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Ebola Virus DiseasePhase 1NCT04723602

Evaluation of Safety, Tolerability and Immune Responses of Ebola-S and Marburg Vaccines in Healthy Adults

A Phase 1 study testing cAd3-Marburg and cAd3-EBO-S in people with Ebola Virus Disease and Marburg Virus Disease, run by Albert B. Sabin Vaccine Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objective: To evaluate the safety and tolerability of cAd3-EBO-S and cAd3 Marburg vaccines when administered Intramuscular (IM) at a dose of 1 x 10^11 particle units (PU) to healthy adults. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Ebola Virus Disease, Marburg Virus Disease
What is being tested?
cAd3-Marburg and cAd3-EBO-S
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
6 Jan 2021to 14 Dec 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female participant must be between 18-50 (inclusive) years of age;
  • Meet criteria for plasma donation*;
  • Available for clinic follow-up through Day 99 and one additional follow-up call on Day 181 (±14 days);
  • Agrees not to receive any vaccine from day of enrollment through Day 99;
  • Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process;
  • Agree to have photos taken of the vaccination site, if indicated ;
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  • Willing to complete repeated plasmapheresis and other protocol requirements;
  • Must complete an Assessment of Understanding (AoU) by answering 9 out of 10 questions correctly at least once in 3 attempts;
  • Willing to donate blood for sample storage and future unspecified assay development;
  • Able to read (English) and willing to complete informed consent process;
  • In good general health without clinically significant medical history, based on medical history, physical examination, vital signs and clinical laboratory results;
  • Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) ≥ 17 and ≤ 35 within the 28 days prior to vaccination;
  • Laboratory Criteria within 28 days prior to vaccination (normal per testing laboratory) for: complete blood count (CBC) with differential count, alanine aminotransferase (ALT), serum creatinine and total protein;
  • Serology screen negative for infectious diseases (hepatitis B, hepatitis C, HIV, HTLV (Human T-cell leukemia lymphoma virus), Chagas disease, Syphilis;
  • Nucleic acid test (NAT) negative for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), West Nile and Zika;
  • Negative antibody and reverse transcription polymerase chain reaction (RT-PCR) for severe acute respiratory syndrome Covid 2 (SARS CoV-2) and free of current or prior symptoms concerning for COVID-19. Participants with a previous positive RT-PCR, at least 90 days prior to screening as reported in medical history, will not be excluded if they are antibody negative;
  • Female participant specific criteria:
  • Negative pregnancy serum test at screening and, negative urine pregnancy test before vaccination unless one of the following criteria is met:
  • At least 1 year post-menopausal;
  • Surgically sterile;
  • Use of oral, implantable, transdermal or injectable contraceptives for 21 days prior to and agrees to use through Day 181 ;
  • Use of another reliable form of contraception must be approved by the Investigator (e.g., double barrier method, Depo-Provera, intrauterine device, Norplant, oral contraceptives, contraceptive patches);
  • Male participants must agree:
  • Not to father a child or donate sperm through Day 181;
  • To use an effective means of birth control from at least 21 days prior to enrollment through Day 181 if assessed to be of reproductive potential.
  • Meet the criteria described in the AABB (formerly known as American Association of Blood Bank) and Uniform Donor History Questionnaire, with the exception of travel for malaria or Variant Creutzfeldt-Jakob Disease (vCJD) risk

Who cannot join

  • Investigational COVID-19, Ebola or Marburg vaccine in a prior clinical trial or prior receipt of a cAd3 adenoviral vectored investigational vaccine;
  • Use of immunomodulators and systemic glucocorticoids in daily doses of glucocorticoid equivalence > 20 mg of prednisolone in the last 90 days and for periods exceeding 10 days. Non-steroidal anti-inflammatory drugs [NSAIDS] are permitted. Participants that have used less than the stated glucocorticoid dose may still be excluded at the Investigator's discretion;
  • Blood products within 112 days prior to enrollment;
  • Investigational research agents within 90 days prior to enrollment;
  • Any licensed vaccine, inclusive of "live-attenuated" vaccine (e.g., oral polio, yellow fever, measles, etc.), killed, or subunit vaccine, within 28 days prior to enrollment;
  • Any experimental vaccines within 6 months prior to enrollment;
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  • Current anti-tuberculosis prophylaxis or therapy;
  • Female participant specific criteria: woman who is pregnant, breast-feeding or planning to become pregnant through Day 181 (±14 days);
  • Unsatisfactory vein assessment for plasmapheresis via peripheral access (more details in Section 5.2.1)
  • 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 result on a rapid plasma regain (RPR) test (A blood test for Syphilis);
  • 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 or use of anticoagulant medications such as, Coumadin, Eliquis, Pradaxa (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws;
  • A malignancy that is active, currently being treated, or not surgically cured (breast or prostate cancer successfully treated, with or without surgery is excluded; if diagnosed malignancy is 5 or more years prior to enrollment and cured with no ongoing treatment it will NOT be considered an exclusion);
  • Seizure in the past 3 years or treatment for seizure disorder in the past 3 years;
  • Asplenia or functional asplenia;
  • 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;
  • 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 participant's ability to give informed consent.
  • Abnormal laboratory results (per testing laboratory)
  • Positive COVID-19 symptom screen, SARS-CoV-2 RT-PCR, or SARS CoV-2 antibody test

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oklahoma Blood Institute (OBI)

    Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: Phase 1b Trial to Evaluate Safety, Tolerability and Immune Responses of 2 Monovalent Chimpanzee Adenoviral Vectored Filovirus (Ebola-S and Marburg) Vaccines to Healthy Adults, Collection of Plasma/Serum for the Purposes of Assay Development

Primary Objective:

  • To evaluate the safety and tolerability of cAd3-EBO-S and cAd3 Marburg vaccines when administered Intramuscular (IM) at a dose of 1 x 10^11 particle units (PU) to healthy adults.

Secondary Objectives:

  • To evaluate the antibody response to Monovalent Chimpanzee Adenoviral Vectored Filovirus Ebola-S (cAd3-EBO-S) and Monovalent Chimpanzee Adenoviral Vectored Filovirus (Marburg) (cAd3 Marburg) vaccines as assessed by antigen glycoprotein (GP) specific (enzyme-linked immunosorbent assay) ELISA
  • To collect sufficient post-vaccination plasma to support further development of filovirus assays
Read the detailed description

Primary Endpoints: Safety

Assessment of product safety will include clinical observation and monitoring of clinical chemistry and hematology parameters. Safety will be closely monitored after injection and evaluated through Day 99 and one additional safety follow-up telephone call on Day 181 (± 14 Days). The following parameters will be assessed:

  • Occurrence and severity of solicited local reactogenicity signs and symptoms for 7 days following the vaccination
  • Occurrence and severity of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination
  • Change from baseline for safety laboratory measures
  • Occurrence of adverse events of all severities through 28 days after vaccination
  • Occurrence of serious adverse events and new chronic medical conditions through the last safety follow up call at Day 181(± 14 days)

Secondary Endpoints :

  • Antibody levels against vaccines cAd3-EBO-S and cAd3 Marburg as measured by enzyme-linked immunosorbent assay (ELISA) on Day 1, 15, 22, 29, 36, 43, 50, 57 and 64
  • 20 Liters of plasma per vaccine group will be collected for the purpose of assay development
Being tested
cAd3-Marburg, cAd3-EBO-S
Keywords
Coronavirus Disease, Creatine phosphokinase, Clinical Research Associate, Contract Research Organization, Division of AIDS, Disseminated Intravascular Coagulation, Diagnostic Lab of Oklahoma, Deoxyribonucleic Acid, Species Zaire Ebolavirus, Electronic Case Report Form, Ethylenediaminetetraacetic Acid, Ebola Hemorrhagic Fever, Enzyme-Linked Immunosorbent Assay, Food and Drug Administration, Ebola Virus Disease, Degrees Fahrenheit, Good Clinical Practices, Good Laboratory Practices, Grams, Glycoprotein
Medical subject headings
Hemorrhagic Fever, Ebola, Marburg Virus Disease, Disseminated Intravascular Coagulation, Angioedemas, Hereditary, Hepatitis B, Hepatitis C, Acquired Immunodeficiency Syndrome, Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cAd3-MarburgBiological

    A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 1 (N = 16) will receive a single injection of cAd3-Marburg at 1 x 10^11 Particle Units (PU) vaccine.

  • cAd3-EBO-SBiological

    A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 2 (N = 16) will receive a single injection of cAd3-EBO-S at 1 x 10^11 Particle Units (PU) vaccine.

Study groups in NCT04723602
Study groupRoleWhat they receive
cAd3-Marburg at 1 x 10^11 Particle Units (PU)Active comparatorA total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 1 (N = 16) will receive a single injection of cAd3-Marburg at 1 x 10^11 Particle Units (PU) vaccine.
Receives: Biological: cAd3-Marburg
cAd3-EBO-S at 1 x 10^11 PU vaccineActive comparatorA total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 2 (N = 16) will receive a single injection of cAd3-EBO-S at 1 x 10^11 Particle Units (PU) vaccine.
Receives: Biological: cAd3-EBO-S

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of Ebola and Marburg vaccines assessed by clinical observation.

    Safety of Ebola and Marburg vaccines, as seen in local reactogenicity signs and symptoms with diary questionnaire card.

    Measured: 7 Days

  2. Safety of Ebola and Marburg vaccines assessed by clinical observation.

    Safety of Ebola and Marburg vaccines, as seen in systemic reactogenicity signs and symptoms with diary questionnaire card.

    Measured: 7 Days

  3. Safety of Ebola and Marburg vaccines assessed by change from baseline in levels of Complete Blood Count (CBC).

    Safety of Ebola and Marburg vaccines assessed by change in levels of Complete Blood Count (CBC) w/differential count as laboratory measures of safety from baseline.

    Measured: 6 months

  4. Safety of Ebola and Marburg vaccines assessed by change from baseline in levels of Creatinine.

    Safety of Ebola and Marburg vaccines assessed by change in levels of Creatinine as laboratory measures of safety from baseline.

    Measured: 6 months

  5. Safety of Ebola and Marburg vaccines assessed by change from baseline in levels of Alanine Transaminase (ALT).

    Safety of Ebola and Marburg vaccines assessed by change in levels of Alanine Transaminase (ALT) as laboratory measures of safety from baseline.

    Measured: 6 months

  6. Safety of Ebola and Marburg vaccines assessed by adverse experiences.

    Safety of Ebola and Marburg vaccines assessed by adverse events of all severities (Mild, moderate, and severe)

    Measured: 28 days

  7. Safety of Ebola and Marburg vaccines assessed by serious adverse experiences.

    Safety of Ebola and Marburg vaccines assessed by serious adverse events of all severities (Mild, moderate, and severe)

    Measured: 6 months

Secondary outcomes (2)

  1. Evaluation of antibody response to cAd3-EBO-S and cAd3 Marburg vaccines

    Immunogenicity of the Ebola and Marburg vaccines as measured by antigen GP-specific ELISA

    Measured: Measured at Day 1, 15, 22, 29, 36, 43, 50, 57, and 64

  2. Collection of sufficient post-vaccination plasma to support further development of filovirus assays.

    20 L of plasma per vaccine group (N=2) will be collected for the purpose of assay development. 800 mL of plasma will be collected at Day 29. Thereafter, plasma collections will be up to approximately 600 mL. Participants may donate up to 6 total times and all collections will be done within the limits of the FDA approved instructions for use for the Fenwal Alyx collection device.

    Measured: May be collected at Day 29, 36, 43, 50, 57 and/or 64

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2021
  2. Study start6 Jan 2021
  3. Primary completion14 Dec 2021
  4. Study completion14 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
2 cohorts of 16 participants each.
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04723602
Sponsor's protocol ID
Sabin 001
Status last verified
Aug 2022
First submitted
10 Dec 2020
Last updated
3 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sanchez A, Kiley MP, Klenk HD, Feldmann H. Sequence analysis of the Marburg virus nucleoprotein gene: comparison to Ebola virus and other non-segmented negative-strand RNA viruses. J Gen Virol. 1992 Feb;73 ( Pt 2):347-57. doi: 10.1099/0022-1317-73-2-347.

    PubMed 1538192

  • Sanchez A, Kiley MP, Holloway BP, Auperin DD. Sequence analysis of the Ebola virus genome: organization, genetic elements, and comparison with the genome of Marburg virus. Virus Res. 1993 Sep;29(3):215-40. doi: 10.1016/0168-1702(93)90063-s.

    PubMed 8237108

  • Geisbert TW, Jahrling PB. Exotic emerging viral diseases: progress and challenges. Nat Med. 2004 Dec;10(12 Suppl):S110-21. doi: 10.1038/nm1142.

    PubMed 15577929

  • Hensley LE, Jones SM, Feldmann H, Jahrling PB, Geisbert TW. Ebola and Marburg viruses: pathogenesis and development of countermeasures. Curr Mol Med. 2005 Dec;5(8):761-72. doi: 10.2174/156652405774962344.

    PubMed 16375711

  • Ledgerwood JE, DeZure AD, Stanley DA, Coates EE, Novik L, Enama ME, Berkowitz NM, Hu Z, Joshi G, Ploquin A, Sitar S, Gordon IJ, Plummer SA, Holman LA, Hendel CS, Yamshchikov G, Roman F, Nicosia A, Colloca S, Cortese R, Bailer RT, Schwartz RM, Roederer M, Mascola JR, Koup RA, Sullivan NJ, Graham BS; VRC 207 Study Team. Chimpanzee Adenovirus Vector Ebola Vaccine. N Engl J Med. 2017 Mar 9;376(10):928-938. doi: 10.1056/NEJMoa1410863. Epub 2014 Nov 26.

    PubMed 25426834

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cAd3-Marburg and cAd3-EBO-S in people with Ebola Virus Disease and Marburg Virus Disease, run by Albert B. Sabin Vaccine Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of Ebola and Marburg vaccines assessed by clinical observation. (time frame: 7 Days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04723602, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.

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