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Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults<TAB>

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ClinicalTrials.gov Identifier: NCT03783130
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief Summary:

Background:

HIV stands for human immunodeficiency virus, which is the virus that causes AIDS. There is currently no licensed vaccine to prevent HIV infection. Researchers want to test a vaccine called Trimer 4571 for the first time. It was made at the National Institutes of Health and contains no HIV. It will be given mixed with a substance called alum to boost the body s immune response to the vaccine. Alum has been used in licensed vaccines for over 60 years and has been found to be safe.

Objectives:

To see if the vaccine Trimer 4571 is safe, well-tolerated, and to study immune responses to it.

Eligibility:

Healthy adults ages 18-50 years

Design:

Participants will be screened with a physical exam and blood tests. They must agree to not become pregnant and to avoid behavior that will put them at high-risk for HIV infection during the study.

Participants will have about 15 study visits over about 9 months.

The first 6 participants will get a low dose of the vaccine mixed with alum.

Once that is deemed safe, 10 new participants will get a higher dose.

All participants will be randomly assigned to get the vaccine by injection in a muscle or under the skin.

All participants will get a total of 3 vaccine injections over 20 weeks. Each visit where participants receive the vaccine will last about 5 hours. Participants will be watched after each injection. Participants able to get pregnant will have a pregnancy test before each injection.

Participants will get a thermometer and record their temperature and symptoms every day for 1 week after each injection. They will also check the injection site for redness, swelling, or bruising.

At follow-up visits, participants will have blood drawn and be checked for health changes or problems. Follow up visits will last about 1-2 hours.


Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus (HIV) Biological: VRC-HIVRGP096-00-VP Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: VRC 018: A Phase I Dose Escalation, Randomized, Open-Label Clinical Trial to Evaluate Dose, Safety, Tolerability and Immunogenicity of a HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults
Actual Study Start Date : March 7, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Group 1
Subj will receive Trimer 4571, 100 mcg IV on Day 0, Week 8, Week 20
Biological: VRC-HIVRGP096-00-VP
Trimer 4571 drug product is a sterile, aqueous, buffered solution filled under aseptic conditions into single dose vials at a concentration of 500 mcg/mL. The formulation buffer is comprised of 10 mM Sodium Phosphate, 10 mM Sodium Chloride, 7.5% Sorbitol, 0.01% PF-68 at pH 7.2. The drug product is aseptically filled at a volume of 1.2 +/- 0.10 mL in 3 mL glass vials. Vials contain a clear, colorless solution; no turbidity, some small white or translucent particles may be visible.

Experimental: Group 2
Subj will receive Trimer 4571, 100 mcg SC on Day 0, Week 8, Week 20
Biological: VRC-HIVRGP096-00-VP
Trimer 4571 drug product is a sterile, aqueous, buffered solution filled under aseptic conditions into single dose vials at a concentration of 500 mcg/mL. The formulation buffer is comprised of 10 mM Sodium Phosphate, 10 mM Sodium Chloride, 7.5% Sorbitol, 0.01% PF-68 at pH 7.2. The drug product is aseptically filled at a volume of 1.2 +/- 0.10 mL in 3 mL glass vials. Vials contain a clear, colorless solution; no turbidity, some small white or translucent particles may be visible.

Experimental: Group 3
Subj will receive Trimer 4571, 500 mcg IM on Day 0, Week 8, Week 20
Biological: VRC-HIVRGP096-00-VP
Trimer 4571 drug product is a sterile, aqueous, buffered solution filled under aseptic conditions into single dose vials at a concentration of 500 mcg/mL. The formulation buffer is comprised of 10 mM Sodium Phosphate, 10 mM Sodium Chloride, 7.5% Sorbitol, 0.01% PF-68 at pH 7.2. The drug product is aseptically filled at a volume of 1.2 +/- 0.10 mL in 3 mL glass vials. Vials contain a clear, colorless solution; no turbidity, some small white or translucent particles may be visible.

Experimental: Group 4
Subj will receive Trimer 4571, 500 mcg SC on Day 0, Week 8, Week 20
Biological: VRC-HIVRGP096-00-VP
Trimer 4571 drug product is a sterile, aqueous, buffered solution filled under aseptic conditions into single dose vials at a concentration of 500 mcg/mL. The formulation buffer is comprised of 10 mM Sodium Phosphate, 10 mM Sodium Chloride, 7.5% Sorbitol, 0.01% PF-68 at pH 7.2. The drug product is aseptically filled at a volume of 1.2 +/- 0.10 mL in 3 mL glass vials. Vials contain a clear, colorless solution; no turbidity, some small white or translucent particles may be visible.




Primary Outcome Measures :
  1. To evaluate the safety and tolerability of adjuvanted Trimer 4571 administered IM or SC at a dose of 100 mcg to healthy adults [ Time Frame: Day 0, Week 8 and Week 20 ]
    Assess the safety and tolerability

  2. To evaluate the safety and tolerability of adjuvanted Trimer 4571 administered IM or SC at a dose of 500 mcg to healthy adults [ Time Frame: Day 0, Week 8 and Week 20 ]
    Assess the safety and tolerability


Secondary Outcome Measures :
  1. To evaluate the ELISA titer response to adjuvanted Trimer 4571 [ Time Frame: 2 Weeks after the third dose ]
    Evaluate humoral and cellular immunogenicity



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:   Yes
Criteria
  • INCLUSION CRITERIA:

A subject must meet all of the following criteria:

  1. Able and willing to complete the informed consent process.
  2. 18-50 years old, inclusive, on day of enrollment.
  3. Available for clinic follow-up through the last study visit.
  4. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
  5. Willing to donate blood for sample storage to be used for future research.
  6. In good general health without clinically significant medical history.
  7. Physical examination and laboratory results without clinically significant findings.
  8. Body Mass Index (BMI) less than or equal to 40.
  9. Assessed as low risk for HIV acquisition by agreeing to discuss HIV infection risks, agreeing to risk reduction counseling, and agreeing to avoid behavior associated with high risk of HIV exposure through the end of study.
  10. Screening laboratory values within 56 days prior to enrollment that meet the following criteria:

    • Hemoglobin within the institutional normal limits
    • White blood cell (WBC) count between 2,500-12,000/mm^3
    • WBC differential absolute cell counts either within institutional normal range or accompanied by site PI or Associate Investigator (AI) approval, except neutrophils and lymphocytes must specifically be within the range of greater than or equal to 0.75 x the lower limit of normal (LLN) and lees than or equal to 1.25 x the upper limit of normal (ULN) for neutrophil and lymphocyte absolute counts
    • Platelets = 125,000-500,000/m^3
    • Alanine aminotransferase (ALT) less than or equal to 1.25 x ULN based on the institutional normal range
    • Serum creatinine less than or equal to 1.1 x ULN based on the institutional normal range
    • Negative for HIV infection by an FDA approved method of detection

    Woman-specific (if presumed to be of childbearing potential):

  11. Agrees to use effective means of birth control from at least 21 days prior to enrollment through the end of the study.
  12. Negative beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment.

EXCLUSION CRITERIA:

A subject will be excluded if one or more of the following conditions apply:

Woman-specific:

  1. Breast-feeding or planning to become pregnant through the end of study.

    Subject has received any of the following:

  2. An investigational HIV vaccine.
  3. Systemic glucocorticoid use equal or greater than prednisone 20mg/day within 4 weeks prior to enrollment, or other medication use likely to impair vaccine response.
  4. Blood products within 16 weeks prior to enrollment.
  5. Live attenuated vaccines within 4 weeks prior to enrollment.
  6. Inactivated vaccines within 2 weeks prior to enrollment.
  7. Investigational research agents within 4 weeks prior to enrollment.
  8. Current allergen immunotherapy with antigen injections, unless on maintenance schedule.
  9. Current anti-TB prophylaxis or therapy.

    Subject has any of the following:

  10. Serious reactions to vaccines that preclude receipt of study injections as determined by the principal investigator or designee.
  11. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
  12. Hypertension that is not well controlled.
  13. Evidence of significant autoimmune disease or immunodeficiency.
  14. Idiopathic urticaria within the past year.
  15. 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.

  16. 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.
  17. Asplenia or functional asplenia.
  18. Any other chronic or clinically significant condition that in the opinion of the investigator would jeopardize the safety or rights of the study subject including but not limited to: diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of: drug or alcohol abuse, asthma, psychiatric disorders, heart disease, or cancer.

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): NCT03783130


Contacts
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Contact: VRC Clinic (301) 451-8715 vaccines@nih.gov

Locations
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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
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Principal Investigator: Martin R Gaudinski, 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: NCT03783130     History of Changes
Other Study ID Numbers: 190031
19-I-0031
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 5, 2019

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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) ):
Human Immunodeficiency Virus
Immune Response
Neutralizing Antibodies
HIV Prevention
Immune Responses
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs