NCT05626803Phase 2Completed

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers

Study sponsor: Vaxart

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-10-16Actual

Enrollment · participants135Actual

Source updated2025-04-15Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Norovirus Infections

Treatments or interventions studied

Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/doseDrug
Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/doseDrug
Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/doseDrug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Number of Participants With Solicited Symptoms of Reactogenicity (Gastrointestinal [GI] and Systemic); description: Solicited adverse events (AEs) are predefined signs and symptoms of reactogenicity for which the participants were specifically questioned, and which were noted by the participant in their Solicited Symptom Diary for 7 days after drug administration, including: * fever (any temperature 100.4°F or higher) * headache * myalgia (muscle pain) * abdominal pain * anorexia (defined as not eating) * nausea * vomiting * diarrhoea * malaise/fatigue. The severity of each solicited symptoms of reactogenicity was graded by the participant as mild, moderate, severe or life-threatening. Participants with multiple Solicited AEs were only counted once in summarizing overall percentages of Solicited AEs, the highest severity of which was used.; timeFrame: Up to Day 8; measure: Number of Participants With Unsolicited AEs; description: Treatment emergent AEs (TEAEs) are defined as AEs that occurred following the first administration of study medication. An unsolicited AE is an observed AE that did not fulfill the conditions prelisted in terms of diagnosis and/or onset window post-vaccination. The severity of each AE was graded by the participant as mild, moderate or severe/ life-threatening.; timeFrame: Up to Day 29; measure: Serum - Anti-Vaccine Protein 1 (VP1) GI.1 Immunoglobulin A (IgA) Levels by Meso Scale Discovery (MSD) Assay; description: Serum levels of Anti-VP1 GI.1 IgA were evaluated using cellular and humoral immune (HI) function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.; timeFrame: Day 1 and Day 29; measure: Fold Rise in Serum - Anti-VP1 GI.1 IgA Levels by MSD Assay; description: Serum levels of Anti-VP1 GI.1 IgA were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.; timeFrame: Day 1 and Day 29; measure: Serum - Anti-VP1 GII.4 IgGA Levels by MSD Assay; description: Serum levels of Anti-VP1 GII.4 IgA were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.; timeFrame: Day 1 and Day 29; measure: Fold Rise in Serum - Anti-VP1 GII.4 IgA Levels by MSD Assay; description: Serum levels of Anti-VP1 GII.4 IgA were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.; timeFrame: Day 1 and Day 29; measure: Serum - Anti-VP1 GI.1 Immunoglobulin G (IgG) Levels by MSD Assay; description: Serum levels of Anti-VP1 GI.1 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.; timeFrame: Day 1 and Day 29; measure: Fold Rise in Serum - Anti-VP1 GI.1 IgG Levels by MSD Assay; description: Serum levels of Anti-VP1 GI.1 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.; timeFrame: Day 1 and Day 29; measure: Serum - Anti-VP1 GII.4 IgG Levels by MSD Assay; description: Serum levels of Anti-VP1 GII.4 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.; timeFrame: Day 1 and Day 29; measure: Fold Rise in Serum - Anti-VP1 GII.4 IgG Levels by MSD Assay; description: Serum levels of Anti-VP1 GII.4 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.; timeFrame: Day 1 and Day 29; measure: Serum - Anti-VP1 GI.1 Blocking Antibodies (BT50) Titers by MSD Assay; description: Serum levels of Anti-VP1 GI.1 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method.; timeFrame: Day 1 and Day 29; measure: Fold Rise in Serum - Anti-VP1 GI.1 BT50 Titers by MSD Assay; description: Serum levels of Anti-VP1 GI.1 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1).; timeFrame: Day 1 and Day 29; measure: Serum - Anti-VP1 GII.4 BT50 Titers by MSD Assay; description: Serum levels of Anti-VP1 GII.4 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method.; timeFrame: Day 1 and Day 29; measure: Fold Rise in Serum - Anti-VP1 GII.4 BT50 Titers by MSD Assay; description: Serum levels of Anti-VP1 GII.4 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.; timeFrame: Day 1 and Day 29

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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