Safety of and Immune Response to an HIV DNA Plasmid Vaccine Followed by HIV Adenoviral Vector Vaccine in Healthy African Adults
Primary Purpose
HIV Infections
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
VRC-HIVDNA016-00-VP
VRC-HIVADV014-00-VP
Vaccine placebo
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Preventive Vaccine, HIV Seronegativity
Eligibility Criteria
Inclusion Criteria:
- At risk for HIV
- Have had sexual intercourse with an HIV infected partner OR have had sexual intercourse with more than one person within the 3 months prior to study entry OR infected with a sexually transmitted disease within the 3 months prior to study entry
- Willing to comply with the protocol
- Willing to undergo HIV testing and HIV counseling and receive HIV test results
- Willing to use acceptable forms of contraception
Exclusion Criteria:
- HIV-1 or HIV-2 infected
- History of immunodeficiency or autoimmune disease
- Use of corticosteroids or immunosuppressive, antiviral, anticancer, or other medications considered significant by investigator within 6 months prior to study entry
- Certain abnormal laboratory values
- Acute or chronic medical condition considered progressive
- Hepatitis B or hepatitis C virus infection or untreated syphilis
- Live attenuated vaccine within 30 days prior to study
- Planned receipt of investigational product within 30 days after first vaccination
- Other medically indicated subunit or killed vaccine within 14 days prior to study entry
- Planned receipt of other medically killed vaccine investigational product within 14 days after first vaccination
- Blood transfusion within 120 days of study entry
- Immunoglobulin within 60 days of study entry
- Participation within the last 3 months, or planned participation in another clinical study of investigational product currently or during the course of this study
- Another investigational HIV vaccine at any time
- History of severe local or systemic reactogenicity to vaccines
- History of severe allergic reactions
- History of recurrent urticaria
- Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt or ideation in the 3 years prior to study entry
- Uncontrolled hypertension
- Pregnant, breastfeeding, or planning to become pregnant within 4 months following last study vaccination
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
DNA vaccine at baseline, Month 1, and Month 2, and the adenoviral vector vaccine at Month 6.
Placebo vaccine
Outcomes
Primary Outcome Measures
Safety and tolerability, as assessed by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse events
immunogenicity as assessed by the proportion of participants who develop HIV-specific T-cell responses and/or to ENV A-, B-, or C-specific antibodies and magnitude of those responses
Secondary Outcome Measures
Recruitment, enrollment, and retention rates by gender and risk category for participating trial sites
safety, tolerability, and immunogenicity endpoints in participants with varying pre-existing immunity to adenovirus
Full Information
NCT ID
NCT00415649
First Posted
December 21, 2006
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
International AIDS Vaccine Initiative
1. Study Identification
Unique Protocol Identification Number
NCT00415649
Brief Title
Safety of and Immune Response to an HIV DNA Plasmid Vaccine Followed by HIV Adenoviral Vector Vaccine in Healthy African Adults
Official Title
A Phase II, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by Recombinant, Multiclade HIV-1 Adenoviral Vector Vaccine in Healthy Adult Volunteers at Risk for HIV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
International AIDS Vaccine Initiative
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of and immune response to an HIV DNA vaccine followed by an adenoviral vector HIV vaccine in healthy African adults at risk for HIV infection.
Detailed Description
Due to the availability of antiretroviral therapy, AIDS-related deaths have lessened in the United States. However, these therapies are widely inaccessible to the developing world. The need for a safe and affordable vaccine that will prevent HIV infection is of utmost importance. To generate a broadly protective vaccine, it is necessary to develop a multivalent vaccine containing a defined combination of immunogens from the most globally prevalent HIV subtypes. This study will evaluate the safety, tolerability, and immunogenicity of a multiclade HIV-1 DNA plasmid vaccine,VRC-HIVDNA016-00-VP, followed by a multiclade recombinant HIV-1 adenoviral vector vaccine, HIVADV014-00-VP.
This study will last about 27 months. Participants will be randomly assigned to one of two groups. Group A will receive the DNA vaccine at baseline, Month 1, and Month 2, and the adenoviral vector vaccine at Month 6; Group B will receive placebo. There will be 20 study visits over 2 years. Physical exams, vital signs measurements, adverse event evaluation, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Preventive Vaccine, HIV Seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
DNA vaccine at baseline, Month 1, and Month 2, and the adenoviral vector vaccine at Month 6.
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo vaccine
Intervention Type
Biological
Intervention Name(s)
VRC-HIVDNA016-00-VP
Intervention Type
Biological
Intervention Name(s)
VRC-HIVADV014-00-VP
Intervention Type
Biological
Intervention Name(s)
Vaccine placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Safety and tolerability, as assessed by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse events
Time Frame
throughout study
Title
immunogenicity as assessed by the proportion of participants who develop HIV-specific T-cell responses and/or to ENV A-, B-, or C-specific antibodies and magnitude of those responses
Time Frame
throughout study
Secondary Outcome Measure Information:
Title
Recruitment, enrollment, and retention rates by gender and risk category for participating trial sites
Time Frame
throughout study
Title
safety, tolerability, and immunogenicity endpoints in participants with varying pre-existing immunity to adenovirus
Time Frame
throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At risk for HIV
Have had sexual intercourse with an HIV infected partner OR have had sexual intercourse with more than one person within the 3 months prior to study entry OR infected with a sexually transmitted disease within the 3 months prior to study entry
Willing to comply with the protocol
Willing to undergo HIV testing and HIV counseling and receive HIV test results
Willing to use acceptable forms of contraception
Exclusion Criteria:
HIV-1 or HIV-2 infected
History of immunodeficiency or autoimmune disease
Use of corticosteroids or immunosuppressive, antiviral, anticancer, or other medications considered significant by investigator within 6 months prior to study entry
Certain abnormal laboratory values
Acute or chronic medical condition considered progressive
Hepatitis B or hepatitis C virus infection or untreated syphilis
Live attenuated vaccine within 30 days prior to study
Planned receipt of investigational product within 30 days after first vaccination
Other medically indicated subunit or killed vaccine within 14 days prior to study entry
Planned receipt of other medically killed vaccine investigational product within 14 days after first vaccination
Blood transfusion within 120 days of study entry
Immunoglobulin within 60 days of study entry
Participation within the last 3 months, or planned participation in another clinical study of investigational product currently or during the course of this study
Another investigational HIV vaccine at any time
History of severe local or systemic reactogenicity to vaccines
History of severe allergic reactions
History of recurrent urticaria
Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt or ideation in the 3 years prior to study entry
Uncontrolled hypertension
Pregnant, breastfeeding, or planning to become pregnant within 4 months following last study vaccination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pontiano Kaleebu, MD, PhD
Organizational Affiliation
Medical Research Council/Uganda Viral Research Institute (UVRI) Uganda Research Unit on AIDS, UVRI/International AIDS Vaccine Initiative HIV Vaccine Program
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
16362986
Citation
Barouch DH. Rational design of gene-based vaccines. J Pathol. 2006 Jan;208(2):283-9. doi: 10.1002/path.1874.
Results Reference
background
PubMed Identifier
17109335
Citation
Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Gu L, Martin JE, Novik L, Chakrabarti BK, Butman BT, Gall JG, King CR, Andrews CA, Sheets R, Gomez PL, Mascola JR, Nabel GJ, Graham BS; Vaccine Research Center 006 Study Team. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector. J Infect Dis. 2006 Dec 15;194(12):1638-49. doi: 10.1086/509258. Epub 2006 Nov 8. Erratum In: J Infect Dis. 2009 Oct 15;200(8):1352-3.
Results Reference
background
PubMed Identifier
11390574
Citation
Moore JP, Parren PW, Burton DR. Genetic subtypes, humoral immunity, and human immunodeficiency virus type 1 vaccine development. J Virol. 2001 Jul;75(13):5721-9. doi: 10.1128/JVI.75.13.5721-5729.2001. No abstract available.
Results Reference
background
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Safety of and Immune Response to an HIV DNA Plasmid Vaccine Followed by HIV Adenoviral Vector Vaccine in Healthy African Adults
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