Yellow Fever Vaccination Reaction
Conditions
Brief summary
This is an open-label, randomized, exploratory study to evaluate the human immune response to reduced subcutaneous (SQ) dosing of Yellow Fever vaccine compared to the standard FDA approved subcutaneous vaccination dose. The current dose of the US FDA licensed Yellow Fever vaccine is approximately 55,000 plaque-forming unit(s) (PFU) in 0.5 mL administered SQ. Using the licensed dosage as standard, investigators are evaluating reduced doses of 1/5th (0.10 mL) and 1/10th (0.05 mL) standard Yellow Fever vaccine (YF-VAX).
Detailed description
Up to 150 individuals will be screened in order to randomize 90 eligible individuals to one of three groups: Group 1- YF-VAX® standard dose 0.5 mL SQ = 30 subjects; Group 2-0.10 mL (1/5th) SQ = 30 subjects; Group 3-0.05 mL (1/10th) SQ = 30 subjects.
Interventions
BIOLOGICALYellow Fever Vaccine
Administered subcutaneously once.
Sponsors
US Army Medical Research Institute of Infectious Diseases
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and Females 18 to 50 years of age. 2. In good health, as determined by pertinent medical history, physical examination, vital signs, and clinical safety laboratory evaluations. 3. Female of child bearing potential: Has a negative pregnancy test and is willing to use a reliable form of contraception for the duration of the study after vaccination. 4. Negative human immunodeficiency virus (HIV) antibody screen, seronegative for hepatitis B surface antigen (HBsAg) and hepatitis C antibody (following HIV and hepatitis testing, subjects will be provided with counseling and referral for health care if any test is positive). 5. Ability to comprehend and a willingness to sign an informed consent, which includes the Health Insurance Portability and Accountability Act (HIPAA) Authorization, and a separate consent form for HIV testing. 6. Be willing to comply with all follow-up visits, testing, adverse event (AE) reporting, and completion of diary card.
Exclusion criteria
1. Receipt of any other investigational vaccine or investigational drug within 28 days prior to or after vaccination with YF-VAX® vaccine. 2. Have had any known flavivirus disease or receipt of any flavivirus vaccine, licensed or investigational at any time; in addition to any yellow fever vaccine, these include; Japanese Encephalitis (JE), St. Louis Encephalitis, Tick Borne Encephalitis (TBE), West Nile, Dengue, Zika virus 3. Anticipates receipt of any other vaccine within 28 days of YF-VAX®. Influenza vaccination will be permitted but not within 14 days of YF-VAX®. 4. Acute or chronic medical conditions, or medications that, in the Principal Investigator's (PI) opinion, would impair the subject's ability to respond to vaccination. 5. Hypersensitivity to any vaccine, eggs or egg products, or allergy to any component of the YF-VAX® (sorbitol, gelatin) or latex. 6. Corticosteroids ≥20 mg/day of prednisone for ≥ 2 weeks suppresses the immune system. Low-dose corticosteroid topical products and nasal sprays used sporadically (i.e. prn--according to circumstances) are permissible. 7. History of immunosuppression, by any cause--primary or acquired immunodeficiencies, transplantation, malignant neoplasm, lymphoma, leukemia, thymoma, myasthenia gravis, radiation, immunosuppressive drugs, including antimetabolites, tumor necrosis factor (TNF)-alpha inhibitors (etanercept), interleukin-1 (IL-1) blocking agents and other monoclonal antibodies targeting immune cells (e.g., rituximab, alemtuzumab, etc), etc. 8. Receipt of or anticipates receipt of/or donation of blood or blood products for 2 months after receipt of YF-VAX®. (Note: Blood banks require a minimum 2 week interval between the receipt of this FDA licensed vaccine and blood donations; however because of the blood collections in this study, an interval of 2 months is requested). 9. Female: Pregnant (or planning to become pregnant) or breastfeeding for the duration of the study after receipt of YF-VAX®. 10. Clinically significant abnormal laboratory tests (generally 2 times the upper limit of normal or as determined by the PI).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Up to 28 days post vaccination | Rate of Adverse Events of fractional doses vs standard dose of YF-VAX. |
| Neutralizing Antibody Response | The primary data point is day 28 post-vaccination. | For each group determine the PRNT50 neutralizing antibody response rate at the primary data point at post-vaccination day 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viremia | First 14 days following vaccination. | Compare the rate of viremia by Reverse Transcription Polymerase Chain Reaction (RT-PCR) \[copies/mL\] of fractional doses vs standard dose. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPhillip R Pittman, M.D., M.P.H.
US Army Medical Research Institute of Infectious Diseases
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 88 Participants |
| Age, Continuous | 32.5 Years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race/Ethnicity, Customized Race American Indian/Alaskan Native | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 5 Participants |
| Race/Ethnicity, Customized Race Black/African American | 3 Participants |
| Race/Ethnicity, Customized Race Hispanic or Latino | 2 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian/Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race Others | 2 Participants |
| Race/Ethnicity, Customized Race White | 20 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 | 0 / 29 |
| other Total, other adverse events | 15 / 29 | 11 / 30 | 7 / 29 |
| serious Total, serious adverse events | 1 / 29 | 0 / 30 | 0 / 29 |
Outcome results
None listed