Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine (NCT04854746) | Clinical Trial Compass
CompletedPhase 1
Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine
United States66 participantsStarted 2021-04-26
Plain-language summary
A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study is designed to assess the safety, tolerability, immunogenicity, and efficacy of 3 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to 80 years old)
Who can participate
Age range55 Years ā 80 Years
SexALL
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Inclusion criteria
ā. 55 to 80 years old inclusive at the time of signing the Informed Consent Form (ICF).
ā. In stable and good general health, without significant medical illness, based on medical history, physical examination and vital signs at screening
ā. Safety laboratory values within the following range criteria at screening:
ā. Laboratory value of \< grade 1 elevation from normal or decrease from normal with no clinical significance (NCS) for alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin,
ā. Laboratory value of \< grade 1 from normal with no NCS for:
ā. Body mass index (BMI) between 17 and 35 kg/m2 at screening
ā. Available for all planned visits and phone calls, and willing to complete all protocol- defined procedures and assessments (including ability and willingness to swallow multiple small enteric-coated tablets per study dose).
ā. Male or female participants Female participants must provide a negative pregnancy test at screening and baseline or be at least one year post-menopausal or surgically sterile. Female participants of childbearing potential must be willing to use a reliable oral, implantable, transdermal or injectable contraceptive for 30 days prior to and until 60 days post last study drug administration. The form of contraception must be approved by the Investigator Contraception use by men should be consistent with local regulations regarding the methods of contraception for participants in clinical studies.
Exclusion criteria
ā
What they're measuring
1
Rate of Solicited Adverse Events
Timeframe: Day 1 (Vaccination) to 7 days post vaccination
2
Rate of Unsolicited Adverse Events
Timeframe: Day 1 (Vaccination) to 28 days post vaccination
. Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline
ā. Cancer, or treatment for cancer treatment, within past 3 years (excluding basal cell carcinoma or squamous cell carcinoma)
ā. Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus
ā. History of irritable bowel disease or other inflammatory digestive or gastrointestinal condition that could affect the distribution/safety evaluation of an orally administered vaccine targeting the mucosa of the small intestine.