HIVIS 03: A phase I/II trial to assess the safety and immunogenicity of a plasmid DNA-MVA prime boost HIV-1 vaccine candidate among volunteers in Dar es Salaam, Tanzania

Phase 1

Completed

• Conditions: HIV-1; Infections and Infestations; Unspecified human immunodeficiency virus [HIV] disease

• Registration Number: ISRCTN90053831
• Lead Sponsor: Swedish Institute for Infectious Disease Control (SMI) (Sweden)

Brief Summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24321091 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25874723

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-10
• Study Completion: 2009-12-31
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Both males and females, age: 18 to 40 years
2. Willing to undergo counselling and HIV testing
3. Have a negative antigen/antibody ELISA for HIV infection
4. Able to give informed consent
5. Literacy corresponding to a minimum of 7 years of primary education
6. Resident in Dar es Salaam, and willing to remain so for the duration of the study
7. At low risk of HIV infection, defined as the absence of an identifiable risk factor/ behaviour:
7.1. Sexual partner with HIV
7.2. Sexual partner with unknown HIV serostatus who is also unwilling to use protective condoms consistently in all sexual relations
7.3. Sexual partner is known to be at high risk for HIV
7.4. More than one sexual partner in the last 6 months
7.5. History of being an alcoholic (as medically defined or more than 35 units /week)
7.6. History of STI within the past 6 months
8. Verbal assurances that adequate birth control measures are used not to conceive/father a child during the study and up to 4 months after the last vaccine injection
9. Have a negative urinary pregnancy test
10. Be willing to practice safe sex for the duration of the study to avoid sexually transmitted infections including HIV.
11. Good health as determined by medical history, physical examination, clinical judgment and by key laboratory parameters (reference ranges are in accordance with data generated at MUHAS for haematology values, and that generated at Mbeya (MMRP) for biochemical parameters. Exclusion by presence of Diabetes mellitus will be based on the WHO cut-off value of a fasting blood glucose <7.8 mmol/l). Hence no grade 1 or higher routine laboratory parameters, defined as:
11.1. Hb >10.5g/dl
11.2. White blood cell count >1,300/mm^3
11.3. Granulocytes >6.4/mm^3
11.4. Lymphocytes >1.0/mm^3
11.5. Platelets >120,000/mm^3
11.6. CD4 >400 cells/mm^3
11.7. Random blood glucose 2.5-7.0 mmol/L; if elevated, then a fasting blood glucose <7.8 mmol/l
11.8. Bilirubin <1.25 x upper limit of normal (ULN)
11.9.ALT <1.25 x ULN
11.10. Creatinine <1.25 x ULN
11.11. Urine dipstick for protein and blood: negative or trace. (If either is >=1+, obtain complete urinalysis (UA). If microscopic UA confirms evidence of haematuria or if proteinuria >=1+, the volunteer is ineligible)

Exclusion Criteria

1. Active tuberculosis or other systemic infectious process elicited by review of systems, physical examination and laboratory detection, such as detection of Hepatitis B surface antigen, or active syphilis
2. Have a history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention
3. Autoimmune disease by history and physical examination
4. Severe eczema
5. Have a history of psychiatric, medical 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.
6. History of grand-mal epilepsy, or currently taking anti-epileptics
7. Have received blood or blood products or immunoglobulins in the past 3 months
8. Are receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy.
9. Have used experimental therapeutic agents within 30 days of study entry
10. Have received 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 immunisation to avoid potential confusion of adverse reactions)
11. Have previously received an HIV candidate vaccine
12. History of severe local or general reaction to vaccination defined as:
12.1. Local: Extensive, indurated redness and swelling involving most of the major circumference of the arm, not resolving within 72 hours
12.2. General: Fever >=39.5°C within 48 hours, anaphylaxis, bronchospasm, laryngeal oedema, collapse, convulsions or encephalopathy within 72 hours
13. Are lactating mothers
14. Are study site employees who are involved in the protocol and may have direct access to the immunogenicity results
15. Unlikely to comply with protocol as judged by the principal investigator or his designate

Study & Design

• Study Type: Interventional
• Study Design: Not specified