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

• Status: Active, not recruiting
• Trial end date: 2020-01-03
• Target enrollment: 90
• Participant gender: All

Summary

Background:

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:

Participants will be screened in a different protocol.

Participants will have 13 visits over 1 year.

Some participants will receive just vaccine. Some will receive vaccine mixed with alum, which could make the body respond to the vaccine better.

All will receive their dose by injection in the upper arm. They will receive two doses, one at the beginning of the study and another 12 weeks later.

Participants will be watched for 1 hour after injection. They will be called 1 day after.

They will keep track of their temperature and side effects for 7 days after.

Participants will receive a ruler to measure any changes on their skin at the injection site.

At all visits, participants will be checked for health changes or problems. They may have blood drawn.

At some visits, participants will have samples taken from their nose and mouth.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Aluminum Hydroxide; Aluminum sulfate; Antibodies; Vaccines

Criteria

• INCLUSION:

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. WBC and differential either within institutional normal range or accompanied by Principal Investigator (PI) or designee approval.

9. Platelets = 125,000 500,000/mm3.

10. Hemoglobin within institutional normal range.

11. Creatinine less than or equal to 1.1 x ULN.

12. 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 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-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.