TaMoVac-01

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR2010050002122368
• Date of registration: 23/05/2010
• Primary sponsor: Swedish Institute for Infectious Disease Control
• Public title: TaMoVac-01
• Scientific title: A Phase I/II trial to assess safety and immunogenicity of i.d. DNA priming, i.m. MVA and i.m. rgp140/GLA-AF boosting in healthy volunteers in Tanzania and to develop further HIV vaccine trial capacity building in Tanzania
• Date of first enrolment: 2010-05-26
• Target sample size: 120
• Recruitment status: Closed to recruitment: follow up complete
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2010050002122368
• Study type: interventional
• Study design: Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously,; Randomised,; Simple randomisation,; Allocation was determined by the holder of the sequence who is situated off site,

Countries of recruitment

South Africa

Contacts

• Name: Muhammad Bakari
• Affiliation: Senior Lecturer at MUHAS

• Name: Muhammad Bakari
• Affiliation: Senior Lecturer at MUHAS

Key inclusion & exclusion criteria

Inclusion criteria: 1. Age: 18 to 40 years
2. Willing to undergo counseling and HIV testing
3. Have a negative antigen/antibody ELISA for HIV infection
4. Able to give informed consent
5. Satisfactory completion of an assessment of understanding prior to enrolment defined as 90% correct answers after three opportunities to take test.
6. Basic abilities to read and write.
7. Resident in Dar es Salaam or Mbeya, and willing to remain so for the duration of the study
8. At low risk of HIV infection, defined as the absence of an identifiable risk factor/ behavior
9. Verbal assurances that adequate birth control measures are used not to conceive/father a child during the study and up to 3 months after the last vaccine injection
10. Women shall have a negative urinary pregnancy test
11. Be willing to practice safe sex for the duration of the study to avoid sexually transmitted infections including HIV.
12. Good health as determined by medical history, physical examination, clinical judgment and by key laboratory parameters as judged by the study physician.

Exclusion criteria: 1. At risk of HIV infection as mentioned above in the inclusion criteria
2. Active tuberculosis or other systemic infectious process elicited by review of systems, physical examination and laboratory detection (for example detection of Hepatitis B surface antigen, or active syphilis).
3. A history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention
4. Autoimmune disease by history and physical examination.
5. Hives or recurrent hives and severe eczema
6. 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.
7. History of grand-mal epilepsy, or currently taking anti-epileptics
8. Received blood or blood products or immunoglobulins in the past 3 months.
9. Receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy.
10. Use of experimental therapeutic agents within 30 days of study entry.
11. Reception of 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}.
12. Abnormality in ECG that could indicate risk or make interpretation of vaccine effects difficult according to the study operating procedures.
13. Previously received an HIV candidate vaccine.
14. History of severe local or general reaction to vaccination in the past
15. Lactating mother
16. Study site employees who are involved in the protocol
17. Ulikeliness of protocol compliance

Age minimum: 18 Year
Age maximum: 40 Year
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS
null

Primary Outcome(s)

Immunogenicity by IFN-gamma ELISPOT

Safety

Secondary Outcome(s)

Immunogenicity by intracellular cytokine staining (ICS)

Immunogenicity by Lymphoproliferation Assay (LPA)

Source(s) of Monetary Support

European and Developing Countries Clinical Trials Partnership (EDCTP)

Secondary Sponsor(s)

Muhimbili University of Health and Allied Sciences