Biomaterial Database

Immunogenicity of partial doses of live oral cholera vaccine CVD 103-HgR in children in the United States. 2023

James M McCarty, and David Cassie, and Lisa Bedell

Stanford University, Stanford, CA, United States. Electronic address: jmccart2@stanford.edu.

In a phase 4, placebo-controlled, double-blind, multi-center study performed to assess the immunogenicity of a single oral dose of live, attenuated cholera vaccine, volunteers aged 2-17 years were randomized 6:1 to receive 1 × 109 colony forming units of PXVX0200 or placebo. In the subset of subjects who consumed < 80 % of the vaccine dose, seroconversion rates were calculated and stratified by amount consumed. Of 468 subjects dosed, a subset of 33 (7 %) received < 80 % of the vaccine dose. SVA seroconversion occurred in 75.8 % of these subjects, including 100 % (7/7) of those who took 50-80 % and 69.2 % (18/26) of those who took < 50 %, versus 98.5 % of those who consumed 80 % or more. 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.

UI	MeSH Term	Description	Entries
D002648	Child	A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL.	Children
D002771	Cholera	An acute diarrheal disease endemic in India and Southeast Asia whose causative agent is VIBRIO CHOLERAE. This condition can lead to severe dehydration in a matter of hours unless quickly treated.	Vibrio cholerae Infection,Choleras,Infection, Vibrio cholerae,Infections, Vibrio cholerae,Vibrio cholerae Infections
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000071497	Immunogenicity, Vaccine	The capacity of VACCINES to stimulate the ADAPTIVE IMMUNE RESPONSE to produce antibodies and antigen-specific T-CELL responses. It is typically measured in vaccinated individuals in observational studies setting.	Antigenicity, Vaccine,Vaccine Antigenicity,Vaccine Immunogenicity
D000284	Administration, Oral	The giving of drugs, chemicals, or other substances by mouth.	Drug Administration, Oral,Administration, Oral Drug,Oral Administration,Oral Drug Administration,Administrations, Oral,Administrations, Oral Drug,Drug Administrations, Oral,Oral Administrations,Oral Drug Administrations
D000907	Antibodies, Bacterial	Immunoglobulins produced in a response to BACTERIAL ANTIGENS.	Bacterial Antibodies
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D014613	Vaccines, Attenuated	Live vaccines prepared from microorganisms which have undergone physical adaptation (e.g., by radiation or temperature conditioning) or serial passage in laboratory animal hosts or infected tissue/cell cultures, in order to produce avirulent mutant strains capable of inducing protective immunity.	Attenuated Vaccine,Vaccines, Live, Attenuated,Attenuated Vaccines,Vaccine, Attenuated
D022121	Cholera Vaccines	Vaccines or candidate vaccines used to prevent infection with VIBRIO CHOLERAE. The original cholera vaccine consisted of killed bacteria, but other kinds of vaccines now exist.	Cholera Vaccine,Vaccine, Cholera,Vaccines, Cholera