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Healthy VolunteersPhase 1/2HIVIS06NCT01461447

Safety Study of an Additional MVA Vaccine in Volunteers Who Received 3 DNA Vaccines Followed by 2 MVA Vaccines

A Phase 1/2 study testing Modified Vaccinia Ankara in people with Healthy Volunteers, run by Muhimbili University of Health and Allied Sciences at 1 site in Tanzania.

Completed

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

Official record
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Trial summary

The purpose of the study is to determine the safety and immunogenecity of a third MVA in the HIVIS 03 volunteers who have received 3 HIVIS DNA vaccines followed by boosting with 2 MVA vaccines. The investigators postulate that the Immune responses that were observed in the HIVIS 03 trial are likely to wane over time. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Modified Vaccinia Ankara
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTanzania
Study dates
Mar 2012to May 2012
Phase
Phase 1/2
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Have completed the HIVIS03/TaMoVac01 WP1 protocol and received the active vaccine
  • Willing to undergo counseling and HIV testing
  • Are not infected by HIV infection as indicated by a negative PCR reaction against HIV.
  • Able to give informed consent
  • Resident in Dar es Salaam, and willing to remain so for the duration of the study
  • At low risk of HIV infection, defined as the absence of an identifiable risk factor/ behavior:
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  • sexual partner with HIV
  • sexual partner with unknown HIV serostatus who is also unwilling to use protective condoms consistently in all sexual relations
  • sexual partner is known to be at high risk for HIV
  • more than one sexual partner in the last 6 months.
  • history of being an alcoholic [as medically defined or more than 35 units /week]
  • History of STI within past 6 months.
  • Verbal assurances that adequate birth control measures are used not to conceive/father a child during the study and up to 4 months after the 3rd MVA vaccine injection
  • Have a negative urinary pregnancy test for females
  • ECG findings that neither pose a risk for the vaccination nor preclude evaluation of peri/myocarditis.
  • Be willing to practice safe sex for the duration of the study to avoid sexually transmitted infections including HIV.
  • Good health as determined by medical history, physical examination, clinical judgment and by key laboratory parameters
  • Reference ranges will be in accordance with data generated at MUHAS for hematology values, and biochemical parameters. Exclusion by presence of Diabetes mellitus will be based on the WHO cut-off value of a Fasting Blood Glucose >7.8 mmol/l
  • No grade 1 or higher routine laboratory parameters (see section on appendix 3 DAIDS chart for Definitions). Hence lab parameters have to be as follows:
  • Hb >10.5g/dl
  • White blood cell count >1,300/mm3
  • Lymphocytes >1.0/ mm3
  • Platelets >120,000/ mm3
  • CD4 >400cells/ mm3
  • Random Blood Glucose 2.5-7.0 mmol/L; if elevated, then a Fasting Blood Glucose <7.8 mmol/l
  • Bilirubin <1.25 x uln
  • ALT <1.25 x uln
  • Creatinine <1.25 x uln
  • Urine dipstick for protein and blood: negative or trace. (If either is ≥ 1+, obtain complete urinalysis (UA). If microscopic UA confirms evidence of hematuria or if proteinuria ≥ 1+, the volunteer is ineligible).

Who cannot join

  • Active tuberculosis or other systemic infectious process elicited by review of systems, physical examination and laboratory detection. Such as detection of Hepatitis B surface antigen, or active syphilis.
  • Have a history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention
  • Autoimmune disease by history and physical examination.
  • Severe eczema
  • Have history of psychiatric, medical and/or substance abuse problems during the past 6 months that the investigator believes would adversely affect the volunteer's ability to participate in the trial.
  • History of grand-mal epilepsy, or currently taking anti-epileptics
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  • Have received blood or blood products or immunoglobulins in the past 3 months.
  • Are receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy.
  • Have used experimental therapeutic agents within 30 days of study entry.
  • Have received any live, attenuated vaccine within 60 days of study entry. {NOTE: Medically indicated subunit or killed vaccines (e.g., Hepatitis A or Hepatitis B) are not exclusionary but should be given at least 2 weeks before or after HIV immunization to avoid potential confusion of adverse reactions}.
  • History of severe local or general reaction to vaccination defined as:
  • Local: Extensive, indurated redness and swelling involving most of the major circumference of the arm, not resolving within 72 hours
  • General: Fever >= 39.5 0C within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
  • Are lactating mothers
  • Are study site employees who are involved in the protocol and may have direct access to the immunogenicity results
  • Unlikely to comply with protocol as judged by the principal investigator or her designate.

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

  • Muhimbili University of Health and Allied Sciences

    Dar es Salaam

Other trials in Tanzania

About this study

Official title: Safety and Immunogenicity Following Further Boosting With HIV-1 MVA-CMDR Vaccine to HIVIS03 Volunteers Who Were Primed With HIV-1 DNA Low Dose Intradermally or 'Standard' Dose Intramuscularly and Boosted With MVA-CMDR Vaccine

The purpose of the study is to determine the safety and immunogenecity of a third MVA in the HIVIS 03 volunteers who have received 3 HIVIS DNA vaccines followed by boosting with 2 MVA vaccines.

The investigators postulate that the Immune responses that were observed in the HIVIS 03 trial are likely to wane over time. To date it is unknown how these responses should best be maintained. In this study the investigators seek to boost immune responses, especially the antibody responses induced by the second MVA boost.

Since the HIV specific antibodies were induced only after the second MVA injection, it is hypothesized that a 3rd MVA will give rise to even higher and sustained antibody titers.

Being tested
Modified Vaccinia Ankara

What participants receive

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

  • Modified Vaccinia AnkaraBiological

    Healthy volunteers will receive intramuscularly 1 injection of MVA-CMDR 1ml (Total 10 power 8 pfu) boost injection in the left deltoid muscle.

Study groups in NCT01461447
Study groupRoleWhat they receive
MVAExperimentalVolunteers who were primed with 3 HIVIS DNA and further boosted with 2 MVA vaccine will receive a third MVA there shall not be an comparator for this study.
Receives: Biological: Modified Vaccinia Ankara

What is being measured

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

  1. Proportion of volunteers with humoral and cellular immune responses elicited by 2 different immunization schedules (id or im DNA priming) prior to MVA boosting

    Measured: 1 month after vaccination

  2. Safety assessed by the number of solicited and non solicited adverse events following immunization

    Measured: 1 month after vaccination

Secondary outcomes (1)

  1. Number of staff trained and able to conduct HIV-related vaccine studies at MUHAS.

    Measured: Two months

Timeline

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

  1. First posted28 Oct 2011 (estimated)
  2. Study startMar 2012
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 1/2
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01461447
Sponsor's protocol ID
HIVIS 06
Acronym
HIVIS06
Status last verified
May 2012
First submitted
20 Oct 2011
Last updated
24 May 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Modified Vaccinia Ankara in people with Healthy Volunteers, run by Muhimbili University of Health and Allied Sciences at 1 site in Tanzania.

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 29 inclusion and 16 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 24 May 2012. 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 Tanzania. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Proportion of volunteers with humoral and cellular immune responses elicited by 2 different immunization schedules (id or im DNA priming) prior to MVA boosting (time frame: 1 month after vaccination). The study lists 2 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 NCT01461447.

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 24 May 2012.

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