Prevention of Zika InfectionPhase 1NCT02840487
Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults
A Phase 1 study testing VRC-ZKADNA085-00-VP in people with Prevention of Zika Infection and Zika-Specific Immune Response, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
Background: The Zika virus is passed to humans by infected mosquitos. It usually causes fever, rash, joint pain, and red eyes. Recently, some cases of microcephaly (abnormally small head) were reported in babies born to mothers infected with the Zika virus. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Prevention of Zika Infection, Zika-Specific Immune Response
- What is being tested?
- VRC-ZKADNA085-00-VP
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Aug 2016to 14 Mar 2019
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 35 years old
- Available for clinic visits for 24 months after enrollment
- 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
- In good general health without clinically significant medical history
Show all 19Show fewer
- 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
- Agrees not to receive licensed or investigational flavivirus vaccines through 4 weeks after last study injection
- INCLUSION CRITERIA - LABORATORY CRITERIA WITHIN 56 DAYS PRIOR TO ENROLLMENT:
- Hemoglobin within institutional normal limits or accompanied by the site PI or designee approval
- WBC and differential either within institutional normal range or accompanied by site PI or designee approval
- Total lymphocyte count greater than or equal to 800 cells/mm^3
- Platelets = 125,000 - 500,000/mm^3
- Alanine aminotransferase (ALT) less than or equal to 1.25 x institutional upper limit of normal (ULN)
- Serum creatinine less than or equal to 1.1 x institutional ULN
- Negative for HIV infection by an FDA approved method of detection
- INCLUSION CRITERIA - CRITERIA APPLICABLE TO WOMEN OF CHILDBEARING POTENTIAL:
- Negative human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on day of enrollment
- Agrees to use an effective means of birth control from at least 21 days prior to enrollment through 12 weeks after the last study vaccination
Who cannot join
- Breast-feeding or planning to become pregnant while participating through 12 weeks after the last study vaccination
- EXCLUSION CRITERIA - SUBJECT HAS RECEIVED ANY OF THE FOLLOWING:
- More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
- Blood products within 16 weeks prior to enrollment
- Inactivated vaccines within 2 weeks prior to enrollment
- Live attenuated vaccines within 4 weeks prior to enrollment
Show all 25Show fewer
- Investigational research products within 4 weeks prior to enrollment or planning to receive investigational products while on the study
- Current allergen immunotherapy with antigen injections, unless on maintenance schedule
- Current anti-TB prophylaxis or therapy
- EXCLUSION CRITERIA - SUBJECT HAS A HISTORY OF ANY OF THE FOLLOWING CLINICALLY SIGNIFICANT CONDITIONS:
- Laboratory confirmed ZIKV infection by self-report
- Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the site investigator
- Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
- Asthma that is not well controlled
- Diabetes mellitus (type I or II), with the exception of gestational diabetes
- Evidence of autoimmune disease or immunodeficiency
- Idiopathic urticaria within the past 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 malignancy that is likely to recur during the period of the study
- 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
- Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
- Guillain-Barre Syndrome, Bell s palsy or similar neurological conditions
- Psychiatric condition that precludes compliance with the protocol; past or present psychoses; or within 5 years prior to enrollment, a history of 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 Ctr. for Vaccine Development
Baltimore, Maryland, 21201
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Hope Clinic - Emory Vaccine Ctr
Decatur, Georgia, 30030
About this study
Official title: VRC 319: A Phase I/Ib, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of A Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults
Background:
The Zika virus is passed to humans by infected mosquitos. It usually causes fever, rash, joint pain, and red eyes. Recently, some cases of microcephaly (abnormally small head) were reported in babies born to mothers infected with the Zika virus. Rare cases of a severe nerve weakness called Guillain-Barr(SqrRoot)(Copyright) syndrome were reported in some people with Zika virus infection. There is currently no cure for or vaccine against the infection. VRC-ZKADNA085-00-VP is a new vaccine that instructs the body to make a small amount of Zika virus protein. The body may use this to build an immune response.
Read more
Objective:
To see if VRC-ZKADNA085-00-VP is safe and causes any side effects.
Eligibility:
Healthy people ages 18 35
Design:
Participants will be screened through a separate protocol with:
- Medical history
- Physical exam
- Lab and urine tests
Participants will be randomly assigned to 1 of 4 study groups. They will have about 18 clinic visits over 2 years. Most will occur in the first year, with long-term follow-up visits at months 18 and 24. Visits include a physical exam and blood and urine tests.
Participants will have vaccine injections. A high-pressure device pushes the vaccine through the skin and into the muscle of the upper arm. They will have 2-3 injections depending on their group.
Vaccine visits last 4-6 hours. Others last 1-2 hours.
Participants will keep a diary for 7 days after each injection. They will record their temperature and measure any skin changes at the injection site each day.
Participants might have extra visits and blood tests if they have health changes.
Read the detailed description
Study Design:
This is a Phase I/Ib, randomized, multicenter clinical study to evaluate the safety, tolerability, and immunogenicity of four vaccination regimens against Zika virus (ZIKV) disease. Vaccination regimens with the VRC-ZKADNA085-00-VP (ZIKV DNA) vaccine administered on Day 0 and Week 8 (Group 1); on Day 0 and Week 12 (Group 2); on Day 0, Weeks 4 and 8 (Group 3); and on Day 0, Weeks 4 and 20 (Group 4) will be tested. The primary hypothesis is that the ZIKV DNA vaccine will be safe and well tolerated in healthy adults. A secondary hypothesis is that all vaccine regimens will elicit a ZIKV-specific immune response. The primary objectives are to evaluate the safety and tolerability of the investigational vaccine regimens in healthy adults. Secondary objectives are related to the immunogenicity of the vaccination regimens.
Product Description:
The investigational VRC-ZKADNA085-00-VP vaccine was developed by the Vaccine Research Center (VRC), NIAID, and is composed of a single closed-circular DNA plasmid that encodes the wild type precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV. Vaccine is supplied in single dose vials at a concentration of 4 mg/mL. ZIKV DNA vaccine dose will be 4 mg administered as an intramuscular (IM) injection in the deltoid muscle.
Subjects:
Healthy adults 18 to 35 years of age.
Study Plan:
Subjects will be enrolled at up to 3 study sites, randomized equally into the 4 study groups, and will receive 2-3 vaccinations. The protocol requires up to 18 scheduled clinic visits and a telephone follow-up contact after each study injection. Solicited reactogenicity will be evaluated using a 7-day diary card. Assessment of vaccine safety will include clinical observation and monitoring of hematological and chemical parameters at clinical visits through the 44 weeks on the study.
-VRC 319 Study Schema
- Group:1; Subjects*: 20; Day 0; Week 8;
- Group:2; Subjects*: 20; Day 0; Week 12;
- Group:3; Subjects*: 20; Day 0; Week 4; Week 8;
- Group:4; Subjects*: 20; Day 0; Week 4; Week 20;
- TOTAL; Subjects*: 80
- Up to 120 total enrollments are permitted if additional subjects are needed for assessment of safety and immune responses.
Study Duration:
Subjects will be evaluated for safety and immune responses throughout the study for 44 weeks following the first vaccine administration and for durability of immune responses at two additional long term follow-up visits at 18 and 24 months.
- Being tested
- VRC-ZKADNA085-00-VP
- Keywords
- Zika Infection, Flavivirus, Vaccine-Mediated Protection, Immune Response, Arthropod-Borne Virus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRC-ZKADNA085-00-VPBiological
VRC-ZKADNA085-00-VP is an investigational ZIKV DNA vaccine that is intended to prevent Zika virus infection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0 and Week 8. Receives: Biological: VRC-ZKADNA085-00-VP |
| Group 2 | Experimental | ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0 and Week 12. Receives: Biological: VRC-ZKADNA085-00-VP |
| Group 3 | Experimental | ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0, Week 4 and Week 8. Receives: Biological: VRC-ZKADNA085-00-VP |
| Group 4 | Experimental | ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0,Week 4 and Week 20. Receives: Biological: VRC-ZKADNA085-00-VP |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of four vaccination regimens with ZIKV DNA vaccine (VRC-ZKADNA085-00-VP) administered IM at 4 mg.
Measured: Through 44 weeks of study participation
Secondary outcomes (1)
To evaluate the magnitude and frequency of ZIKV-specific antibodyresponse as measured by neutralization assay.
Measured: Four weeks after the second and third injections for each regimen.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start2 Aug 2016
- Primary completion14 Mar 2019
- Study completion14 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prevention of Zika InfectionStudies 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
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Martin R Gaudinski, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840487
- Sponsor's protocol ID
- 160148
- Other IDs
- 16-I-0148
- Status last verified
- 14 Mar 2019
- First submitted
- 19 Jul 2016
- Last updated
- 18 Mar 2019
- Results posted
- No
- FDA-regulated drug
- Yes
Publications
Fauci AS, Morens DM. Zika Virus in the Americas--Yet Another Arbovirus Threat. N Engl J Med. 2016 Feb 18;374(7):601-4. doi: 10.1056/NEJMp1600297. Epub 2016 Jan 13. No abstract available.
PubMed 26761185Ledgerwood JE, Pierson TC, Hubka SA, Desai N, Rucker S, Gordon IJ, Enama ME, Nelson S, Nason M, Gu W, Bundrant N, Koup RA, Bailer RT, Mascola JR, Nabel GJ, Graham BS; VRC 303 Study Team. A West Nile virus DNA vaccine utilizing a modified promoter induces neutralizing antibody in younger and older healthy adults in a phase I clinical trial. J Infect Dis. 2011 May 15;203(10):1396-404. doi: 10.1093/infdis/jir054. Epub 2011 Mar 11.
PubMed 21398392Chang LJ, Dowd KA, Mendoza FH, Saunders JG, Sitar S, Plummer SH, Yamshchikov G, Sarwar UN, Hu Z, Enama ME, Bailer RT, Koup RA, Schwartz RM, Akahata W, Nabel GJ, Mascola JR, Pierson TC, Graham BS, Ledgerwood JE; VRC 311 Study Team. Safety and tolerability of chikungunya virus-like particle vaccine in healthy adults: a phase 1 dose-escalation trial. Lancet. 2014 Dec 6;384(9959):2046-52. doi: 10.1016/S0140-6736(14)61185-5. Epub 2014 Aug 14.
PubMed 25132507Gaudinski MR, Houser KV, Morabito KM, Hu Z, Yamshchikov G, Rothwell RS, Berkowitz N, Mendoza F, Saunders JG, Novik L, Hendel CS, Holman LA, Gordon IJ, Cox JH, Edupuganti S, McArthur MA, Rouphael NG, Lyke KE, Cummings GE, Sitar S, Bailer RT, Foreman BM, Burgomaster K, Pelc RS, Gordon DN, DeMaso CR, Dowd KA, Laurencot C, Schwartz RM, Mascola JR, Graham BS, Pierson TC, Ledgerwood JE, Chen GL; VRC 319; VRC 320 study teams. Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials. Lancet. 2018 Feb 10;391(10120):552-562. doi: 10.1016/S0140-6736(17)33105-7. Epub 2017 Dec 5.
PubMed 29217376
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VRC 319: A Phase I/Ib, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of A Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults
- ClinicalTrials.gov ID
- NCT02840487
- Acronym / sponsor ID
- 160148
- Keywords
- Zika Infection, Flavivirus, Vaccine-Mediated Protection, Immune Response, Arthropod-Borne Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 2 Aug 2016
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 14 Mar 2019 (actual)
- First posted
- 21 Jul 2016 (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:
The Zika virus is passed to humans by infected mosquitos. It usually causes fever, rash, joint pain, and red eyes. Recently, some cases of microcephaly (abnormally small head) were reported in babies born to mothers infected with the Zika virus. Rare cases of a severe nerve weakness called Guillain-Barr(SqrRoot)(Copyright) syndrome were reported in some people with Zika virus infection. There is currently no cure for or vaccine against the infection. VRC-ZKADNA085-00-VP is a new vaccine that instructs the body to make a small amount of Zika virus protein. The body may use this to build an immune response.
Objective:
To see if VRC-ZKADNA085-00-VP is safe and causes any side effects.
Eligibility:
Healthy people ages 18 35
Design:
Participants will be screened through a separate protocol with:
- Medical history
- Physical exam
- Lab and urine tests
Participants will be randomly assigned to 1 of 4 study groups. They will have about 18 clinic visits over 2 years. Most will occur in the first year, with long-term follow-up visits at months 18 and 24. Visits include a physical exam and blood and urine tests.
Participants will have vaccine injections. A high-pressure device pushes the vaccine through the skin and into the muscle of the upper arm. They will have 2-3 injections depending on their group.
Vaccine visits last 4-6 hours. Others last 1-2 hours.
Participants will keep a diary for 7 days after each injection. They will record their temperature and measure any skin changes at the injection site each day.
Participants might have extra visits and blood tests if they have health changes.
Detailed description
Study Design:
This is a Phase I/Ib, randomized, multicenter clinical study to evaluate the safety, tolerability, and immunogenicity of four vaccination regimens against Zika virus (ZIKV) disease. Vaccination regimens with the VRC-ZKADNA085-00-VP (ZIKV DNA) vaccine administered on Day 0 and Week 8 (Group 1); on Day 0 and Week 12 (Group 2); on Day 0, Weeks 4 and 8 (Group 3); and on Day 0, Weeks 4 and 20 (Group 4) will be tested. The primary hypothesis is that the ZIKV DNA vaccine will be safe and well tolerated in healthy adults. A secondary hypothesis is that all vaccine regimens will elicit a ZIKV-specific immune response. The primary objectives are to evaluate the safety and tolerability of the investigational vaccine regimens in healthy adults. Secondary objectives are related to the immunogenicity of the vaccination regimens.
Product Description:
The investigational VRC-ZKADNA085-00-VP vaccine was developed by the Vaccine Research Center (VRC), NIAID, and is composed of a single closed-circular DNA plasmid that encodes the wild type precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV. Vaccine is supplied in single dose vials at a concentration of 4 mg/mL. ZIKV DNA vaccine dose will be 4 mg administered as an intramuscular (IM) injection in the deltoid muscle.
Subjects:
Healthy adults 18 to 35 years of age.
Study Plan:
Subjects will be enrolled at up to 3 study sites, randomized equally into the 4 study groups, and will receive 2-3 vaccinations. The protocol requires up to 18 scheduled clinic visits and a telephone follow-up contact after each study injection. Solicited reactogenicity will be evaluated using a 7-day diary card. Assessment of vaccine safety will include clinical observation and monitoring of hematological and chemical parameters at clinical visits through the 44 weeks on the study.
-VRC 319 Study Schema
- Group:1; Subjects*: 20; Day 0; Week 8;
- Group:2; Subjects*: 20; Day 0; Week 12;
- Group:3; Subjects*: 20; Day 0; Week 4; Week 8;
- Group:4; Subjects*: 20; Day 0; Week 4; Week 20;
- TOTAL; Subjects*: 80
- Up to 120 total enrollments are permitted if additional subjects are needed for assessment of safety and immune responses.
Study Duration:
Subjects will be evaluated for safety and immune responses throughout the study for 44 weeks following the first vaccine administration and for durability of immune responses at two additional long term follow-up visits at 18 and 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: VRC-ZKADNA085-00-VPZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0 and Week 8. |
| Group 2 | Experimental | Biological: VRC-ZKADNA085-00-VPZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0 and Week 12. |
| Group 3 | Experimental | Biological: VRC-ZKADNA085-00-VPZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0, Week 4 and Week 8. |
| Group 4 | Experimental | Biological: VRC-ZKADNA085-00-VPZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0,Week 4 and Week 20. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
Key exclusion criteria (25 listed)
- Breast-feeding or planning to become pregnant while participating through 12 weeks after the last study vaccination
- More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
- Blood products within 16 weeks prior to enrollment
- Inactivated vaccines within 2 weeks prior to enrollment
- Live attenuated vaccines within 4 weeks prior to 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-ZKADNA085-00-VPVRC-ZKADNA085-00-VP is an investigational ZIKV DNA vaccine that is intended to prevent Zika virus infection. | Biological | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
To evaluate the safety and tolerability of four vaccination regimens with ZIKV DNA vaccine (VRC-ZKADNA085-00-VP) administered IM at 4 mg.
Time frame: Through 44 weeks of study participation
1 secondary outcome
To evaluate the magnitude and frequency of ZIKV-specific antibodyresponse as measured by neutralization assay.
Time frame: Four weeks after the second and third injections for each regimen.
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 18 Mar 2019.
- Background: PubMed 26761185Fauci AS, Morens DM. Zika Virus in the Americas--Yet Another Arbovirus Threat. N Engl J Med. 2016 Feb 18;374(7):601-4. doi: 10.1056/NEJMp1600297. Epub 2016 Jan 13. No abstract available.
- Background: PubMed 21398392Ledgerwood JE, Pierson TC, Hubka SA, Desai N, Rucker S, Gordon IJ, Enama ME, Nelson S, Nason M, Gu W, Bundrant N, Koup RA, Bailer RT, Mascola JR, Nabel GJ, Graham BS; VRC 303 Study Team. A West Nile virus DNA vaccine utilizing a modified promoter induces neutralizing antibody in younger and older healthy adults in a phase I clinical trial. J Infect Dis. 2011 May 15;203(10):1396-404. doi: 10.1093/infdis/jir054. Epub 2011 Mar 11.
- Background: PubMed 25132507Chang LJ, Dowd KA, Mendoza FH, Saunders JG, Sitar S, Plummer SH, Yamshchikov G, Sarwar UN, Hu Z, Enama ME, Bailer RT, Koup RA, Schwartz RM, Akahata W, Nabel GJ, Mascola JR, Pierson TC, Graham BS, Ledgerwood JE; VRC 311 Study Team. Safety and tolerability of chikungunya virus-like particle vaccine in healthy adults: a phase 1 dose-escalation trial. Lancet. 2014 Dec 6;384(9959):2046-52. doi: 10.1016/S0140-6736(14)61185-5. Epub 2014 Aug 14.
- Derived from this study: PubMed 29217376Gaudinski MR, Houser KV, Morabito KM, Hu Z, Yamshchikov G, Rothwell RS, Berkowitz N, Mendoza F, Saunders JG, Novik L, Hendel CS, Holman LA, Gordon IJ, Cox JH, Edupuganti S, McArthur MA, Rouphael NG, Lyke KE, Cummings GE, Sitar S, Bailer RT, Foreman BM, Burgomaster K, Pelc RS, Gordon DN, DeMaso CR, Dowd KA, Laurencot C, Schwartz RM, Mascola JR, Graham BS, Pierson TC, Ledgerwood JE, Chen GL; VRC 319; VRC 320 study teams. Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials. Lancet. 2018 Feb 10;391(10120):552-562. doi: 10.1016/S0140-6736(17)33105-7. Epub 2017 Dec 5.
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.
Martin R Gaudinski, M.D. 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-ZKADNA085-00-VP in people with Prevention of Zika Infection and Zika-Specific Immune Response, 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 19 inclusion and 25 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 18 Mar 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?
To evaluate the safety and tolerability of four vaccination regimens with ZIKV DNA vaccine (VRC-ZKADNA085-00-VP) administered IM at 4 mg. (time frame: Through 44 weeks of study participation). 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 NCT02840487, which also lists 4 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 18 Mar 2019.