Are you interested in receiving experimental vaccines against RSV and Herpes Zoster Virus?
This clinical research study is looking at the safety and effectiveness of a vaccine for Respiratory Syncytial Virus (RSV), a contagious virus that can cause infections in the lungs and air passages. People of all ages can be infected with RSV, and infections may occur more than once, even within the same year. Older adults, especially those older than 60, are at rick of developing a serious infection caused by RSV. There is currently no approved vaccine for the prevention of RSV infection, nor specific therapeutics beyond supportive care to treat an infection with RSV.
Herpes Zoster virus, also referred to as shingles, is caused by varicella zoster virus (VZV), the same virus that causes chickenpox. After a person recovers from chickenpox, the virus stays dormant (inactive) in the body. This virus can reactivate years later, causing shingles.
Would you like to take part?
As a volunteer in a research study, you will receive study-related medical care from the study doctor and regular follow up of your condition to monitor the effectiveness of the care you will receive. The results of this research will be used to find out if the investigational vaccine being studied will be of benefit to other patients with RSV, and whether it will be made widely available in Canada. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are ≥50 years of age at the time of the first study intervention administration.
- A female participant of non-childbearing potential.
- Are a female participant of childbearing potential, you may be enrolled in the study, if:
- You have practiced adequate contraception from 1 month prior to study intervention administration.
- You have a negative pregnancy test on the day of and prior to study intervention administration.
- You have agreed to continue effective contraception until the end of the study.
- In the opinion of the investigator, can and will comply with the requirements of the protocol. Written or witnessed informed consent obtained from the participant prior to any study specific procedure being performed.
- Are living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
- Are medically stable in the opinion of the investigator at the time of first study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable
You may not qualify to participate in this study if you:
- Are a female planning to become pregnant or planning to discontinue contraceptive precautions.
- Have any confirmed or suspected autoimmune disorders, immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
- Have a history of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, in particular any history of severe allergic reaction to any vaccine component.
- Have a history of Guillain-Barré syndrome.
- Have any history of dementia or any medical condition that moderately or severely impairs cognition.
- Have recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.
- Have any significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
- Have any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Have clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of herpes zoster.
- Have a history of previous vaccination with any licensed or investigational recombinant adjuvanted zoster vaccine (HZ/su vaccine; Shingrix) before the study start or planned receipt through study participation.
- Have a history of previous vaccination with any licensed or investigational live herpes zoster vaccine (Zostavax) in the last 2 years from enrollment, or planned receipt through study participation.
- Have any previous vaccination with licensed or investigational RSV vaccine.
- Use any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions, or their planned use during the study period.
- Have planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration.o In the case of COVID-19 and inactivated/subunit/split influenza vaccines, this time window can be decreased to 14 days before and after each study intervention administration provided COVID-19 vaccine use is in line with local governmental recommendations.
- Have planned or actual administration of adjuvanted quadrivalent influenza vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration.
- Have had administration of long-acting immune-modifying drugs during the period starting 180 days before the administration of first dose of study interventions or planned administration at any time during the study period (e.g., infliximab).
- Have had administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the administration of first dose of study interventions or planned administration during the study period.
- Any chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune modifying drugs during the period starting 90 days prior to the first study intervention dose or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled, topical or intra-articular steroids are allowed.
- Are concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational vaccine/product (IMP) (drug or invasive medical device).
- Have a history of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
- Are bedridden.
- Are planning move during the study conduct that prohibits participation until study end.
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.