YF-VAX SUMMARY
YF-VAX®, Yellow Fever Vaccine, for subcutaneous use, is prepared by culturing the 17D-204 strain of yellow fever virus in living avian leukosis virus-free (ALV-free) chicken embryos. The vaccine contains sorbitol and gelatin as a stabilizer, is lyophilized, and is hermetically sealed under nitrogen. No preservative is added. The vaccine must be reconstituted immediately before use with the sterile diluent provided (Sodium Chloride Injection USP - contains no preservative). YF-VAX® is formulated to contain not less than 4.74 log10 plaque forming units (PFU) per 0.5 mL dose. The vaccine appears slightly opalescent and light orange in color after reconstitution.
YF-VAX® is recommended for active immunization of persons 9 months of age and older in the following categories:
PERSONS LIVING IN OR TRAVELING TO ENDEMIC AREAS
While the actual risk for contracting yellow fever during travel is probably low, variability of itineraries and behaviors and the seasonal incidence of disease make it difficult to predict the actual risk for a given individual traveling to a known endemic or epidemic area. Persons greater than or equal to 9 months of age traveling to or living in areas of South America and Africa where yellow fever infection is officially reported at the time of travel should be vaccinated. Vaccination is also recommended for travel outside the urban areas of countries that do not officially report the disease but that lie in a yellow fever endemic zone.
INTERNATIONAL TRAVEL
Yellow fever vaccination may be required for international travel. Some countries in Africa require evidence of vaccination from all entering travelers and some countries may waive the requirements for travelers staying less than 2 weeks that are coming from areas where there is no current evidence of significant risk for contracting yellow fever. Some countries require an individual, even if only in transit, to have a valid International Certificate of Vaccination if the individual has been in countries either known or thought to harbor yellow fever virus. The certificate becomes valid 10 days after vaccination with YF-VAX®. 2,21 In no instance should infants less than 9 months of age receive yellow fever vaccine, because of the risk of encephalitis (see CONTRAINDICATIONS and ADVERSE REACTIONS sections).
LABORATORY PERSONNEL
Those laboratory personnel who might be exposed to virulent yellow fever virus or to concentrated preparations of the yellow fever vaccine strain by direct or indirect contact or by aerosols should be vaccinated. 2
As with any vaccine, vaccination with YF-VAX® may not protect 100% of susceptible individuals (see CLINICAL PHARMACOLOGY section).
For simultaneous administration of other vaccines see PRECAUTIONS section, Drug Interactions subsection.
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NEWS HIGHLIGHTS
Published Studies Related to YF-VAX (Yellow Fever Vaccine)
Intradermally administered yellow fever vaccine at reduced dose induces a protective immune response: a randomized controlled non-inferiority trial. [2008.04.23]
CONCLUSIONS: Intradermal administration of one fifth of the amount of yellow fever vaccine administered subcutaneously results in protective seroimmunity in all volunteers. Albeit this vaccination route should enable vaccination of five-times as many individuals at risk for disease, these results should now be confirmed in field studies in areas with potential yellow fever virus transmission to change vaccination policy. TRIAL REGISTRATION: Nederlands Trial Register ISRCTN46326316.
Live attenuated chimeric yellow fever dengue type 2 (ChimeriVax-DEN2) vaccine: Phase I clinical trial for safety and immunogenicity: effect of yellow fever pre-immunity in induction of cross neutralizing antibody responses to all 4 dengue serotypes. [2006.03]
A randomized double-blind Phase I Trial was conducted to evaluate safety, tolerability, and immunogenicity of a yellow fever (YF)-dengue 2 (DEN2) chimera (ChimeriVax-DEN2) in comparison to that of YF vaccine (YF-VAX). Forty-two healthy YF naive adults randomly received a single dose of either ChimeriVax-DEN2 (high dose, 5 log plaque forming units [PFU] or low dose, 3 log PFU) or YF-VAX by the subcutaneous route (SC)...
Yellow fever 17D vaccine safety and immunogenicity in the elderly. [2005.09]
The incidence of serious and severe multisystem adverse events (AEs) following yellow fever (YF) 17D vaccine is higher in persons of advanced age... The neutralizing antibody response, which is the mediator of protective immunity to YF, is not diminished in healthy, elderly persons.
Reactogenicity of yellow fever vaccines in a randomized, placebo-controlled trial. [2005.06]
OBJECTIVE: To compare the reactogenicity of three yellow fever (YF) vaccines from WHO-17D and Brazilian 17DD substrains (different seed-lots) and placebo... CONCLUSIONS: The frequency of adverse events post-immunization against YF, accounting for the background occurrence of nonspecific signs and symptoms, was shown for the first time to be similar for vaccines from 17D and 17DD substrains. The data also provided evidence against viscerotropism of vaccine virus.
Immunogenicity and safety of BERNA-YF compared with two other 17D yellow fever vaccines in a phase 3 clinical trial. [2005.03]
BERNA-YF (Flavimun) is a live, attenuated yellow fever (YF) vaccine of the 17D strain produced by Berna Biotech Ltd. following a transfer of technology from the Robert Koch Institute (RKI) in Berlin, Germany... All three vaccines were well tolerated and no serious adverse events were reported.
Clinical Trials Related to YF-VAX (Yellow Fever Vaccine)
Yellow Fever Virus Vaccine and Immune Globulin Study [Recruiting]
The purpose of this study is to determine whether immune globulin can limit the amount of
yellow fever vaccine virus present in the blood after vaccination without compromising the
immunity associated with the yellow fever vaccine. The study will enroll 80 participants in
two groups of 40 each. The first group will receive the yellow fever vaccine with salt-water
placebo. The second group will receive yellow fever vaccine with immune globulin. The amount
of vaccine virus and immune response in both groups will be compared. Yellow fever vaccine
has been used to protect humans against Yellow Fever Vaccine disease since the 1930s.
Human Immune Responses to The Yellow Fever Virus Vaccine [Recruiting]
The objective of this study is to study immune memory generated against the yellow fever
vaccine (YFV) in participants who recently received the YFV vaccine. Volunteers who are
planning to travel to yellow fever endemic areas will be recruited into this study.
Volunteers will receive the yellow fever vaccine at the Hope Clinic of Emory University or
at their private health care provider's office. Blood tests will be drawn before the
vaccination and at 3 visits following vaccination. The study will last approximately 3
months.
The Effect of Extended Yellow Fever Vaccine Information on Symptom Reports Following Vaccination [Recruiting]
This study aims to investigate the effect of providing additional information about possible
mild side effects of the yellow fever vaccination on the reporting of physical symptoms.
Additionally, the project aims to investigate the relationship between individual
characteristics (trait anxiety and perceived sensitivity to medication) and the reporting of
physical symptoms, as well as possible interactions between the level of information
provided and individual characteristics. We hypothesize that more information about mild
symptoms provided to participants will increase the number of reported symptoms after
vaccination.
Trial of Yellow Fever Inactivated Vaccine [Not yet recruiting]
The Phase 1 trial is a single-center, randomized, double blind, placebo-controlled,
dose-ranging out-patient study designed to provide the first clinical data on the safety,
tolerability and immunogenicity of XRX-001 inactivated yellow fever vaccine in 60 healthy
male and female volunteers, 18-49 years of age. Subjects will receive two inoculations of
one of two dose levels of XRX-001 vaccine. A control group will receive placebo.
Safety will be determined by the incidence and severity of adverse events in each treatment
group and in the combined cohorts in the double blind treatment period up to 42 days
post-vaccination. Subjects will also be followed-up at 6 and 12 months to determine severe
adverse events (SAEs) and changes in health status.
Efficacy will be assessed by neutralizing antibody response to the vaccine. The co-primary
immunogenicity endpoints will be the dose-response analysis of seroconversion rates
(fourfold or greater increase in neutralizing antibody titer between baseline and Day 42)
and of the 50% plaque reduction neutralization test (PRNT50) geometric mean titers (GMT) at
Day 42.
Secondary immunogenicity endpoints will include:
1. The seroconversion rates and GMT neutralizing antibody titers for all dose groups
combined on Days 21 and 42.
2. The reverse cumulative distribution curve of antibody titers on Days 21 and 42 for each
dose group and for all dose groups combined
3. The duration of antibody titers displaying the seroconversion rate and GMT across all
time-points to Month 12, by treatment group and for both dose groups combined.
Immune Response to Yellow Fever Vaccination in Adults With Atopic Dermatitis [Recruiting]
The main objective of the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) is to
reduce the risk of the fatal reaction, eczema vaccinatum (EV), to the smallpox vaccination
in those with atopic dermatitis (AD). Since vaccination with live vaccinia virus (VV) in
individuals with AD increases the risk of EV, a yellow fever vaccine was chosen. The purpose
of this study is to determine the immune response to a yellow fever vaccine in adults with
AD.
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