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This is a phase 1 open-label pharmacodynamics study in healthy adults. The purpose of the study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, has an impact on delivery location. The secondary objective is to evaluate delivery with fasting versus fed status.
Full description
This is a pharmacodynamics study in healthy adult males. The purpose of the study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, impacts the location and time of initial and complete disintegration of the drug product. The secondary objective is to evaluate delivery with fasting versus fed status.
Enrollment
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Inclusion criteria
Exclusion criteria
Administration of any vaccine within 4 weeks preceding DP administration or during the study through the active period (Day 36), or any licensed or investigational adjuvanted vaccine within 12 months preceding DP administration, or planned use of any licensed or investigational adjuvanted vaccine during the study through the 12-month safety follow- up period
Use of any investigational drug or device the greater of: within 4 weeks preceding DP administration, or planned use of the above stated during the study through the study active period (Day 36) OR within 5 half-lives of an investigational drug product
Use of concomitant medications that may interfere with normal gastrointestinal tract function, including but not limited to those listed below:
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
Any one of the following ECG findings within 30 days prior to administration:
Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies
Cancer, or treatment for cancer, within past 3 years (excluding basal cell carcinoma, squamous cell carcinoma, and cervical cancer in situ)
Radiation exposure from clinical trials, including that from the present study, and from diagnostic X-rays, but excluding background radiation, exceeding a target organ (colon) dose of 50 mSv (5 rems) from a single dose within the last 30 days or a cumulative dose of 150 mSv (15 rems) in the last 12 months. No subject whose occupation requires monitoring for radiation exposure may be enrolled in the study.
Presence of household members who are neonates, pregnant women, or hematopoietic stem cell transplant or solid organ transplant recipients or who are immunocompromised including those who are HIV positive.
History of drug, alcohol or chemical abuse within 1 year prior to administration
Acute disease within 72 hours prior to administration defined as the presence of a moderate or severe illness with or without fever (as determined by the Investigator through medical history and physical examination) or any acute respiratory or gastrointestinal illness even with mild symptoms occurring within 7 days of administration
Presence of a fever ≥ 38ºC measured orally at baseline
Positive urine drug screen for drugs of abuse at screening
Positive breath or urine alcohol test at screening
Consistent/habitual smoking (> 10 cigarettes/day) within 6 months prior to administration
History or presence of acute/chronic diarrhea or constipation
History of serious reactions to any vaccination such as anaphylaxis, respiratory problems, Guillain-Barre syndrome, hives or abdominal pain
History of a hypersensitivity or allergic reaction to any component of the investigational DP, including but not limited to fish gelatin
History of irritable bowel disease or inflammatory digestive or gastrointestinal condition that could affect the distribution / safety evaluation of an orally administered DP targeting the mucosa of the small intestine. Such conditions may include but are not limited to:
Any condition that resulted in the absence or removal of the spleen
History of any form of angioedema
Male subject who is unwilling to use an acceptable method of contraception, as listed below, for the duration of the study and continuing for 90 days after the subject's last study DP dose. Acceptable methods of contraception include the following: (1) complete abstinence from intercourse beginning with the first dose of study DP and continuing for 90 days after the final study DP dose, (2) male subject sterilization (vasectomy), (3) sterilization of or non-childbearing potential female partner (bilateral tubal ligation/salpingectomy, hysterectomy, post-menopausal), (4) use of hormonal contraception by female partner (implantable, patch, oral, injectable), (5) use of an intrauterine device (IUD) or intrauterine system by female partner, (6) barrier methods (condom by male or an occlusive cap [diaphragm or cervical/vault caps] by female partner) with concomitant spermicidal foam/gel/film/cream/suppository use, (7) any other birth control method with published data showing a failure rate that is < 1% per year. Male subjects should not donate sperm for the duration of the study and for 90 days after the last DP dose. Male subjects who are not sexually active but become active, must comply with the contraceptive requirements above.
Any condition that, in the opinion of the Investigator, might interfere with ability to assess the primary study objectives
Primary purpose
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8 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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