Healthy Adult Immune Responses to VaccinePhase 1NCT02408913
VRC 208: Dose, Safety and Immunogenicity of a Recombinant Modified Vaccinia Virus Ankara Ebola Vaccine, VRC-EBOMVA079-00-VP (MVA-EbolaZ), Administered Alone or as a Boost to cAd3-Ebola Vaccines in Healthy Adults
A Phase 1 study testing VRC-EBOMVA079-00-VP (MVA-EbolaZ) and VRC-EBOADC069-00-VP (cAd3-EBO) in people with Healthy Adult Immune Responses to Vaccine, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
Background: Ebola virus is a rare disease that starts with fever and muscle aches, but can lead to death. The 2014 Ebola outbreak in West Africa is the largest to date. There are no approved treatments for Ebola. Read more about this study
- Who is it for?
- Ages 18 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Immune Responses to Vaccine
- What is being tested?
- VRC-EBOMVA079-00-VP (MVA-EbolaZ) and VRC-EBOADC069-00-VP (cAd3-EBO)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Mar 2015to 6 Apr 2017
- 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 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A volunteer must meet all of the following criteria to be eligible:
- 18 to 50 years old.
- Available for clinical follow-up through the last study visit.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Able and willing to complete the informed consent process.
- Willing to donate blood for sample storage to be used for future research.
Show all 22Show fewer
- In good general health without clinically significant medical history.
- 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:
- Hemoglobin within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.
- White blood cells (WBC) = 3,300-12,000 cells/mm(3).
- WBC differential either within institutional normal range or accompanied by the PI or designee approval.
- Total lymphocyte count greater than or equal to 800 cells/mm(3).
- Platelets = 125,000-400,000/mm(3).
- Alanine aminotransferase (ALT) less than or equal to 1.25 times upper limit of normal.
- Serum creatinine less than or equal to 1.1 times upper limit of normal.
- Partial thromboplastin time (PTT) less than or equal to 1.1 times upper limit of normal or accompanied by the Principal Investigator (PI) or designee approval.
- Prothrombin time (PT) less than or equal to1.1 times upper limit of normal or accompanied by the Principal Investigator (PI) or designee approval.
- HIV-uninfected as evidenced by a negative FDA-approved HIV diagnostic blood test.
- -Female-Specific Criteria:
- Negative beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment if woman is presumed to be of reproductive potential.
- Agrees to use an effective means of birth control from at least 21 days prior to enrollment through 24 weeks after last study vaccination if presumed to be of reproductive potential.
Who cannot join
- A volunteer will be excluded if one or more of the following conditions apply:
- Volunteer has received any of the following substances:
- Investigational Marburg vaccine in a prior clinical trial.
- Investigational Ebola vaccine in a prior clinical trial.
- Investigational cAd3 or MVA vaccines in a prior clinical trial.
- Evidence of increased cardiovascular disease risk defined as >10% five year risk by the non-laboratory method.
Show all 31Show fewer
- Electrocardiogram (ECG) with clinically significant abnormalities (examples may include: pathologic Q waves, significant ST-T wave changes, left ventricular hypertrophy, any non-sinus rhythm excluding isolated premature atrial contractions, right or left bundle branch block, advanced A-V heart block). ECG abnormalities determined by a cardiologist to be clinically insignificant as related to study participation do not preclude study enrollment.
- Type 1 hypersensitivity reaction to aminoglycoside antibiotics.
- More than 10 days of systemic immunosuppressive medications except for short-term treatments of minor ailments in otherwise healthy volunteers, or cytotoxic medications within the 4 weeks prior to enrollment, or any within the 14 days 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.
- Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal within 2 weeks of initial study vaccine administration unless approved by the study Principal Investigator (PI) or designee
- Current anti-tuberculosis prophylaxis or therapy.
- -Female-specific criteria:
- Woman who is breast-feeding or planning to become pregnant during the 24 weeks of study participation.
- -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.
- Clinically significant autoimmune disease or immunodeficiency.
- Asthma that is not well controlled.
- Diabetes mellitus (type I or II), with the exception of gestational diabetes.
- 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 IM injections or blood draws.
- Malignancy that is active or history of a malignancy that is likely to recur during the period of the study.
- 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 volunteer s ability to give informed consent.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland, Baltimore
Baltimore, Maryland, 21201-1595
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Hope Clinic - Emory Vaccine Ctr
Decatur, Georgia, 30030
About this study
Official title: VRC 208: Phase 1/1b Open-Label Clinical Trial to Evaluate Dose, Safety and Immunogenicity of Recombinant Modified Vaccinia Virus Ankara Ebola Vaccine,VRC-EBOMVA079-00-VP, Administered Alone or as Boost to cAd3-Ebola Vaccines in Healthy Adults
Background:
- Ebola virus is a rare disease that starts with fever and muscle aches, but can lead to death. The 2014 Ebola outbreak in West Africa is the largest to date. There are no approved treatments for Ebola. Researchers want to see if two new vaccines VRC-EBOMVA079-00-VP (MVA-EbolaZ) and VRC-EBOADC069-00VP ( cAd3-EBO ) are safe and able to induce an immune response against Ebola.
Read more
Objectives:
- To see if the two new vaccines are safe and if they cause any side effects. Also, to study immune responses to the vaccines.
Eligibility:
- Healthy adults ages 18-66
Design:
- Participants will get one or two study vaccine injections depending on the study group they are assigned to. Each injection will repeat the same schedule:
- A needle and syringe will inject the vaccine into an upper arm muscle.
- 1-2 days later, participants must call the clinic to report how they feel.
- For 7 days they will check their temperature with a thermometer given to them. They will look at the injection site, and measure any redness or swelling with a ruler. They will write down any symptoms they have.
- In the first 2 months, participants will have at least 6 clinic visits and 1 phone contact. At each visit, participants will be checked for health changes or problems. They will tell how they feel and if they have taken any medications. Blood and urine samples may be collected.
- Participants might need to have extra clinic visits and laboratory tests if they have health changes that need to be checked.
Read the detailed description
This Phase 1/1b study will examine dose, safety, tolerability and immunogenicity of an investigational MVA-vectored Ebola vaccine in healthy adults. The vaccine encodes wild type (WT) glycoprotein (GP) from Zaire strain of Ebola and will be administered intramuscularly (IM) with needle and syringe. The safety and tolerability of the MVA-EbolaZ will be evaluated at escalating doses of 1x10(7) and 1x10(8) plaque forming units (PFU). Part 1 includes enrollment of vaccine-naive subjects to conduct a dose escalation of the MVA-EbolaZ vaccine and to evaluate the vaccine as a boost for the cAd3-EBO vaccine. In Part 2 of the study, up to 140 subjects who received the cAd3-EBO or cAd3-EBOZ vaccine in VRC 207 study will be boosted with MVA-EbolaZ. The hypotheses are that the study vaccines will be safe and elicit immune responses to Ebola GP, and that the prime-boost regimens will be safe and result in a more polyfunctional response to Ebola GP that is of greater magnitude and duration than response to either of the vaccines alone.
- Being tested
- VRC-EBOMVA079-00-VP (MVA-EbolaZ), VRC-EBOADC069-00-VP (cAd3-EBO)
- Keywords
- Immunity, Ebola Virus, Ebola Hemorrhagic Fever, Healthy, Filovirus
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRC-EBOMVA079-00-VP (MVA-EbolaZ)Biological
Ebola Modified Vaccinia Virus Ankara Vaccine
VRC-EBOADC069-00-VP (cAd3-EBO)Biological
Ebola Chimpanzee Adenovirus Vector Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Experimental | MVA-EbolaZ 1x10(8) PFU Receives: Biological: VRC-EBOMVA079-00-VP (MVA-EbolaZ) |
| Group 3 | Experimental | cAd3-EBO 2x10(11) PU followed by MVAEbolaZ 1x10(8) PFU at 8 weeks Receives: Biological: VRC-EBOMVA079-00-VP (MVA-EbolaZ); Biological: VRC-EBOADC069-00-VP (cAd3-EBO) |
| Group1 | Experimental | MVA-EbolaZ 1x10(7) PFU Receives: Biological: VRC-EBOMVA079-00-VP (MVA-EbolaZ) |
| Groups 4 to 7 | Experimental | MVA-EbolaZ 1x10(8) PFU administered in VRC 208 to participants who received cAd3-EBO or cAd3-EBOZ in VRC 207. Receives: Biological: VRC-EBOMVA079-00-VP (MVA-EbolaZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic reactogenicity signs and symptoms.
Measured: Daily for 7 days following the vaccination
Occurrence of adverse events of all severities.
Measured: Through 4 weeks after each injection
Occurrence of serious adverse events and new chronic medical conditions.
Measured: Through 48 weeks after last injection
Secondary outcomes (2)
Antibody responses as measured by ELISA and neutralization assays.
Measured: 4 weeks after vaccination.
T cell responses as measured by intracellular cytokine staining (ICS)assay.
Measured: 4 weeks after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study start26 Mar 2015
- Primary completion6 Apr 2017
- Study completion6 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult Immune Responses to VaccineStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Julie E Ledgerwood, D.O., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408913
- Sponsor's protocol ID
- 150107
- Other IDs
- 15-I-0107
- Status last verified
- 6 Apr 2017
- First submitted
- 3 Apr 2015
- Last updated
- 11 Apr 2019
- Results posted
- No
Publications
Stanley DA, Honko AN, Asiedu C, Trefry JC, Lau-Kilby AW, Johnson JC, Hensley L, Ammendola V, Abbate A, Grazioli F, Foulds KE, Cheng C, Wang L, Donaldson MM, Colloca S, Folgori A, Roederer M, Nabel GJ, Mascola J, Nicosia A, Cortese R, Koup RA, Sullivan NJ. Chimpanzee adenovirus vaccine generates acute and durable protective immunity against ebolavirus challenge. Nat Med. 2014 Oct;20(10):1126-9. doi: 10.1038/nm.3702. Epub 2014 Sep 7.
PubMed 25194571Ledgerwood 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 25426834Kibuuka H, Berkowitz NM, Millard M, Enama ME, Tindikahwa A, Sekiziyivu AB, Costner P, Sitar S, Glover D, Hu Z, Joshi G, Stanley D, Kunchai M, Eller LA, Bailer RT, Koup RA, Nabel GJ, Mascola JR, Sullivan NJ, Graham BS, Roederer M, Michael NL, Robb ML, Ledgerwood JE; RV 247 Study Team. Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial. Lancet. 2015 Apr 18;385(9977):1545-54. doi: 10.1016/S0140-6736(14)62385-0. Epub 2014 Dec 23.
PubMed 25540891
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VRC 208: Phase 1/1b Open-Label Clinical Trial to Evaluate Dose, Safety and Immunogenicity of Recombinant Modified Vaccinia Virus Ankara Ebola Vaccine,VRC-EBOMVA079-00-VP, Administered Alone or as Boost to cAd3-Ebola Vaccines in Healthy Adults
- ClinicalTrials.gov ID
- NCT02408913
- Acronym / sponsor ID
- 150107
- Keywords
- Immunity, Ebola Virus, Ebola Hemorrhagic Fever, Healthy, Filovirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 26 Mar 2015
- Primary completion
- 6 Apr 2017 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Ebola virus is a rare disease that starts with fever and muscle aches, but can lead to death. The 2014 Ebola outbreak in West Africa is the largest to date. There are no approved treatments for Ebola. Researchers want to see if two new vaccines VRC-EBOMVA079-00-VP (MVA-EbolaZ) and VRC-EBOADC069-00VP ( cAd3-EBO ) are safe and able to induce an immune response against Ebola.
Objectives:
- To see if the two new vaccines are safe and if they cause any side effects. Also, to study immune responses to the vaccines.
Eligibility:
- Healthy adults ages 18-66
Design:
- Participants will get one or two study vaccine injections depending on the study group they are assigned to. Each injection will repeat the same schedule:
- A needle and syringe will inject the vaccine into an upper arm muscle.
- 1-2 days later, participants must call the clinic to report how they feel.
- For 7 days they will check their temperature with a thermometer given to them. They will look at the injection site, and measure any redness or swelling with a ruler. They will write down any symptoms they have.
- In the first 2 months, participants will have at least 6 clinic visits and 1 phone contact. At each visit, participants will be checked for health changes or problems. They will tell how they feel and if they have taken any medications. Blood and urine samples may be collected.
- Participants might need to have extra clinic visits and laboratory tests if they have health changes that need to be checked.
Detailed description
This Phase 1/1b study will examine dose, safety, tolerability and immunogenicity of an investigational MVA-vectored Ebola vaccine in healthy adults. The vaccine encodes wild type (WT) glycoprotein (GP) from Zaire strain of Ebola and will be administered intramuscularly (IM) with needle and syringe. The safety and tolerability of the MVA-EbolaZ will be evaluated at escalating doses of 1x10(7) and 1x10(8) plaque forming units (PFU). Part 1 includes enrollment of vaccine-naive subjects to conduct a dose escalation of the MVA-EbolaZ vaccine and to evaluate the vaccine as a boost for the cAd3-EBO vaccine. In Part 2 of the study, up to 140 subjects who received the cAd3-EBO or cAd3-EBOZ vaccine in VRC 207 study will be boosted with MVA-EbolaZ. The hypotheses are that the study vaccines will be safe and elicit immune responses to Ebola GP, and that the prime-boost regimens will be safe and result in a more polyfunctional response to Ebola GP that is of greater magnitude and duration than response to either of the vaccines alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Experimental | Biological: VRC-EBOMVA079-00-VP (MVA-EbolaZ)MVA-EbolaZ 1x10(8) PFU |
| Group 3 | Experimental | Biological: VRC-EBOMVA079-00-VP (MVA-EbolaZ), Biological: VRC-EBOADC069-00-VP (cAd3-EBO)cAd3-EBO 2x10(11) PU followed by MVAEbolaZ 1x10(8) PFU at 8 weeks |
| Group1 | Experimental | Biological: VRC-EBOMVA079-00-VP (MVA-EbolaZ)MVA-EbolaZ 1x10(7) PFU |
| Groups 4 to 7 | Experimental | Biological: VRC-EBOMVA079-00-VP (MVA-EbolaZ)MVA-EbolaZ 1x10(8) PFU administered in VRC 208 to participants who received cAd3-EBO or cAd3-EBOZ in VRC 207. |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 18 to 50 years old.
- Available for clinical follow-up through the last study visit.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Able and willing to complete the informed consent process.
- Willing to donate blood for sample storage to be used for future research.
Key exclusion criteria (31 listed)
- Investigational Marburg vaccine in a prior clinical trial.
- Investigational Ebola vaccine in a prior clinical trial.
- Investigational cAd3 or MVA vaccines in a prior clinical trial.
- Evidence of increased cardiovascular disease risk defined as >10% five year risk by the non-laboratory method.
- Electrocardiogram (ECG) with clinically significant abnormalities (examples may include: pathologic Q waves, significant ST-T wave changes, left ventricular hypertrophy, any non-sinus rhythm excluding isolated premature atrial contractions, right or left bundle branch block, advanced A-V heart block). ECG abnormalities determined by a cardiologist to be clinically insignificant as related to study participation do not preclude study enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRC-EBOMVA079-00-VP (MVA-EbolaZ)Ebola Modified Vaccinia Virus Ankara Vaccine | Biological | Group 2, Group 3, Group1, Groups 4 to 7 |
| VRC-EBOADC069-00-VP (cAd3-EBO)Ebola Chimpanzee Adenovirus Vector Vaccine | Biological | Group 3 |
Primary outcome
Local and systemic reactogenicity signs and symptoms.
Time frame: Daily for 7 days following the vaccination
Occurrence of adverse events of all severities.
Time frame: Through 4 weeks after each injection
Occurrence of serious adverse events and new chronic medical conditions.
Time frame: Through 48 weeks after last injection
2 secondary outcomes
Antibody responses as measured by ELISA and neutralization assays.
Time frame: 4 weeks after vaccination.
T cell responses as measured by intracellular cytokine staining (ICS)assay.
Time frame: 4 weeks after vaccination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Background: PubMed 25194571Stanley DA, Honko AN, Asiedu C, Trefry JC, Lau-Kilby AW, Johnson JC, Hensley L, Ammendola V, Abbate A, Grazioli F, Foulds KE, Cheng C, Wang L, Donaldson MM, Colloca S, Folgori A, Roederer M, Nabel GJ, Mascola J, Nicosia A, Cortese R, Koup RA, Sullivan NJ. Chimpanzee adenovirus vaccine generates acute and durable protective immunity against ebolavirus challenge. Nat Med. 2014 Oct;20(10):1126-9. doi: 10.1038/nm.3702. Epub 2014 Sep 7.
- Background: PubMed 25426834Ledgerwood 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.
- Background: PubMed 25540891Kibuuka H, Berkowitz NM, Millard M, Enama ME, Tindikahwa A, Sekiziyivu AB, Costner P, Sitar S, Glover D, Hu Z, Joshi G, Stanley D, Kunchai M, Eller LA, Bailer RT, Koup RA, Nabel GJ, Mascola JR, Sullivan NJ, Graham BS, Roederer M, Michael NL, Robb ML, Ledgerwood JE; RV 247 Study Team. Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial. Lancet. 2015 Apr 18;385(9977):1545-54. doi: 10.1016/S0140-6736(14)62385-0. Epub 2014 Dec 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie E Ledgerwood, D.O. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRC-EBOMVA079-00-VP (MVA-EbolaZ) and VRC-EBOADC069-00-VP (cAd3-EBO) in people with Healthy Adult Immune Responses to Vaccine, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites 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 22 inclusion and 31 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 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Local and systemic reactogenicity signs and symptoms. (time frame: Daily for 7 days following the vaccination). The study lists 3 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 NCT02408913, which also lists 3 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 11 Apr 2019.