A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy… (NCT05626803) | Clinical Trial Compass
CompletedPhase 2
A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers
United States135 participantsStarted 2023-01-26
Plain-language summary
This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. In stable and good general health, without significant medical illness, based on medical history, physical examination, and vital signs at screening based on investigator judgement.
✓. Body mass index (BMI) between \>/= 17.0 and \</= 35.0 kg/m2 at screening SNG.
✓. Available for all planned visits and tele-health appointment, and willing to complete all protocol-defined procedures and assessments (including ability and willingness to swallow multiple small enteric-coated tablets per study dose).
✓. Female subjects must not be breastfeeding and must provide a negative pregnancy test at screening and pre-dose.
✓. Female subjects must fulfill one of the following criteria:
✓. Capable of understanding and giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
Exclusion criteria
✕. Known clotting/bleeding issues and/or personal and family history with increased risk of bleeding or clotting.
✕. 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 With Solicited Symptoms of Reactogenicity (Gastrointestinal [GI] and Systemic)
Timeframe: Up to Day 8
2
Number of Participants With Unsolicited AEs
Timeframe: Up to Day 29
3
Serum - Anti-Vaccine Protein 1 (VP1) GI.1 Immunoglobulin A (IgA) Levels by Meso Scale Discovery (MSD) Assay
Timeframe: Day 1 and Day 29
4
Fold Rise in Serum - Anti-VP1 GI.1 IgA Levels by MSD Assay
Timeframe: Day 1 and Day 29
5
Serum - Anti-VP1 GII.4 IgGA Levels by MSD Assay
Timeframe: Day 1 and Day 29
6
Fold Rise in Serum - Anti-VP1 GII.4 IgA Levels by MSD Assay
Timeframe: Day 1 and Day 29
7
Serum - Anti-VP1 GI.1 Immunoglobulin G (IgG) Levels by MSD Assay
Timeframe: Day 1 and Day 29
8
Fold Rise in Serum - Anti-VP1 GI.1 IgG Levels by MSD Assay
✕. Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus- type 1 and 2
✕. 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:
✕. History of any form of angioedema
✕. History of serious reactions to vaccination such as anaphylaxis, respiratory problems, hives or abdominal pain
✕. Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic.
9
Serum - Anti-VP1 GII.4 IgG Levels by MSD Assay
Timeframe: Day 1 and Day 29
10
Fold Rise in Serum - Anti-VP1 GII.4 IgG Levels by MSD Assay