A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 1… (NCT06944717) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old
United States60 participantsStarted 2025-03-03
Plain-language summary
The primary objective of this study is to determine the safety and immunogenicity of low and high dose regimens of a next generation norovirus bivalent G1.1 and G2.4 vaccine candidate in healthy participants.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. ≥ 18 and ≤ 80 years old at the time of signing the Informed Consent Form (ICF).
✓. In stable and good general health and without significant medical illness (based on review of medical history, physical examination, current health status, and vital signs at Screening) as determined by the Investigator, with Screening lab values within normal limits or abnormalities assessed as not clinically significant.
✓. Body mass index (BMI) \> 17.0 and \< 35.0 kg/m\^2 at Screening.
✓. Available for all planned visits and tele-health appointments, and willing to complete all Protocol-defined procedures and assessments (including ability and willingness to swallow multiple small enteric-coated tablets per study dose).
✓. Male or female participants.
✓. Female participants must not be breastfeeding and must provide a negative pregnancy test at Screening and pre-dose on Day 0.
✓. Female participants must fulfill at least one of the following criteria:
✓. Male participants must fulfill one of the following criteria:
Exclusion criteria
✕. 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 prior to Screening and reconfirmed at baseline.
✕. Cancer, or treatment for cancer or any procedure or preventive medication for cancer or to prevent recurrence, within past 3 years (excluding fully treated and resolved basal cell carcinoma or squamous cell carcinoma).
What they're measuring
1
Number of Participants Experiencing Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose
Timeframe: 7 days
2
Duration of Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose
Timeframe: Approximately 1 year
3
Severity of Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose
Timeframe: 7 days
4
Number of Participants Experiencing Unsolicited Adverse Events (AE) for 28 Days Following the Study Intervention Dose
Timeframe: 28 days
5
Number of Participants Experiencing Unsolicited New Onset of Chronic Illness (NOCI) for 28 Days Following the Study Intervention Dose
Timeframe: 28 days
6
Duration of Unsolicited AEs for 28 Days Following the Study Intervention Dose
Timeframe: Approximately 1 year
7
Duration of Unsolicited NOCIs for 28 Days Following the Study Intervention Dose
✕. Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus- type 1 and 2, asplenia, and functional asplenia.
✕. 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. Such conditions may include but are not limited to:
✕. Any history of:
✕. History of diagnosis or treatment in past 5 years of:
✕. History of any form of angioedema.
✕. History of serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain.
8
Severity of Unsolicited AEs for 28 Days Following the Study Intervention Dose
Timeframe: 28 days
9
Severity of Unsolicited NOCIs for 28 Days Following the Study Intervention Dose
Timeframe: 28 days
10
Geometric Mean Titer (GMT) at Day 0 of Serum Functional Antibody Against GI.1 Measured by Norovirus Blocking Antibody Assay (NBAA)
Timeframe: Day 0
11
GMT at Day 28 of Serum Functional Antibody Against GI.1 Measured by NBAA
Timeframe: Day 28
12
GMT at Day 0 of Serum Functional Antibody Against GII.4 Measured by NBAA
Timeframe: Day 0
13
GMT at Day 28 of Serum Functional Antibody Against GII.4 Measured by NBAA
Timeframe: Day 28
14
Geometric Mean Fold Rise (GMFR) from Day 0 to Day 28 of Serum Functional Antibody Against GI.1 Measured by NBAA
Timeframe: From Day 0 to Day 28
15
GMFR from Day 0 to Day 28 of Serum Functional Antibody Against GII.4 Measured by NBAA