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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

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ClinicalTrials.gov Identifier: NCT03049488
Recruitment Status : Recruiting
First Posted : February 10, 2017
Last Update Posted : September 7, 2018
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 Biological: VRC-RSVRGP084-00VP Phase 1

Detailed Description:
This is a Phase I, open label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of VRC-RSVRGP084-00-VP alone or with alum adjuvant in a 2-injection regimen. The hypotheses are that the vaccine will be safe and tolerable for human administration, and will induce detectable immune response. The primary objective is to evaluate the safety and tolerability of the investigational vaccine at 3 dose levels administered alone or with alum adjuvant as a homologous boost in healthy adults. Secondary objectives relate to humoral and cellular immunogenicity of the investigational vaccine regimen.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel 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
Estimated Primary Completion Date : January 3, 2019
Estimated Study Completion Date : January 3, 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.
Biological: VRC-RSVRGP084-00VP
VRC-RSVRGP084-00-VP is an investigational vaccine that is intended to prevent respiratory synctial virus.

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.
Biological: VRC-RSVRGP084-00VP
VRC-RSVRGP084-00-VP is an investigational vaccine that is intended to prevent respiratory synctial virus.

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.
Biological: VRC-RSVRGP084-00VP
VRC-RSVRGP084-00-VP is an investigational vaccine that is intended to prevent respiratory synctial virus.




Primary Outcome Measures :
  1. To evaluate the safety and tolerability of DS-Cav1 alone or with adjuvant when administered IM at 50 mcg, or 150 mcg, or 500 mcg to healthy adults. [ Time Frame: Through 44 weeks of study participation. ]

Secondary Outcome Measures :
  1. To evaluate the antibody response as measured by neutralization assay of DS-Cav1 alone or with adjuvant. [ Time Frame: 2 and or 4 weeks posted first injection. ]
  2. To evaluate the antibody response as measured by neutralization assay of DS-Cav 1 alone or with adjuvant. [ Time Frame: 2 and or 4 weeks post second injection. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Contacts
Contact: Pamela Costner, R.N. (301) 451-8715 vaccines@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: VRC Clinic    301-451-8715    vaccines@nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Michelle C Crank, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03049488     History of Changes
Other Study ID Numbers: 170058
17-I-0058
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 4, 2018

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

Additional relevant MeSH terms:
Vaccines
Antibodies
Aluminum Hydroxide
Aluminum sulfate
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents