Phase 2
Completed N=60
Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) Universal Influenza Vaccine in Healthy Adults
Source: ClinicalTrials.gov NCT00921947 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Aug 2011
Primary outcomePrimary: Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) — 0; 13; 2; 3 participants
Summary
1. To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population.
2. To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked immunosorbent assay (ELISA) in a healthy adult population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) |
0; 13; 2; 3; 0; 0 | — |
| PRIMARY Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Anti-M2e Serum Antibody Concentration |
0.011; 0.012; 0.376; 0.375; 0.255; 0.248 | — |
Eligibility Criteria
Inclusion Criteria
- Adult men or women aged 18 to 49 years inclusive.
- Able and willing to provide written informed consent to participate.
- Healthy, as determined by medical history, physical examination, and vital signs.
- Willing to receive the unlicensed (VAX102) vaccine given as an i.m. or s.c. injection.
- Willing to provide multiple blood specimens collected by venipuncture.
- Females should avoid becoming pregnant during the course of the study
- Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of the first and preceding receipt of the second (booster) vaccination.
- Must exhibit comprehension of the study requirements; expressed availability for the required study period and expect to reside in the study area during the entire study period, and ability to attend scheduled visits.
Exclusion Criteria
- Persons under 18 years old or 50 years or older.
- Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease.
- Person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination.
- Persons who have had a prior serious reaction to influenza vaccine.
- Persons with a history of anaphylactic-type reaction to injected vaccines.
- Persons with a history of drug or chemical abuse in the year preceding the study.
- Persons who received an influenza vaccine for the current influenza season or those who plan to receive an influenza vaccine while participating in the study.
- Persons who received any other vaccine within one week prior to enrollment (may delay enrollment).
- Persons who have had a respiratory illness or illness with fever within three days of study enrollment (may delay enrollment).
- Persons currently participating in another research study involving any study medications (medicines or vaccines).
Data sourced from ClinicalTrials.gov (NCT00921947). 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. Informational only — not medical advice.