You are being asked to take part in a research study of a new vaccine. We hope to learn about the
safety of this experimental vaccine. This page will give you key information to help you decide
whether or not you want to participate in the study. More detailed information can be found on the
next pages. Ask the research team questions during the consent process and use the contact
information on this form to ask questions later.
What is the purpose, procedures and duration of this study?
By doing this study, we hope to learn about the safety of an experimental vaccine against Lassa
fever. Lassa fever is caused by Lassa virus. At this time, there is no licensed vaccine available to
protect people from getting Lassa fever. Your participation in this research study will last about 14
months.
What are the reasons you might choose to volunteer for this study?
There is no direct benefit to you from being in this study. However, the information we collect from
this study may help develop an effective Lassa fever vaccine.
What are the reasons you might not choose to volunteer for this study?
The potential risks are those associated with drawing blood, intramuscular injection (a shot into your
upper arm muscle) of the study vaccine, possible reactions to the study vaccine and loss of
confidentiality. For a complete description of the risks, please refer to the Detailed Consent.
Do you have to take part in this study?
You do not have to take part in this research. It is your choice whether or not you want to take part.
You can agree to take part and later change your mind. If you choose not to take part or choose to
stop taking part at any time, there will be no penalty to you or loss of benefits to which you are
otherwise entitled.
How are study participants selected?
You must be a healthy adult between 18 and 50 years of age (have not yet reached your
51st birthday by the time of their vaccination).
You must be informed about this study and be able to answer questions about the study.
You must be willing to give written consent to participate.
You must not have had Lassa fever previously.
If born female, you must not be pregnant or breastfeeding, and if you are sexually active in
a way that could lead you to get pregnant, you must be willing to use an effective method of
contraception for at least four months after receiving the study vaccine. If you are using a
hormonal form of contraception such as birth control pills or hormonal injection or implant,
they must be started at least two weeks before the vaccination visit. Contraception is not
necessary if you do not have the potential to get pregnant (e.g., you had a hysterectomy or
were surgically sterilized or are post-menopausal).
If born male and are sexually active in a way that could lead you to cause pregnancy, you
should use effective birth control (male condoms) and not make a woman pregnant until at
least four months after receiving the study vaccine.
If you are sexually active, you must use either male or female condoms with all sexual
partners starting after vaccination and continuing for four months after receiving the study
vaccine.
There are other criteria that the study staff will ask you about or check in order to decide
whether you are able to participate in the study or not.