

METHODOLOGY

We assessed adult North American volunteers (n = 46) who were vaccinated with 5 × 108 colony-forming units (CFU) of oral cholera vaccine CVD 103-HgR and then orally challenged with approximately 1 × 105 CFU of wild-type V. cholerae O1 El Tor Inaba strain N16961, either 10 or 90 days post-vaccination.

PRINCIPAL FINDINGS

Vaccination was associated with induction of significant serum IgM and IgA anti-OSP and vibriocidal antibody responses within 10 days of vaccination. There was significant correlation between anti-OSP and vibriocidal antibody responses. IgM and IgA anti-OSP responses on day 10 following vaccination were associated with lower post-challenge stool volume (r = -0.44, P = 0.002; r = -0.36, P = 0.01; respectively), and none of 27 vaccinees who developed a ≥1.5 fold increase in any antibody isotype targeting OSP on day 10 following vaccination compared to baseline developed moderate or severe cholera following experimental challenge, while 5 of 19 who did not develop such anti-OSP responses did (P = 0.01).

CONCLUSION

Oral vaccination with live attenuated cholera vaccine CVD 103-HgR induces antibodies that target V. cholerae OSP, and these anti-OSP responses correlate with protection against diarrhea following experimental challenge with V. cholerae O1.

TRIAL REGISTRATION

ClinicalTrials.gov NCT01895855.

Authors+Show Affiliations

Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America. Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America. Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America. Harvard Medical School, Boston, Massachusetts, United States of America.Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), Laboratory of Bioorganic Chemistry (LBC), National Institutes of Health, Bethesda, Maryland, United States of America.National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), Laboratory of Bioorganic Chemistry (LBC), National Institutes of Health, Bethesda, Maryland, United States of America.Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America. Harvard Medical School, Boston, Massachusetts, United States of America.Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America. Harvard Medical School, Boston, Massachusetts, United States of America.Merck & Co., Inc., Kenilworth, New Jersey, United States of America.Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.PaxVax, Inc., Redwood City, California, United States of America.PaxVax, Inc., Redwood City, California, United States of America.Vaccine Testing Center, Department of Medicine University of Vermont College of Medicine, Burlington, Vermont, United States of America.Vaccine Testing Center, Department of Medicine University of Vermont College of Medicine, Burlington, Vermont, United States of America.Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, United States of America.Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.PaxVax, Inc., Redwood City, California, United States of America.Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America. Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, United States of America.Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America. Harvard Medical School, Boston, Massachusetts, United States of America. Department of Immunology and Infectious Disease, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29624592

Citation

Islam, Kamrul, et al. "Anti-O-specific Polysaccharide (OSP) Immune Responses Following Vaccination With Oral Cholera Vaccine CVD 103-HgR Correlate With Protection Against Cholera After Infection With Wild-type Vibrio Cholerae O1 El Tor Inaba in North American Volunteers." PLoS Neglected Tropical Diseases, vol. 12, no. 4, 2018, pp. e0006376.
Islam K, Hossain M, Kelly M, et al. Anti-O-specific polysaccharide (OSP) immune responses following vaccination with oral cholera vaccine CVD 103-HgR correlate with protection against cholera after infection with wild-type Vibrio cholerae O1 El Tor Inaba in North American volunteers. PLoS Negl Trop Dis. 2018;12(4):e0006376.
Islam, K., Hossain, M., Kelly, M., Mayo Smith, L. M., Charles, R. C., Bhuiyan, T. R., Kováč, P., Xu, P., LaRocque, R. C., Calderwood, S. B., Simon, J. K., Chen, W. H., Haney, D., Lock, M., Lyon, C. E., Kirkpatrick, B. D., Cohen, M., Levine, M. M., Gurwith, M., ... Ryan, E. T. (2018). Anti-O-specific polysaccharide (OSP) immune responses following vaccination with oral cholera vaccine CVD 103-HgR correlate with protection against cholera after infection with wild-type Vibrio cholerae O1 El Tor Inaba in North American volunteers. PLoS Neglected Tropical Diseases, 12(4), e0006376. https://doi.org/10.1371/journal.pntd.0006376
Islam K, et al. Anti-O-specific Polysaccharide (OSP) Immune Responses Following Vaccination With Oral Cholera Vaccine CVD 103-HgR Correlate With Protection Against Cholera After Infection With Wild-type Vibrio Cholerae O1 El Tor Inaba in North American Volunteers. PLoS Negl Trop Dis. 2018;12(4):e0006376. PubMed PMID: 29624592.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Anti-O-specific polysaccharide (OSP) immune responses following vaccination with oral cholera vaccine CVD 103-HgR correlate with protection against cholera after infection with wild-type Vibrio cholerae O1 El Tor Inaba in North American volunteers. AU - Islam,Kamrul, AU - Hossain,Motaher, AU - Kelly,Meagan, AU - Mayo Smith,Leslie M, AU - Charles,Richelle C, AU - Bhuiyan,Taufiqur Rahman, AU - Kováč,Pavol, AU - Xu,Peng, AU - LaRocque,Regina C, AU - Calderwood,Stephen B, AU - Simon,Jakub K, AU - Chen,Wilbur H, AU - Haney,Douglas, AU - Lock,Michael, AU - Lyon,Caroline E, AU - Kirkpatrick,Beth D, AU - Cohen,Mitchell, AU - Levine,Myron M, AU - Gurwith,Marc, AU - Harris,Jason B, AU - Qadri,Firdausi, AU - Ryan,Edward T, Y1 - 2018/04/06/ PY - 2018/01/10/received PY - 2018/03/08/accepted PY - 2018/04/18/revised PY - 2018/4/7/pubmed PY - 2018/6/15/medline PY - 2018/4/7/entrez SP - e0006376 EP - e0006376 JF - PLoS neglected tropical diseases JO - PLoS Negl Trop Dis VL - 12 IS - 4 N2 - BACKGROUND: Cholera is an acute voluminous dehydrating diarrheal disease caused by toxigenic strains of Vibrio cholerae O1 and occasionally O139. A growing body of evidence indicates that immune responses targeting the O-specific polysaccharide (OSP) of V. cholerae are involved in mediating protection against cholera. We therefore assessed whether antibody responses against OSP occur after vaccination with live attenuated oral cholera vaccine CVD 103-HgR, and whether such responses correlate with protection against cholera. METHODOLOGY: We assessed adult North American volunteers (n = 46) who were vaccinated with 5 × 108 colony-forming units (CFU) of oral cholera vaccine CVD 103-HgR and then orally challenged with approximately 1 × 105 CFU of wild-type V. cholerae O1 El Tor Inaba strain N16961, either 10 or 90 days post-vaccination. PRINCIPAL FINDINGS: Vaccination was associated with induction of significant serum IgM and IgA anti-OSP and vibriocidal antibody responses within 10 days of vaccination. There was significant correlation between anti-OSP and vibriocidal antibody responses. IgM and IgA anti-OSP responses on day 10 following vaccination were associated with lower post-challenge stool volume (r = -0.44, P = 0.002; r = -0.36, P = 0.01; respectively), and none of 27 vaccinees who developed a ≥1.5 fold increase in any antibody isotype targeting OSP on day 10 following vaccination compared to baseline developed moderate or severe cholera following experimental challenge, while 5 of 19 who did not develop such anti-OSP responses did (P = 0.01). CONCLUSION: Oral vaccination with live attenuated cholera vaccine CVD 103-HgR induces antibodies that target V. cholerae OSP, and these anti-OSP responses correlate with protection against diarrhea following experimental challenge with V. cholerae O1. TRIAL REGISTRATION: ClinicalTrials.gov NCT01895855. SN - 1935-2735 UR - https://www.unboundmedicine.com/medline/citation/29624592/Anti_O_specific_polysaccharide__OSP__immune_responses_following_vaccination_with_oral_cholera_vaccine_CVD_103_HgR_correlate_with_protection_against_cholera_after_infection_with_wild_type_Vibrio_cholerae_O1_El_Tor_Inaba_in_North_American_volunteers_ L2 - http://dx.plos.org/10.1371/journal.pntd.0006376 DB - PRIME DP - Unbound Medicine ER -