HIV InfectionsPhase 2NCT00820846
Safety of and Immune Response to a Prime-Boost Vaccine Regimen in HIV-Uninfected Vaccine-Naive Adults
A Phase 2 study testing pGA2/JS7 DNA vaccine and MVA/HIV62 vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety of and immune response to a two-vaccine regimen in healthy, HIV-uninfected adults who have never received an HIV preventive vaccine before. 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?
- pGA2/JS7 DNA vaccine and MVA/HIV62 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 299 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Jan 2009to Sep 2014
- 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
- Access to a participating HIV Vaccine Trials Network (HVTN) clinical research center and willing to be followed for the planned duration of the study
- Ability and willingness to provide informed consent
- Assessment of understanding: completion of a questionnaire prior to first vaccination; demonstration of understanding for all questionnaire items answered incorrectly
- Willingness to receive HIV test results
- Good general health as shown by medical history, physical exam, and screening laboratory tests
- Certain specified laboratory values. More information on this criterion can be found in the study protocol.
Show all 9Show fewer
- If pregnancy is possible, must agree to use contraception from at least 21 days prior to enrollment through the last protocol visit for sexual activity that could lead to pregnancy. More information on this criterion can be found in the study protocol.
- Willingness to discuss HIV infection risks, amenable to HIV risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit, and willing to continue annual follow-up contact after the last required protocol clinic visit for a total of 5 years following enrollment
- Assessed by clinic staff as being at "low risk" of HIV infection on the basis of sexual behaviors within the 12 months prior to enrollment. More information on this criterion can be found in the study protocol.
Who cannot join
- HIV vaccine(s) or other experimental vaccines, received in a prior HIV vaccine trial. More information on this criterion can be found in the study protocol.
- Receipt of smallpox vaccination
- Excessive alcohol use, frequent binge drinking, chronic marijuana abuse, or use of any other illicit drugs, such as cocaine or methamphetamine, within the past 12 months
- History of newly acquired or newly diagnosed syphilis; history of newly acquired gonorrhea, nongonococcal urethritis, herpes simplex virus type 2 (HSV2), chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis,epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B within the past 12 months
- Immunosuppressive medication received within 168 days before first vaccination. Certain medications are excluded from this criterion; more information can be found in the study protocol.
- Blood products received within 120 days before first vaccination
Show all 32Show fewer
- Immunoglobulin received within 60 days before first vaccination
- Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection
- Influenza vaccine or any vaccines that are not live attenuated and were received within 14 days prior to first vaccination or that are scheduled within 14 days after injection
- Allergy treatment with antigen injections within 30 days before first vaccination or scheduled within 14 days after injection
- Intent to participate in another study of an investigational research agent during the planned duration of this study
- Current anti-tuberculosis (TB) prophylaxis or therapy
- Clinically significant medical condition. More information on this criterion can be found in the study protocol.
- Any medical, psychiatric, or social condition or occupational or other responsibility that in the opinion of the investigator might interfere with the study protocol
- Serious adverse reactions to vaccines. More information on this criterion can be found in the study protocol.
- Allergy to eggs and/or egg products
- History of or known active cardiac disease. More information on this criterion can be found in the study protocol.
- Participants who have two or more of the following cardiac risk factors: (1) participant report of history of elevated blood cholesterol defined as fasting low-density lipoprotein (LDL) greater than 160 mg/dL; (2) first degree relative (e.g., mother, father, sister, or brother) who had coronary artery disease before the age of 50 years; (3) current smoker; or (4) body mass index greater than or equal to 35.
- Electrocardiogram (ECG) with clinically significant findings. More information on this criterion can be found in the study protocol.
- Autoimmune disease
- Immunodeficiency
- Asthma other than mild, well-controlled asthma. More information on this criterion can be found in the study protocol.
- Diabetes mellitus, type 1 or type 2, including cases controlled with diet alone. Those with a history of isolated gestational diabetes are not excluded.
- Thyroidectomy or thyroid disease requiring medication during the last 12 months
- Angioedema within the last 3 years if episodes are considered serious or have required medication within the last 2 years
- Hypertension. More information on this criterion can be found in the study protocol.
- Body mass index greater than or equal to 40
- Bleeding disorder diagnosed by a doctor
- Malignancy. Participants with surgical excisions and subsequent observation periods, that in the investigator's estimation have a reasonable assurance of sustained cure or are unlikely to recur during the period of study, are not excluded.
- Seizure disorder, unless the participant has not required medication or had a seizure within the last 3 years.
- Asplenia
- Pregnant or breastfeeding
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States10 sites
Alabama CRS
Birmingham, Alabama, 35294
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, 02115-6110
Fenway Health (FH) CRS
Boston, Massachusetts, 02215-4302
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, 30030
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, 37232-2582
Columbia P&S CRS
New York, New York, 10032-3732
New York Blood Center CRS
New York, New York, 10065
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, 14642
Bridge HIV CRS
San Francisco, California, 94143
Seattle Vaccine and Prevention CRS
Seattle, Washington, 98109-1024
About this study
Official title: A Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of pGA2/JS7 DNA and MVA/HIV62, in Healthy, HIV Uninfected Vaccinia-naive Adult Participants
The purpose of this study is to evaluate the safety of and immune response to a two-vaccine regimen in healthy, HIV-uninfected adults who have never received an HIV preventive vaccine before.
Read the detailed description
Some of the first HIV vaccines were designed to trigger neutralizing antibody responses as a way to prevent HIV infection. Unfortunately, the first versions of these vaccines were not able to achieve their desired response. An alternative strategy to the antibody approach is the stimulation of HIV-specific CD8 T-lymphocyte (CTL) responses. CTL responses were previously demonstrated to play an important role in the control of simian immunodeficiency virus (SIV), the HIV equivalent seen in rhesus macaque monkeys. Additionally, other studies suggest CTLs play an important role in viral control during chronic infection. Based on this information, several groups have shifted their focus to the development of CTL-based vaccines, some of which have entered advanced clinical trials.
A DNA/rMVA vaccine strategy is structured to bring about both T-cell and antibody responses. The primary vaccination is DNA based and will express only HIV proteins as a way to produce an HIV-focused immune response. An rMVA vaccine strategy expresses both HIV and MVA proteins and may amplify the focused response of a DNA vaccination. Participants in this study will receive either a combined DNA/rMVA vaccine strategy, in which they receive both types of vaccines; an rMVA vaccine strategy, in which they receive only the rMVA vaccine; or a placebo. The DNA and rMVA are physically two different vaccinations given at separate times, but in the DNA/rMVA group, they will be used together to make up one preventive regimen. Both vaccine components express noninfectious virus-like particles.
This study is a multicenter, randomized study that is conducted in two parts and comprised of five groups. In all groups, participants will receive four injections. In Part A, Groups 1 and 2 will be compared. In Group 1, participants will receive two shots of the DNA vaccine and two shots of the rMVA vaccine. In Group 2, participants will receive four placebo injections. In Part B, Groups 3, 4, and 5 will be compared. In Group 3, the combination vaccine strategy will be used again; in Group 4, a single-vaccine strategy of three injections of the rMVA vaccine and one injection of placebo will be given; and in Group 5, participants will again receive four placebo injections. The study will last for a total of 12 months for participants, including enrollment and follow-up.
- Conditions
- HIV Infections
- Being tested
- pGA2/JS7 DNA vaccine, Placebo, MVA/HIV62 vaccine
- 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.
pGA2/JS7 DNA vaccineBiological
1 mL of pGA2/JS7 DNA vaccine
PlaceboBiological
1 mL of sodium chloride for injection
MVA/HIV62 vaccineBiological
1 mL of recombinant modified vaccinia Ankara/HIV clade B gag-pol-env (MVA/HIV62)
| Study group | Role | What they receive |
|---|---|---|
| Part A, Group 1 | Experimental | Participants will receive two injections of the pGA2/JS7 DNA vaccine and then two injections of the MVA/HIV62 vaccine Receives: Biological: pGA2/JS7 DNA vaccine; Biological: MVA/HIV62 vaccine |
| Part A, Group 2 | Placebo comparator | Participants will receive four placebo injections Receives: Biological: Placebo |
| Part B, Group 3 | Experimental | Participants will receive two injections of the pGA2/JS7 DNA vaccine and then two injections of the MVA/HIV62 vaccine Receives: Biological: pGA2/JS7 DNA vaccine; Biological: MVA/HIV62 vaccine |
| Part B, Group 4 | Experimental | Participants will receive three injections of the MVA/HIV62 vaccine and one injection of the placebo Receives: Biological: Placebo; Biological: MVA/HIV62 vaccine |
| Part B, Group 5 | Placebo comparator | Participants will receive four placebo injections Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of severe local and systemic reactogenicity signs and symptoms
Measured: Throughout study
Frequency of adverse events and assessed relationship to study products
Measured: Throughout study
Laboratory measures of safety, including boxplots of white blood cells (WBC), neutrophils, lymphocytes, hemoglobin, platelets, alanine aminotransferase (ALT), creatinine, and cardiac troponin results at baseline and following vaccination
Measured: At study entry and following vaccinations
Number of participants with early discontinuation of vaccinations, by treatment group and reason for discontinuation
Measured: Throughout study
Secondary outcomes (6)
Responses to individual HIV potential T-cell epitope (PTE) peptide pools representing Env, Gag, and Pol
Measured: Throughout study
Percentage of responding CD4+ and CD8+ T cells producing interferon (IFN)-gamma, interleukin (IL)-2, tumor necrosis factor (TNF)-alpha, CD57, perforin, or granzyme B or demonstrating other functions
Measured: Measured at study completion
Frequency and titer of humoral responses detected by HIV binding antibody assays to p55 Gag and gp140 Env
Measured: Measured at study completion
Frequency of vaccine-induced positive results with end of study HIV serological testing by commercial assays
Measured: Measured at study completion
Frequency of CD4+ T-cell responses
Measured: Measured 2 weeks following last MVA vaccination
Frequency of CD8+ T-cell responses
Measured: Measured 2 weeks following last MVA vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2012
- Study completionSep 2014
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
- Who is masked
- Participant, Care provider
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Paul A Goepfert, MD, Study chair, UAB, Div. of Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820846
- Sponsor's protocol ID
- HVTN 205
- Other IDs
- 10658
- Status last verified
- Aug 2022
- First submitted
- 8 Jan 2009
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miedema F. A brief history of HIV vaccine research: stepping back to the drawing board? AIDS. 2008 Sep 12;22(14):1699-703. doi: 10.1097/QAD.0b013e3283021a61.
PubMed 18753857Rerks-Ngarm S, Brown AE, Khamboonruang C, Thongcharoen P, Kunasol P. HIV/AIDS preventive vaccine 'prime-boost' phase III trial: foundations and initial lessons learned from Thailand. AIDS. 2006 Jul 13;20(11):1471-9. doi: 10.1097/01.aids.0000237362.26370.f8. No abstract available.
PubMed 16847401Goepfert PA, Elizaga ML, Seaton K, Tomaras GD, Montefiori DC, Sato A, Hural J, DeRosa SC, Kalams SA, McElrath MJ, Keefer MC, Baden LR, Lama JR, Sanchez J, Mulligan MJ, Buchbinder SP, Hammer SM, Koblin BA, Pensiero M, Butler C, Moss B, Robinson HL; HVTN 205 Study Group; National Institutes of Allergy and Infectious Diseases HIV Vaccines Trials Network. Specificity and 6-month durability of immune responses induced by DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles. J Infect Dis. 2014 Jul 1;210(1):99-110. doi: 10.1093/infdis/jiu003. Epub 2014 Jan 7.
PubMed 24403557Huang Y, Zhang L, Janes H, Frahm N, Isaacs A, Kim JH, Montefiori D, McElrath MJ, Tomaras GD, Gilbert PB. Predictors of durable immune responses six months after the last vaccination in preventive HIV vaccine trials. Vaccine. 2017 Feb 22;35(8):1184-1193. doi: 10.1016/j.vaccine.2016.09.053. Epub 2017 Jan 25.
PubMed 28131393
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of pGA2/JS7 DNA and MVA/HIV62, in Healthy, HIV Uninfected Vaccinia-naive Adult Participants
- ClinicalTrials.gov ID
- NCT00820846
- Acronym / sponsor ID
- HVTN 205
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jan 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Jan 2009 (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 of and immune response to a two-vaccine regimen in healthy, HIV-uninfected adults who have never received an HIV preventive vaccine before.
Detailed description
Some of the first HIV vaccines were designed to trigger neutralizing antibody responses as a way to prevent HIV infection. Unfortunately, the first versions of these vaccines were not able to achieve their desired response. An alternative strategy to the antibody approach is the stimulation of HIV-specific CD8 T-lymphocyte (CTL) responses. CTL responses were previously demonstrated to play an important role in the control of simian immunodeficiency virus (SIV), the HIV equivalent seen in rhesus macaque monkeys. Additionally, other studies suggest CTLs play an important role in viral control during chronic infection. Based on this information, several groups have shifted their focus to the development of CTL-based vaccines, some of which have entered advanced clinical trials.
A DNA/rMVA vaccine strategy is structured to bring about both T-cell and antibody responses. The primary vaccination is DNA based and will express only HIV proteins as a way to produce an HIV-focused immune response. An rMVA vaccine strategy expresses both HIV and MVA proteins and may amplify the focused response of a DNA vaccination. Participants in this study will receive either a combined DNA/rMVA vaccine strategy, in which they receive both types of vaccines; an rMVA vaccine strategy, in which they receive only the rMVA vaccine; or a placebo. The DNA and rMVA are physically two different vaccinations given at separate times, but in the DNA/rMVA group, they will be used together to make up one preventive regimen. Both vaccine components express noninfectious virus-like particles.
This study is a multicenter, randomized study that is conducted in two parts and comprised of five groups. In all groups, participants will receive four injections. In Part A, Groups 1 and 2 will be compared. In Group 1, participants will receive two shots of the DNA vaccine and two shots of the rMVA vaccine. In Group 2, participants will receive four placebo injections. In Part B, Groups 3, 4, and 5 will be compared. In Group 3, the combination vaccine strategy will be used again; in Group 4, a single-vaccine strategy of three injections of the rMVA vaccine and one injection of placebo will be given; and in Group 5, participants will again receive four placebo injections. The study will last for a total of 12 months for participants, including enrollment and follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A, Group 1 | Experimental | Biological: pGA2/JS7 DNA vaccine, Biological: MVA/HIV62 vaccineParticipants will receive two injections of the pGA2/JS7 DNA vaccine and then two injections of the MVA/HIV62 vaccine |
| Part A, Group 2 | Placebo comparator | Biological: PlaceboParticipants will receive four placebo injections |
| Part B, Group 3 | Experimental | Biological: pGA2/JS7 DNA vaccine, Biological: MVA/HIV62 vaccineParticipants will receive two injections of the pGA2/JS7 DNA vaccine and then two injections of the MVA/HIV62 vaccine |
| Part B, Group 4 | Experimental | Biological: Placebo, Biological: MVA/HIV62 vaccineParticipants will receive three injections of the MVA/HIV62 vaccine and one injection of the placebo |
| Part B, Group 5 | Placebo comparator | Biological: PlaceboParticipants will receive four placebo injections |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Access to a participating HIV Vaccine Trials Network (HVTN) clinical research center and willing to be followed for the planned duration of the study
- Ability and willingness to provide informed consent
- Assessment of understanding: completion of a questionnaire prior to first vaccination; demonstration of understanding for all questionnaire items answered incorrectly
- Willingness to receive HIV test results
- Good general health as shown by medical history, physical exam, and screening laboratory tests
Key exclusion criteria (32 listed)
- HIV vaccine(s) or other experimental vaccines, received in a prior HIV vaccine trial. More information on this criterion can be found in the study protocol.
- Receipt of smallpox vaccination
- Excessive alcohol use, frequent binge drinking, chronic marijuana abuse, or use of any other illicit drugs, such as cocaine or methamphetamine, within the past 12 months
- History of newly acquired or newly diagnosed syphilis; history of newly acquired gonorrhea, nongonococcal urethritis, herpes simplex virus type 2 (HSV2), chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis,epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B within the past 12 months
- Immunosuppressive medication received within 168 days before first vaccination. Certain medications are excluded from this criterion; more information can be found in the study protocol.
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 |
|---|---|---|
| pGA2/JS7 DNA vaccine1 mL of pGA2/JS7 DNA vaccine | Biological | Part A, Group 1, Part B, Group 3 |
| Placebo1 mL of sodium chloride for injection | Biological | Part A, Group 2, Part B, Group 4, Part B, Group 5 |
| MVA/HIV62 vaccine1 mL of recombinant modified vaccinia Ankara/HIV clade B gag-pol-env (MVA/HIV62) | Biological | Part A, Group 1, Part B, Group 3, Part B, Group 4 |
Primary outcome
Frequency of severe local and systemic reactogenicity signs and symptoms
Time frame: Throughout study
Frequency of adverse events and assessed relationship to study products
Time frame: Throughout study
Laboratory measures of safety, including boxplots of white blood cells (WBC), neutrophils, lymphocytes, hemoglobin, platelets, alanine aminotransferase (ALT), creatinine, and cardiac troponin results at baseline and following vaccination
Time frame: At study entry and following vaccinations
Number of participants with early discontinuation of vaccinations, by treatment group and reason for discontinuation
Time frame: Throughout study
6 secondary outcomes
Responses to individual HIV potential T-cell epitope (PTE) peptide pools representing Env, Gag, and Pol
Time frame: Throughout study
Percentage of responding CD4+ and CD8+ T cells producing interferon (IFN)-gamma, interleukin (IL)-2, tumor necrosis factor (TNF)-alpha, CD57, perforin, or granzyme B or demonstrating other functions
Time frame: Measured at study completion
Frequency and titer of humoral responses detected by HIV binding antibody assays to p55 Gag and gp140 Env
Time frame: Measured at study completion
Frequency of vaccine-induced positive results with end of study HIV serological testing by commercial assays
Time frame: Measured at study completion
Frequency of CD4+ T-cell responses
Time frame: Measured 2 weeks following last MVA vaccination
Frequency of CD8+ T-cell responses
Time frame: Measured 2 weeks following last MVA vaccination
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 9 Aug 2022.
- Background: PubMed 18753857Miedema F. A brief history of HIV vaccine research: stepping back to the drawing board? AIDS. 2008 Sep 12;22(14):1699-703. doi: 10.1097/QAD.0b013e3283021a61.
- Background: PubMed 16847401Rerks-Ngarm S, Brown AE, Khamboonruang C, Thongcharoen P, Kunasol P. HIV/AIDS preventive vaccine 'prime-boost' phase III trial: foundations and initial lessons learned from Thailand. AIDS. 2006 Jul 13;20(11):1471-9. doi: 10.1097/01.aids.0000237362.26370.f8. No abstract available.
- Background: PubMed 24403557Goepfert PA, Elizaga ML, Seaton K, Tomaras GD, Montefiori DC, Sato A, Hural J, DeRosa SC, Kalams SA, McElrath MJ, Keefer MC, Baden LR, Lama JR, Sanchez J, Mulligan MJ, Buchbinder SP, Hammer SM, Koblin BA, Pensiero M, Butler C, Moss B, Robinson HL; HVTN 205 Study Group; National Institutes of Allergy and Infectious Diseases HIV Vaccines Trials Network. Specificity and 6-month durability of immune responses induced by DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles. J Infect Dis. 2014 Jul 1;210(1):99-110. doi: 10.1093/infdis/jiu003. Epub 2014 Jan 7.
- Derived from this study: PubMed 28131393Huang Y, Zhang L, Janes H, Frahm N, Isaacs A, Kim JH, Montefiori D, McElrath MJ, Tomaras GD, Gilbert PB. Predictors of durable immune responses six months after the last vaccination in preventive HIV vaccine trials. Vaccine. 2017 Feb 22;35(8):1184-1193. doi: 10.1016/j.vaccine.2016.09.053. Epub 2017 Jan 25.
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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.
Paul A Goepfert, MD study chair
UAB, Div. of Infectious Diseases
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pGA2/JS7 DNA vaccine and MVA/HIV62 vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in 2 countries.
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 9 inclusion and 32 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 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Peru. 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. 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 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?
Frequency of severe local and systemic reactogenicity signs and symptoms (time frame: Throughout study). The study lists 4 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 NCT00820846, 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 9 Aug 2022.