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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03049488
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief 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.


Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Drug: VRC-RSVRGP084-00VP Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: VRC 317: A Phase I Randomized, Open-Label Clinical Trial to Evaluate 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
Actual Study Start Date : February 22, 2017
Actual Primary Completion Date : October 3, 2019
Actual Study Completion Date : April 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1, Group 2
DS-Cav 1 or DS-Cav 1 + alum administered at 50 mcg with needle and syringe at day 0 and week 12.
Drug: VRC-RSVRGP084-00VP
VRC-RSVRGP084-00-VP is a sterile, aqueous, buffered solution filled into single dose vials

Experimental: Group 3, Group 4
DS-Cav 1 or DS-Cav 1 + alum administered at 150 mcg with needle and syringe at day 0 and week 12.
Drug: VRC-RSVRGP084-00VP
VRC-RSVRGP084-00-VP is a sterile, aqueous, buffered solution filled into single dose vials

Experimental: Group 5, Group 6
DS-Cav 1 or DS-Cav 1 + alum administered at 500 mcg with needle and syringe at day 0 and week 12.
Drug: VRC-RSVRGP084-00VP
VRC-RSVRGP084-00-VP is a sterile, aqueous, buffered solution filled into single dose vials




Primary Outcome Measures :
  1. To evaluate the safety and tolerability of DS-Cav1 alone or with adjuvant when administered IM at a dose of 150 mcg to healthy adults. [ Time Frame: Through 44 weeks of study participation ]
    Assessment of product safety will include clinical observation and monitoring of hematological and chemical parameters. Reactogenicity will be closely monitored for 7 days after each product administration and safety evaluated by clinical visits through the study duration.

  2. To evaluate the safety and tolerability of DS-Cav1 alone or with adjuvant when administered IM at a dose of 50 mcg to healthy adults. [ Time Frame: Through 44 weeks of study participation. ]
    Assessment of product safety will include clinical observation and monitoring of hematological and chemical parameters. Reactogenicity will be closely monitored for 7 days after each product administration and safety evaluated by clinical visits through the study duration.

  3. To evaluate the safety and tolerability of DS-Cav1 alone or with adjuvant when administered IM at a dose of 500 mcg to healthy adults. [ Time Frame: Through 44 weeks of study participation ]
    Assessment of product safety will include clinical observation and monitoring of hematological and chemical parameters. Reactogenicity will be closely monitored for 7 days after each product administration and safety evaluated by clinical visits through the study duration.


Secondary Outcome Measures :
  1. To evaluate the antibody response as measured by neutralization assay of DS- Cavl alone or with adjuvant [ Time Frame: 4 weeks post first injection ]
  2. To evaluate the antibody response as measured by neutralization assay of DS-Cavl alone or with adjuvant [ Time Frame: 4 weeks post second injection ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049488


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Grace L Chen, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

Additional Information:
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03049488    
Other Study ID Numbers: 170058
17-I-0058
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Immune Response
Respiratory Syncytial Virus
Vaccine-Mediated Protection
Neutralizing Antibody
Antibody Response