Safety and Immunogenicity of CVD 1902 Oral Attenuated Vaccine to Prevent S. Paratyphi A Infection

Completed · Phase 1 · Has a placebo group

Conditions studied: Salmonella

In brief

The purpose of this study is to determine whether CVD 1902 (a live, attenuated, oral vaccine) is safe and effective in the prevention of Salmonella enterica serovar paratyphi A infection.

Key facts

Study ID

NCT01129453

Run by

University of Maryland, Baltimore

People needed

51

Starts

2010-05-01

Expected to finish

2013-04-01

Last updated by the study team

2021-04-30

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 to 45 years, inclusive
• Good health as determined by a screening evaluation within 35 days before vaccination
• Able to understand and comply with study requirements
• Provides informed, written consent prior to any study procedures
• Agrees to indefinite storage of unused identifiable clinical specimens at the CVD for use in future research, which may require separate IRB approval
• Agrees not to participate in another investigational vaccine or drug trial during the 6-month study; agrees not to receive a licensed vaccine within 14 days of inoculation (if inactivated) or within 30 days of inoculation (if live attenuated)
• If female, has no childbearing potential, i.e., either surgically sterilized or 1 year postmenopausal, or agrees to abstain from becoming pregnant from the day of screening through Day 56 of the trial by using one of the following methods of birth control: abstinence, intrauterine contraceptive device, oral contraceptives or equivalent hormonal contraception (e.g., progestogen-only implantable, cutaneous hormonal patch, injectable contraceptives, or vaginal hormonal ring), diaphragm or condom in combination with spermicide, or is in a relationship with a vasectomized partner
• Agrees not to donate blood to a blood bank for 12 months after receiving the vaccine

You may not qualify if…

• An acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (this includes, but is not limited to:
• Diabetes mellitus
• Heart disease (hospitalization for a heart attack or arrhythmia)
• Seizure disorder (febrile seizures as a child <5 years old or a post-concussive seizure not requiring treatment are acceptable)
• Recurrent infections (>2 hospitalization for invasive bacterial infections, e.g., pneumonia, meningitis)
• Immunosuppression as a result of underlying illness or treatment with immunosuppressive drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
• Active neoplastic disease (or treatment for a neoplastic disease) within past 5 years (excluding non-melanoma skin cancer) or a history of any hematologic malignancy
• Any of the following gastrointestinal conditions:
• History of any of the following types of abdominal surgery:
• Any major gastrointestinal surgery (e.g., intestinal resection or splenectomy)
• Laparotomy (e.g., hysterectomy, Caesarian section, or appendectomy) within the last 3 years
• Laparoscopic abdominal surgery within the past year
• A history of cholelithiasis, cholecystitis, other chronic gall bladder disease or empyema of the gall bladder (these subjects can be included only if gall bladder was surgically removed).
• Crohn's disease, ulcerative colitis, irritable bowel disease, celiac disease, or gastrointestinal ulcers in the past 10 years
• Bleeding in stool (other than small amounts from straining) in past 12 months
• Recurrent diarrhea (>5 episodes in past 6 months, each lasting 3 days, with 1 week between them)
• Known allergy or intolerance to penicillins (applicable to women only), ciprofloxacin, trimethoprim/sulfamethoxazole, or corn
• A current illness requiring daily medication other than vitamins, birth control pills, or topical medications
• A history of enteric fever, typhoid fever, or prolonged fever (lasting 3 or more days) within one month after return from international travel, or known exposure to S. Paratyphi or S. Typhi by laboratory work
• A history of having received live oral Ty21a typhoid vaccine or killed whole cell parenteral typhoid vaccine (used by the US Navy into the 1990s)
• Medical, occupational, or family problems resulting from alcohol or illicit drug use in the past 12 months
• Anticipates any of the following during 30 days after discharge from the Inpatient Ward:
• Shares a household with a child under the age of 3 years
• Household or sexual contact with someone with weakened immunity (e.g., someone with HIV infection, someone receiving treatment for cancer, a pregnant woman, or an elderly person older than 70 years)
• Occupation as a foodhandler, childcare (for children <3 years), or health care worker with direct patient contact

Where it is running

• Shin Nippon Biomedical Laboratories (SNBL) Inpatient Facility — Baltimore, Maryland, United States
• University of Maryland, Baltimore Center for Vaccine Development — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.