Status:
COMPLETED
Safety and Immunogenicity Study of a DNA Priming and MVA Boosting Strategy of HIV Vaccine
Lead Sponsor:
Instituto Nacional de Saúde, Mozambique
Collaborating Sponsors:
Swedish Institute for Communicable Disease Control, Sweden
European and Developing Countries Clinical Trials Partnership (EDCTP)
Conditions:
HIV Infections
Eligibility:
All Genders
18-26 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- Age: 18 to 26 years
- Willing to undergo HIV (Human Immunodeficiency Virus) counseling and testing
- Have a negative antigen/antibody or antibody ELISA for HIV infection
- Able to give informed consent
- Satisfactory completion of an assessment of understanding prior to enrolment defined as 89% correct answers after three opportunities to take the test
- Basic abilities to read and write
- Resident in Maputo, 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 (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
- 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.
- Women shall have a negative urine pregnancy test
- 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 as judged by the study physician.
- 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.
Exclusion
- At risk of HIV infection as mentioned above in the inclusion criteria
- Active tuberculosis or other systemic infectious process elicited by review of systems, physical examination and laboratory detection
- A history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention
- Autoimmune disease by history and physical examination
- Hives or recurrent hives and severe eczema
- 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
- History of epilepsy, or currently taking anti-epileptics
- Received blood or blood products or immunoglobulins in the past 3 months
- Receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy
- Use of experimental therapeutic agents within 30 days of study entry
- Reception of any live, attenuated vaccine within 60 days of study entry.
- Abnormality in Electrocardiogram (ECG) that could indicate risk or make interpretation of vaccine effects difficult according to the study operating procedures
- Previously received an HIV vaccine candidate
- History of severe local or general reaction to vaccination defined as:
- Local: Extensive, indurate 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 edema; collapse; convulsions or encephalopathy within 72 hours
- Being a lactating mother
- 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 his designate.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01407497
Start Date
August 1 2011
End Date
August 1 2013
Last Update
December 4 2013
Active Locations (1)
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1
Centro de Investigação e Treino em Saúde de Polana Caniço
Maputo, Cidade de Maputo, Mozambique