Safety and Immunogenicity Study of a DNA Priming and MVA Boosting Strategy of HIV Vaccine
NCT ID: NCT01407497
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2011-08-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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IA
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
DNA 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
IB
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
Saline 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
IIA
1200 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
DNA HIVIS and MVA-CMDR
1200 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
IIB
2 x 0.2 ml of saline solution i.d at weeks 0, 4 and 12 ; saline solution i.m at weeks 24 and 36
Saline solution
2 x 0.2 ml of saline solution i.d at weeks 0, 4 and 12 ; saline solution i.m at weeks 24 and 36
Interventions
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DNA 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
DNA HIVIS and MVA-CMDR
1200 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
Saline 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
Saline solution
2 x 0.2 ml of saline solution i.d at weeks 0, 4 and 12 ; saline solution i.m at weeks 24 and 36
Eligibility Criteria
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Inclusion Criteria
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
2. Active tuberculosis or other systemic infectious process elicited by review of systems, physical examination and laboratory detection
3. A history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention
4. Autoimmune disease by history and physical examination
5. Hives or recurrent hives and severe eczema
6. 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
7. History of epilepsy, or currently taking anti-epileptics
8. Received blood or blood products or immunoglobulins in the past 3 months
9. Receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy
10. Use of experimental therapeutic agents within 30 days of study entry
11. Reception of any live, attenuated vaccine within 60 days of study entry.
12. Abnormality in Electrocardiogram (ECG) that could indicate risk or make interpretation of vaccine effects difficult according to the study operating procedures
13. Previously received an HIV vaccine candidate
14. 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
15. Being a lactating mother
16. Study site employees who are involved in the protocol and may have direct access to the immunogenicity results
17. Unlikely to comply with protocol as judged by the principal investigator or his designate.
Exclusion Criteria
* 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.
18 Years
26 Years
ALL
Yes
Sponsors
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Swedish Institute for Communicable Disease Control, Sweden
UNKNOWN
European and Developing Countries Clinical Trials Partnership (EDCTP)
OTHER_GOV
Instituto Nacional de Saúde, Mozambique
OTHER_GOV
Responsible Party
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Principal Investigators
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Ilesh Jani, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Saúde, Mozambique
Nafissa Osman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Central de Maputo
Locations
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Centro de Investigação e Treino em Saúde de Polana Caniço
Maputo, Cidade de Maputo, Mozambique
Countries
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References
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Viegas EO, Tembe N, Nilsson C, Meggi B, Maueia C, Augusto O, Stout R, Scarlatti G, Ferrari G, Earl PL, Wahren B, Andersson S, Robb ML, Osman N, Biberfeld G, Jani I, Sandstrom E. Intradermal HIV-1 DNA Immunization Using Needle-Free Zetajet Injection Followed by HIV-Modified Vaccinia Virus Ankara Vaccination Is Safe and Immunogenic in Mozambican Young Adults: A Phase I Randomized Controlled Trial. AIDS Res Hum Retroviruses. 2018 Feb;34(2):193-205. doi: 10.1089/AID.2017.0121. Epub 2017 Nov 27.
Other Identifiers
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TAMOVAC-01-MZ
Identifier Type: -
Identifier Source: org_study_id