Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults
Condition: Respiratory Syncytial Virus
Intervention: VRC-RSVRGP084-00-VP; Aluminum Hydroxide Suspension
Intervention description: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.; Aluminum Hydroxide Suspension, alum, is an adjuvant.
Intervention MeSH terms: Aluminum Hydroxide
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immune Response; Respiratory Syncytial Virus; Vaccine-Mediated Protection; Neutralizing Antibody; Antibody Response

Summary:

      Background:

      Respiratory Syncytial Virus (RSV) is a virus that infects the lungs and breathing passages.
      Healthy adults who are infected generally have mild cold symptoms for a week or two. But it
      can also be serious, especially for infants and older adults. It can be spread by direct or
      indirect contact with respiratory secretions. Researchers want to study a new vaccine to
      prevent RSV.

      Objective:

      To see if a vaccine for RSV is safe and if it causes side effects.

      Eligibility:

      Healthy adults 18-50 years old

      Design:

      Volunteers were screened in a separate screening protocol.

      Subjects had 13 visits over 1 year.

      Some subjects received just vaccine. Some received vaccine mixed with alum adjuvant.

      All subjects received their dose by injection in the upper arm. They received up to two
      doses, one at the beginning of the study and another 12 weeks later.

      Subjects were monitored for 1 hour after injection and called to check on their safety 1 day
      after.

      Subjects recorded their temperature and side effects for 7 days after each vaccination.

      Subjects were provided with a thermometer to measure their temperature and a ruler to measure
      any changes if these occurred on their skin at the injection site.

      At all visits, subjects were checked for health changes or problems. They may have had blood
      drawn.

      At some visits, subjects had samples collected from their nose and mouth.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

               1. 18 to 50 years of age.

               2. Willing and able to complete the informed consent process.

               3. Available for clinic visits through 44 weeks after enrollment.

               4. Able to provide proof of identity to the satisfaction of the study clinician
                  completing the enrollment process.

               5. Willing to donate blood and mucosal samples to be stored and used for future
                  research.

               6. In good general health without clinically significant medical history.

               7. Physical examination and laboratory results without clinically significant
                  findings and a Body Mass Index (BMI) less than or equal to 40 within the 56 days
                  prior to enrollment. Laboratory criteria within 56 days prior to enrollment:

               8. White Blood Cell (WBC) and differential either within institutional normal range
                  or accompanied by Principal Investigator (PI) or designee approval.

               9. Platelets = 125,000-500,000/mm^3.

              10. Hemoglobin within institutional normal range.

              11. Creatinine less than or equal to 1.1 x upper limit of normal (ULN).

              12. Alanine aminotransferase (ALT) less than or equal to 1.25 x ULN.

              13. Negative for HIV infection by an FDA approved method of detection.

                  Criteria applicable to women of childbearing potential:

              14. Negative result on a human chorionic gonadotropin pregnancy test on day of
                  enrollment before receiving study product.

              15. Agree to use effective means of birth control from at least 21 days before
                  enrollment through 4 weeks after the last injection.

          -  EXCLUSION CRITERIA:

        Criteria applicable to women of childbearing potential:

          1. Breast-feeding or planning to become pregnant through 4 weeks after the last
             injection.

             Subject has received any of the following:

          2. More than 10 days of systemic immunosuppressive medications or cytotoxic medications
             within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment.

          3. Blood products within 16 weeks prior to enrollment.

          4. Live attenuated vaccines within 4 weeks prior to enrollment.

          5. Inactivated vaccines within 2 weeks prior to enrollment.

          6. Investigational research agents within 4 weeks prior to enrollment or planning to
             receive investigational products while on the study.

          7. Current allergen immunotherapy with antigen injections, unless on maintenance
             schedule.

          8. Current anti-tuberculosis(TB) prophylaxis or therapy.

             Subject has any of the following:

          9. Serious reactions to vaccines that preclude receipt of study injections as determined
             by the investigator.

         10. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.

         11. Asthma that is not well controlled.

         12. Diabetes mellitus (type I or II), with the exception of gestational diabetes.

         13. Thyroid disease that is not well controlled.

         14. Hypertension that is not well controlled.

         15. Evidence of autoimmune disease or immunodeficiency.

         16. Idiopathic urticaria within the past year.

         17. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or
             platelet disorder requiring special precautions) or significant bruising or bleeding
             difficulties with IM injections or blood draws.

         18. Malignancy that is active or history of malignancy that is likely to recur during the
             study.

         19. Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol
             withdrawal more than 3 years ago, or 3) seizures that have not required treatment
             within the last 3 years.

         20. Asplenia, functional asplenia or any condition resulting in the absence or removal of
             the spleen.

         21. Psychiatric condition that precludes compliance with the protocol; past or present
             psychoses; or within 5 years prior to enrollment, a history of suicide plan or
             attempt.

         22. Any medical, psychiatric, or social condition that, in the judgment of the
             investigator, is a contraindication to protocol participation or impairs a subject s
             ability to give informed consent.