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HIV InfectionsPhase 1NCT01407497

Safety and Immunogenicity Study of a DNA Priming and MVA Boosting Strategy of HIV Vaccine

A Phase 1 study testing DNA HIVIS and MVA-CMDR and Saline solution in people with HIV Infections, run by Instituto Nacional de Saúde, Mozambique at 1 site in Mozambique.

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

While antiretroviral drugs have shown great promise in reducing HIV replication and thus in reducing HIV/AIDS associated morbi-mortality and HIV transmission, the cost is substantial and side effects are a potentially limiting factor. Read more about this study

Who is it for?
Ages 18 to 26 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
DNA HIVIS and MVA-CMDR and Saline solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteMozambique
Study dates
Aug 2011to Aug 2013
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 26 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age: 18 to 26 years
  • Willing to undergo HIV (Human Immunodeficiency Virus) counseling and testing
  • Have a negative antigen/antibody or antibody ELISA for HIV infection
  • Able to give informed consent
  • Satisfactory completion of an assessment of understanding prior to enrolment defined as 89% correct answers after three opportunities to take the test
  • Basic abilities to read and write
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  • Resident in Maputo, 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 (their presence is therefore an exclusion criteria):
  • 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 Sexually Transmitted Infection (STI) within past 6 months
  • Verbal assurances that adequate birth control methods are used not to conceive/father a child during the study and up to 3 months after the last vaccine injection.
  • Women shall have a negative urine pregnancy test
  • 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 as judged by the study physician.
  • Laboratory criteria:
  • Hemoglobin >10.5g/dl
  • White blood cell count <13,000/mm3
  • Neutrophils >1,300/mm3
  • Lymphocytes >1.000/ mm3
  • Platelets >120,000/ mm3
  • Random Blood Glucose < 6.44 mmol/L; if elevated, then a Fasting Blood Glucose < 6.11mmol/L (according to DAIDS Table for Lab Criteria)
  • Bilirubin <1.25 x uln
  • Alanine transaminase (ALT) <1.25 x uln
  • Urine dipstick for protein and blood: negative or trace. (If either is ¿ 1+, complete urinalysis (UA) will be performed.

Who cannot join

  • At risk of HIV infection as mentioned above in the inclusion criteria
  • Active tuberculosis or other systemic infectious process elicited by review of systems, physical examination and laboratory detection
  • A history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention
  • Autoimmune disease by history and physical examination
  • Hives or recurrent hives and severe eczema
  • A history of psychiatric, medical (including traditional medicine) 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
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  • History of epilepsy, or currently taking anti-epileptics
  • Received blood or blood products or immunoglobulins in the past 3 months
  • Receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy
  • Use of experimental therapeutic agents within 30 days of study entry
  • Reception of any live, attenuated vaccine within 60 days of study entry.
  • Abnormality in Electrocardiogram (ECG) that could indicate risk or make interpretation of vaccine effects difficult according to the study operating procedures
  • Previously received an HIV vaccine candidate
  • History of severe local or general reaction to vaccination defined as:
  • Local: Extensive, indurate 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 edema; collapse; convulsions or encephalopathy within 72 hours
  • Being a lactating mother
  • 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 his designate.

Trial locations and contacts

1 site in 1 country.

Mozambique1 site

  • Centro de Investigação e Treino em Saúde de Polana Caniço

    Maputo, Cidade de Maputo

Other trials in Mozambique

About this study

Official title: A Phase I Trial to Assess Safety and Immunogenicity of i.d. DNA Priming and i.m. MVA Boosting in Healthy Volunteers in Mozambique and to Develop Further HIV Vaccine Trial Capacity Building in Mozambique

While antiretroviral drugs have shown great promise in reducing HIV replication and thus in reducing HIV/AIDS associated morbi-mortality and HIV transmission, the cost is substantial and side effects are a potentially limiting factor. Development of an effective safe-affordable vaccine is likely to be the best way to stop further virus spread. The study aims to determine safety and immunogenicity of the DNA-vaccine at a dose of 600µg and 1200µg delivered id in combination with MVA-CMDR boost im.

Conditions
HIV Infections
Being tested
DNA HIVIS and MVA-CMDR, Saline solution
Keywords
HIV, Vaccine, DNA, Prevention
Medical subject headings
HIV Infections

What participants receive

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

  • DNA HIVIS and MVA-CMDRBiological

    600 µg i.d. (separate plasmids pools) of DNA priming at weeks 0, 4 and 12; 108 pfu i.m. MVA boosting at weeks 24 and 36

  • DNA HIVIS and MVA-CMDRBiological

    1200 µg i.d. (separate plasmids pools) of DNA priming at weeks 0, 4 and 12 ; 108 pfu i.m. MVA boosting at weeks 24 and 36

  • Saline solutionBiological

    2 x 0.1 ml of saline solution i.d at weeks 0, 4 and 12 ; saline solution i.m at weeks 24 and 36

  • Saline solutionBiological

    2 x 0.2 ml of saline solution i.d at weeks 0, 4 and 12 ; saline solution i.m at weeks 24 and 36

Study groups in NCT01407497
Study groupRoleWhat they receive
IAActive comparator600 µg i.d. (separate plasmids pools) of DNA priming at weeks 0, 4 and 12 108 pfu i.m. MVA boosting at weeks 24 and 36
Receives: Biological: DNA HIVIS and MVA-CMDR
IBPlacebo comparator2 x 0.1 ml of saline solution i.d at weeks 0, 4 and 12 saline solution i.m at weeks 24 and 36
Receives: Biological: Saline solution
IIAActive comparator1200 µg i.d. (separate plasmids pools) of DNA priming at weeks 0, 4 and 12;108 pfu i.m. MVA boosting at weeks 24 and 36
Receives: Biological: DNA HIVIS and MVA-CMDR
IIBPlacebo comparator2 x 0.2 ml of saline solution i.d at weeks 0, 4 and 12 ; saline solution i.m at weeks 24 and 36
Receives: Biological: Saline solution

What is being measured

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

  1. Adverse events (local and system reactogenicity)

    The safety of immunization will be assessed by clinical features and standard clinical chemistry and hematological tests. Safety endpoints: Adverse events will be assessed using a standard format for soliciting local and systemic reactogenicity to the vaccine and collection of unsolicited adverse events. Solicited reactogenicity will be evaluated for 7 days following each vaccination. All other AE will be collected from the time of first injection until the end of the study follow-up period.

    Measured: 44 weeks

  2. Immunogenicity

    The primary immunogenicity endpoint will be determined by the interferon gamma (IFN-gama) enzyme linked immunospot (ELISPOT) assay.

    Secondary immunogenicity endpoints will include cellular immune responses determined by intracellular cytokine staining and T cell proliferation assays as well as binding antibody and neutralizing antibody responses.

    Measured: 44 weeks

Timeline

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

  1. First posted2 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionMar 2013
  4. Study completionAug 2013

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01407497
Sponsor's protocol ID
TAMOVAC-01-MZ
Status last verified
Dec 2013
First submitted
1 Aug 2011
Last updated
4 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Viegas EO, Tembe N, Nilsson C, Meggi B, Maueia C, Augusto O, Stout R, Scarlatti G, Ferrari G, Earl PL, Wahren B, Andersson S, Robb ML, Osman N, Biberfeld G, Jani I, Sandstrom E. Intradermal HIV-1 DNA Immunization Using Needle-Free Zetajet Injection Followed by HIV-Modified Vaccinia Virus Ankara Vaccination Is Safe and Immunogenic in Mozambican Young Adults: A Phase I Randomized Controlled Trial. AIDS Res Hum Retroviruses. 2018 Feb;34(2):193-205. doi: 10.1089/AID.2017.0121. Epub 2017 Nov 27.

    PubMed 28969431

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DNA HIVIS and MVA-CMDR and Saline solution in people with HIV Infections, run by Instituto Nacional de Saúde, Mozambique at 1 site in Mozambique.

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 28 inclusion and 19 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 4 Dec 2013. 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 Mozambique. 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?

Adverse events (local and system reactogenicity) (time frame: 44 weeks). 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 NCT01407497, 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 4 Dec 2013.

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