HIV InfectionsPhase 1NCT00376090
Safety of and Immune Response to a Modified Vaccinia Ankara (MVA) HIV Vaccine in HIV Uninfected Adults
A Phase 1 study testing MVA-CMDR in people with HIV Infections, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and the immune responses to the HIV vaccine candidate, MVA-CMDR. This vaccine was designed to induce immune responses to three HIV "passenger" genes encoded with the viral vector, MVA. 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?
- MVA-CMDR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Dec 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
- A participant must meet all of the following criteria:
- Low risk for HIV infection
- 18 to 40 years at the time of enrollment and vaccinia naive
- Good health
- Availability for 12 months of participation.
- Successful completion of the Test of Understanding
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- Able and willing to give informed consent.
- HEMATOCRIT: WOMEN: 35 %-45 %; MEN 36 % - 49 %
- White cell count: 3,000 - 11,000 cells/mm3
- Platelets: 125,000 - 450,000 per mm3
- Normal cardiac enzyme level at second Screening Visit
- Urinalysis (UA) for protein and blood: negative or trace.
- Normal liver function tests to include ALT/AST, alkaline phosphatase, GGT (< 1.25x institutional upper limits of normal) and CPK (< 480) and creatinine (< 1.25 mg/dL)
- Negative serology for HIV infection
- Any female volunteer must have a negative serum or urine pregnancy test at the screening visit as well as immediately prior to each vaccine/placebo vaccination, as well as verbal assurance that adequate birth control measures have been followed for 60 days prior to the first vaccine/placebo vaccination and will continue to be followed for at least 3months after the final vaccine/placebo vaccination. This means using any of the following methods: Birth control drugs that prevent pregnancy given by pills, shots or placed under the skin, Male or female condoms with or without a cream or gel that kills sperm, diaphragm or cervical cap with a cream or gel that kills sperm, or Abstinence
Who cannot join
- A volunteer will be excluded if one or more of the following conditions apply.
- A woman who:
- Is pregnant.
- Is breast-feeding.
- Anyone who:
- Is U.S. military personnel.
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- Acknowledges engaging in highest-risk behavior within six months of study entry
- Has active tuberculosis or other systemic infectious process by review of systems and physical examination.
- Has history of or known cardiac disease including any of the following: prior myocardial infarction (heart attack), angina pectoris, congestive heart failure, conduction disturbances, repolarization (ST segment or T wave) abnormalities, serious cardiac arrhythmias (ventricular tachycardia or ventricular fibrillation), cardiomyopathy, pericarditis, stroke or transient ischemic attack, chest pain or shortness of breath with activity (e.g. climbing stairs), valvular heart disease including mitral valve prolapse, or other heart conditions under the care of a doctor.
- Has ECG on Screening Visit 2 with clinical significant findings, or features that would interfere with the assessment of myo/pericarditis (as determined by the contract ECG Lab) including any of the following: conduction disturbance (atrioventricular or intraventricular condition, left or right bundle branch block, AB block of any degree or QTc prolongation), repolarization (ST segment or T wave) abnormality, significant atrial or ventricular arrhythmia, frequent atrial or ventricular ectopy (e.g. frequent premature atrial contractions, 2 premature ventricular contractions in a row), ST elevation consistent with ischemia, or evidence of past or evolving myocardial infarction
- Has history of seizure disorder, immunodeficiency, chronic illness, autoimmune disease, diabetes mellitus active malignancy or use of immunosuppressive medications.
- Has evidence of psychiatric, medical and/or substance abuse problems during the past six months that the investigator believes would adversely affect the volunteer's ability to participate in the trial.
- Has occupational or other responsibilities that would prevent completion of participation in the study.
- Has received any live attenuated vaccine within 60 days of study entry.
- Has used experimental therapeutic agents within 30 days of study entry.
- Has received blood products or immunoglobulins in the past three months.
- Has history of anaphylaxis or other serious adverse reactions to vaccines.
- Has previously received an HIV vaccine or an MVA or vaccinia vaccine.
- Has chronic or active Hepatitis B or Hepatitis C virus infection or active syphilis (positive RPR and FTA).
- Has had an immediate type hypersensitivity reaction to eggs, egg products or neomycin/streptomycin (used to prepare MVA vaccine).
- Is a study site employee.
Trial locations and contacts
1 site in 1 country.
United States1 site
US Military HIV Research Program
Rockville, Maryland, 20850
About this study
Official title: A Phase I Double-Blind, Randomized, Dose Escalating, Placebo-Controlled, Study of Safety and Immunogenicity of WRAIR/NIH Live Recombinant MVA-CMDR (HIV-1 CM235 Env/ CM240 Gag/Pol) Administered by Intramuscular (IM) or Intradermal (ID) Route In HIV-Uninfected Adults
The purpose of this study is to determine the safety and the immune responses to the HIV vaccine candidate, MVA-CMDR. This vaccine was designed to induce immune responses to three HIV "passenger" genes encoded with the viral vector, MVA.
- Conditions
- HIV Infections
- Being tested
- MVA-CMDR, Placebo
- Keywords
- MVA vector, Immunogenicity, HIV vaccine, HIV preventative 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.
MVA-CMDRBiological
10^7 PFU IM, 1.0 mL
PlaceboBiological
1.0 mL IM
MVA-CMDRBiological
10^6 PFU ID, 0.1 mL
PlaceboBiological
0.1 mL ID
MVA-CMDRBiological
10^8 PFU IM, 1.0 mL
MVA-CMDRBiological
10^7 PFD ID, 0.1 mL
| Study group | Role | What they receive |
|---|---|---|
| Group I Vaccine | Experimental | Not described Receives: Biological: MVA-CMDR |
| Group I Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
| Group II Vaccine | Experimental | Not described Receives: Biological: MVA-CMDR |
| Group II Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
| Group III Vaccine | Experimental | Not described Receives: Biological: MVA-CMDR |
| Group III Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
| Group IV Vaccine | Experimental | Not described Receives: Biological: MVA-CMDR |
| Group IV Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Evaluate the safety and tolerability of MVA-CMDR (HIV-1 CM235 Env/CM240 Gag/Pol) administered by IM or ID injection to HIV uninfected adults
Measured: Study Day 0 through 8 months post-vaccination
Secondary outcomes (1)
Immunogenicity
Evaluate the ability of MVA-CMDR (HIV-1 CM235 Env/CM240 Gag/Pol) to induce HIV antigen specific cellular and humoral immune responses
Measured: Study Day 0 through Study Day 280
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startJul 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mary Marovich, MD, DTM&H, Principal investigator, US Military HIV Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376090
- Sponsor's protocol ID
- RV 158
- Other IDs
- A-12403, WRAIR 1143
- Status last verified
- Oct 2017
- First submitted
- 13 Sep 2006
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Currier JR, Ngauy V, de Souza MS, Ratto-Kim S, Cox JH, Polonis VR, Earl P, Moss B, Peel S, Slike B, Sriplienchan S, Thongcharoen P, Paris RM, Robb ML, Kim J, Michael NL, Marovich MA. Phase I safety and immunogenicity evaluation of MVA-CMDR, a multigenic, recombinant modified vaccinia Ankara-HIV-1 vaccine candidate. PLoS One. 2010 Nov 15;5(11):e13983. doi: 10.1371/journal.pone.0013983.
PubMed 21085591
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Double-Blind, Randomized, Dose Escalating, Placebo-Controlled, Study of Safety and Immunogenicity of WRAIR/NIH Live Recombinant MVA-CMDR (HIV-1 CM235 Env/ CM240 Gag/Pol) Administered by Intramuscular (IM) or Intradermal (ID) Route In HIV-Uninfected Adults
- ClinicalTrials.gov ID
- NCT00376090
- Acronym / sponsor ID
- RV 158
- Conditions
- HIV Infections
- Keywords
- MVA vector, Immunogenicity, HIV vaccine, HIV preventative vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- Jul 2005 (actual)
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Sep 2006 (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 and the immune responses to the HIV vaccine candidate, MVA-CMDR. This vaccine was designed to induce immune responses to three HIV "passenger" genes encoded with the viral vector, MVA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group I Vaccine | Experimental | Biological: MVA-CMDR |
| Group I Placebo | Placebo comparator | Biological: Placebo |
| Group II Vaccine | Experimental | Biological: MVA-CMDR |
| Group II Placebo | Placebo comparator | Biological: Placebo |
| Group III Vaccine | Experimental | Biological: MVA-CMDR |
| Group III Placebo | Placebo comparator | Biological: Placebo |
| Group IV Vaccine | Experimental | Biological: MVA-CMDR |
| Group IV Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Low risk for HIV infection
- 18 to 40 years at the time of enrollment and vaccinia naive
- Good health
- Availability for 12 months of participation.
- Successful completion of the Test of Understanding
Key exclusion criteria (21 listed)
- A volunteer will be excluded if one or more of the following conditions apply.
- Is pregnant.
- Is breast-feeding.
- Is U.S. military personnel.
- Acknowledges engaging in highest-risk behavior within six months of 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 |
|---|---|---|
| MVA-CMDR10^7 PFU IM, 1.0 mL | Biological | Group I Vaccine |
| Placebo1.0 mL IM | Biological | Group I Placebo, Group III Placebo |
| MVA-CMDR10^6 PFU ID, 0.1 mL | Biological | Group II Vaccine |
| Placebo0.1 mL ID | Biological | Group II Placebo, Group IV Placebo |
| MVA-CMDR10^8 PFU IM, 1.0 mL | Biological | Group III Vaccine |
| MVA-CMDR10^7 PFD ID, 0.1 mL | Biological | Group IV Vaccine |
Primary outcome
Safety and Tolerability
Time frame: Study Day 0 through 8 months post-vaccination
Evaluate the safety and tolerability of MVA-CMDR (HIV-1 CM235 Env/CM240 Gag/Pol) administered by IM or ID injection to HIV uninfected adults
1 secondary outcome
Immunogenicity
Time frame: Study Day 0 through Study Day 280
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 16 Oct 2017.
- Derived from this study: PubMed 21085591Currier JR, Ngauy V, de Souza MS, Ratto-Kim S, Cox JH, Polonis VR, Earl P, Moss B, Peel S, Slike B, Sriplienchan S, Thongcharoen P, Paris RM, Robb ML, Kim J, Michael NL, Marovich MA. Phase I safety and immunogenicity evaluation of MVA-CMDR, a multigenic, recombinant modified vaccinia Ankara-HIV-1 vaccine candidate. PLoS One. 2010 Nov 15;5(11):e13983. doi: 10.1371/journal.pone.0013983.
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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.
Mary Marovich, MD, DTM&H principal investigator
US Military HIV Research Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MVA-CMDR in people with HIV Infections, run by U.S. Army Medical Research and Development Command 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 15 inclusion and 21 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 16 Oct 2017. 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. Some participants in this study may receive a placebo. 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 and Tolerability (time frame: Study Day 0 through 8 months post-vaccination). 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 NCT00376090, which also lists 1 linked publication.
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 16 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.