HIVIS03

A phase I/II trial to assess safety & immunogenicity of a plasmid DNA-MVA prime boost HIV-1 vaccine candidate among volunteers in DaresSalaam, Tanzani

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR2009040001075080

Enrollment

Unknown

Registered

2009-03-24

Start date

2007-02-20

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Interventions

Priming with intramuscular DNA, Boosting with intramuscular MVA

Saline

Priming with intradermal DNA, Boosting with intradermal MVA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 18-40 years Willing to be counseled & HIV tested Negative HIV Ag/Ab ELISA Informed consent Minimum 7 years of 1° Education. Resident in Dar es Salaam At low risk of HIV, (absence of: sexual partner with HIV, partner with unknown HIV serostatus and unwilling to use protection in sexual relations, partner known to be at high risk for HIV, >1 sexual partner in last 6 months, alcoholic (>35 units/week), STI in past 6 months). Assurances for birth control measures till 4 months after last vaccination Negative UPT Willingness for safe sex practice Good health by clinical & lab parameters: (FBG 10.5g/dl, WBC count >1,300/mm3, Granulocytes >6.4/ mm3, Lymphocytes >1.0/ mm3, Platelets >120,000/ mm3, CD4 >400cells/mm3, RBG 2.5-7.0 mmol/L; if elevated, then a FBG <7.8 mmol/l, Bilirubin <1.25 x uln, ALT <1.25 x uln, Creatinine <1.25 x uln, -ve/trace urine dipstick for protein and blood)

Exclusion criteria

Exclusion criteria: Active TB/other systemic infection Positive HBsAg Active syphilis Immunodeficiency/chronic illness Autoimmune disease Severe eczema Psychiatric/substance abuse problem in past 6 months Grand-mal epilepsy, or current use of anti-epileptics Blood/Blood products/immunoglobulins use in past 3 months Immunosuppressive therapy. Experimental therapeutic agents within 30 days of study entry Any live, attenuated vaccination within 60 days of study entry Receipt of an HIV candidate vaccine. Severe local or general reaction to vaccination Lactating mothers Study site employees Protocol non-compliance

Design outcomes

Primary

Measure	Time frame
Safety of Immunization;Immunogenicity, cellular & Humoral	—

Countries

United Republic of Tanzania

Contacts

Public ContactMuhammad Bakari

Senior Lecturer, Department of Internal Medicine, School of Medicine, MUHAS

mbakari@muhas.ac.tz+255 754 387328

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026