HIV Infections
Conditions
Keywords
HIV, Vaccine, DNA, Prevention
Brief summary
While antiretroviral drugs have shown great promise in reducing HIV replication and thus in reducing HIV/AIDS associated morbi-mortality and HIV transmission, the cost is substantial and side effects are a potentially limiting factor. Development of an effective safe-affordable vaccine is likely to be the best way to stop further virus spread. The study aims to determine safety and immunogenicity of the DNA-vaccine at a dose of 600µg and 1200µg delivered id in combination with MVA-CMDR boost im.
Interventions
BIOLOGICALDNA HIVIS and MVA-CMDR
600 µg i.d. (separate plasmids pools) of DNA priming at weeks 0, 4 and 12; 108 pfu i.m. MVA boosting at weeks 24 and 36
BIOLOGICALSaline solution
2 x 0.1 ml of saline solution i.d at weeks 0, 4 and 12 ; saline solution i.m at weeks 24 and 36
Sponsors
Swedish Institute for Communicable Disease Control, Sweden
European and Developing Countries Clinical Trials Partnership (EDCTP)
Instituto Nacional de Saúde, Mozambique
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 26 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age: 18 to 26 years 2. Willing to undergo HIV (Human Immunodeficiency Virus) counseling and testing 3. Have a negative antigen/antibody or antibody ELISA for HIV infection 4. Able to give informed consent 5. Satisfactory completion of an assessment of understanding prior to enrolment defined as 89% correct answers after three opportunities to take the test 6. Basic abilities to read and write 7. Resident in Maputo, 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 (their presence is therefore an
Exclusion criteria
): * 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 Sexually Transmitted Infection (STI) within past 6 months 9. Verbal assurances that adequate birth control methods 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 urine 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. 13. Laboratory criteria: * Hemoglobin \>10.5g/dl * White blood cell count \<13,000/mm3 * Neutrophils \>1,300/mm3 * Lymphocytes \>1.000/ mm3 * Platelets \>120,000/ mm3 * Random Blood Glucose \< 6.44 mmol/L; if elevated, then a Fasting Blood Glucose \< 6.11mmol/L (according to DAIDS Table for Lab Criteria) * Bilirubin \<1.25 x uln * Alanine transaminase (ALT) \<1.25 x uln * Urine dipstick for protein and blood: negative or trace. (If either is ¿ 1+, complete urinalysis (UA) will be performed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (local and system reactogenicity) | 44 weeks | The safety of immunization will be assessed by clinical features and standard clinical chemistry and hematological tests. Safety endpoints: Adverse events will be assessed using a standard format for soliciting local and systemic reactogenicity to the vaccine and collection of unsolicited adverse events. Solicited reactogenicity will be evaluated for 7 days following each vaccination. All other AE will be collected from the time of first injection until the end of the study follow-up period. |
| Immunogenicity | 44 weeks | The primary immunogenicity endpoint will be determined by the interferon gamma (IFN-gama) enzyme linked immunospot (ELISPOT) assay. Secondary immunogenicity endpoints will include cellular immune responses determined by intracellular cytokine staining and T cell proliferation assays as well as binding antibody and neutralizing antibody responses. |
Countries
Mozambique
Outcome results
None listed