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Completed

NCT Number: NCT01697007

A Phase II Trial to Assess the Safety and Immunogenicity of DNA Priming Administered by the ID Zetajet® With or Without ID Derma Vax™ Electroporation Followed by IM MVA Boosting in Healthy Volunteers in Tanzania and Mozambique

Electroporation will increase the efficiency of DNA priming in terms of immune responses and will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine concentration will reduce the number of shots necessary to deliver the full dose and induce comparable immune responses as with lower DNA vaccine concentrations.

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Key information

Conditions

Vaccines HIV Immunogenicity Safety

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Instituto Nacional de Saude, Maputo, Mozambique

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to undergo counselling and HIV testing.
  • Have a negative antigen/antibody ELISA for HIV infection.
  • Able to give informed consent.
  • Basic abilities to read and write.
  • Satisfactory completion of an assessment of understanding prior to enrolment defined as 90% correct answers after three opportunities to take test.
  • Resident of the region where the study is taking place.
  • At low risk of HIV infection.
  • Verbal assurances for adequate birth control measures.
  • Healthy as evidenced by clinical and laboratory measures

Exclusion criteria

  • At risk of HIV infection.
  • Active tuberculosis.
  • A history of immunodeficiency, ongoing medical and/or psychiatric condition and/or chronic illness requiring continuous or frequent medical intervention.
  • Autoimmune disease.
  • Hives and severe eczema.
  • Substance abuse problems.
  • History of grand-mal epilepsy.
  • 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.
  • History of cardiac disease

Treatment and study plan

HIVIS DNA vaccine

Biological

Zetajet

Device

Derma Vax Electroporation

Device

Modified Vaccinia Ankara (MVA-CDMR)

Biological

Primary outcomes

  1. The presence of an interferon gamma ELISpot responses to a pool of HIV peptides encoded by the vaccine to which there was no response at baseline

    Time frame: 2 weeks after the last vaccination

  2. Grade 3 or above local and systemic solicited adverse events

    Time frame: Within 2 weeks post each immunization up to week 64 from enrollment

Secondary outcomes

  1. The presence of CD4+ and CD8+ T-cell cytokine responses to pools of HIV peptides assessed by Intracellular cytokine staining

    Time frame: 2 weeks post last vaccination

Other outcomes

  1. Any grade of adverse event that results in a clinical decision to discontinue further immunizations.

    Time frame: After receiving the first immunization until 64 weeks from enrollment

  2. The presence of HIV-specific binding antibodies and the titer when these are present

    Time frame: Up to week 64 from enrollment

  3. The presence of neutralizing antibodies and the titer when these are present

    Time frame: Approximately between week 64-68 after enrollment

  4. The magnitude of interferon gamma ELISpot responses measured by the number of spot forming cells per million PBMCs in response to pools of HIV-peptides in the assay

    Time frame: 2 weeks post the last vaccination

  5. Any grade of adverse event that occurs in a participant that has received at lease one immunization

    Time frame: After the first immunization up to 64 weeks

Sponsors and collaborators

Lead sponsor

Muhimbili University of Health and Allied Sciences

Other

Collaborators

  • Imperial College London
  • Instituto Nacional de Saúde, Mozambique
  • Karolinska Institutet
  • Ludwig-Maximilians - University of Munich
  • Mbeya medical research program
  • Medical Research Council
  • National Institute for Medical Research, Tanzania
  • Swedish Institute for Infectious Disease Control
  • US Military HIV Research Program

Registry information

Acronym: TaMoVac II

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Oct 2, 2012
Registry last updated
Jun 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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