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Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45.
Vaccine. 2018 02 01; 36(6):833-840.V

Abstract

The attenuated recombinant Vibrio cholerae O1 vaccine strain CVD 103-HgR, re-developed as PXVX0200, elicits a rapid serum vibriocidal antibody (SVA) response and protects against cholera diarrhea in volunteer challenge studies. We performed a phase 3, placebo controlled, double blind, multi-center study to further assess the safety, immunogenicity, and lot-to-lot consistency of PXVX0200. Adult volunteers 18-45 years of age were randomized 8:1 to receive a single dose of 1 × 109 CFU of PXVX0200 from three production lots or saline placebo. Immunogenicity endpoints included SVA and anti-cholera toxin (CT) antibody levels on days 1, 11, 29, 91 and 181. Safety was assessed by comparing solicited signs and symptoms on days 1-8, unsolicited adverse events through day 29 and serious adverse events through day 181. A total of 3146 participants were enrolled, including 2795 vaccine and 351 placebo recipients. The SVA seroconversion rates at day 11 were 94% and 4% in the PXVX0200 and placebo recipients, respectively (P < .0001). Cumulative SVA seroconversion occurred among 96% of vaccine recipients. PXVX0200 SVA GMTs peaked on day 11 and remained significantly higher than placebo through day 181 while the fold-rise over baseline in PXVX0200 anti-CT antibody was significantly greater than placebo at every post-vaccination time point. Most reactogenicity was mild and resolved within 1-3 days with headache and diarrhea more frequently reported in PXVX0200 recipients. There were no differences in unsolicited adverse events and no study-related serious adverse events. Immunogenicity and safety endpoints were equivalent between the three production lots. PXVX0200 is immunogenic and well tolerated across multiple production lots.

CLINICAL TRIALS REGISTRATION

Clinicaltrials.gov NCT02094586.

Authors+Show Affiliations

Stanford University School of Medicine, 291 Campus Drive, Stanford, CA 94305, USA.PaxVax, Inc., 555 Twin Dolphin Drive, Ste. 360, Redwood City, CA 94065, USA.PaxVax, Inc., 555 Twin Dolphin Drive, Ste. 360, Redwood City, CA 94065, USA.PaxVax, Inc., 555 Twin Dolphin Drive, Ste. 360, Redwood City, CA 94065, USA.PaxVax, Inc., 555 Twin Dolphin Drive, Ste. 360, Redwood City, CA 94065, USA. Electronic address: mgurwith@paxvax.com.

Pub Type(s)

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

Language

eng

PubMed ID

29317118

Citation

McCarty, James M., et al. "Safety and Immunogenicity of Single-dose Live Oral Cholera Vaccine Strain CVD 103-HgR in Healthy Adults Age 18-45." Vaccine, vol. 36, no. 6, 2018, pp. 833-840.
McCarty JM, Lock MD, Hunt KM, et al. Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45. Vaccine. 2018;36(6):833-840.
McCarty, J. M., Lock, M. D., Hunt, K. M., Simon, J. K., & Gurwith, M. (2018). Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45. Vaccine, 36(6), 833-840. https://doi.org/10.1016/j.vaccine.2017.12.062
McCarty JM, et al. Safety and Immunogenicity of Single-dose Live Oral Cholera Vaccine Strain CVD 103-HgR in Healthy Adults Age 18-45. Vaccine. 2018 02 1;36(6):833-840. PubMed PMID: 29317118.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45. AU - McCarty,James M, AU - Lock,Michael D, AU - Hunt,Kristin M, AU - Simon,Jakub K, AU - Gurwith,Marc, Y1 - 2018/01/06/ PY - 2017/10/10/received PY - 2017/12/09/revised PY - 2017/12/19/accepted PY - 2018/1/11/pubmed PY - 2018/9/12/medline PY - 2018/1/11/entrez SP - 833 EP - 840 JF - Vaccine JO - Vaccine VL - 36 IS - 6 N2 - : The attenuated recombinant Vibrio cholerae O1 vaccine strain CVD 103-HgR, re-developed as PXVX0200, elicits a rapid serum vibriocidal antibody (SVA) response and protects against cholera diarrhea in volunteer challenge studies. We performed a phase 3, placebo controlled, double blind, multi-center study to further assess the safety, immunogenicity, and lot-to-lot consistency of PXVX0200. Adult volunteers 18-45 years of age were randomized 8:1 to receive a single dose of 1 × 109 CFU of PXVX0200 from three production lots or saline placebo. Immunogenicity endpoints included SVA and anti-cholera toxin (CT) antibody levels on days 1, 11, 29, 91 and 181. Safety was assessed by comparing solicited signs and symptoms on days 1-8, unsolicited adverse events through day 29 and serious adverse events through day 181. A total of 3146 participants were enrolled, including 2795 vaccine and 351 placebo recipients. The SVA seroconversion rates at day 11 were 94% and 4% in the PXVX0200 and placebo recipients, respectively (P < .0001). Cumulative SVA seroconversion occurred among 96% of vaccine recipients. PXVX0200 SVA GMTs peaked on day 11 and remained significantly higher than placebo through day 181 while the fold-rise over baseline in PXVX0200 anti-CT antibody was significantly greater than placebo at every post-vaccination time point. Most reactogenicity was mild and resolved within 1-3 days with headache and diarrhea more frequently reported in PXVX0200 recipients. There were no differences in unsolicited adverse events and no study-related serious adverse events. Immunogenicity and safety endpoints were equivalent between the three production lots. PXVX0200 is immunogenic and well tolerated across multiple production lots. CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov NCT02094586. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/29317118/Safety_and_immunogenicity_of_single_dose_live_oral_cholera_vaccine_strain_CVD_103_HgR_in_healthy_adults_age_18_45_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(17)31823-6 DB - PRIME DP - Unbound Medicine ER -