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

HIV Clinical Trial

— TaMoVac II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697007
• Other study ID #: TaMoVac II
• Status: Completed
• Phase: Phase 2
• First received: September 22, 2012
• Last updated: June 26, 2015
• Start date: November 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Muhimbili University of Health and Allied Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: Food & Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• HIV
• Immunogenicity
• Safety
• Vaccines

Intervention

Biological:
• HIVIS DNA vaccine

Device:
• Zetajet

• Derma Vax Electroporation

Biological:
• Modified Vaccinia Ankara (MVA-CDMR)

Locations

Country	Name	City	State
Mozambique	Instituto Nacional de Saude	Maputo
Tanzania	Muhimbili University of Health and Allied Sciences	Dar es Salaam
Tanzania	Mbeya Medical Research Programme	Mbeya

Sponsors (10)

Lead Sponsor	Collaborator
Muhimbili University of Health and Allied Sciences	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

Countries where clinical trial is conducted

Mozambique,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Any grade of adverse event that results in a clinical decision to discontinue further immunizations.		After receiving the first immunization until 64 weeks from enrollment	Yes
Other	The presence of HIV-specific binding antibodies and the titer when these are present		Up to week 64 from enrollment	No
Other	The presence of neutralizing antibodies and the titer when these are present		Approximately between week 64-68 after enrollment	No
Other	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		2 weeks post the last vaccination	No
Other	Any grade of adverse event that occurs in a participant that has received at lease one immunization		After the first immunization up to 64 weeks	Yes
Primary	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		2 weeks after the last vaccination	No
Primary	Grade 3 or above local and systemic solicited adverse events		Within 2 weeks post each immunization up to week 64 from enrollment	Yes
Secondary	The presence of CD4+ and CD8+ T-cell cytokine responses to pools of HIV peptides assessed by Intracellular cytokine staining		2 weeks post last vaccination	No