Phase 2
N=179
A Phase 2 Influenza A Challenge Study Following Oral Administration of an H1N1 HA Ad-Vector Seasonal Flu Vaccine
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT02918006 ↗Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Number of Subjects With Influenza-like Clinical Illness and Laboratory Confirmed Infection Post Challenge With a Homologous A Strain Influenza Virus — 17; 19; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VXA-A1.1 (Biological); Fluzone® (Biological); Placebo Tablets (Other); Saline Solution for Placebo IM Injection (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vaxart
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Influenza-like Clinical Illness and Laboratory Confirmed Infection Post Challenge With a Homologous A Strain Influenza Virus |
17; 19; 15 | — |
Summary
A Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009 (H1N1) Challenge Study Following Administration of an Oral H1N1 Hemagglutinin (HA) Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant (VXA-A1.1) to Healthy Adult Volunteers.
Eligibility Criteria
Inclusion Criteria
- Male or female volunteers aged 18 - 49 years, inclusive
- Able to give written informed consent
- Low pre-existing antibodies to the study vaccine
- In general good health (no clinically significant health concerns)
- Safety laboratory normal range or not clinically significant (NCS), with few exceptions
- Body mass index (BMI) between 17 and 35
- Comprehension of the study requirements with ability and willingness to complete all assessments and comply with scheduled visits and contacts
- Female participants must have a negative pregnancy test at screening
Exclusion Criteria
- Receipt of any influenza vaccine within two years prior to study
- Use of any investigational vaccine/adjuvanted vaccine within 8 weeks of study
- Use of any investigational drug or device within 4 weeks of study
- Use of any licensed vaccine within 30 days of study
- Presence of significant uncontrolled medical or psychiatric illness within 3 months of study
- Clinically significant and/or protocol defined ECG abnormality
- Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies
- Cancer, or treatment for cancer, within 3 years of study
- History of drug, alcohol or chemical abuse within 1 year
- Receipt of blood or blood products within 6 months of study
- Donation of blood within 4 weeks of study
- Presence of a fever ≥ 38ºC measured orally at baseline
- Stool sample with occult blood at screening
- Positive urine drug screen for drugs of abuse at screening
- Positive breath or urine alcohol test at screening or baseline
- Consistent/habitual smoking within 2 months prior to vaccination
- History of serious reactions to any vaccination such as anaphylaxis, respiratory problems, Guillain-Barre syndrome, hives or abdominal pain
- Asthma, bronchiectasis or chronic obstructive pulmonary disease
- Any known allergy or intolerance to oseltamivir
Data sourced from ClinicalTrials.gov (NCT02918006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.