Safety and Immunogenicity Study of a DNA Priming and MVA Boosting Strategy of HIV Vaccine
A Phase I Trial to Assess Safety and Immunogenicity of i.d. DNA Priming and i.m. MVA Boosting in Healthy Volunteers in Mozambique and to Develop Further HIV Vaccine Trial Capacity Building in Mozambique
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedDecember 4, 2013
December 1, 2013
1.6 years
August 1, 2011
December 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse events (local and system reactogenicity)
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.
44 weeks
Immunogenicity
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.
44 weeks
Study Arms (4)
IA
ACTIVE COMPARATOR600 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
PLACEBO COMPARATOR2 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
ACTIVE COMPARATOR1200 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
PLACEBO COMPARATOR2 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
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro de Investigação e Treino em Saúde de Polana Caniço
Maputo, Cidade de Maputo, Mozambique
Related Publications (1)
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.
PMID: 28969431DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilesh Jani, PhD
Instituto Nacional de Saúde, Mozambique
- PRINCIPAL INVESTIGATOR
Nafissa Osman, MD, PhD
Hospital Central de Maputo
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2011
First Posted
August 2, 2011
Study Start
August 1, 2011
Primary Completion
March 1, 2013
Study Completion
August 1, 2013
Last Updated
December 4, 2013
Record last verified: 2013-12