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.
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).
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.
Published Studies Related to YF-VAX (Yellow Fever Vaccine)
Concomitant or sequential administration of live attenuated Japanese encephalitis chimeric virus vaccine and yellow fever 17D vaccine: randomized double-blind phase II evaluation of safety and immunogenicity. [2010.11]
A randomized, double-blind, study was conducted to evaluate the safety, tolerability and immunogenicity of a live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) co-administered with live attenuated yellow fever vaccine (YF-17D strain; Stamaril(R), Sanofi Pasteur) or administered successively...
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.
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.
Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine [Recruiting]
The aim of this study is to evaluate the administration of CYD dengue vaccine following a
compressed schedule in different populations.
- To describe the humoral immune response to each of the 4 parental dengue virus
serotypes at baseline and 28 days after CYD dengue vaccine Dose 3 in defined study
- To describe the persistence of the humoral immune response to each of the 4 parental
dengue virus serotypes 6 months after CYD dengue vaccine Dose 3 in defined study
- To describe the humoral immune response to each of the 4 parental dengue virus
serotypes at baseline and 28 days after CYD dengue vaccine Dose 1 and Dose 2 in defined
study groups, irrespective of whether or not Yellow fever (YF) vaccine has been
- To describe the YF humoral immune response at baseline and 1, 3, and 7 months after
injection of the YF vaccine at Month 0 in Groups 3 and 4.
- To describe the safety profile in terms of solicited injection site and systemic
events, unsolicited adverse events and serious adverse events after each injection of
CYD dengue vaccine and/or YF vaccine.
Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers [Recruiting]
The study is designed to evaluate whether the first CYD dengue vaccination can be
administered concomitantly with Stamaril® yellow fever vaccine during the same day and
visit, but at 2 different sites of administration.
- To demonstrate the non-inferiority of the immune response against Yellow Fever in
flavivirus (FV)-naïve subjects at baseline receiving one dose of Stamaril vaccine
administered concomitantly with the first dose of CYD dengue vaccine compared to
subjects receiving one dose of Stamaril vaccine concomitantly with placebo.
- To assess the non-inferiority of yellow fever immune response 28 days post-Stamaril
vaccination based on seroconversion rates regardless of the FV status of subjects at
- To describe the safety of Stamaril vaccine administered concomitantly with the first
dose of CYD dengue vaccine, or Stamaril administered concomitantly with placebo.
- To describe the safety of CYD dengue vaccine after the first dose of CYD dengue vaccine
administered concomitantly with Stamaril vaccine or CYD vaccine administered alone.
Training Study to Characterize Biomarkers to Chickenpox and Yellow Fever Vaccines [Not yet recruiting]
It is thought that vaccines trigger innate inflammatory responses to induce antigenspecific
adaptive immunity (the desired effect), but excessive inflammation may lead to serious
inflammatory complications or unwanted side effects. Currently there is a lack of reliable
biomarkers (a measurable biological response that predicts something) able to predict severe
inflammation and this has resulted in the development of several vaccines being terminated
and the withdrawal of some licensed vaccines which were associated with inflammatory
This study is part of the BIOVACSAFE project which is a 5year â‚¬30M project funded by the
Innovative Medicine Initiative. The project involves a series of clinical studies using
licensed vaccines as benchmarks to generate clinical data on inflammation and identify
biomarkers that can be used to predict acceptable reactogenicity. The target is to identify
biomarkers that can predict the occurrence of beneficial and detrimental effects in response
to a vaccine. Such biomarkers could be used in future vaccine development programs to
optimize selection of vaccine candidates with a profile that will be unlikely to generate
worrisome safety signals once they are in generalized use.
This study is one in a series of "training" studies which will each use different licensed
vaccines that are prototypical representatives of a class of vaccine used in a particular
target population. Forty eight subjects will be randomised into three groups to receive: A)
Varicella zoster vaccine (n = 20), B) Yellow Fever vaccine (n = 20), C) Saline placebo (n =
8). Following a screening visit, participants will undergo a seven day residential visit
which will include immunization and intensive monitoring of physiological (e. g. heart rate,
oral temperature, blood pressure) metabolic and immune (innate and adaptive) parameters.
This visit will be followed up by four outpatient visits with further monitoring and blood
Turnover of Antigen Specific Lymphocytes After Immunization With the Yellow Fever Vaccine [Recruiting]
The yellow fever vaccine is a live, attenuated virus that results in a robust immune
response, especially in the T cell compartment. We have been studying immune responses to
live viral infections using the yellow fever vaccine as a model for a live viral infection.
In this study, we are interested in looking at the processing and lifespan of yellow fever
specific CD8 T cells.
We plan to accomplish this by measuring DNA replication and cell proliferation in humans
using a naturally occurring stable isotope called deuterium (D20). This technique has been
used to track the turnover of a number of human cell types in vivo. We plan to use D20
labeling to track YFV specific CD8+ T cells in human vaccinees who are positive for a
specific HLA type, HLA A202.
Deuterium labeled water (D2O), also known as heavy water is physically and chemically very
similar to ordinary drinking water. In water, two hydrogen atoms bond to an oxygen and
create H20. However in deuterated water, deuterium atoms replace the hydrogen atoms.
Deuterium is a form of hydrogen that has an extra neutron. This neutron gives the atom extra
weight, hence the name "heavy water." This extra weight can be detected in the lab with very
sensitive instruments. Scientists have been using heavy water as a tracer to gain a better
understanding of animal and human metabolic rates. Deuterium is in fact already in the water
we drink daily. It is not radioactive, and it occurs naturally at a concentration of about 1
part per 5,000. Researchers have used heavy water since 1934 as a safe and effective tool in