Phase 2a Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults
- Conditions
- Respiratory Syncytial Virus InfectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-003887-21-GB
- Lead Sponsor
- hVIVO Services Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 62
1. An informed consent document signed and dated by the participant and the Investigator.
2. Aged between 18 and 50 years old on the day of signing the consent form.
3. In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), ECG, and routine laboratory tests as determined by the Investigator.
4. A documented medical history prior to enrolment.
5. The following criteria are applicable to female participants participating in the study.
a)Females of childbearing potential must have a negative pregnancy test prior to enrolment.
b)Females of non-childbearing potential:
a.Post-menopausal females; defined as having a history of amenorrhea for >12 months with no alternative medical cause, and /or by FSH level >40mIU/mL, confirmed by laboratory.
Documented status as being surgically sterile (e.g. tubal ligation, hysterectomy, bilateral salpingectomy and bilateral oophorectomy).
6. The following criteria apply to female and male participants:
a)Female participants of childbearing potential must use one form of highly effective contraception. Hormonal methods must be in place from at least 2 weeks prior to the first study visit. The contraception use must continue until 28 days after the date of viral challenge/last dosing with IMP (whichever occurs last). Highly effective contraception is as described below:
a.Established use of hormonal methods of contraception described below (for a minimum of 2 weeks prior to the first study visit). When hormonal methods of contraception are used, male partners are required to use a condom with a spermicide:
i.combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
1.oral
2.intravaginal
3.transdermal
ii.progestogen-only hormonal contraception associated with inhibition of ovulation:
1.oral
2.injectable
3.implantable
b.Intrauterine device (IUD)
c.Intrauterine hormone-releasing system (IUS)
d.Bilateral tubal ligation
e.Male sterilisation (with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate) where the vasectomised male is the sole partner for that woman.
f.True abstinence - sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.
b)Male participants must agree to the contraceptive requirements below at entry to quarantine and continuing until 28 days after the date of Viral challenge / last dosing with IMP (whichever occurs last):
a.Use a condom with a spermicide to prevent pregnancy in a female partner or to prevent exposure of any partner (male and female) to the IMP.
b.Male sterilisation with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate (please note that the use of condom with spermicide will still be required to prevent partner exposure). This applies only to males participating in the study.
c.In addition, for female partners of child bearing potential, that partner must use another form of contraception such as one of the highly effec
1. History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to the first study visit.
2.a) Any history or evidence of any other clinically significant or currently active systemic comorbidities including psychiatric disorders (includes participants with a history of depression and/or anxiety).
b) And/or other major disease that, in the opinion of the Investigator, may put the
participant at undue risk, or interfere with a participant completing the study and
necessary investigations (e.g autoimmune disease or immunodeficiency).
3. Participants who have smoked = 10 pack years at any time [10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years]).
4. A total body weight = 50 kg and Body Mass Index (BMI) =18 kg/m2 and =35kg/m2.
5. Females who:
a.Are breastfeeding, or
b. Have been pregnant within 6 months prior to the study.
6. History of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the PI.
7. Venous access deemed inadequate for the phlebotomy and cannulation demands of the
study.
8. a. Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge, (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month will be excluded).
b.Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first study visit and/or history of being hospitalized due to epistaxis on any previous occasion.
c. Any nasal or sinus surgery within 3 months of the first study visit.
9.Unless medically necessary (e.g. during an outbreak or pandemic situation) and at the PI’s discretion
a) Evidence of vaccinations within the 4 weeks prior to the planned date of viral
challenge/first dosing with IMP (whichever occurs first).
b) Intention to receive any vaccination(s) before the last day of Follow-up. (NB. No
travel restrictions will apply after the Day 28 Follow-up visit).
10. Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 2 months prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first) or planned during the 2 months after the viral challenge.
11.a) Receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first).
b) Previous vaccination with any licensed or investigational RSV vaccine before enrolment into the study.
c) Receipt of three or more investigational drugs within the previous 12 months prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first).
d) Prior inoculation with a virus from the same virus-family as the challenge virus.
e) Prior participation in another human viral challenge study with a respiratory virus in the preceding 3 months, taken from the date of viral challenge in the previous study to the date of expected viral challenge in this study.
f) Receipt of treatment with immunosuppressive therapy.
12. a. Confirmed positive test for drugs of abuse and cotinine on first study visit. One repeat test allowed at PI discretion.
b. History or presence of alcohol addiction, or excessive use o
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method