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cAd3-Marburg Vaccine 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: NCT03475056
Recruitment Status : Completed
First Posted : March 23, 2018
Last Update Posted : February 26, 2020
Sponsor:
Collaborator:
US Military HIV Research Program
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
RV 507 is a Phase I, open-label study to examine safety, tolerability and immunogenicity of an investigational Marburg vaccine given by intramuscular (IM) injection to healthy adults. The study is a dose escalation of VRC-MARADC087-00-VP, a chimpanzee adenovirus serotype 3 vector vaccine, which encodes wild type (WT) glycoprotein (GP) from Marburgvirus.

Condition or disease Intervention/treatment Phase
Marburg Virus Disease Biological: cAd3-Marburg vaccine Phase 1

Detailed Description:
It is anticipated that about 100 volunteers will be screened in order to enroll a total of 40 participants. The 40 enrolled participants will be evenly split, with 20 in each of the two dosage groups for cAd3-Marburg. The dose escalation plan includes daily review of any new safety data by a study clinician, regular review of safety data by the protocol team and a staged enrollment plan with required interim safety reviews. The study will begin with enrollment of 3 participants into Group 1 at a rate of 1 participant per day. After at least 7 days of follow-up for the first 3 vaccinated participants, an interim safety review will occur before enrollment of additional participants into the group. If no safety issues are identified, an additional 17 participants will be enrolled to complete Group 1. When there is a minimum of seven days of follow-up safety data from the last enrolled participant in Group 1, an interim safety review will occur. Once no safety issues are identified, enrollment of participants into the next dose level will begin with the enrollment of 3 participants at a rate of 1 participant per day. After at least 7 days of follow-up for the first 3 vaccinated participants in Group 2, an interim safety review will occur before the enrollment of additional participants into Group 2. If no safety issues are identified, an additional 17 participants will be enrolled to complete Group 2.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose escalation
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: RV 507: A Phase I Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Marburg Chimpanzee Adenovirus Vector Vaccine, VRC-MARADC087-00-VP (cAd3-Marburg), in Healthy Adults
Actual Study Start Date : October 9, 2018
Actual Primary Completion Date : December 19, 2019
Actual Study Completion Date : December 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: cAd3-Marburg vaccine at 1x10(10) PU dose
Twenty (20) subjects enrolled in Group 1 will receive a 1x10(10) PU dose of cAd3-Marburg vaccine administered intramuscular (IM) with needle and syringe in a volume of 1 mL.
Biological: cAd3-Marburg vaccine
The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
Other Name: VRC-MARADC087-00-VP

Experimental: Ad3-Marburg vaccine at 1x10(11) PU dose
Twenty (20) subjects enrolled in Group 2 will receive a 1x10(11) PU dose of cAd3-Marburg vaccine administered intramuscular (IM) with needle and syringe in a volume of 1 mL.
Biological: cAd3-Marburg vaccine
The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
Other Name: VRC-MARADC087-00-VP




Primary Outcome Measures :
  1. To evaluate the safety and tolerability of cAd3-Marburg when administered IM at a dose of 1 x 10(10) PU to healthy adults [ Time Frame: Over 48 weeks after vaccine administration ]
    Safety

  2. To evaluate the safety and tolerability of cAd3-Marburg when administered IM at a dose of 1 x 10(11) PU to healthy adults [ Time Frame: Over 48 weeks after vaccine administration ]
    Safety


Secondary Outcome Measures :
  1. To evaluate the antibody responses to the GP insert and cAd3 vector after vaccination as assessed by ELISA and antigen-specific and vector- specific neutralization assays. [ Time Frame: 4 weeks after vaccination ]
    Immunogenicity

  2. To evaluate the T cell responses to the GP insert and cAd3 vector after vaccination as assessed by ICS. [ Time Frame: 4 weeks after vaccination ]
    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:

  1. 18 to 50 years old
  2. Available for clinical follow-up through Week 48 after enrollment
  3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. Proof of identity includes a valid U.S. government-issued or state-issued photo ID such as a driver's license, military ID, or U.S. passport.
  4. Able and willing to provide a personal mobile phone number or home phone number at which the participant can be reliably contacted. Participants will be contacted primarily for study visit 2A (Appendix 1), as a reminder of an upcoming visit, and after missed visits for rescheduling purposes.
  5. Able and willing to complete the informed consent process and demonstrate understanding with a passing score (90% or greater) on the Assessment of Understanding (AOU) by the third attempt.
  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) ≤ 40 within the 56 days prior to enrollment.

    Laboratory Criteria within 56 days prior to enrollment:

  8. Hemoglobin ≥ 11.5 g/dL for women; ≥13.0 g/dL for men.
  9. White blood cells (WBC) = 3,300-12,000 cells/mm3.
  10. Total lymphocyte count ≥ 800 cells/mm3.
  11. Platelets = 125,000 - 400,000/mm3.
  12. Alanine aminotransferase (ALT) ≤ 1.25 x upper limit of normal.
  13. Serum creatinine ≤ 1 x upper limit of normal.
  14. HIV-uninfected as evidenced by a negative FDA-approved HIV diagnostic blood test.

    Female-Specific Criteria:

  15. Negative β-HCG (human chorionic gonadotropin) pregnancy test; serum β-HCG at screening (or urine if screening is the same day as enrollment) and urine β-HCG at enrollment if woman is of reproductive potential.
  16. Agrees to use an effective means of birth control from at least 21 days prior to enrollment through 24 weeks after study vaccination if assessed to be of reproductive potential.

Exclusion Criteria:

Volunteer has received any of the following substances:

  1. Investigational Ebola or Marburg vaccine in a prior clinical trial or prior receipt of a cAd3 adenoviral vectored investigational vaccine.
  2. Immunosuppressive medications within 2 weeks prior to enrollment.
  3. Blood products within 112 days (16 weeks) prior to enrollment.
  4. Investigational research agents within 28 days (4 weeks) prior to enrollment.
  5. Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.
  6. Subunit or killed vaccines within 14 days (2 weeks) prior to enrollment.
  7. Current anti-tuberculosis prophylaxis or therapy.

    Female-specific criteria:

  8. Woman who is pregnant, breast-feeding or planning to become pregnant during the first 24 weeks after study vaccine administration.

    Volunteer has a history of any of the following clinically significant conditions:

  9. Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
  10. Allergic reaction to excipients in the study vaccine including gentamycin, neomycin or streptomycin.
  11. Clinically significant autoimmune disease or immunodeficiency.
  12. Asthma that is not well controlled.
  13. Positive syphilis serology. False-positive results will also exclude a participant.
  14. Diabetes mellitus (type I or II).
  15. Thyroid disease that is not well controlled.
  16. A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
  17. Idiopathic urticaria within the last 1 year.
  18. Hypertension that is not well controlled.
  19. 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.
  20. A malignancy that is active, currently being treated, or not surgically cured.
  21. Seizure in the past 3 years or treatment for seizure disorder in the past 3 years.
  22. Asplenia or functional asplenia.
  23. Psychiatric condition that precludes compliance with the protocol; past or present psychoses; or within five years prior to enrollment, history of a suicide plan or attempt.
  24. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer'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): NCT03475056


Locations
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United States, Maryland
WRAIR Clinical Trials Center,
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
US Military HIV Research Program
Investigators
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Principal Investigator: Melinda Hamer, M.D. WRAIR Clinical Trials Center
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03475056    
Other Study ID Numbers: RV 507
WRAIR #2438 ( Other Identifier: WRAIR )
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Institute of Allergy and Infectious Diseases (NIAID):
Marburg virus
Marburg vaccine
cAd3-Marburg vaccine
Additional relevant MeSH terms:
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Virus Diseases
Marburg Virus Disease
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections