cAd3-Marburg Vaccine in Healthy Adults

Completed · Phase 1

Conditions studied: Marburg Virus Disease

In brief

RV 507 was a Phase I, open-label study to examine the safety, tolerability and immunogenicity of an investigational Marburg vaccine given by intramuscular (IM) injection to healthy adults. The study was a dose escalation of VRC-MARADC087-00-VP, a chimpanzee adenovirus serotype 3 (cAd3) vector vaccine, which encodes wild type (WT) glycoprotein (GP) from Marburgvirus.

Key facts

Study ID

NCT03475056

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

40

Starts

2018-10-09

Expected to finish

2019-12-19

Last updated by the study team

2022-08-11

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 to 50 years old
• Available for clinical follow-up through Week 48 after enrollment
• 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 identification (ID) such as a driver's license, military ID, or U.S. passport.
• 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.
• 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.
• In good general health without clinically significant medical history.
• 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:
• Hemoglobin ≥ 11.5 g/dL for women; ≥13.0 g/dL for men.
• White blood cells (WBC) = 3,300-12,000 cells/mm\^3.
• Total lymphocyte count ≥ 800 cells/mm\^3.
• Platelets = 125,000 - 400,000/mm\^3.
• Alanine aminotransferase (ALT) ≤ 1.25 x upper limit of normal.
• Serum creatinine ≤ 1 x upper limit of normal.
• HIV-uninfected as evidenced by a negative FDA-approved HIV diagnostic blood test.
• Female-Specific Criteria:
• 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.
• 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.

You may not qualify if…

• Volunteer has received any of the following substances:
• Investigational Ebola or Marburg vaccine in a prior clinical trial or prior receipt of a cAd3 vectored investigational vaccine.
• Immunosuppressive medications within 2 weeks prior to enrollment.
• Blood products within 112 days (16 weeks) prior to enrollment.
• Investigational research agents within 28 days (4 weeks) prior to enrollment.
• Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.
• Subunit or killed vaccines within 14 days (2 weeks) prior to enrollment.
• Current anti-tuberculosis prophylaxis or therapy.
• Female-specific criteria:
• 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:
• Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
• Allergic reaction to excipients in the study vaccine including gentamycin, neomycin or streptomycin.
• Clinically significant autoimmune disease or immunodeficiency.
• Asthma that is not well controlled.
• Positive syphilis serology. False-positive results will also exclude a participant.
• Diabetes mellitus (type I or II).
• Thyroid disease that is not well controlled.
• A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
• Idiopathic urticaria within the last 1 year.
• Hypertension that is not well controlled.
• Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular (IM) injections or blood draws.
• A malignancy that is active, currently being treated, or not surgically cured.
• Seizure in the past 3 years or treatment for seizure disorder in the past 3 years.
• Asplenia or functional asplenia.

Where it is running

• WRAIR Clinical Trials Center, — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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