HIV NegativePhase 1NCT01386489
Immune Responses to Two Experimental HIV Vaccines in Healthy Adults
A Phase 1 study testing VRC-HIVDNA016-00-VP and VRC-HIVADV014-00-VP in people with HIV Negative and Adaptive Immunity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response to two experimental HIV vaccines currently in development at the VRC. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- HIV Negative, Adaptive Immunity, Innate Immunity
- What is being tested?
- VRC-HIVDNA016-00-VP and VRC-HIVADV014-00-VP
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2011to 19 Mar 2014
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult
Who may be able to join
- A volunteer must meet all of the following criteria:
- 18 to 50 years old.
- No prior vaccinations with an HIV vaccine or adenoviral vector vaccine.
- Available for clinical follow-up for up to 36 weeks after enrollment and committed to follow-up contacts through 144 weeks after enrollment.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Able and willing to complete the informed consent process.
Show all 32Show fewer
- Willing to donate oral, rectal and genital secretion samples and blood samples for research that will be stored and used for future research.
- Willing to discuss HIV infection risks with the study clinicians, assessed as low risk for HIV infection, amenable to HIV risk reduction counseling, and committed to maintaining behavior consistent with low risk of HIV exposure through the last required clinic visit in the protocol schedule.
- In good general health without clinically significant medical history.
- Physical examination and laboratory results without clinically significant findings and a weight 50 kg or more with body mass index (BMI) less than or equal to 40 within the 56 days prior to enrollment.
- Laboratory Criteria within 56 days prior to enrollment:
- Hemoglobin greater than or equal to 11.2 g/dL for women; greater than or equal to 13.0 g/dL for men.
- White blood cells (WBC) = 3,000-12,000 cells/mm(3).
- Differential and platelet count either within institutional normal range or accompanied by site physician approval.
- Alanine aminotransferase (ALT) less than or equal to 1.75 times upper limit of normal.
- HIV-uninfected as evidenced by a negative FDA-approved HIV diagnostic blood test or negative HIV polymerase chain reaction (PCR) test.
- Seronegative (defined as less than 1:12) for adenovirus serotype 5 antibody as measured by the NVITAL assay within 84 days (12 weeks) prior to enrollment.
- Male-Specific Criterion:
- A male participant must be fully circumcised as assessed by screening physical examination.
- Female-Specific Criteria:
- Negative Beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.
- A female participant must meet any of the following pregnancy prevention criteria:
- No reproductive potential because of menopause [one year without menses] or because of tubal ligation,
- or
- Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and through 12 weeks after the last vaccination on the study schedule,
- or
- Participant agrees to consistently practice contraception at least 21 days prior to enrollment and through 12 weeks after the last vaccination on the study schedule by one of the following methods:
- condoms, male or female, with or without a spermicide
- diaphragm or cervical cap with spermicide
- intrauterine device
- contraceptive pills or patch, vaginal ring, injection or other FDA-approved contraceptive method
- male partner has previously undergone a vasectomy.
Who cannot join
- A volunteer will be excluded if one or more of the following conditions apply:
- Woman who is breast-feeding or planning to become pregnant during study participation.
- Woman who is known to not have a cervix or who report having a clinically significant abnormal Pap smear without a subsequent normal result.
- Volunteer has received any of the following substances:
- Systemic immunosuppressive medications or cytotoxic medications within the 12 weeks prior to enrollment. [With the exception that a short course (duration of 10 days or less or a single injection) of corticosteroids for a self-limited condition at least 2 weeks prior to enrollment in the study will not exclude study participation.]
- Blood products or immunoglobulin within 56 days (8 weeks) prior to enrollment.
Show all 25Show fewer
- Investigational research agents within 28 days (4 weeks) prior to enrollment.
- Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.
- Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days (2 weeks) prior to enrollment.
- Current anti-tuberculosis prophylaxis or therapy.
- Volunteer has a history of any of the following clinically significant conditions:
- Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
- Clinically significant autoimmune disease or immunodeficiency.
- Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.
- Diabetes mellitus (type I or II), with the exception of gestational diabetes.
- Thyroid disease that is not well controlled.
- A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
- Generalized idiopathic urticaria within the 1 year prior to enrollment.
- Hypertension that is not well controlled by medication.
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
- Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study.
- Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years.
- Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
- Psychiatric condition that precludes compliance with the protocol; past or present psychoses; disorder requiring lithium; or within five years prior to enrollment, history of a suicide plan or attempt.
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer s ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: VRC 016: A Phase 1b Open-Label, Randomized Clinical Trial to Evaluate Early Innate and Adaptive Immune Responses to the Investigational HIV-1 Vaccines: VRC-HIVADV014-00-VP and VRC-HIVDNA016-00-VP in Ad5 Seronegative Healthy Adults
Background:
The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response to two experimental HIV vaccines currently in development at the VRC. One is known as the rAd5 vaccine and the other is known as the DNA vaccine. These vaccines are made with pieces of manufactured DNA. They do not contain live or killed HIV. It is impossible for study vaccines to give you HIV and they cannot cause you to give HIV to someone else. Both of these experimental vaccines have been given to people before in other research studies. They have not been approved for treating or preventing HIV infection.
Read more
Purpose:
The main purpose of this study is to look in detail at the body s immune responses after the experimental HIV vaccines are given and to assess safety of the study vaccines.
Eligibility:
Healthy volunteers between the ages of 18 and 50 who are not infected with HIV and who meet the eligibility requirements.
Design:
Participants will be screened with a medical history (including questions about sexual history and drug use), physical exam, and blood tests.
The study will have two groups:
<TAB>One group will receive one injection of the rAd5 vaccine, and have 8 clinic visits over 3 months.
<TAB>The second group will have three injections of the DNA vaccine, one injection of the rAd5 vaccine, and have 12 clinic visits over 6 months.
All participants will be asked to provide blood and body fluid samples for testing during the study.
Payment for participation will be provided....
Read the detailed description
Study Design:
This is a hypothesis-generating descriptive study to evaluate the kinetics and pattern of early innate and adaptive immune responses to the VRC recombinant adenoviral vector serotype 5 vaccine, VRC-HIVADV014-00-VP (rAd5). The rAd5 vaccine has been previously administered to more than 1000 study subjects and characterized as safe and immunogenic. A difference in the pattern of vaccine antigen-specific immune responses observed when rAd5 is given as a single agent compared to after priming by a 6-plasmid DNA vaccine, VRCHIVDNA016-00-VP, has previously been reported. This study will randomize vaccine-naive subjects to receive a single injection of rAd5 or to the DNA primerAd5 boost regimen that is now in a large Phase II study. Collection of blood, rectal, oral and genital specimens for characterization of early innate and adaptive immune responses will follow receipt of rAd5. The hypothesis is that the pattern of early innate and adaptive immune responses elicited by the rAd5 vaccine administered after priming with DNA vaccine will be distinctly different from the pattern elicited when rAd5 is administered as a single agent. The primary objectives are to describe the kinetics and pattern of early innate and adaptive immune responses that occur in blood samples early after administration of rAd5 vaccine alone and after administration following 3 DNA prime injections. Secondary and exploratory objectives are related safety, as well as the pattern of immune responses in mucosal samples and in blood samples.
Product Description:
VRC-HIVDNA016-00-VP [6-plasmid DNA vaccine] is composed of 6 closed, circular DNA plasmids that encode for HIV-1 Gag, Pol and Nef proteins (from clade B) and Env glycoproteins from clade A, clade B, and clade C, which are combined in equal proportions. All injections will be at 4 mg dose in a 1 mL volume administered intramuscularly (IM) by Biojector (registered trademark) into deltoid muscle.
VRC-HIVADV014-00-VP (rAd5 vaccine) is composed of 4 recombinant nonreplicating adenoviral vectors that encode for HIV-1 Gag/Pol polyproteins (from clade B) and Env glycoproteins from clade A, clade B, and clade C, which are combined in a 3:1:1:1 ratio, respectively, in a final formulation buffer (FFB). All injections will be at 10(10) PU dose in a 1 mL volume administered IM by needle and syringe into deltoid muscle.
Subjects:
The study target accrual is at least 20 subjects who complete collection of blood, oral, rectal and genital specimens through 2 weeks after the rAd5 vaccination. To account for potential discontinuations from the study, enrollment may include up to 36 HIV-uninfected adults, ages 18-50 years old that are HIV vaccine-naive and adenovirus serotype 5 (Ad5) antibody negative at screening; males must be fully circumcised.
Study Plan:
Subjects will be randomized at a 1:1 ratio to receive a single injection of rAd5 or the DNA prime-rAd5 boost schedule and will be stratified by gender to achieve approximately equal distribution of each gender into the two vaccination schedules. Subjects randomized to Group 1 may receive the vaccination on enrollment day or schedule the day of vaccination to occur within 6 weeks followed by the expected 24 hours in the inpatient unit and day 3 post-vaccination sample collections for the frequent sampling that will immediately ensue according to the sample collection schedule. Subjects randomized to Group 2 will receive the first of three DNA vaccinations and schedule projected dates for the subsequent injections and timepoints with intensive sample collection schedules. Due to the need to commit to about 3 days of disruption in normal daily activities, starting with the day of rAd5 vaccination on either schedule, flexibility in scheduling of the rAd5 vaccination is included in the protocol plan.
Subjects from both groups will be admitted to the NIH Clinical Center overnight for the first 24 hours following vaccination with rAd5. On the rAd5 vaccination day, peripheral blood samples will be collected for serum, plasma and peripheral blood mononuclear cells at seven target time points in the first 24 hours as follows: pre-injection and post-injection hours 1, 3, 6, 12, 18 and 24; then days 3, 5, 7, 14 and 28 post-rAd5 vaccine. Mucosal sampling will occur on day 14 after rAd5 vaccine. This will include buccal mucosa, rectal secretions, cervical secretions (from women) and semen samples (from men). There will be a blood collection to assess innate immunity following the 3rd DNA vaccination in Group 2 with blood draws at pre-injection and at post-injection hours 1, 3, 6 and 18.
The safety of vaccinations and the research plan will be monitored by a protocol safety review team.
Study Duration:
Subjects will be followed in the clinic through 12 weeks after last study injection and contacted for long term follow-up 12 weeks later and then every 48 weeks through Study Week 144.
- Conditions
- HIV Negative, Adaptive Immunity, Innate Immunity
- Being tested
- VRC-HIVDNA016-00-VP, VRC-HIVADV014-00-VP
- Keywords
- HIV-uninfected, Mucosal Immunity, Kinetics, Cytokines, Chemokines, Healthy Volunteer, HV
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
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the kinetics and patterns over the time of innate and adaptive immunologic responses in peripheral blood as well as the pattern of adaptive immune responses at a single timepoint in mucosal samples following vaccination with the rAd5...
Secondary outcomes (1)
To assess the safety and tolerability of the investigational vaccines.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study start17 Jun 2011
- Primary completion9 Mar 2014
- Study completion19 Mar 2014
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 NegativeStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Julie E Ledgerwood, D.O., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386489
- Sponsor's protocol ID
- 110197
- Other IDs
- 11-I-0197
- Status last verified
- 19 Mar 2014
- First submitted
- 30 Jun 2011
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
McElrath MJ, Haynes BF. Induction of immunity to human immunodeficiency virus type-1 by vaccination. Immunity. 2010 Oct 29;33(4):542-54. doi: 10.1016/j.immuni.2010.09.011.
PubMed 21029964Borrow P, Shattock RJ, Vyakarnam A; EUROPRISE Working Group. Innate immunity against HIV: a priority target for HIV prevention research. Retrovirology. 2010 Oct 11;7:84. doi: 10.1186/1742-4690-7-84.
PubMed 20937128Koup RA, Roederer M, Lamoreaux L, Fischer J, Novik L, Nason MC, Larkin BD, Enama ME, Ledgerwood JE, Bailer RT, Mascola JR, Nabel GJ, Graham BS; VRC 009 Study Team; VRC 010 Study Team. Priming immunization with DNA augments immunogenicity of recombinant adenoviral vectors for both HIV-1 specific antibody and T-cell responses. PLoS One. 2010 Feb 2;5(2):e9015. doi: 10.1371/journal.pone.0009015.
PubMed 20126394
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VRC 016: A Phase 1b Open-Label, Randomized Clinical Trial to Evaluate Early Innate and Adaptive Immune Responses to the Investigational HIV-1 Vaccines: VRC-HIVADV014-00-VP and VRC-HIVDNA016-00-VP in Ad5 Seronegative Healthy Adults
- ClinicalTrials.gov ID
- NCT01386489
- Acronym / sponsor ID
- 110197
- Conditions
- HIV Negative, Adaptive Immunity, Innate Immunity
- Keywords
- HIV-uninfected, Mucosal Immunity, Kinetics, Cytokines, Chemokines, Healthy Volunteer, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 17 Jun 2011
- Primary completion
- 9 Mar 2014 (actual)
- Study completion
- 19 Mar 2014 (actual)
- First posted
- 1 Jul 2011 (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.
Background:
The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response to two experimental HIV vaccines currently in development at the VRC. One is known as the rAd5 vaccine and the other is known as the DNA vaccine. These vaccines are made with pieces of manufactured DNA. They do not contain live or killed HIV. It is impossible for study vaccines to give you HIV and they cannot cause you to give HIV to someone else. Both of these experimental vaccines have been given to people before in other research studies. They have not been approved for treating or preventing HIV infection.
Purpose:
The main purpose of this study is to look in detail at the body s immune responses after the experimental HIV vaccines are given and to assess safety of the study vaccines.
Eligibility:
Healthy volunteers between the ages of 18 and 50 who are not infected with HIV and who meet the eligibility requirements.
Design:
Participants will be screened with a medical history (including questions about sexual history and drug use), physical exam, and blood tests.
The study will have two groups:
<TAB>One group will receive one injection of the rAd5 vaccine, and have 8 clinic visits over 3 months.
<TAB>The second group will have three injections of the DNA vaccine, one injection of the rAd5 vaccine, and have 12 clinic visits over 6 months.
All participants will be asked to provide blood and body fluid samples for testing during the study.
Payment for participation will be provided....
Detailed description
Study Design:
This is a hypothesis-generating descriptive study to evaluate the kinetics and pattern of early innate and adaptive immune responses to the VRC recombinant adenoviral vector serotype 5 vaccine, VRC-HIVADV014-00-VP (rAd5). The rAd5 vaccine has been previously administered to more than 1000 study subjects and characterized as safe and immunogenic. A difference in the pattern of vaccine antigen-specific immune responses observed when rAd5 is given as a single agent compared to after priming by a 6-plasmid DNA vaccine, VRCHIVDNA016-00-VP, has previously been reported. This study will randomize vaccine-naive subjects to receive a single injection of rAd5 or to the DNA primerAd5 boost regimen that is now in a large Phase II study. Collection of blood, rectal, oral and genital specimens for characterization of early innate and adaptive immune responses will follow receipt of rAd5. The hypothesis is that the pattern of early innate and adaptive immune responses elicited by the rAd5 vaccine administered after priming with DNA vaccine will be distinctly different from the pattern elicited when rAd5 is administered as a single agent. The primary objectives are to describe the kinetics and pattern of early innate and adaptive immune responses that occur in blood samples early after administration of rAd5 vaccine alone and after administration following 3 DNA prime injections. Secondary and exploratory objectives are related safety, as well as the pattern of immune responses in mucosal samples and in blood samples.
Product Description:
VRC-HIVDNA016-00-VP [6-plasmid DNA vaccine] is composed of 6 closed, circular DNA plasmids that encode for HIV-1 Gag, Pol and Nef proteins (from clade B) and Env glycoproteins from clade A, clade B, and clade C, which are combined in equal proportions. All injections will be at 4 mg dose in a 1 mL volume administered intramuscularly (IM) by Biojector (registered trademark) into deltoid muscle.
VRC-HIVADV014-00-VP (rAd5 vaccine) is composed of 4 recombinant nonreplicating adenoviral vectors that encode for HIV-1 Gag/Pol polyproteins (from clade B) and Env glycoproteins from clade A, clade B, and clade C, which are combined in a 3:1:1:1 ratio, respectively, in a final formulation buffer (FFB). All injections will be at 10(10) PU dose in a 1 mL volume administered IM by needle and syringe into deltoid muscle.
Subjects:
The study target accrual is at least 20 subjects who complete collection of blood, oral, rectal and genital specimens through 2 weeks after the rAd5 vaccination. To account for potential discontinuations from the study, enrollment may include up to 36 HIV-uninfected adults, ages 18-50 years old that are HIV vaccine-naive and adenovirus serotype 5 (Ad5) antibody negative at screening; males must be fully circumcised.
Study Plan:
Subjects will be randomized at a 1:1 ratio to receive a single injection of rAd5 or the DNA prime-rAd5 boost schedule and will be stratified by gender to achieve approximately equal distribution of each gender into the two vaccination schedules. Subjects randomized to Group 1 may receive the vaccination on enrollment day or schedule the day of vaccination to occur within 6 weeks followed by the expected 24 hours in the inpatient unit and day 3 post-vaccination sample collections for the frequent sampling that will immediately ensue according to the sample collection schedule. Subjects randomized to Group 2 will receive the first of three DNA vaccinations and schedule projected dates for the subsequent injections and timepoints with intensive sample collection schedules. Due to the need to commit to about 3 days of disruption in normal daily activities, starting with the day of rAd5 vaccination on either schedule, flexibility in scheduling of the rAd5 vaccination is included in the protocol plan.
Subjects from both groups will be admitted to the NIH Clinical Center overnight for the first 24 hours following vaccination with rAd5. On the rAd5 vaccination day, peripheral blood samples will be collected for serum, plasma and peripheral blood mononuclear cells at seven target time points in the first 24 hours as follows: pre-injection and post-injection hours 1, 3, 6, 12, 18 and 24; then days 3, 5, 7, 14 and 28 post-rAd5 vaccine. Mucosal sampling will occur on day 14 after rAd5 vaccine. This will include buccal mucosa, rectal secretions, cervical secretions (from women) and semen samples (from men). There will be a blood collection to assess innate immunity following the 3rd DNA vaccination in Group 2 with blood draws at pre-injection and at post-injection hours 1, 3, 6 and 18.
The safety of vaccinations and the research plan will be monitored by a protocol safety review team.
Study Duration:
Subjects will be followed in the clinic through 12 weeks after last study injection and contacted for long term follow-up 12 weeks later and then every 48 weeks through Study Week 144.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (32 listed)
- 18 to 50 years old.
- No prior vaccinations with an HIV vaccine or adenoviral vector vaccine.
- Available for clinical follow-up for up to 36 weeks after enrollment and committed to follow-up contacts through 144 weeks after enrollment.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Able and willing to complete the informed consent process.
Key exclusion criteria (25 listed)
- Woman who is breast-feeding or planning to become pregnant during study participation.
- Woman who is known to not have a cervix or who report having a clinically significant abnormal Pap smear without a subsequent normal result.
- Systemic immunosuppressive medications or cytotoxic medications within the 12 weeks prior to enrollment. [With the exception that a short course (duration of 10 days or less or a single injection) of corticosteroids for a self-limited condition at least 2 weeks prior to enrollment in the study will not exclude study participation.]
- Blood products or immunoglobulin within 56 days (8 weeks) prior to enrollment.
- Investigational research agents within 28 days (4 weeks) prior to enrollment.
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 | – |
| VRC-HIVADV014-00-VP | Biological | – |
Primary outcome
To describe the kinetics and patterns over the time of innate and adaptive immunologic responses in peripheral blood as well as the pattern of adaptive immune responses at a single timepoint in mucosal samples following vaccination with the rAd5...
1 secondary outcome
To assess the safety and tolerability of the investigational vaccines.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Background: PubMed 21029964McElrath MJ, Haynes BF. Induction of immunity to human immunodeficiency virus type-1 by vaccination. Immunity. 2010 Oct 29;33(4):542-54. doi: 10.1016/j.immuni.2010.09.011.
- Background: PubMed 20937128Borrow P, Shattock RJ, Vyakarnam A; EUROPRISE Working Group. Innate immunity against HIV: a priority target for HIV prevention research. Retrovirology. 2010 Oct 11;7:84. doi: 10.1186/1742-4690-7-84.
- Background: PubMed 20126394Koup RA, Roederer M, Lamoreaux L, Fischer J, Novik L, Nason MC, Larkin BD, Enama ME, Ledgerwood JE, Bailer RT, Mascola JR, Nabel GJ, Graham BS; VRC 009 Study Team; VRC 010 Study Team. Priming immunization with DNA augments immunogenicity of recombinant adenoviral vectors for both HIV-1 specific antibody and T-cell responses. PLoS One. 2010 Feb 2;5(2):e9015. doi: 10.1371/journal.pone.0009015.
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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.
Julie E Ledgerwood, D.O. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRC-HIVDNA016-00-VP and VRC-HIVADV014-00-VP in people with HIV Negative and Adaptive Immunity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 32 inclusion and 25 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: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To describe the kinetics and patterns over the time of innate and adaptive immunologic responses in peripheral blood as well as the pattern of adaptive immune responses at a single timepoint in mucosal samples following vaccination with the rAd5.... 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 NCT01386489, 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 16 Dec 2019.