HIV InfectionsPhase 1NCT00428337
Safety of and Immune Response to a DNA Vaccine and a Recombinant HIV-1-MVA Vaccine, Separately and in Combination, in Healthy Adults
A Phase 1 study testing EP-1233 and MVA-mBN32 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
The purpose of this study is to determine the safety of and immune response to two experimental vaccines, designed for use in combination, for the prevention of HIV infection in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- EP-1233 and MVA-mBN32
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2007to Aug 2008
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health
Who cannot join
- Previous receipt of smallpox vaccination
- HIV-infected
- Hepatitis B surface antigen positive
- Participation in prior HIV vaccination trial
- Immunosuppressive medications within 168 days prior to study entry
- Receipt of blood products within 120 days of study entry
Show all 9Show fewer
- Receipt of live attenuated, medically indicated subunit, or killed (inactivated) vaccines within 30 days of study entry
- Certain abnormal lab values
- Pregnant or breastfeeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt Vaccine CRS
Nashville, Tennessee, 37232
Univ. of Rochester HVTN CRS
Rochester, New York, 14642
San Francisco Vaccine and Prevention CRS
San Francisco, California, 94102
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of DNA Vaccine EP-1233 and Recombinant MVA-HIV Polytope Vaccine MVA-mBN32, Separately and in a Combined Prime-boost Regimen, When Given to Healthy, Vaccinia-naive, HIV-1-uninfected Adults
The purpose of this study is to determine the safety of and immune response to two experimental vaccines, designed for use in combination, for the prevention of HIV infection in healthy adults.
Read the detailed description
The worldwide HIV/AIDS epidemic may only be controlled through the development of a safe and effective vaccine that will prevent HIV infection. DNA-based vaccines alone promote a weak immune response but when used as priming immunogens, followed by a recombinant viral vaccine that is a very attenuated vaccinia (smallpox) vaccine presenting the same immunogens as a booster, immunization with such a combination regimen seems to induce much stronger responses. EP-1233 is a DNA-HIV-recombinant vaccine designed to interact with CD4 (helper-inducer) and CD8 (cytotoxic) T lymphocytes (T cells) to prime CD4 and CD8 cells to respond to HIV components. MVA-mBN32 is a HIV-recombinant viral (MVA) vaccine that through other ways of interacting with CD4 and CD8 cells to immunize (boost) with similar HIV immunogens, may result in a stronger immune response.
The purpose of this study is to determine the safety of and immune response to two experimental vaccines for the prevention of HIV infection, individually and in combination, in healthy adults who have not been previously vaccinated against smallpox. Participants will be randomly assigned to one of three groups. All participants will receive injections at Days 0, 28, 84, and 168 of the study. Participants assigned to Group 1 will receive, on Day 0, one injection in each arm of EP-1233 or placebo and the same study product (EP-1233 or the DNA placebo) on Day 28. Thereafter, each Group 1 participant will receive one injection of MVA-mBN32 or placebo on Days 84 and 168. Groups 2 and 3 will not begin enrollment until safety and immunogenicity data from Group 1 have been evaluated. Participants assigned to Group 2 will receive only the DNA vaccine EP-1233 (or placebo) in each arm on all injection days. Participants in Group 3 will not begin enrollment until safety and immunogenicity data from Group 1 have been evaluated. Participants assigned to Group 3 will receive a consistent regimen of MVA-mBN32 (or placebo) on all injection days. Participants will be required to keep a symptom log for 3 days after each injection and attend clinical visits on Day 0, 14, 28, 42, 84, 98, 168, 182, 273, and 364 of the study. At each of the 10 visits, a physical exam, cardiac assessment, and HIV risk reduction and prevention counseling will occur. Blood collection will occur on Days 0, 14, 42, 98, 182, 273, and 364. Urine collection will occur on Days 14, 42, 98, and 182.
- Conditions
- HIV Infections
- Being tested
- EP-1233, MVA-mBN32
- Keywords
- HIV Seronegativity, EP1233, MVA-mBN32, HIV Preventive Vaccine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP-1233Biological
DNA-HIV-recombinant vaccine
MVA-mBN32Biological
HIV-recombinant viral vaccine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive one injection of DNA vaccine EP-1233 or placebo in each shoulder on Days 0 and 28 and one injection of MVA-mBN32 or placebo in each arm on Days 84 and 168 Receives: Biological: EP-1233; Biological: MVA-mBN32 |
| 2 | Experimental | Participants will receive one injection of DNA vaccine EP-1233 or placebo in each shoulder on Days 0, 28, 84, and 168 Receives: Biological: EP-1233 |
| 3 | Experimental | Participants will receive one injection of MVA-mBN32 or placebo in each arm on Days 0, 28, 84, and 168 Receives: Biological: MVA-mBN32 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of vaccination, as measured by number of adverse events, local and systemic reactogenicity signs and symptoms, changes in electrocardiogram (ECG), cardiac troponin I levels, and differences in other safety laboratory measures
Measured: Throughout study
Secondary outcomes (3)
HIV-specific intracellular cytokine staining (ICS) assay and/or interferon-gamma ELISA responses
Measured: At 2 weeks following the third and fourth injection
Vaccinia-specific neutralizing binding assays performed on serum samples from participants receiving the MVA vaccine
Measured: At 2 weeks following the final vaccination
Self reports on social impact of participation in study
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startApr 2007
- Study completionAug 2008
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 HIV InfectionsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network, Pharmexa-Epimmune, Bavarian Nordic
- Responsible party
- Sponsor
- Investigators
- Geoffrey Gorse, Study chair, Saint Louis University School of MedicineChristine Mhorag Hay, Study chair, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428337
- Sponsor's protocol ID
- HVTN 067
- Other IDs
- 10394
- Status last verified
- Oct 2021
- First submitted
- 29 Jan 2007
- Last updated
- 14 Oct 2021
- Results posted
- No
Publications
Dale CJ, Thomson S, De Rose R, Ranasinghe C, Medveczky CJ, Pamungkas J, Boyle DB, Ramshaw IA, Kent SJ. Prime-boost strategies in DNA vaccines. Methods Mol Med. 2006;127:171-97. doi: 10.1385/1-59745-168-1:171.
PubMed 16988455Ostrowski MA, Yu Q, Yue FY, Liu J, Jones B, Gu XX, Loutfy M, Kovacs CM, Halpenny R. Why can't the immune system control HIV-1? Defining HIV-1-specific CD4+ T cell immunity in order to develop strategies to enhance viral immunity. Immunol Res. 2006;35(1-2):89-102. doi: 10.1385/IR:35:1:89.
PubMed 17003512Rodriguez-Chavez IR, Allen M, Hill EL, Sheets RL, Pensiero M, Bradac JA, D'Souza MP. Current advances and challenges in HIV-1 vaccines. Curr HIV/AIDS Rep. 2006 Feb;3(1):39-47. doi: 10.1007/s11904-006-0007-0.
PubMed 16522258Elizaga ML, Vasan S, Marovich MA, Sato AH, Lawrence DN, Chaitman BR, Frey SE, Keefer MC; MVA Cardiac Safety Working Group. Prospective surveillance for cardiac adverse events in healthy adults receiving modified vaccinia Ankara vaccines: a systematic review. PLoS One. 2013;8(1):e54407. doi: 10.1371/journal.pone.0054407. Epub 2013 Jan 17.
PubMed 23349878
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of DNA Vaccine EP-1233 and Recombinant MVA-HIV Polytope Vaccine MVA-mBN32, Separately and in a Combined Prime-boost Regimen, When Given to Healthy, Vaccinia-naive, HIV-1-uninfected Adults
- ClinicalTrials.gov ID
- NCT00428337
- Acronym / sponsor ID
- HVTN 067
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, EP1233, MVA-mBN32, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network, Pharmexa-Epimmune, Bavarian Nordic
- Study start
- Apr 2007
- Study completion
- Aug 2008 (actual)
- First posted
- 30 Jan 2007 (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.
The purpose of this study is to determine the safety of and immune response to two experimental vaccines, designed for use in combination, for the prevention of HIV infection in healthy adults.
Detailed description
The worldwide HIV/AIDS epidemic may only be controlled through the development of a safe and effective vaccine that will prevent HIV infection. DNA-based vaccines alone promote a weak immune response but when used as priming immunogens, followed by a recombinant viral vaccine that is a very attenuated vaccinia (smallpox) vaccine presenting the same immunogens as a booster, immunization with such a combination regimen seems to induce much stronger responses. EP-1233 is a DNA-HIV-recombinant vaccine designed to interact with CD4 (helper-inducer) and CD8 (cytotoxic) T lymphocytes (T cells) to prime CD4 and CD8 cells to respond to HIV components. MVA-mBN32 is a HIV-recombinant viral (MVA) vaccine that through other ways of interacting with CD4 and CD8 cells to immunize (boost) with similar HIV immunogens, may result in a stronger immune response.
The purpose of this study is to determine the safety of and immune response to two experimental vaccines for the prevention of HIV infection, individually and in combination, in healthy adults who have not been previously vaccinated against smallpox. Participants will be randomly assigned to one of three groups. All participants will receive injections at Days 0, 28, 84, and 168 of the study. Participants assigned to Group 1 will receive, on Day 0, one injection in each arm of EP-1233 or placebo and the same study product (EP-1233 or the DNA placebo) on Day 28. Thereafter, each Group 1 participant will receive one injection of MVA-mBN32 or placebo on Days 84 and 168. Groups 2 and 3 will not begin enrollment until safety and immunogenicity data from Group 1 have been evaluated. Participants assigned to Group 2 will receive only the DNA vaccine EP-1233 (or placebo) in each arm on all injection days. Participants in Group 3 will not begin enrollment until safety and immunogenicity data from Group 1 have been evaluated. Participants assigned to Group 3 will receive a consistent regimen of MVA-mBN32 (or placebo) on all injection days. Participants will be required to keep a symptom log for 3 days after each injection and attend clinical visits on Day 0, 14, 28, 42, 84, 98, 168, 182, 273, and 364 of the study. At each of the 10 visits, a physical exam, cardiac assessment, and HIV risk reduction and prevention counseling will occur. Blood collection will occur on Days 0, 14, 42, 98, 182, 273, and 364. Urine collection will occur on Days 14, 42, 98, and 182.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: EP-1233, Biological: MVA-mBN32Participants will receive one injection of DNA vaccine EP-1233 or placebo in each shoulder on Days 0 and 28 and one injection of MVA-mBN32 or placebo in each arm on Days 84 and 168 |
| 2 | Experimental | Biological: EP-1233Participants will receive one injection of DNA vaccine EP-1233 or placebo in each shoulder on Days 0, 28, 84, and 168 |
| 3 | Experimental | Biological: MVA-mBN32Participants will receive one injection of MVA-mBN32 or placebo in each arm on Days 0, 28, 84, and 168 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Good general health
Key exclusion criteria (9 listed)
- Previous receipt of smallpox vaccination
- HIV-infected
- Hepatitis B surface antigen positive
- Participation in prior HIV vaccination trial
- Immunosuppressive medications within 168 days prior to study entry
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 |
|---|---|---|
| EP-1233DNA-HIV-recombinant vaccine | Biological | 1, 2 |
| MVA-mBN32HIV-recombinant viral vaccine | Biological | 1, 3 |
Primary outcome
Safety of vaccination, as measured by number of adverse events, local and systemic reactogenicity signs and symptoms, changes in electrocardiogram (ECG), cardiac troponin I levels, and differences in other safety laboratory measures
Time frame: Throughout study
3 secondary outcomes
HIV-specific intracellular cytokine staining (ICS) assay and/or interferon-gamma ELISA responses
Time frame: At 2 weeks following the third and fourth injection
Vaccinia-specific neutralizing binding assays performed on serum samples from participants receiving the MVA vaccine
Time frame: At 2 weeks following the final vaccination
Self reports on social impact of participation in study
Time frame: Throughout study
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 14 Oct 2021.
- Background: PubMed 16988455Dale CJ, Thomson S, De Rose R, Ranasinghe C, Medveczky CJ, Pamungkas J, Boyle DB, Ramshaw IA, Kent SJ. Prime-boost strategies in DNA vaccines. Methods Mol Med. 2006;127:171-97. doi: 10.1385/1-59745-168-1:171.
- Background: PubMed 17003512Ostrowski MA, Yu Q, Yue FY, Liu J, Jones B, Gu XX, Loutfy M, Kovacs CM, Halpenny R. Why can't the immune system control HIV-1? Defining HIV-1-specific CD4+ T cell immunity in order to develop strategies to enhance viral immunity. Immunol Res. 2006;35(1-2):89-102. doi: 10.1385/IR:35:1:89.
- Background: PubMed 16522258Rodriguez-Chavez IR, Allen M, Hill EL, Sheets RL, Pensiero M, Bradac JA, D'Souza MP. Current advances and challenges in HIV-1 vaccines. Curr HIV/AIDS Rep. 2006 Feb;3(1):39-47. doi: 10.1007/s11904-006-0007-0.
- Derived from this study: PubMed 23349878Elizaga ML, Vasan S, Marovich MA, Sato AH, Lawrence DN, Chaitman BR, Frey SE, Keefer MC; MVA Cardiac Safety Working Group. Prospective surveillance for cardiac adverse events in healthy adults receiving modified vaccinia Ankara vaccines: a systematic review. PLoS One. 2013;8(1):e54407. doi: 10.1371/journal.pone.0054407. Epub 2013 Jan 17.
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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.
Geoffrey Gorse study chair
Saint Louis University School of Medicine
Christine Mhorag Hay study chair
University of Rochester
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 EP-1233 and MVA-mBN32 in people with HIV Infections, 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 1 inclusion and 9 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 14 Oct 2021. 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?
Safety of vaccination, as measured by number of adverse events, local and systemic reactogenicity signs and symptoms, changes in electrocardiogram (ECG), cardiac troponin I levels, and differences in other safety laboratory measures (time frame: Throughout study). 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 NCT00428337, 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 14 Oct 2021.