A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults
Condition: Respiratory Syncytial Virus (RSV)
Intervention: RSV F subunit 45 μg No adjuvant; RSV F subunit 45 μg Aluminum hydroxide adjuvant; RSV F subunit 45 μg MF59 adjuvant; RSV F subunit 90 μg No adjuvant; RSV F subunit 90 μg Aluminum hydroxide adjuvant; RSV F subunit 90 μg MF59 adjuvant; RSV F subunit 135 μg No adjuvant; RSV F subunit 135 μg Aluminum hydroxide adjuvant; RSV F subunit 135 μg MF59 adjuvant; Placebo
Intervention description: 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
Intervention MeSH terms: Aluminum Hydroxide; MF59 oil emulsion
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Antibodies; Respiratory syncytial virus; Safety; Healthy adults; Immunogenicity

Summary:

      The purpose of this study is to evaluate the safety and immunogenicity of two doses of the
      investigational RSV F subunit vaccine administered intramuscularly (IM). In this current
      Phase 1, first-in-human study, the three different antigen amounts that have been selected
      will be evaluated in a stepwise manner in three different cohorts (Cohort 1: low dosage of
      RSV F subunit vaccine, Cohort 2: middle dosage of RSV F subunit vaccine, and Cohort 3: high
      dosage of RSV F subunit vaccine). In addition, the effect of an adjuvant, either aluminum
      hydroxide or MF59, and antibody kinetics post-vaccination at different time points will be
      evaluated as compared to unadjuvanted RSV F subunit vaccine at the same dosage levels.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy males and non-pregnant females 18 to 45 years of age at time of enrollment.

          2. Individuals who have given written consent after the nature of the study has been
             explained according to local regulatory requirements.

          3. Individuals in good health as determined by the outcome of the medical history,
             physical examination and clinical judgment of the investigator.

          4. Individuals who can comply with the study procedures and are available for follow up.

        Exclusion Criteria:

          1. Individuals with any severe chronic or acute disease.

          2. Individuals with a history of illness or with an ongoing illness that may pose
             additional risk to the subject if he/she participates in the study, including the
             following:

               -  History of any chronic respiratory illness, including current diagnosis of asthma
                  within 2 years, exercise induced wheezing, reactive airway disease, emphysema,
                  chronic bronchitis, cystic fibrosis or chronic obstructive pulmonary disease
                  (COPD).

               -  Any respiratory illness within 7 days prior to receiving the first study
                  injection.

               -  Any active pulmonary infection or other inflammatory conditions, even in the
                  absence of febrile episodes, within 14 days prior to the first study injection.

               -  Hepatitis B or hepatitis C infection.

          3. Individuals who have had a malignancy or lymphoproliferative disorder within the past
             5 years.

          4. Individuals with known or suspected impairment of the immune system including but not
             limited to HIV, autoimmune disorders, immunosuppressive therapy, and diabetes
             mellitus.

          5. Individuals with any history of progressive or severe neurologic disorder, seizure
             disorder or Guillian-Barré syndrome.

          6. Individuals with a known bleeding diathesis, or any condition that may be associated
             with a prolonged bleeding time.

          7. Individuals with a BMI > 35 kg/m2. BMI is to be calculated by the following formula:
             subject weight at baseline divided by subject height in meters multiplied by the
             subject height in meters. The numerical result will be rounded to the nearest 0.1.

          8. Individuals who are allergic to any of the vaccine components, or with a history of
             anaphylaxis after vaccination.

          9. Individuals who during the 90 days prior to enrollment receive any medications or
             other treatments that may adversely affect the immune system such as allergy
             injections, immune globulin, interferon, immunomodulators, cytotoxic drugs or other
             drugs known to be frequently associated with significant major organ toxicity.

         10. Individuals who receive systemic immunosuppressive agents including steroids. Prior
             corticosteroid therapy should be discontinued 28 days prior to enrollment. Individuals
             using inhaled or topical corticosteroids will be permitted.

         11. Receipt or donation of blood or blood products 8 weeks prior to vaccination or planned
             receipt or donation during the study period.

         12. Individuals participating in any clinical trial with another investigational product
             28 days prior to receiving the first study vaccination or intent to participate in
             another clinical study at any time during the conduct of this study.

         13. Individuals who have received any vaccine 28 days prior to enrollment in this study,
             or who plan to receive any non-study vaccines within 28 days of the second dose of
             study vaccine.

         14. Individuals with any clinically significant abnormal safety laboratory result, as
             judged by the investigator.

         15. If female, 'of childbearing potential', sexually active and has not used any of the
             'acceptable contraceptive methods' for at least two months prior to study entry.

             Childbearing potential is defined as status post onset of menarche and not meeting any
             of the following conditions: menopausal for at least two years; sterile status after
             bilateral tubal ligation for at least one year, immediately after bilateral
             oophorectomy or after hysterectomy.

             Acceptable methods of birth control are defined as one or more of the following:

               -  Hormonal contraceptives.

               -  Barrier each and every time during intercourse.

               -  Intrauterine device (IUD).

               -  Monogamous relationship with vasectomized partner. Partner must have been
                  vasectomized for at least six months prior to subject's study entry.

         16. If female subject of childbearing potential and have a positive urine pregnancy test
             prior to study vaccinations, or are currently lactating.

         17. If female of childbearing potential and sexually active, refusal to use an 'acceptable
             contraceptive method' through to three weeks after last study vaccination.

         18. Individuals with behavioral or cognitive impairment or psychiatric disease that, in
             the opinion of the investigator, may interfere with the subject's ability to
             participate in the study.

         19. Individuals with a history of drug or alcohol abuse within the past 2 years.

         20. Individuals who are acting as study personnel or immediate family members or the
             spouse of study personnel.

         21. Individuals with a body temperature ≥38 °C (≥100.4◦F) within 3 days of intended study
             vaccination.

         22. Individuals with any condition that, in the opinion of the investigator, would
             interfere with the primary study objectives.