HIV InfectionsPhase 2NCT00415649
Safety of and Immune Response to an HIV DNA Plasmid Vaccine Followed by HIV Adenoviral Vector Vaccine in Healthy African Adults
A Phase 2 study testing VRC-HIVDNA016-00-VP and VRC-HIVADV014-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- VRC-HIVDNA016-00-VP and VRC-HIVADV014-00-VP
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- VRC-HIVDNA016-00-VP, VRC-HIVADV014-00-VP, Vaccine placebo
- Keywords
- HIV Preventive Vaccine, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRC-HIVDNA016-00-VPBiological
VRC-HIVADV014-00-VPBiological
Vaccine placeboBiological
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | DNA vaccine at baseline, Month 1, and Month 2, and the adenoviral vector vaccine at Month 6. Receives: Biological: VRC-HIVDNA016-00-VP; Biological: VRC-HIVADV014-00-VP |
| B | Placebo comparator | Placebo vaccine Receives: Biological: Vaccine placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability, as assessed by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse events
Measured: throughout study
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
Measured: throughout study
Secondary outcomes (2)
Recruitment, enrollment, and retention rates by gender and risk category for participating trial sites
Measured: throughout study
safety, tolerability, and immunogenicity endpoints in participants with varying pre-existing immunity to adenovirus
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- International AIDS Vaccine Initiative
- Responsible party
- Sponsor
- Investigators
- Pontiano Kaleebu, MD, PhD, Study chair, Medical Research Council/Uganda Viral Research Institute (UVRI) Uganda Research Unit on AIDS, UVRI/International AIDS Vaccine Initiative HIV Vaccine Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415649
- Sponsor's protocol ID
- IAVI V002
- Other IDs
- 10419
- Status last verified
- Oct 2021
- First submitted
- 21 Dec 2006
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Barouch DH. Rational design of gene-based vaccines. J Pathol. 2006 Jan;208(2):283-9. doi: 10.1002/path.1874.
PubMed 16362986Catanzaro 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.
PubMed 17109335Moore 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.
PubMed 11390574
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00415649
- Acronym / sponsor ID
- IAVI V002
- Conditions
- HIV Infections
- Keywords
- HIV Preventive Vaccine, HIV Seronegativity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- International AIDS Vaccine Initiative
- First posted
- 25 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: VRC-HIVDNA016-00-VP, Biological: VRC-HIVADV014-00-VPDNA vaccine at baseline, Month 1, and Month 2, and the adenoviral vector vaccine at Month 6. |
| B | Placebo comparator | Biological: Vaccine placeboPlacebo vaccine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRC-HIVDNA016-00-VP | Biological | A |
| VRC-HIVADV014-00-VP | Biological | A |
| Vaccine placeboPlacebo comparator | Biological | B |
Primary outcome
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
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
2 secondary outcomes
Recruitment, enrollment, and retention rates by gender and risk category for participating trial sites
Time frame: throughout study
safety, tolerability, and immunogenicity endpoints in participants with varying pre-existing immunity to adenovirus
Time frame: throughout study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Background: PubMed 16362986Barouch DH. Rational design of gene-based vaccines. J Pathol. 2006 Jan;208(2):283-9. doi: 10.1002/path.1874.
- Background: PubMed 17109335Catanzaro 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.
- Background: PubMed 11390574Moore 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pontiano Kaleebu, MD, PhD study chair
Medical Research Council/Uganda Viral Research Institute (UVRI) Uganda Research Unit on AIDS, UVRI/International AIDS Vaccine Initiative HIV Vaccine Program
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VRC-HIVDNA016-00-VP and VRC-HIVADV014-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00415649, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.