A Phase 2a clinical study to assess the safety, immunogeniocity, and efficacy of a MVA-BN-RSV Vaccine against viral respiratory infection in a challenge setting in healthy volunteers.
- Conditions
- pper and lower respiratory tract infections caused by Respiratory Syncytical VirusMedDRA version: 20.0 Level: LLT Classification code 10039247 Term: RSV infection System Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2017-004582-27-BE
- Lead Sponsor
- Bavarian Nordic A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 72
1. Informed Consent Form signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study.
2. Male or female, between 18 and 55 years old (extremes included) at screening.
3. General good health, without clinically relevant medical illness, physical exam findings, or laboratory abnormalities, as determined by the investigator.
4. Willing to adhere to the prohibitions and restrictions specified in this protocol, including willingness to stay confined to the CPU for the required duration.
5. Willingness to have samples stored for future research to investigate vaccine and RSV associated changes in immunity.
6. Absent or low levels of pre-existing RSV neutralizing antibodies, as determined by PRNT° Strain A assay (= 30 % of average population).
7. Female subjects should fulfil one of the following criteria:
a. At least 1 year post-menopausal (amenorrhea >12 months and/or follicle-stimulating hormone >according to local lab values mIU/mL) prior to screening;
b. Surgically sterile (bilateral oophorectomy, hysterectomy);
c. Will use contraceptives as outlined in inclusion criterion 8 from screening to discharge.
8. Female subjects of childbearing potential and male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control from at least 30 days prior to administration of the MVA-BN-RSV vaccine to until 30 days after virus inoculation with the challenge virus.
Note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined double barrier method, oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, abstinence, sterilization, tubal ligation and vasectomy.
9. Female subject has a negative pregnancy test at screening and admission to the CPU for virus inoculation.
Note: Pregnancy testing will consist of a serum (beta-)human chorionic gonadotropin (HCG) test at screening and admission to the CPU and urine pregnancy tests at other visits, in all women of childbearing potential (WOCBP).
10. Negative hepatitis panel (including hepatitis B surface antigen and anti-hepatitis C virus antibodies) and negative human immunodeficiency virus antibody and antigen screens at screening.
11. Troponin I within normal limits
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Has an acute or chronic medical condition that, in the opinion of the investigator, would render the study procedures unsafe or would interfere with the evaluation of the responses, including but not limited to, neurologic, cardiovascular, respiratory, hepatic, hematologic, rheumatologic, endocrine, gastrointestinal, renal, autoimmune, or immune suppression conditions.
2. Laboratory parameters (such as complete or full blood count (CBC/FBC), serum biochemistry including aspartate aminotransferase (AST), alanine amino transferase (ALT), alkaline phosphokinase (ALP), bilirubin, or creatinine values), pulse rate and/or blood pressure, or ECG outside normal range and deemed clinically relevant by the investigator.
3. Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the trial protocol.
4. A medical, occupational, or family problem as a result of alcohol or illicit drug use during the 12 months prior to screening.
5. Routine smoker (>4 cigarettes or other tobacco-based products per week) of a tobacco product or marijuana currently or in the past year prior to screening.
6. Current alcohol abuse or addiction (positive alcohol breath test at screening or upon check-in at the clinical site).
Excessive use of alcohol is an intake of >21 units per week for males and >14 units per week for females where one alcohol unit is defined as 10 mL or 8 g of pure alcohol. A single unit is equal to one 25 mL (single) measure of whisky (alcohol by volume [ABV] 40%), or a third of a pint of beer (190 mL; ABV 5-6%) or half a standard (175 mL) glass of wine (ABV 12%).
7. Current illicit drug abuse (positive drug screen for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates at screening or upon admission to the clinical site) or addiction.
8. Presence of any febrile illness (=38.0°C oral) or symptoms suggestive of a viral respiratory infection within 2 weeks prior to vaccination.
9. Subjects with a positive result on below-listed adventitious agent screening (qualitative PCR testing) within 2 days prior to virus inoculation (i.e., at admission to the CPU): Subjects will be excluded in case of a positive result for: influenza A, influenza B, RSV, Bordetella pertussis, Chlamydophila pneumoniae or Mycoplasma pneumoniae.
10. Use of corticosteroids (including nasal preparations) or immunosuppressive drugs within 30 days before vaccination and ending at the last visit of the active trial phase. Topical corticosteroids are allowed.
11. A history of anaphylaxis.
12. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. tris[hydroxymethyl]-amino methane, chicken embryo fibroblast proteins, gentamycin, eggs or aminoglycosides) or challenge agent.
13. A history of asthma within the past 10 years prior to screening, or a current diagnosis of asthma or reactive airway disease associated with exercise or allergic rhinitis, with the exception of seasonal hay fever, house dust mite or allergy to animals.
14. Chronic Obstructive Airways Disease or any respiratory illness associated with reduced lung capacity or capability.
15. A know
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