Vaxchora (oral cholera vaccine) / Emergent Biosolutions, Bavarian Nordic - LARVOL DELTA

CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera (clinicaltrials.gov) - P4 | N=240 | Recruiting | Sponsor: University of Maryland, Baltimore | Trial completion date: May 2025 ➔ May 2029 | Trial primary completion date: May 2025 ➔ May 2029

Trial completion date • Trial primary completion date • Cholera • Infectious Disease

Immunologic Responses to a Live Attenuated Oral Cholera Vaccine (clinicaltrials.gov) - P2 | N=34 | Active, not recruiting | Sponsor: Emory University | Recruiting ➔ Active, not recruiting | N=50 ➔ 34

Enrollment change • Enrollment closed • Cholera

Immunologic Responses to a Live Attenuated Oral Cholera Vaccine (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Emory University | Trial completion date: Jun 2025 ➔ Jan 2026 | Trial primary completion date: Jun 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Cholera

CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera (clinicaltrials.gov) - P4 | N=240 | Recruiting | Sponsor: University of Maryland, Baltimore | Trial completion date: Oct 2023 ➔ May 2025 | Trial primary completion date: Oct 2023 ➔ May 2025

Trial completion date • Trial primary completion date • Cholera • Infectious Disease • CD8 • IFNG • TNFA

Single Dose Oral Vaxchora Vaccine (CVD103-HgR) for the Prevention of Cholera in Travelers (ASTMH 2023) - "A single oral dose of Vaxchora vaccine provides safe and rapid protection in adults and children traveling to areas with cholera. SVA seroconversion, the correlate of protection in the cholera challenge trial, occurs in most individuals in as little as 7 days."

Cholera • Infectious Disease • Pediatrics

Immunologic Responses to a Live Attenuated Oral Cholera Vaccine (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Emory University | Suspended ➔ Recruiting

Enrollment open • Cholera

Immunogenicity of partial doses of live oral cholera vaccine CVD 103-HgR in children in the United States. (PubMed, Vaccine) - "Vaccination with PXVX0200 produced an immune response in most children who received partial dosing. Since SVA seroconversion is a strong correlate of protection, PXVX0200 may protect against cholera infection in children who ingest only part of the vaccine dose."

Journal • Cholera • Infectious Disease • Pediatrics

Predicting Vibrio cholerae infection and symptomatic disease: a systems serology study. (PubMed, Lancet Microbe) - "Several biomarkers predict protection better than vibriocidal titres. A model based on protection against infection among household contacts was predictive of protection against both infection and diarrhoeal illness in challenged vaccinees, suggesting that models based on observed conditions in a cholera-endemic population might be more likely to identify broadly applicable correlates of protection than models trained on single experimental settings."

Journal • Allergy • Cholera • Immunology • Infectious Disease

Safety and Immunogenicity of Live Oral Cholera Vaccine CVD 103-HgR (PXVX0200) in Children and Adolescents 2 to 17 Years of Age (ASTMH 2022) - "The study vaccine was well accepted, with 99.4%, 91.0% and 82.7% of cohort 1, 2 and 3 recipients, respectively, taking at least 80% of the dose. CVD 103-HgR is safe, immunogenic and well-tolerated in children and adolescents 2-17 years of age, and SVAs persist for at least 2 years in a majority of adolescents."

Clinical • Cholera

Partial Doses of Live Oral Cholera Vaccine CVD 103-HgR (PXVX0200) Induce Serum Vibriocidal Antibodies (SVA) in Children (ASTMH 2022) - "Vaccination with PXVX0200 produced an immune response in most children who received partial dosing. Since SVA seroconversion is a strong correlate of protection, PXVX0200 may protect against cholera infection in children who ingest only part of the vaccine dose."

Clinical • Cholera • Infectious Disease

Cholera Vaccine: Recommendations of the Advisory Committee on Immunization Practices, 2022. (PubMed, MMWR Recomm Rep) - "ACIP recommends CVD 103-HgR, the only cholera vaccine licensed for use in the United States, for prevention of cholera among travelers aged 2-64 years to an area with active cholera transmission. Health care providers can use these guidelines to develop the pretravel consultation for persons traveling to areas with active cholera transmission."

Journal • Cardiovascular • Cholera • Gastrointestinal Disorder • Infectious Disease • Nephrology • Renal Disease

Immunologic Responses to a Live Attenuated Oral Cholera Vaccine (clinicaltrials.gov) - P2 | N=50 | Suspended | Sponsor: Emory University | Trial completion date: Jun 2023 ➔ Jun 2025 | Trial primary completion date: Jul 2022 ➔ Jun 2024

Trial completion date • Trial primary completion date • Cholera • Immunology

Development of Pediatric Dosage Preparation for CVD 103-HgR Live Oral Cholera Vaccine. (PubMed, Am J Trop Med Hyg) - "An alternate preparation method was developed for reconstitution in baby formula. Vaccine preparation methods to make PXVX0200 appropriate for pediatric administration will facilitate administration of the vaccine to improve compliance and protect children from cholera infection while traveling."

Journal • Cholera • Infectious Disease • Pediatrics

Blood Donor CVD 9000 (clinicaltrials.gov) - P4 | N=3 | Terminated | Sponsor: University of Maryland, Baltimore | N=200 ➔ 3 | Trial completion date: Oct 2038 ➔ Oct 2021 | Recruiting ➔ Terminated; lack of funding

Enrollment change • Preclinical • Trial completion date • Trial termination • Cholera

Update on CVD 103-HgR single-dose, live oral cholera vaccine. (PubMed, Expert Rev Vaccines) - "Next steps include a Phase 4 study in infants (6-23 months). Additional information is needed regarding duration of immunity, the need for and timing of revaccination, and efficacy data from lower-middle-income countries."

Journal • Cholera

Human Challenge Studies for Vaccine Development : Regulatory Aspects of Human Challenge Studies. (PubMed, Curr Top Microbiol Immunol) - "However, human challenge trials or controlled human infection models have been used in vaccine clinical development to generate supportive data for establishment of correlates of protection, supportive data for licensure, as well as licensure in the case of Vaxchora by the US FDA...NRAs may agree that HCTs are innovative, promising tools to accelerate vaccine development; however, a strong benefit/risk assessment is needed to ensure the safety of study participants. Lastly, it is important to consider the regulatory framework in which the human challenge trial may be conducted."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • NRAS

CVD 103-HgR live, attenuated cholera vaccine strain viability in drinking waters from the US and Europe. (PubMed, Sci Rep) - "These studies give high confidence in the stability of CVD 103-HgR reconstituted in a variety of bottled waters. Waters containing copper, including tap water, should not be used to reconstitute CVD 103-HgR strain oral vaccine due to the common use of copper plumbing."

Journal • Cholera

Immunologic Responses to a Live Attenuated Oral Cholera Vaccine (clinicaltrials.gov) - P2; N=50; Suspended; Sponsor: Emory University; Trial completion date: Nov 2022 ➔ Jun 2023; Trial primary completion date: Jan 2021 ➔ Jul 2022

Trial completion date • Trial primary completion date • Cholera • Immunology

Parenteral Vaccination with a Cholera Conjugate Vaccine Boosts Vibriocidal and Anti-OSP Responses in Mice Previously Immunized with an Oral Cholera Vaccine. (PubMed, Am J Trop Med Hyg) - "To address whether cholera conjugate vaccine would boost immune responses following oral cholera vaccination, we immunized mice with oral cholera vaccine Inaba CVD 103-HgR or buffer only (placebo) on day 0, followed by parenteral boosting immunizations on days 14, 42, and 70 with cholera conjugate vaccine Inaba OSP: recombinant tetanus toxoid heavy chain fragment or PBS/placebo...A combined vaccination approach, which includes oral cholera vaccination followed by parenteral cholera conjugate vaccine boosting, results in increased immune responses that have been associated with protection against cholera. These results suggest that such an approach should be evaluated in humans."

Journal • Preclinical • Cholera • Infectious Disease • Tetanus

Long-Term Immunogenicity of Live Oral Cholera Vaccine CVD 103-HgR in Adolescents Aged 12-17 Years in the United States. (PubMed, Am J Trop Med Hyg) - "Geometric mean titers and GMFI both peaked at day 11 and remained greater than baseline at all time points, including day 730. Vaccination with PXVX0200 produces an immune response which persists for at least 2 years in adolescents aged 12-17 years."

Clinical • Journal

Home Administration of CVD 103-HgR: A Live Attenuated Oral Cholera Vaccine. (PubMed, Am J Trop Med Hyg) - "Finally, the vaccine was effectively neutralized with hot water and soap to prevent bacterial environmental contamination in the event of an accidental spill. The conclusion is that PXVX0200 oral vaccine is stable, easy to formulate and dispose of, and is amenable to self-administration."

Journal

Safety and Immunogenicity of Live Oral Cholera Vaccine CVD 103-HgR in Children Aged 2-5 Years in the United States. (PubMed, Am J Trop Med Hyg) - "Most reactogenicity was mild to moderate, and there were no study-related SAEs. PXVX0200 appears safe and immunogenic in children aged 2-5 years."

Clinical • Journal

VAXCHORA Pediatric Study to Assess Safety and Immunogenicity (clinicaltrials.gov) - P4; N=550; Completed; Sponsor: Emergent BioSolutions; Active, not recruiting ➔ Completed

Clinical • Trial completion • Pediatrics

Pre-existing Helicobacter pylori serum IgG enhances the vibriocidal antibody response to CVD 103-HgR live oral cholera vaccine in Malian adults. (PubMed, Sci Rep) - "Among H. pylori seropositive vaccine recipients, there were no significant associations between PGI, PGII and PGI:PGII levels and vibriocidal seroconversion. The enhanced seroconversion to oral cholera vaccine CVD 103-HgR among H. pylori seropositive African adults provides further evidence of the immunomodulating impact of H. pylori on oral vaccine immunogenicity."

Clinical • Journal • Immune Modulation • Immunology • Infectious Disease • Inflammation

Immunologic Responses to a Live Attenuated Oral Cholera Vaccine (clinicaltrials.gov) - P2; N=50; Suspended; Sponsor: Emory University; Trial completion date: Nov 2021 ➔ Nov 2022; Recruiting ➔ Suspended

Trial completion date • Trial suspension • Immunology