HIV InfectionsPhase 2NCT00498056
Safety and Effectiveness of an HIV DNA Vaccine Followed by an HIV Adenoviral Vector Vaccine for Prevention of HIV Infection in the Americas and Africa
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 development of a safe and effective vaccine is the best strategy for preventing the spread of HIV-1. The purpose of this study is to determine the safety and effectiveness of and immune responses to an HIV vaccine regimen in healthy adults at risk for HIV infection. Read more about this study
- Who is it for?
- Ages 18 to 45 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, Injection or infusion
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At risk for HIV-1 sexual exposure within 24 weeks prior to study entry. More information about this criterion is available in the protocol.
- HIV uninfected within 6 weeks prior to study entry
- Willing to undergo HIV testing and counseling
- Willing to receive HIV test results
- Willing to use highly reliable method for contraception for at least the first 6 months of study
Who cannot join
- Participation in a clinical trial of another investigational product within 12 weeks prior to study entry
- Contraindication to intramuscular injections, history of bleeding disorder, or use of anticoagulant therapy in the 4 weeks prior to study entry
- Previously received an investigational HIV vaccine
- History of severe local or systemic reactogenicity to vaccines or severe allergic reactions or recurrent rash for unknown reasons in the 5 years prior to study entry
- Received an inactivated vaccine within the 2 weeks prior to study entry or of live attenuated within 4 weeks of study entry
- Received any blood products or any immunomodulatory agents within 12 weeks of study entry
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- History of cancer. Participants with a history of localized squamous cell or basal cell carcinoma of the skin are not excluded.
- History of clinically significant autoimmune disease or immune deficiency syndrome
- Use of immunosuppressive medications within 24 weeks of study entry. Participants who have completed a short course of steroids more than 2 weeks prior to study entry, or using inhaled or topical steroids are not excluded.
- Seizure disorder. Participants who have had seizures with fever under the age of 2, seizures secondary to alcohol withdrawal more than 3 years prior to study entry, or a singular seizure more than 3 years ago that has not recurred or required treatment within the last 3 years are not excluded.
- Any medical condition or acute medical illness that, in the opinion of the investigator, would interfere with the study
- Pregnancy, plan to become pregnant, or breastfeeding
About this study
Official title: A Phase IIB Test-of-Concept, Randomized, Double-Blind, Placebo-Controlled, International Clinical Trial to Evaluate the Efficacy, Safety, and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in HIV Uninfected Persons
The development of a safe and effective vaccine is the best strategy for preventing the spread of HIV-1. The purpose of this study is to determine the safety and effectiveness of and immune responses to an HIV vaccine regimen in healthy adults at risk for HIV infection.
Read the detailed description
The number of people infected by HIV-1 worldwide continues to increase. However, antiretroviral therapy is largely unavailable in low- and middle- income countries where risk of infection is very high. The development of a safe and effective vaccine to prevent HIV infection is urgently needed. This study will evaluate the effectiveness, safety, and immunogenicity of an experimental multiclade HIV vaccine, VRC-HIVDNA016-00-VP, followed by an adenovirus-vectored vaccine boost, VRC-HIVADV014-00-VP, in HIV uninfected adults. Both vaccines code for proteins from HIV subtypes A, B, and C, which together represent 75% to 85% of new HIV infections in the world. Adenoviral type 5-based vaccines have improved induction of HIV-specific CD8 cytotoxic T-lymphocyte cell responses, which correlate with lower HIV burden (viral load) and slower disease progression in primates and in HIV-1 infected people whose disease does not progress over the long term. The purpose of this study is to determine the safety and effectiveness of and immune response to a series of multiclade DNA vaccine injections followed by a booster injection of a multiclade adenovirus vaccine against HIV-1 infection in healthy adults at risk for HIV infection in North and South America, the Caribbean, and Africa.
This study will last from about 3 years to 5 years, because the length of the study depends on how quickly people enroll and how quickly during the study new HIV-1 infections occur. Study participants will be randomly assigned to receive a total of three injections of the DNA vaccine VRC-HIVDNA016-00-VP followed by one injection of the adenovirus vaccine VRC-HIVADV014-00-VP, for a total of four injections of vaccine or four injections of placebo. Injections will occur at study entry and Weeks 4, 8, and 24. Prior to the study injections, participants will have their vital signs and weight measured, and blood collection will occur. Participants will be observed in the clinic for at least 30 minutes after each injection for immediate reactions to the vaccines. At all injection visits, HIV risk-reduction counseling, HIV risk assessment, pregnancy prevention counseling, and training on how to use memory cards will also occur. For 3 to 7 days after each injection, participants will be asked to record information about injection site pain, redness, size, swelling, temperature, general well-being, and headaches on their memory cards. Additional study visits will occur on Weeks 1, 12, 28, 48, 72, 96, 120, and 144. At these visits, physical examinations, blood collection, and social impact questionnaires may also be done. Any study participants who become infected with HIV while on the study will be monitored for at least 72 weeks after diagnosis or at least 12 weeks after the study reaches its primary evaluation time point (whichever is longer). The study investigators are committed to providing access to local standard of care and treatment to those study participants who are found to be HIV-1 infected.
- Conditions
- HIV Infections
- Being tested
- VRC-HIVDNA016-00-VP, VRC-HIVADV014-00-VP, VRC-HIVDNA016-00-VP placebo, VRC-HIVADV014-00-VP placebo
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine
- 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
DNA vaccine administered intramuscularly
VRC-HIVADV014-00-VPBiological
Adenovirus vaccine administered intramuscularly
VRC-HIVDNA016-00-VP placeboBiological
DNA vaccine placebo administered intramuscularly
VRC-HIVADV014-00-VP placeboBiological
Adenovirus vaccine placebo administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive a total of three injections of the DNA vaccine VRC-HIVDNA016-00-VP followed by one injection of the adenovirus vaccine VRC-HIVADV014-00-VP. Injections will occur at study entry and Weeks 4, 8, and 24. Receives: Biological: VRC-HIVDNA016-00-VP; Biological: VRC-HIVADV014-00-VP |
| 2 | Placebo comparator | Participants will receive a total of three injections of the DNA vaccine VRC-HIVDNA016-00-VP placebo followed by one injection of the adenovirus vaccine VRC-HIVADV014-00-VP placebo. Injections will occur at study entry and Weeks 4, 8, and 24. Receives: Biological: VRC-HIVDNA016-00-VP placebo; Biological: VRC-HIVADV014-00-VP placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquisition of HIV infection, reduction in viral load in those who become infected, and adverse events (AEs)
Measured: At 26 weeks or later from study entry and from first study injection for AEs
Seroconversion with HIV RNA or HIV DNA detection, average of two viral load measurements, and AEs graded on the DAIDS AE Grading Table
Measured: Early after diagnosis of HIV infection and throughout the study for AEs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Centers for Disease Control and Prevention, HIV Vaccine Trials Network, International AIDS Vaccine Initiative, US Military HIV Research Program, Vaccine Research Center
- Responsible party
- Sponsor
- Investigators
- Scott M. Hammer, MD, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498056
- Sponsor's protocol ID
- PAVE 100
- Other IDs
- 10500
- Status last verified
- Oct 2021
- First submitted
- 5 Jul 2007
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. doi: 10.2174/1566524033479825.
PubMed 12699356Gaschen B, Taylor J, Yusim K, Foley B, Gao F, Lang D, Novitsky V, Haynes B, Hahn BH, Bhattacharya T, Korber B. Diversity considerations in HIV-1 vaccine selection. Science. 2002 Jun 28;296(5577):2354-60. doi: 10.1126/science.1070441.
PubMed 12089434Johnston MI, Fauci AS. An HIV vaccine--evolving concepts. N Engl J Med. 2007 May 17;356(20):2073-81. doi: 10.1056/NEJMra066267. No abstract available.
PubMed 17507706Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. doi: 10.2174/1389450043490686.
PubMed 14738219
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 IIB Test-of-Concept, Randomized, Double-Blind, Placebo-Controlled, International Clinical Trial to Evaluate the Efficacy, Safety, and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in HIV Uninfected Persons
- ClinicalTrials.gov ID
- NCT00498056
- Acronym / sponsor ID
- PAVE 100
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine
- 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
- Centers for Disease Control and Prevention, HIV Vaccine Trials Network, International AIDS Vaccine Initiative, US Military HIV Research Program, Vaccine Research Center
- First posted
- 9 Jul 2007 (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 development of a safe and effective vaccine is the best strategy for preventing the spread of HIV-1. The purpose of this study is to determine the safety and effectiveness of and immune responses to an HIV vaccine regimen in healthy adults at risk for HIV infection.
Detailed description
The number of people infected by HIV-1 worldwide continues to increase. However, antiretroviral therapy is largely unavailable in low- and middle- income countries where risk of infection is very high. The development of a safe and effective vaccine to prevent HIV infection is urgently needed. This study will evaluate the effectiveness, safety, and immunogenicity of an experimental multiclade HIV vaccine, VRC-HIVDNA016-00-VP, followed by an adenovirus-vectored vaccine boost, VRC-HIVADV014-00-VP, in HIV uninfected adults. Both vaccines code for proteins from HIV subtypes A, B, and C, which together represent 75% to 85% of new HIV infections in the world. Adenoviral type 5-based vaccines have improved induction of HIV-specific CD8 cytotoxic T-lymphocyte cell responses, which correlate with lower HIV burden (viral load) and slower disease progression in primates and in HIV-1 infected people whose disease does not progress over the long term. The purpose of this study is to determine the safety and effectiveness of and immune response to a series of multiclade DNA vaccine injections followed by a booster injection of a multiclade adenovirus vaccine against HIV-1 infection in healthy adults at risk for HIV infection in North and South America, the Caribbean, and Africa.
This study will last from about 3 years to 5 years, because the length of the study depends on how quickly people enroll and how quickly during the study new HIV-1 infections occur. Study participants will be randomly assigned to receive a total of three injections of the DNA vaccine VRC-HIVDNA016-00-VP followed by one injection of the adenovirus vaccine VRC-HIVADV014-00-VP, for a total of four injections of vaccine or four injections of placebo. Injections will occur at study entry and Weeks 4, 8, and 24. Prior to the study injections, participants will have their vital signs and weight measured, and blood collection will occur. Participants will be observed in the clinic for at least 30 minutes after each injection for immediate reactions to the vaccines. At all injection visits, HIV risk-reduction counseling, HIV risk assessment, pregnancy prevention counseling, and training on how to use memory cards will also occur. For 3 to 7 days after each injection, participants will be asked to record information about injection site pain, redness, size, swelling, temperature, general well-being, and headaches on their memory cards. Additional study visits will occur on Weeks 1, 12, 28, 48, 72, 96, 120, and 144. At these visits, physical examinations, blood collection, and social impact questionnaires may also be done. Any study participants who become infected with HIV while on the study will be monitored for at least 72 weeks after diagnosis or at least 12 weeks after the study reaches its primary evaluation time point (whichever is longer). The study investigators are committed to providing access to local standard of care and treatment to those study participants who are found to be HIV-1 infected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: VRC-HIVDNA016-00-VP, Biological: VRC-HIVADV014-00-VPParticipants will receive a total of three injections of the DNA vaccine VRC-HIVDNA016-00-VP followed by one injection of the adenovirus vaccine VRC-HIVADV014-00-VP. Injections will occur at study entry and Weeks 4, 8, and 24. |
| 2 | Placebo comparator | Biological: VRC-HIVDNA016-00-VP placebo, Biological: VRC-HIVADV014-00-VP placeboParticipants will receive a total of three injections of the DNA vaccine VRC-HIVDNA016-00-VP placebo followed by one injection of the adenovirus vaccine VRC-HIVADV014-00-VP placebo. Injections will occur at study entry and Weeks 4, 8, and 24. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- At risk for HIV-1 sexual exposure within 24 weeks prior to study entry. More information about this criterion is available in the protocol.
- HIV uninfected within 6 weeks prior to study entry
- Willing to undergo HIV testing and counseling
- Willing to receive HIV test results
- Willing to use highly reliable method for contraception for at least the first 6 months of study
Key exclusion criteria (12 listed)
- Participation in a clinical trial of another investigational product within 12 weeks prior to study entry
- Contraindication to intramuscular injections, history of bleeding disorder, or use of anticoagulant therapy in the 4 weeks prior to study entry
- Previously received an investigational HIV vaccine
- History of severe local or systemic reactogenicity to vaccines or severe allergic reactions or recurrent rash for unknown reasons in the 5 years prior to study entry
- Received an inactivated vaccine within the 2 weeks prior to study entry or of live attenuated within 4 weeks of study entry
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-VPDNA vaccine administered intramuscularly | Biological | 1 |
| VRC-HIVADV014-00-VPAdenovirus vaccine administered intramuscularly | Biological | 1 |
| VRC-HIVDNA016-00-VP placeboDNA vaccine placebo administered intramuscularly | Biological | 2 |
| VRC-HIVADV014-00-VP placeboAdenovirus vaccine placebo administered intramuscularly | Biological | 2 |
Primary outcome
Acquisition of HIV infection, reduction in viral load in those who become infected, and adverse events (AEs)
Time frame: At 26 weeks or later from study entry and from first study injection for AEs
Seroconversion with HIV RNA or HIV DNA detection, average of two viral load measurements, and AEs graded on the DAIDS AE Grading Table
Time frame: Early after diagnosis of HIV infection and throughout the study for AEs
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 12699356Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. doi: 10.2174/1566524033479825.
- Background: PubMed 12089434Gaschen B, Taylor J, Yusim K, Foley B, Gao F, Lang D, Novitsky V, Haynes B, Hahn BH, Bhattacharya T, Korber B. Diversity considerations in HIV-1 vaccine selection. Science. 2002 Jun 28;296(5577):2354-60. doi: 10.1126/science.1070441.
- Background: PubMed 17507706Johnston MI, Fauci AS. An HIV vaccine--evolving concepts. N Engl J Med. 2007 May 17;356(20):2073-81. doi: 10.1056/NEJMra066267. No abstract available.
- Background: PubMed 14738219Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. doi: 10.2174/1389450043490686.
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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.
Scott M. Hammer, MD study chair
Columbia University
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 12 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?
Acquisition of HIV infection, reduction in viral load in those who become infected, and adverse events (AEs) (time frame: At 26 weeks or later from study entry and from first study injection for AEs). 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 NCT00498056, which also lists 4 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.