Status:
COMPLETED
Safety Study of an Additional MVA Vaccine in Volunteers Who Received 3 DNA Vaccines Followed by 2 MVA Vaccines
Lead Sponsor:
Muhimbili University of Health and Allied Sciences
Collaborating Sponsors:
Karolinska Institutet
Swedish Institute for Infectious Disease Control
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to determine the safety and immunogenecity of a third MVA in the HIVIS 03 volunteers who have received 3 HIVIS DNA vaccines followed by boosting with 2 MVA vaccines. The i...
Eligibility Criteria
Inclusion
- Have completed the HIVIS03/TaMoVac01 WP1 protocol and received the active vaccine
- Willing to undergo counseling and HIV testing
- Are not infected by HIV infection as indicated by a negative PCR reaction against HIV.
- Able to give informed consent
- Resident in Dar es Salaam, and willing to remain so for the duration of the study
- At low risk of HIV infection, defined as the absence of an identifiable risk factor/ behavior:
- sexual partner with HIV
- sexual partner with unknown HIV serostatus who is also unwilling to use protective condoms consistently in all sexual relations
- sexual partner is known to be at high risk for HIV
- more than one sexual partner in the last 6 months.
- history of being an alcoholic \[as medically defined or more than 35 units /week\]
- History of STI within past 6 months.
- 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 3rd MVA vaccine injection
- Have a negative urinary pregnancy test for females
- ECG findings that neither pose a risk for the vaccination nor preclude evaluation of peri/myocarditis.
- Be willing to practice safe sex for the duration of the study to avoid sexually transmitted infections including HIV.
- Good health as determined by medical history, physical examination, clinical judgment and by key laboratory parameters
- Reference ranges will be in accordance with data generated at MUHAS for hematology values, and 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
- No grade 1 or higher routine laboratory parameters (see section on appendix 3 DAIDS chart for Definitions). Hence lab parameters have to be as follows:
- Hb \>10.5g/dl
- White blood cell count \>1,300/mm3
- Lymphocytes \>1.0/ mm3
- Platelets \>120,000/ mm3
- CD4 \>400cells/ mm3
- Random Blood Glucose 2.5-7.0 mmol/L; if elevated, then a Fasting Blood Glucose \<7.8 mmol/l
- Bilirubin \<1.25 x uln
- ALT \<1.25 x uln
- Creatinine \<1.25 x uln
- Urine dipstick for protein and blood: negative or trace. (If either is ≥ 1+, obtain complete urinalysis (UA). If microscopic UA confirms evidence of hematuria or if proteinuria ≥ 1+, the volunteer is ineligible).
Exclusion
- 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.
- Have a history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention
- Autoimmune disease by history and physical examination.
- Severe eczema
- Have 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.
- History of grand-mal epilepsy, or currently taking anti-epileptics
- Have received blood or blood products or immunoglobulins in the past 3 months.
- Are receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy.
- Have used experimental therapeutic agents within 30 days of study entry.
- 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 immunization to avoid potential confusion of adverse reactions}.
- History of severe local or general reaction to vaccination defined as:
- Local: Extensive, indurated redness and swelling involving most of the major circumference of the arm, not resolving within 72 hours
- General: Fever \>= 39.5 0C within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
- Are lactating mothers
- Are study site employees who are involved in the protocol and may have direct access to the immunogenicity results
- Unlikely to comply with protocol as judged by the principal investigator or her designate.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01461447
Start Date
March 1 2012
End Date
May 1 2012
Last Update
May 24 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania